Table of Contents

Title page · Introduction · Outline of Contents · Appendix

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I. General Background

A. Early Regulation of Food And Drugs

Silber, Daniel J., The Jewish Dietary Laws and their Foundation (1994)

Gertler, Nicholas B., The Historical Development of Animal Toxicity Testing From Its Ancient Origins to the Middle of the Twentieth Century (1997)

*Wilkenfeld, Wendy Ann, Food Regulation in Biblical Law (1998)

*Singla, Rohit K., Missed Opportunities: The Vaccine Act of 1813 (1998)

Stone, Lesley A., A Contextual Introduction to Islamic Food Restrictions (1998)

Donnelly, John V., III, Genesis: The Birth of the FDA in the Patent Office (1999)

*DeWitt, Patricia J.B., A Brief History of Tea: The Rise and Fall of the Tea Importation Act (2000)

*Bush, James F., "By Hercules!  The More Common the Wine, the More Wholesome!"  Science and the Adulteration of Food and Other Natural Products in Ancient Rome, 57 Food & Drug L. J. (2002)

*Sandukas, Gregory P., Gently Down the Stream: How Exploding Steamboat Boilers in the 19th Century Ignited Federal Public Welfare Regulation [redacted version] (2002) [unredacted version]

*Walch, Angela, A Spurious Solution to a Genuine Problem: An In-Depth Look at the Import Drugs Act of 1848 (2002)

*Aksakal, Layla J., The Sick Man and His Medicine: Public Health Reform in the Ottoman Empire and Egypt (2003)

*Heath, Wesley J., America's First Drug Regulation Regime: The Rise and Fall of the Import Drug Act of 1848, 59 Food & Drug L.J. 169 (2004)

*Hershman, Jeremy A., A "Taste" of Jewish Law: The Laws of Blessings on Food (2003)

*Hershman, Lisa B., Shemittah: The Jewish Sabbatical Year (2003)

*Gurtman, Ronit, Shehitah: Jewish Ritual Slaughter (2005)

Lobato, John K., A Timeless Journey: Food and Ritual as Belief in Mythology and Society [redacted version] (2007) [unredacted version]

*Nelson, Sarah S., Poisoners, Potions, and Priestesses: Ancient Athenian Legal Cases at the Intersection of Law, Medicine, and Magic (2007)

B. The Federal Food and Drugs Act of 1906

Ryan, Kathleen May, Upton Sinclair's The Jungle (1995)

*Ryan, Kathleen May, The Meaning of Meat in Industrial Social Protest Novels; An Analysis of Upton Sinclair's The Jungle and Yuri Olesha's Envy (1996)

*Diamond, Jenny Ann, Who Shall Meet the Foe if Not She? Women's Participation in the Movement Leading Up to the Federal Food and Drug Act of 1906, As Seen Through the Pages of Good Housekeeping (2002)

Karuga, Catherine N., The Expansion of FDA's Enforcement Powers from 1906 to 2003 (2003)

Gaughan, Anthony, Harvey Wiley, Theodore Roosevelt, and the Federal Regulation of Food and Drugs (2004)

Desai, Ronak D., James Wilson, Harvey Wiley, and the Bureau of Chemistry: Examining the "Political" Dimensions of the Administration and Enforcement of the Pure Food and Drugs Act, 1906-1912 (2011).

C. The Federal Food, Drug, and Cosmetic Act of 1938

Glauberman, Scott P., The Real Thalidomide Baby: The Evolution Of The FDA In The Shadow of Thalidomide, 1960-1997 (1997)

*Dean, James R., The FDA at War: Securing the Food that Secured Victory, 53 Food & Drug L.J. 453 (1998)

*Chung, Daniel Park, Ideals and Issues from a Critical View of the Supreme Court's Jurisprudence in FDA Regulation of Human Drugs (2003)

Gordon, Alex S., The Delicate Dance of Immersion and Insulation: The Politicization of the FDA Commissioner (2003)

D. FDA Mission and Resources

Comer, Katherine M., Rethinking Priorities Under the Federal Food, and Cosmetic Act (From the Basement Up) (1996)

McFarland, Joshua L., Insufficient FDA Resources: Leveling the Playing Field and Reducing Fraud by Altering Incentives (2001)

McGlinch, Peg, Hollow Government: Resource Constraints and Workload Expansion at the Food and Drug Administration [redacted version] (2001) [unredacted version]

*Ting, Andrew Sing, Penis Enlargement, Cheap Viagra, and Noni Juice: Evaluating and Winning the War Against Health Product Spam (2004)

Zymaris, Alithea, Reforming the Food Safety System: What If Consolidation Isn’t Enough? 120 Harv. L. Rev. 1345 (2007)

E. The Philosophy of Regulation

Carlin, Norman F., Informing Public Choice: Risk Perception Heuristics, Agency Paternalism, and Individual Autonomy in Food and Drug Safety Regulation (1994)

Pompeo, Michael R., Pliny the Elder meets James Madison (1994)

Schmolka, Andrew F., In Search of the Optimal Balance: FDA's Safety Mandate and the Autonomy Rights of Individuals (1994)

Silverman, Allison B., FDA Regulation Affecting Consumer Choice (1994)

Urso, Johannes David, What's Fresh? And What Could It Possibly Have to do with the Orphan Drug Act? (1994)

Selassie, Sengal, M. G., Food and Drug Regulatory Change Analyzed Through Martin Luther King, Jr.'s Letter from the Birmingham Jail (1996)

Ho, Chadwick A., A Psychological Model of Food and Drug Law (1997)

Baughman, Matthew H., Public Health and the Healthy Public: a Communitarian Perspective on Privatization and the FDA (1998)

*Blot, Madeleine M., The Right to Stay Alive? (1998)

*Frantz, Gregory A., Consumerism, Conformity, and Uncritical Thinking in America (2000)

Cook, Kathryn R., The Presidential FDA: Politics Meet Science (2001)

Hermes, Clinton D., Political Science and the FDA (2001)

*Prout, Alison, Putting a Pricetag on Life: The Value of Life and the FDA (2004)

*Elliott, Nathan B., The FDA and the Political Pendulum : A Preliminary Look Back at Authority, Challenges, and the Future of the Agency (2007)

*Edwards, Amanda K., Reversing the Legacy of “Bad Blood”: Utilizing the Media, Legislatures, the Judiciary, Federal Agencies, and Private Enterprise to Comprehensively Reform Contemporary Policies and Industry Practices that Adversely Impact African-American Health and Undervalue Life in the African-American Community (2007)

*Coleman, Kelley D., In the Internet of Public Health: A Strategic Approach to Defining the FDA's Role in Eliminating Health Disparities (2008).

*Jacobs, Sharon B., Crises, Congress, and Cognitive Biases: A Critical Examination of Food and Drug Legislation in the United States, 64 Food & Drug L.J. 599 (2009).

Schachar, Carmel D., Ending the Charade: Revisting the Ban on Political Influence in FDA Decision Making in Light of Tummino v. Torti (2010).

F. Constitutional Issues

1. Freedom of Speech

Lefko, Tami K., Disease-Prevention Claims and the First Amendment: "Who Will Protect Us From Our Protectors?" (1994)

Weissman, Kenneth I., First Amendment Scrutiny of FDA's Fight Against Misbranding: Placing Labeling on the Spectrum of Speech (1995)

*Caputo, David J., Tobacco Advertising and the First Amendment: A "Strange Constitutional Doctrine" Indeed (1996)

Friedman, David J., The Effect of Truths, Misperceptions, and Fears on Current and Optimal Food Irradiation Policies (1997)

Comerford, Kathryn Louise, The FDA's Shrinking Place in the Constitutional Universe -- Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998) (1999)

Collins, Elisabeth B., The Truth Hurts?: FDA Regulation of Truth (2000)

*Morrison, Amanda M., Promotion of Unapproved Uses of Approved Drugs and Devices: An Analysis Under the First Amendment (2000)

Hellman, Matthew S., Commercial Drug Claims, the FDA, and the First Amendment (2001)

*Kang, Brian T., Western States Medical and Other Problems with the Doctrine Concerning FDA Regulation of Commercial Speech(2003)

*Larson, Adam, Commercial Speech & Prescription Drug Promotion: Where Have We Been & Are We Going Anywhere? (2005)

*Sukhatme, Neel, Making Sense of Commercial Speech: A Theoretical Framework and A Case Study in Food and Drug Law (2005)

*Carver, Krista Hessler, A Global View of the First Amendment Constraints on FDA, 63 Food & Drug L.J. 151 (2008)

Morgan, Bryson B., The Constitutionality of Restricting the Use of Prescriber-Identifiable Data in Pharmaceutical Detailing After Citizens United v. FEC (2010).

Jenny, Brenna E., Pharma Fights Back: Combating Heightened Prosecution of Off-Label Promotion with Claims of First Amendment Violations (2011).

2. Freedom of Religion

Emery, Scott R., FDA Regulation and Religious Freedom (1994)

Wasserman, Ari D., Kashrut Enforcement (1994)

Fogel, Joshua L., Kosher Food Regulation and the First Amendment: Irreconcilable Differences? (1995)

O'Neill, Louis F., Freedom of Religious Practice and the FDA: The Use of Regulated Substances and Devices as Sacraments (1995)

Ferri, Yildiz R., Food and Drug Law and Religious Freedom: Two Areas of Conflict (1996)

Ray, Supryia M., Paternalism, Hostility, and Concern for the Slippery Slope: Factors in Judicial Decision-Making When Religion and Regulation Collide (1997)

Anonymous, Religion and Medicine: Why does Religion Play a Role in Medical Regulation? (2002)

*Cavanaugh, Jeanne, Scientology and the FDA: A Look Back, A Modern Analysis, And A New Approach (2004)

3. The Takings Clause

*McCants, William D., Take a Label Claim, and Pay Me in the Morning: A Challenge to FDA's Argument that its Final Rule (Jan. 2000) on Structure/Function Claims for Dietary Supplements Does Not Constitute a Compensable Regulatory Taking Under the Fifth Amendment (2000).

4. Privacy

*Lim, Anthony, The Right to Die Movement: From Quinlan to Schiavo (2005)

5. Due Process of Law


G. Related Federal Statues and Agencies

1. The Federal Trade Commission

*Gerhart. Nicole, The FDA and the FTC: An Alphabet Soup Regulating the Misbranding of Food (2002)

2. The Centers for Disease Control

Glicksman, Jason W., CDC Surveillance of FDA-Regulated Products (2003)

*Manzi, Catherine, Sentry at the Gate: A History of the CDC’s Regulation of Biological Agents (2004)

Rodman, Lindsay Lyon, The CDC Model State Emergency Health Powers Act, The CSIS Model Operational Guidelines for Disease Exposure Control and State Legislation for Effective Disease Outbreak Control (2006)

Pennell, Joseph M., Quarantine: Legal Reform for 21st Century Crises (2008)

*Meyers, Carrie S., A Comparison of U.S. and Chinese Laws of Quarantine and Information Dissemintation: Will Law and Politics be the Death of Us? (2008)

3. The Environmental Protection Agency

Anderson, Danica, Losing the Farm: The Failure to Protect Farmworker Families from Pesticides (2010).

4. The Department of Transportation    

5. The International Trade Commission

Yap, Justin B., Butter Cookies in Tins from Denmark": A Case Study of an Investigation by the United States International Trade Commission (2000)

6. The United States Department of Agriculture

Schaffer, Emily J., Is the Fox Guarding the Henhouse?: Who Makes the Rules Behind the USDA's Nutrition Policy, 57 Food & Drug L.J. 371 (2002)

Chen, Susan, In PACA We Trust: Commercial Protection of Suppliers under the Perishable and Agricultural Commodities Act [Redacted Version] (2003) [unredacted version]

*Murphy, Carlyle, Over 187 Billion Served: Food Safety in the National School Lunch Program (2005)

Jeong, Martha, Reinventing School Lunch (2007)

*Strott, Jessica, Lunch Time: A look at the development of, and current controversies surrounding, school meal programs in the United States [redacted version] (2007) [unredacted version] (2007)

Millison, Deanne B., A Review of the History of the Food Stamp Program (2008).

Fotouhi, David, Fundamental but Insufficient: Assessing the USDA Interim Final Rule Recalibrating the Supplemental Nutrition Program for Women, Infants, and Children Food Packages (2009).

*Kammer, Anthony S., Cornography: Perverse Incentives and the United States Corn Subsidy (2011)

Lundin, Rebecca, An Old Debate Bubbles Up--Should Soft Drinks or Sugar-Sweetened Beverages Be Prohibited for Purchase with Federal Food Stamps? (2011)

Rozensher, Michael R., Next Top Farm-to-Consumer Model: Community Supported Agriculture (CSA)? (2011)

Vardner, Joseph Phillip, Proposed Regulations for the Packers and Stockyard Act: 90 Years in the Making, but Is the USDA Ahead of Itself Already? (2011)

7. The Consumer Product Safety Commission

8. The United States Patent and Trademark Office

Song, Victor L., DNA Sequences as Unpatentable Subject Matter (2001)

*Schreiber, Stacey L., Dollars and Senses: Pharmaceutical Product Design is Becoming Vivid (2003)

Lazebik, Ron, Clash of the Titans: Conflicts in the Regulation of Medical Devices by the FDA and PTO (2005)

*Furrow, Michael, Pharmaceutical Patent Life-Cycle Management after KSR v. Teleflex, 63 Food & Drug L.J. 275 (2008)

Michael A. Robinson, Does Patent Term Adjustment Need Adjustment? (2009).

9. The Securities and Exchange Commission

Heinonen, Mikko, Disclosure of the Dealings between Drug Developing Companies and the FDA under the Federal Securities Laws (2002)

10. The Antitrust Laws

*Lee, Christine Jean, Criminal Prosecutions of International Antitrust Conspiracies in the Food and Feed Additive Industry: A Window Into the Changing Landscape of Antitrust Enforcement Priorities and Possibilities (2000)

Sigman, Laura J., Patent Law, Antitrust Enforcement, and Public Access to Pharmaceuticals and Medical Technologies (2003)

11. False Claims Act

*Davis, Mark S., The Effects of False Claims Act Whistleblowers on the Pharmaceutical Industry (2006)

12. Taxation

Sheu, Wendy, The Evolution of the Modern Snack Tax Bill: From World War I to the War Against Obesity (2006)

*Chen, Patricia, Sales Taxation of Food: From the Great Depression to the Streamlined Sales Tax Project [redacted version] (2007) [unredacted version]

White, Maran, Raising the Cost of Unhealthy Food: Can Food Taxes and/or Food Industry Liability Solve America’s Obesity Problem? (2007)

13. Miscellaneous

*Bowman, Melissa, Achieving Nationhood Through Health Care Delivery: A History of the Relationship between the Indian Health Service and Indian Tribes (2005)

H. History of Diseases

Hernandez, Roberto P., The Conquest of Yellow Fever (1996)

*Mayberry, Jason Allen, Scurvy and Vitamin C (2004)

Perl-Matanzo, Hans S., Dr. Louis Tompkins Wright: A Medical Pioneer from Harvard Medical School (2008).

I. Food and Drug Law in Literature and the Arts

Berman, James G., A Felony to Drink Small Beer: Reflections on Food and Drug Metaphors in Shakespeare (1995)

Goldstein, Jonathan M., The Future of Food and Drug Regulation as Depicted in Films (1995)

Powell, Ira M., You Oughta' Be In Pictures: Food, Drugs, Cosmetics, and Medical Devices as Movie Stars (1996)

*Yu, Peilin, Truth in Fiction: Appreciating the Complex Realities of The Pharmaceutical Industry Through Novels (2000)

*Cochran, Jennifer D., Mmmm...Pistol Whip": An Exploration of Food, Drugs, and Medical Devices in The Simpsons [RedactedVersion] (2004) [unredacted version] (2004)

Tonkovich, Russell, Glamorization or Condemnation: The Accuracy of Hollywood’s Portrayal of Heroin Use in Motion Pictures in the 1990’s (2004)

Bush, Devon, A Healthy Dose of Humor: How Comic Strips Illustrate Consumer Reactions to Food Labeling [redacted version: graphics deleted] [unredacted version] (2005)

Wasserstein, Charlotte S., The FDA as Portrayed in Fiction: Incompetent Bureacracy or Effective Vanguard of Public Health? (2011).

J. Animal Welfare

Mandelbaum, Adam I., The Origin and Development of the Animal Welfare Act (1999)

Haas, Samantha J., How We Mistreat the Animals We Eat (2001)

Lewis, Noah, Testing Cosmetics on Animals: An Idea Who's Time Has Gone (2005)

*Miller, Joseph B., The Regulation of Animal Welfare in Food Production (2005)

*Nye, Marisa B., Progress Toward Replacing Animals in Toxicity Testing for Cosmetics (2006)

K. Corporate Responsibility

*Al-Othman, Dalia, The Image and Politics of Coca-Cola: From the Early Years to the Present (2001)

L. FDA-Industry Relations

*Solet, David M., Strategies of Influence: How Corporate Power Directs and Constrains the FDA (2001)

M. Consumer Advocacy

Lan, Iris, Placing Sidney Wolfe's Public Citizen Health Research Group in the Context of the American Consumer Movement (2002)

*Rouse, John, Whistleblower Protections for FDA and Private-Sector Employees (2005)

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II. FDA Enforcement

A. Jurisdiction over Interstate Commerce

B. Jurisdiction over Labeling

Stone, Stephanie Sverdrup, Can the FDA Seize Books as Labeling? (2008)

C. Regulation of Foreign Commerce

1. Export

Fuller, Erin J., FDA's Food and Drug Export Policy: A Proposal for Change (1994)

Kaiser, Steven J., Exporting Unapproved Drugs: Creating Jobs and Increasing Competitiveness in the Global Economy (1994)

Kim, Alan J., Bleeding Hearts v. Market Types: Talking Right Past each Other on Restriction on Drug Export (1994)

Oliver, James C., United States Drug Export Policy: Should American Manufacturers Be Permitted to Export Unapproved Drugs? (1994)

Topol, Rebecca B., The Drug Export Amendments of 1986 (1994)

Pierce, Gregory D., Regulating the Export of Unapproved Drugs (1995)

2. Import

Schisa, M. William, FDA Regulation of Imported Foods in an Age of Globalization (2002)

*Chan, Yee-Ho Irene, Reimportation of U.S. Pharmaceuticals: Political, Economic and Legal Perspectives (2002)

*Theriault, Rene J., Drug Reimportation: Prescription, Placebo or Poison? (2002)

*Pomerantz, Jennifer, Reimportation: The Solution to the High Cost of Prescription Drugs? (2004)

*Lee, Bryan, Reimportation: A First Step or False Step Toward Transparency in the Prescription Drug Market?(2005)

*Ting, Richard T., Food and Drug Administration Regulation of Imported Foods and Compliance With International Trade Obligations (2005)

*Fishman, Janna K., Blame Canada?: State Prescription Drug Importation Programs, the Federal Response, and Why Lawmakers Are Up in Arms (2006)

*Kim, Lauren, Reimportation of Prescription Drugs - Legislative, Executive, Judicial and State and Local Responses (2006)

Koenig, Jonathan, The Federal Food Safety Modernization Act: Impacts in Import and Small-Scale Production Sectors (2011).

3. Foreign Law

Pan, David, Food and Drug Regulation of The People's Republic of China: A Comprehensive Analysis of PRC Food and Drug Regulatory Structures and Laws (1997)

Lumbroso, Ginette, Direct-to-Consumer Advertising of Prescription Drugs: From the United States Experience to Its Implementation in Peru (1999)

Tangahanakanond, Danaya, An Overview of the Food and Drug Administration of Thailand and Related Legislation (1999)

*Arbabi, Amir, The Iranian Food and Drug Regulatory System (2000)

Mou, Rong, U.S. Drug Manufacturers Beware: Application of the PRC Antibribery Law to Drug Marketing and Promotional Practices in China (2002)

Alemanno, Alberto,The Contested Governance of European Food Safety: Why the European Food Safety Authority Is Not an EU-style FDA? [Redacted Version] [Unredacted Version] (2004)

Krishnan, Divya, Are We Ready Yet? Drugs over the counter- An Indian Perspective [Redacted Version] [Unredacted Version] (2006)

Laohapakakul, Duangrat, United States - Thailand Free Trade Agreement Negotiations: Potential Effects on Pharmaceutical Patent Protection in Thailand (2006)

*Llosa, Alicia C., Boticas y Bodegas: The Development of Food and Drug Regulation in Peru, 38 University of Miami Inter-American Law Review 279 (Winter 2006-2007).

Phimkitidej, Kosin, Product Liability Law of Thailand: Analysis of Conundrums under Current Related Laws and Regulations with a Comparative U.S. Approach to the Same Problems Using Contract and Tort Law (2006)

*Lee, Young Kyung, Issues on Food Crime in Korea (2007)

Sun, Xiaopu, An Analysis of New Drug Examination and Approval System of PRC (2008).

Liao, Zhimin, The Medical Regulations in China and Its Effects (2010).

Ricci, Michael C., Trends in the Regulation of Genetically Modified Products in the European Union from 1990 to the Present (2010).

Lee, YunJoh, Regulation of Pharmaceutical Industry Interractions with Health Care Professionals: An Overview of the South Korean Experience (2011).

Mo, Yanan, Who Should Be Blamed for the Chaos in Chinese Food and Drugs Market? (2011).

Park, Sung Joon, Legislative History, Statutory Provisions and Case Law Relating to Countrty of Origin Labelling in Korea (2011).

4. International Treaties

Cromer, Julie D., Before and After the Uruguay Round: How GATT Affects the Import Policy of the FDA, 36 Harvard International L.J. 557 (1995)

Manguiat, Maria Socorro, U.S. Food Importation Policy and the GATT: Is the American Pie Better Protected than the Foreign Pie? (1995)

Muecke, Natalie J., Implications of the Agreement on the Application of Sanitary and Phytosanitary Measures for the Federal Food, Drug, and Cosmetic Act (1995)

Tobin, John E., Pharmaceutical Drug Development, Federal Conservation Law, and Corporate Liability for Overseas Scientific Collection Activities (1995)

*Ridler, Robyn E., Cattle, Dolphins, and the WTO: The Potential Impact of the World Trade Organization Agreements on United States Food Regulation (1998)

*Allen, Theresa M., Globalization of Food and Drug Regulation: Opportunities and Challenges for the Food and Drug Administration (2000)

Meyers, Irina M., The New International Trade Architecture and Food Regulation (2000)

*Torrance, Andrew W., Bioprospecting and the Convention on Biological Diversity (2000)

*Chung, Theresa, Shocking the Conscience of the World: International Norms and the Access to AIDS Treatment in South Africa (2002)

Liao, Wen-tzu, A Global Perspective for the Role of Pharmaceutical Industry when Facing the Germs War (2002)

*Chen, Andrew J., U.S. Global AIDS Policy: Solutions in the National Interest [Redacted Version] (2003) [Unredacted Version]

*Musa, Armando A., The Politics of Food: How Cuba Teamed Up with U.S. Food and Agricultural Interests to Out-Maneuver the Pro-Embargo Lobby (2003)

*Doulamis, John, Getting Back on the Path to Life: Negotiating the International Patent Regime to Provide Access to HIV Medicine to Africa (2004)

*Kazemi, Nahal, Ill at Ease: The Precarious State of the Biological Weapons Convention's Proposed Enforcement Regime, 17 Florida J. Int'l L. 137 (Spring 2005)

Zúñiga, Gloria Sofia, Sanitary and Phytosanitary Measures in the United States of America: Equivalence Policies and Procedures (2007)

5. Mutual Recognition Agreements

6. International Harmonization

Dunkum, Betty L., Nutrition Labeling In The European Community And The United States: A Proposal for Harmonization (1995)

*Hochberg, Ellen, The Need for Comprehensiveness and Increased Enforceability in the Standardization of International Pharmaceutical Regulations (2002)

*Fayad, Nihal, Harmonizing Pharmaceutical Regulation among the United States, the European Union, and Japan: The ICH Initiative (2003)

Maliza, Johanes C., Food Labels, NAFTA, and Harmonization: A Maze of Regulation in North America (2009).

D. Factory Inspection

Shelton, Danielle M., Don't Ask, Don't Tell": An Examination of the FDA's Policy Regarding Quality Control Audits (1994)

Wood, Valerie D., The Pervasively Regulated Business Exception and the FDA (1995)

*Shane, Andrew L., FDA Enforcement and the Constitution: The Validity of FDA Seizures under the Due Process and Just Compensation Clauses (2002)

E. Seizure

F. Injunction

G. Criminal Liability

Blume, Michael S., Criminal Liability Under the Food, Drug, and Cosmetic Act (1995)

*Holt, Breena L., An Examination of Strict Criminal Liability Under the Food, Drug, and Cosmetic Act of 1938: Is It Time for Change? (2000)

Anonymous, Strict Criminal Liability Under the 1938 Food, Drug and Cosmetic Act: Should Deterrence Matter? (2001)

Totino, MaryAnn, A Historical Analysis of the FDA’s Office of Criminal Investigations [redacted version] (2007) [unredacted version] (2007)

Welch, Cassandra H., Making the Punishment Fit the Crime: Sentencing Practices of the Food, Drug, and Cosmetic Act (2007)

H. Civil Money Penalties

I. Debarment

J. Detention

K. Restitution and Disgorgement

*Seifter, Miriam L., Recent Case: Third Circuit Holds That the FDA Can Obtain Restitution on Behalf of Consumers— United States v. Lane Labs-USA Inc., 427 F.3d 219 (3d Cir. 2005), 119 Harv. L. Rev 2636 (2006)

L. [Reserved]

M. Recall

*Curatolo, Tina, Pop-Tarts and Elixirs of Death: An Examination of FDA’s Recall Authority (2005)

N. Publicity

Liu, Leon, The FDA's Use of Adverse Publicity (1998)

Johnson, Shannon E., Publicity and the FDA: An Update (1997)

*Trainer, Nancy G., Flying Below the Radar Screen: The Absence of Information About the FDA (2001)

*Blevins, Kelly C., FDA's Use of Negative Publicity as an Enforcement Mechanism (2003)

Willis, Lisa M., No Cranberries for Thanksgiving: The Impact of FDA Adverse Publicity (2005)

Silberbug, Rebecca C., Journalistic Framing of the Food and Drug Administration: How Do Our Nation's Most Respected Newspapers Report About the FDA? (2008)

O. Informal Warnings

P. Enforcement Statistics

Q. Res Judicata

R. Enforcement Under Other Federal Statutes

*Liebson, Matthew E., The FDA and Title 18: Criminal Enforcement in Food and Drug Cases (1999)

*Vanderhook, Katherine L., A History of Federal Control of Communicable Diseases: Section 261 of the Public Health Service Act (2002)

S. State Enforcement

T. Private Enforcement

Lantieri, Paul, Regulating Food and Drug Companies Privately: A Review of Lanham Act Cases Brought Against FDA-Regulated Products (2001)

*Turko, Jessica L., The Lanham Act and the FD&C Act: Shaping the Law of False Advertising Into a Tool for Drug Manufacturers to Self-Regulate Their Industry and Protect Consumers (2001)

Cisternino, John, Citizen Enforcement and the FDA (2008).

U. Product Liability Tort Law

*Jackson, Kimberly A., Daubert v. Merrell Dow: Missed Opportunity, 50 Food & Drug L.J. 95 (1995)

Huang, Chun-Ming, The Liability of Drug Analysis from the Story of Intravenous Iodine-Contained Contrast Medium (1999)

Bona, Jarod M., Analyzing the Interaction Between the FDA and the State Tort Law (2000)

*Piranian, Heidi, Perez v. Wyeth Laboratories Inc. and the Wisdom of an Advertising Exception to the Learned Intermediary Rule (2000)

*Tragos, Camille N., Fen-Phen Litigation Against American Home Products Corporation: The Widespread Use of Fenfluramine Ponidimin and Dexfenfluramine Redux for Weight Loss, the Health Problems Associated with Those Drugs, the Resulting Litigation Against American Home Products, and the Proposed Settlement Agreement (2000)

Cave, Neil G., A Unified System for Ensuring Drug Safety (2002)

*Rhoten, Roger D.,Selective Serotonin Reuptake Inhibitors: A Critical Look at the Antidepressants and an Assessment of Potential Liability Faced by Their Manufacturers (2002)

*Elias, Margaret W., Trade Associations and Public Safety: Standard Setting in the Era of Expanding Tort Litigation (2007)

V. Economic Analysis of Enforcement

*Queler, Mathew S., An Economic Analysis of Food and Drug Law: Selected Topics in FDA Enforcement (1996)

W. Regulation of the Internet

Chang, John B., The FDA and the Internet (1996)

Melloh, Christina, The Internet . . . Breeding "Friendly Familiarity" (1997)

Brannon, Leah O., Regulating Drug Promotion on the Internet, 54 Food & Drug L.J. 599 (1999)

Burbach, A. Cristina, FDA Regulation of Drugs on the Internet (1999)

Melaugh, David E., The Food and Drug Administration and the Internet (1999)

*Pai, Neerjai Dayananda, Drug Promotion and the Internet: An Analysis of FDA Policy and Recommendation for the Future (1999)

Daly, Karen C. Internet Hoaxes: Public Regulation and Private Remedies (2000)

*Downs, Michael D., Taming "Rogue" Pharmacy Websites: The Response to Illegal Prescription Drug Sales on the Internet (2000)

Hauck, Brian P., Memorandum to Internet Pharmacies: The Regulation and Enforcement of the Internet Pharmacy Industry (2000)

*Voyard, Ernest S., FDA Regulation of the Internet: Education is the Best Medicine (2000)

*Teng, Cheryl M., Internet Pharmacies: Regulatory Problems and Potential Solutions (2002)

X. Regulation of Intellectual Property

*O'Quinn, John C., Protecting Private Intellectual Property from Government Intrusion: Revisiting SmithKline and the Case for Just Compensation 29 Pepperdine L. Rev. 435 (2002)

Y. Bioterrorism

*Kirk, Christine E., Bioterrorism and the Food and Drug Administration: H.R. 3448, Related Legislation and the FDA's Expanding Role in Preventing and Responding to Biological Attack(2002)

*Moore, Erika, Food Sovereignty Revisited: Should the United States Reevaluate Its Commitment to Free Trade in Food Products in the 21st Century? (2002)

Guerra, Marcelo, The FDA’s Role in the Development of Bioterrorist Countermeasures (2004)

*Temko, Janet, BioShield Act of 2004: An Innovative Failure (2006)

Kasper, Sara, National Strategic Stockpile: Will it Really Protect the Nation against Bioterrorism? (2006)

Z. Product Tampering

Weatherhead, Steven D., Rethinking Product Tampering (1996)

Woollen, Michelle L., Do Not Use If Seal Is Broken": Product Tampering and the Case Against Private Tort Liability (1996)

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III. FDA Practice and Procedure

A. Section 701(a) Rulemaking

Carey, John C., Is Rulemaking Old Medicine at the FDA? (1997)

Kolber, Michael S., Rulemaking without the Rules: An Empirical Study of Direct Final Rulemaking, 72 Albany L. Rev. 79 (2009).

Kobick, Julia E., Negotiated Rulemaking: The Next Step in Regulatory Innovation at the Food and Drug Law Administration?, 65 Food & Drug L.J. 425 (2010).

Martini, Kasey L., A Historical Look at FDA's Approach to Regulation and Policymaking (2009).

B. Section 701(e) Rulemaking and Adjudication

C. Primary Jurisdiction

D. Advisory Committees

*Glode, Elizabeth R., Advising Under the Influence?: Conflicts of Interest Among FDA Advisory Committee Members 57 Food & Drug L.J. 293 (2002)

E. Freedom of Information

Smith, Victoria R., A Historical Analysis of the FDA and the Freedom of Information Act (1996)

*Diamond, Evan, Reverse-FOIA Limitations on Agency Actions to Disclose Human Gene Therapy Safety Data, 63 Food & Drug L.J. 321 (2008).

F. Environmental Considerations

*Liftik, Michael E., Food, Drugs, and the Environment: How the Food and Drug Administration Has Interacted with the National Environmental Policy Act of 1969 (2000)

G. User Fees

*Wheeler, Alusheyi J., The Prescription Drug User Fee Act: A Solution to the Drug Lag? (2003)

*Zelenay, James L. Jr., The Prescription Drug User Fee Act: Is a Faster Food and Drug Administration Always a Better Food and Drug Administration?, 60 Food & Drug L.J. 261 (2005)

H. Guidance

*Lewis, Kevin M., Informal Guidance and the FDA (2011).

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IV. Relation of FD&C Act to State Laws

A. State Laws

Cochran, Daniel E., State Agricultural Disparagement Statues: Suing Chicken Little (2001)

*Morenoff, David L., Lost Food and Liability: The Good Samaritan Food Donation Law Story, 57 Food & Drug L.J. 107 (2002)

*Martin, Patricia J., A Survey of Existing State Laws and Legislative Proposals to Deal With Small Clandestine Methamphetamine Labs in Missouri [redacted version: graphics deleted [unredacted version] (2005)

B. Federal Preemption

Nath, Aninda, Appropriateness of Preemption of State Tort Law Liability for Medical Devices Authorized Under the Premarket Notification Process of Section 510(K) of the Federal Food, Drug, and Cosmetic Act (1996)

*Semet, Amy E.,Toward National Uniformity for FDA-Regulated Products (2000)

Blickle, Carl J., Federal Preemption in the Area of Direct-to-Consumer (DTC) Advertising of Prescription Drugs (2006)

Riveira, Ashley, Federal Preemption of State Liability Claims under the FDCA (2006)

*Hicks, Kristin M., FDA Preemption After the Food and Drug Amendments Act of 2007 (2008).

*Jijon, Alissa Danielle, Federal Preemption of State Tort Suits under the Medical Device Amendments of 1976 (2008)

Beshara, Nicholas, Preemption and Compensation under the Federal, Food, Drug and Cosmetic Act (2009).

Harvey, Harlan Benjamin, Wyeth v. Levine: Realizing a Normative Role for the State Tort Claims in Prescription Drug Label Regulation (2009).

Horowitz, Hayley E., Accounting for Prescription Drugs' Unforeseen Risks: A Regulatory Alternative to Tort Liability (2009).

Klein, Jennifer M., Federal Preemption of Municipal Tobacco Ordinances: New York City and the Federal Cigarette Advertising and Labelling Act (2011).

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V. Food

A. Definition of Food

Torpoco, Edward A., Why We Eat What We Eat: Explanations for Human Food Preferences and Implications for Government Regulation (1997)

Foley, Stephen David, A Brief Survey of the Legislative History Concerning the Definition of Food Additives (1997)

Hsu, Christopher D., A Story About a Taiwanese Culinary Practice and Law (2001)

Cheng, Howard, Beyond Food or Drug: An Examination of Food and Drug Law Through a Study of Cannibalism (2002)

B. Regulation of Food Labeling

1. General

Ditkoff, Joseph M., An Economic Approach to Food Labeling (1996)

Wied, Peter J., An Edict from the Thought Police: Reconciling American and European Approaches to Geographical Designations (1997)

Yang, Hannah Y., FDA Regulation of Food Labeling (1999)

Guagliardo, Mara A., Reexamining Food Labels: A Proposal for Labeling Environmental Information on Food Products (2001)

*Moore, Mario, Food Labeling Regulation: A Historical and Comparative Survey (2001)

Gold, H. David, Legal Strategies to Address the Misrepresentation of Vermont Maple Syrup, 59 Food & Drug L.J. (2004)

Melkonian, Raffi, The History and Future of Geographical Indications in Europe and the United States (2005)

Chu, Jennifer, The Latest Development in the Transatlantic Big Stink over Cheeses and other Geographical Indications (2006)

*Satine, Leah, Is My Yogurt Lying? Developing and Applying a Framework for Determining Whether Wellness Claims on Probiotic Yogurts Mislead, 63 Food & Drug L.J. 537 (2008).

Chang, Peter, Country of Origin Labeling: History and Public Choice Theory, 64 Food & Drug L.J. 693 (2009)

Farris, April L., The "Natural" Aversion: The FDA's Reluctance to Define Leading Food-Industry Marketing Claim, and the Pressing Need for a Workable Rule, 65 Food & Drug L.J. 403 (2010)

Hoffman, Selena L., The Ethics of Food Production and Regulation of "Misbranding" (2010)

Jeshema, Sarah E., Labeling Food Production Methods and Technologies (2011).

2. Biotechnology Labeling

Dunkum, Betty L., BST Free: The Debate Over Whether to Allow Voluntary Labeling of Products as "BST Free" -- Not Derived from Dairy Cows Given the Milk Production Hormone BST (1994)

Parasharami, Archis, Do We Have a Right to Know What We're Eating?: Mandatory Labeling for Genetically Modified Foods (2000)

*Choi, Adela M., Biotechnology and the Labeling Dilemma (2001)

Melendez-Juarbe, Hiram A. and Rivera-Torres, Labeling of Genetically Modified Food in the United States: The Roads Not Taken (2002)

*Banks, Khalisha, Regulating Agri-Biotechnology through Information: The European Union and its System for Labeling Foods Containing, Consisting of, & Produced From Genetically Modified Organisms (2005)

Murphy, John F., Mandatory Labeling of Foods Made From Cloned Animals: Grappling with Moral Objections to the Production of Safe Products (2007)

3. Religious Dietary Labeling

Gottlieb, Caren E., Can the FDA Keep Kosher? Regulation of Kosher Claims on Product Labels (1998)

*Marei, Mohamed H., A Rising Star?: Halal Consumer Protection Laws (2001)

*Sicklick, Kenneth, Keeping Kosher in the U.S.A. (2002)

4. The Fair Packaging and Labeling Act

*Wall, Eric C., A Comprehensive Look at the Fair Packaging and Labeling Act of 1966 and the FDA Regulation of Deceptive Labeling and Packaging Practices: 1906 to Today (2002)

C. Regulation of Food Identity and Quality

Straub, Amanda, Retooling Food Standards of Identity To Address Diet-Related Chronic Disease (2003)

D. Regulation Relating to the Nutrient Content of Food

1. Nutrient Composition

Martin, Julie A., Twentieth Century American Nutrition: From Food Standards of Identity to Food Labeling (1996)

*Baxstrom, Anna R., The Skinny on the Trans Fat Controversy [redacted version][unredacted version] (2007)

Walker, Rebecca, Eliminating Trans Fat from the American Diet: A Small Step in the Battle Against Obesity and Related Diseases [redacted version] [unredacted version] (2007)

2. Nutrition Labeling

*Appel, Jacob M., Portion Distortion and Public Perception: How Serving Size Guidelines are Over-Serving the Consumer(2003)

*Black, Julie, There’s a Government in My Soup: the 2005 Dietary Guidelines for Americans [redacted version: graphics deleted] [unredacted version] (2005)

*Anderson, Stacy, Regulation of Fat Content in Food: Recent History and Cultural Commentary (2006)

Szanzi, Jason M., Brain Food: Bringing Psychological Insights to Bear on Modern Nutrition Labeling Efforts, 65 Food & Drug L.J. 159 (2010).

3. Nutrient Descriptors

*Cooper, Andrew, Carbohydrate Nutrient Content Claims: Proposals for FDA Action and Lessons for Regulatory Response to Emerging Consumer Trends (2006)

4. Disease Prevention and Treatment Claims

Dichter, Harold B., FDA and FTC Regulation of Food Health Claims (1994)

Kleiner, Stacy N., FDA and FTC Regulation of Food Health Claims (1995)

Elliott, Matthew J., Happy Inconsistency: Health Claims Standards at the FTC and FDA(1997)

*Sonu, Michelle S., Using Market Exclusivity and Regulation of Health-Related Claims to Foster Innovation of Nutritionally Enhanced Food (1999)

Pappas, Clement D., Maintaining a Level Playing Field: The Need for a Uniform Standard to Evaluate Health Claims for Foods and Dietary Supplements, 57 Food & Drug L.J. 25 (2002)

*Wright, Kevin J., Folic Acid and the American Food Supply: A Historical Account of the FDA's Creation of the Current Folic Acid Regulations (2003)

5. Functional Food

*Baher, Julie Melissa, What Can Your Food Do For You? (And Should FDA Let It?): An Overview of the Regulatory Regime (or Lack Thereof) Surrounding Functional Foods (2006)

E. Dietary Supplements

Davis, Johanna L., FDA's Health Claims Regulation of Dietary Supplements: Examining Alternative Models (1994)

Jackson, Kimberly A., FDA Regulation of Dietary Supplements (1994)

Witherspoon, David B., The Battle Over Dietary Supplement Regulation: More at Stake than Just "Feeling Good" (1994)

Guttman, Catherine R., Sowing the Seeds: An Analysis of FDA Regulation of Herbal Dietary Supplements (1995)

Kaplan, Samuel C., Product of a Culture Clash: An Analysis of the Dietary Supplement Act of 1994 and It's Likely Impact (1995)

Stallings, Kimberly M., Consumer Welfare and the Dietary Supplement Health and Education Act of 1994 (1995)

Toro-Hernandez, Christina, FDA Regulation of Dietary Supplements (1995)

Westfall, Elizabeth S., FDA Regulation of Dietary Supplements (1995)

Holden, Blythe A., Protecting Consumers' Welfare and Their Wallets: Regulation With The Dietary Supplement Health and Education Act of 1994 (1996)

Kato, Ayano, Beta-Carotene and Recent Clinical Trials: The Need to Review Dietary Supplement Labeling (1996)

Lee, Joyce L., Basil and Belladonna: Are Herbs Foods or Drugs (1996)

Garcia, Edouard Alexander, FDA Regulation of Performance Enhancing Supplements -- A Proposal to Reform the Dietary Supplement Health and Education Act of 1994 (1997)

Sims, Brian D., Recreational Weight Lifting And Regulation Of The Dietary Supplement Marketplace (1997)

Ray, Supryia M., Botanical Products Regulation: Remedying the Unstable Dietary Supplement-Drug Divide (1998)

*Dixon, Woodie H., Jr., Dietary Supplement Regulation: Health or Hazard? (1999)

Steiner, Laura, Expanding the Alternatives for Regulating Alternative Medicine Under the Dietary Supplement Health and Education Act of 1994 (1999)

*Hegefeld, Heather, Overview of Federal Regulation of Dietary Supplements: Past, Present, and Future Trends (2000)

*Hegefeld, Heather, Research Guide: The Federal Regulation of Dietary Supplements (2000)

*Ehlers, Brandi E., Ephedra and the FDA (2001)

*Mueller, Erica, A Structure That Does Not Function: An Examination of the History and Current Regulatory Status of Dietary Supplements and Their Label Claims (2001)

*Powell, Karen J., The FDA's Treatment of Structure/Function Claims Under the Dietary Supplement Health and Education Act (2001)

Doogan, Amy K., Herbs and the FDA: Current Regulation, Problems and Suggestions for Change(2002)

*Jones, Adam R., FDA v. Ephedra: Dietary Supplement Regulation under DSHEA (2002)

*O'Brien, Cullin, Regulation of Bodybuilding Magazines (2002)

*Wang, Gerald, Dietary Supplements: A Historical Examination of Its Regulation (2002)

*Grus, Jenny L., Giving You Wings: Should the Food and Drug Administration Investigate the Safety of Red Bull and So-Called Energy Drinks (2003)

*King, Carlotta Denise, Regulation of Sports Products as Dietary Supplements: Should the FDA Have Stricter Requirements? (2003)

Patsner, Bruce, Ephedra vs. FDA: Resolving the Conflict (2003)

*Scarbrough, Brian, Dietary Supplements: A Review of United States Regulation with Emphasis on the Dietary Supplement Health and Education Act of 1994 and Subsequent Activity (2004)

Bradt, Andrew, Not Its Crowning Glory: Obstacles for FDA in Regulating Ingested Dietary Supplements Purporting to Prevent Hair Loss (2005)

McCann, Michael A., Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Coice, 38 Am. J.L. & Med. 215 (2005)

Sitron, Neil M., Should TrimSpa X32 Remain on the Market? An Analysis of TrimSpa X32’s Compliance with FDA and FTC Guidelines (2005)

Fleisher, Jared Michael, Thinking Outside the Bottle: The Need for a New Pragmatism in the Regulation of Dietary Supplements (2008).

Kruzer, Lyndsey M., The Impact on Athletes of the Current Regulatory Scheme for Dietary Supplements (2009).

F. Organic Food

Waanders, Jason M., Growing for the Future: Organic Food Regulation and the Environmental Goals of Organic Agriculture (1998)

*Dungey, Elizabeth A., Drafting Organic Food Regulations: The Case for Incorporating Congressional Intent and Interest Group Commentary (1999)

Ellsworth, Jessica L., The History of Organic Food Regulation (2001)

Jillian, Stephanie, Federal Regulation of Organic Food: A Research Guide for Legal Practitioners & Food Industry Professionals [redacted version: graphics deleted] [unredacted version] (2005)

*Rood, Jocelyn R., Organic and Beyond: How the National Organic Program Came to Be, Current Debates, and Future Application to other “Natural” Food Terms [redacted version] [unredacted version] (2007)

Marisam, Jason B., Regulating Organic Food: The Case for the National Organic Standards Board (2008)

Ullman, Emily S., Organic and Kosher Foods: A Tale of Two Certification Systems (2009)

Osborn, Benjamin R., Protecting Pointless Premiums: Comparing Organic Certification Standards to Consumer Motivation for Purchasing Organics (2010).

G. Medical Food

H. Food Sanitation

1. Good Manufacturing Practices

*Axelrad, Seth, Why FDA Has Adopted HACCP Regulations to Ensure the Safety of Food (2006)

2. Filth

*Brennan, Colleen A., Use of Blending as a Method to Bring Filth Content Within Defect Action Levels: An Idea Whose Time Has Come? (1995)

3. Transportation

*Miller, Julia Ariel, The Regulation of Sanitary Food Transportation in the United States: A Slow Journey on a Long Road, 63 Food & Drug L.J. 35 (2008)

I. Food Safety

1. Toxicity / Food Additives

Bucholtz, Jeffrey S., Memorandum on Possible Changes in Food Safety Provisions of FD&C Act (answer to examination question) (1994)

Curi, Anne J., Reasonable Uncertainty": Aspartame's Safety (1994)

Gevertz, David E., FDA Regulation of Food Additives (1994)

Law, Diane M., FDA Regulation of Aspartame (1994)

Colby, Thomas B., What if Salt Were Discovered Today? An Hypothetical Journey Through the Regulation of Food and Food Additives (1995)

Small, Barry L., Macronutrient Food Ingredient Regulation by FDA (1995)

Dargan, Catherine J., Macrontutrient Food Ingredients (1994)

Benerofe, Steven J., The Approval of Olestra as a Food Additive: Delays in the Process (1996)

Flanagan, Sharon R., Taking the Bitter with the Sweet: A History of Saccharin (1996)

Prothro, Gwendolyn, The Caffeine Conundrum: Caffeine Consumption and Regulation in the United States, 27 Cumberland L. Rev. 65 (1996/1997)

Arora, Vikas, FDA Policymaking in Light of Scientific Uncertainty: The Bittersweet Approval of Aspartame (1997)

Cavan, Marc A., MSG: The Controversy (1997)

Stout, Laura P., Let Them Eat Cake? A Historical Analysis of FDA's Decision to Approve Aspartame(1997)

*Nill, Ashley G., The History of Aspartame (2000)

*Mrazik, David M., Reconsidering Caffeine: An Awake and Alert New Look at America's Most Commonly Consumed Drug (2004)

Singh, Monica, Fact or Fiction? The MSG Controversy (2005)

*Bonds, Tia, FDA Regulation of Carcinogens in Food (2007)

Burnett, Lisa, Sweetness Lite?: Artificial Sweetener Controversies from Saccharin to Sucralose (2007)

Morris, Roblyn G., You Are What You Drink--A Rockstar or a Monster?: An Enviga-rating Regulatory Question (2010).

Mayberger, Caroline L., Four Loko a.k.a. Blackout in a Can: The Federal Regulation of Caffeinated Alcoholic Beverages (2011).

2. Pathogens

Bronner, Ray, Mean Mr. Mustard's Poultry Pavilion: The Regulation of Microbial Pathogens in a Purple Haze of Discord and Uncertainty (1996)

Barry, Andre R., The Enduring Chill: The History of Milk Sanitation (1997)

*Deliganis, Chryssa V., Death by Apple Juice: The Problem of Foodborne Illness, The Regulatory Response, and Further Suggestions for Reform, 53 Food & Drug L.J. 681 (1998)

Castro, Dominique L., Raw Milk Cheeses: Historical Overview, Current Regulations, and the Battle to Preserve Artisinal Cheesemaking (2005)

*Knoll, Laura, Origins of the Regulation of Raw Milk Cheeses In the United States (2005)

Sundstrom, Alex, Moo-nshine: Resistance to FDA Regulation of Raw Milk (2005)

Gerber, Renee A., The Future of Food Safety Regulation: Encouraging Both Food Safety and Environmental Sustainability by Protecting Small Farm Production (2009)

Letourneau, Brienne M., Sea Food, Sea Sick: Dining in the Cruise Ship Industry (2009)

Vanderkruik, Rachel, Development and Efficacy of HACCP in the Fish Industry (2010)

3. Allergens

Kim, Todd, Regulatory Steps Toward Making Lactose Intolerance Tolerable (1996)

*Vamvakias, Amanda K., Food Allergies and Food Labeling: An International Problem (2001)

*Derr, Laura, When Food is Poison: the History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 Food & Drug L. J. 65 (2006).

*Mungovan, Kara S., Allergies in America after the FALCPA: Obstacles Still Facing Allegic Individuals (2008).

4. Color Additives

*Burrows, Adam, The Palette of Our Palates: A brief history of food coloring and its regulation , 8 Comprehensive Reviews in Food Science and Food Safety 394 (October 2009)

J. Restaurants

Hechler, Miriam P., Nutrition Labeling and Restaurants: Issues, Options, and the FDA, 1970-1995 (1995)

Wilan, Jonathan M., Regulation of Prison Food (1996)

Yen, Hope S., Nutrition Labeling for Restaurants: A Proposal for Change (1996)

Fien, Melissa, The Restaurant Industry and the FDA: Striving for a Safer America (2002)

*Naim, Cyrus, Prison Food Law (2005)

Schulman, Tamara H., Menu Labeling: Knowledge for a Healthier America, 47 Harvard Journal on Legislation 587 (2010).

Bernell, Brent L., The History and Impact of the New York City Menu-Labelling Law, 65 Food & Drug L.J. 839 (2010).

K. Pesticide Residues

McCormack, Douglas E., The Debate Over Consumers' Right to Know About the Dangers of Pesticide Residues (1997)

*Smart, James R., All the Stars in the Heavens Were in the Right Place: The Passage of the Food Quality Protection Act of 1996, 17 Stanford Environmental L.J. 273 (1998)

Lindsay, Jonathan M., Working Out the Bugs in Pesticide Regulation: A Survey of the Joint Efforts of the EPA and FDA (1999)

Ling, Amy M.,Missing Links in Interagency Relationships: Starlink Corn and Failures in Interagency Approaches to Regulation and Technology [redacted version] [Unredacted Version] (2005)

L. Environmental Contaminants

*Christenson, Vonn, Regulate This: The Politics and Practice of Poo Farming (2006)

*Ben-Asher, Justin G., Regulating in a Radioactive World: The FDA and Radionuclide Contamination (2011).

M. Packaging and Other Indirect Components

N. Irradiation

Lin, Stanford M., A Continuing Controversy: Labeling Requirements on Irradiated Foods (1994)

*Benerofe, Steven J., The Legislative History of Food Irradiation in the Food Additives Amendment of 1958 (1996)

Freedman, Matthew E., Food Irradiation: Too Many Risks, Too Few Benefits (1998)

Browning, Paul W., Food Irradiation: Too Many Risks, Too Few Benefits

*Prejean, Jonathan E., Irradiation: Why Aren't We Using It? (2001)

O. Alcoholic Beverages

Kilpatrick, Andrea R., I'll Drink to That!: The Case for FDA Regulation of Alcohol Labeling (1996)

Berkey, Judson O., The History of Alcoholic Beverage Labeling Regulation and Its Implications for a Health Claim on Wine Labels (1998)

Byszewski, Elaine Moore, What's in the Wine?: A History of FDA's Role, 57 Food & Drug L. J. 545 (2002)

Golden, Sara Levison, Health Effects & Wine: The FDA Should Regulate the Health Effects on Wine Labels (2002)

*Levinson, Joseph I., Temperance, Taxation and Turmoil: Federal Regulation of Intoxicating Beverages 1789-1918 (2002)

*Munsie, Jeffrey A., A Brief History of the International Regulation of Wine Production (2002)

*Myers, Jenna, Fomentation about Fermentation: A Study on Ingredient Labeling on Alcoholic Beverages (2002)

Wickes, Margaret L., A Toast to the Good Life: Exploring the Regulation of Champagne (2003)

Kan, Jennifer Y., Loco for Four Loko: Regulating Caffeinated Alcoholic Beverages (2011)

Sheeren, David M., Recent Developments in Alcoholical Beverage Labeling Regulation (2011)

P. Meat, Poultry and Eggs

Coble, Charles E., The Department of Agriculture's Regulation of Poultry Under the Poultry Products Inspection Act of 1957 (1997)

*Houston, Crisarla, From the Farm to the Factory: An Overview of the American and European Approaches to Regulation of the Beef Industry, 1 Journal of Food Law & Policy 270 (2005)

*Hurr, Melinda, From “Farm to Table”: Microbiological Foodborne Illness and the Regulation of the Beef Industry [Redacted Version] [Unredacted Version] (2004)

Douglas, Charles William, A Joint American Tradition: Hot Dogs, FDA & USDA(2006)

Policicchio, Jared W., How Would You Like Your Eggs: A History of Egg Regulation and Current Controversies (2011).


Q. Fish and Shellfish

Hauge, Paul M., FDA Regulation of Mercury in Fish (1995)

*Remmer, Sharon M., One Hundred Years of Shellfish Regulation (1998)

*Grooms, Daniel, Not in a Month without an 'R' in Its Name": An Historical Overview of 20th Century Seafood Regulation with a Glimpse of the Challenges at the Beginning of the 21st (2002)

*Feng, Cindy H., Beyond Nigiri and Anisakiasis, The Tale of Sushi: History and Regulation (2006)

R. Other Specific Food Products

Gordon, Meredith B., Such Stuff as Dreams Are Made on: The Story of Caviar, from Prehistory to the Present [Redacted Version][Unredacted Version] (2002)

*Pirina, Jean C., The Regulation of Tea and Its Health-Related Claims in the Wake of Developing Scientific Evidence: Food, Drug, or Dietary Supplement? (2004)

*Ahn, Joyce S., Uncapping the Bottle: A Look Inside the History, Industry, and Regulation of Bottled Water in the United States, 3 Journal of Food Law and Policy 173 (Fall 2007)

*Goedert, Robert, The Chloride Crisis and The Infant Formula Act of 1980 (2007)

Murtagh, Lindsey, United States Regulation of Infant Formula: Looking Backwards Towards a Crisis and Forewards Towards an Opportunity (2009).

S. Obesity

*Berry, Jeremy R., Carbophobia: The Dieting Public's Obsession with Carbohydrates and the U.S. Government's Response (2003)

*Johnson, Sarah C., Countering the Obesity Epidemic: Policy Proposals for a New Century (2003)

*Westover, Melanie, An Evaluation of the Legal Responses to America’s Obesity Epidemic (2004)

*Wolf, Emily, The Obesity Epidemic: Why and How the Government Must Act (2004)

Benloulou, Jonathan, Pelman v. McDonald's: An In-depth Case Study of a Fast Food –Obesity Lawsuit (2005)

*Canavan, Kathryn Erin, Combating Child Obesity in America (2006)

*Lee, Hyun Young Emily, The World Health Organization's Global Strategy on Diet, Physical Activity, and Health: Turning Strategy into Action, 60 Food & Drug L.J. 569 (2005)

Morozova, Natalia, The Obesity Epidemic in France and the United States: What Are We Doing Right and What Can We Learn from Each Other? (2006)

Sindelar, Jeffrey C., Proteins and Fats and Carbs, Oh My! Escaping the Hysteria of Dieting in America [redacted version] [unredacted version] (2007)

Yau, Michelle C.,Food as a Means of Self-Torture: Have FDA Policies Facilitated the growth of Eating Disorders? [redacted version][unredacted version] (2003)

Buschell, Ryan M., Educating the American Obese: Reviewing a Questionable Theoretical Framework (2010)

*Zamora, Elizabeth A., Waging War on the Obseity Epidemic: Are Regulatory Measures the Answer? (2011).

T. Eating Disorders

Yau, Michelle C., Food as a Means of Self-Torture: Have FDA Policies Facilitated the growth of Eating Disorders? [redacted version][unredacted version] (2003)

U. Hunger

*Ellison, Jon, Hunger in America: A History of Public and Private Responses (2004)

*Lee, Donna, The North Korean Famine and Food Shortage: The Problem, the Politics, and the Policy (2006)

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VI. Human Drugs

A. Definition of Drug

Zimmerman, William R., The History and Enforcement of the Intended Use Regulations (1996)

B. Prescription Drug Promotion

1. Physician Labeling

Nuzzo, James L. J., Independent Prescribing Authority of Advanced Practice Nurses, 53 Food & Drug L. J. 35 (1998)

Goldstein, Lori M., Drug Therapy and Pregnancy: Unknown Risks Lead to Hard Choices [Redacted Version] (2001) [unredacted version not available]

*Sun, Angela A., A Drug by Any Other Name: The Power of Naming and the Medical and Regulatory Impact of Misnaming Prescription Drugs (2001)

2. Patient Labeling

Johnson, Jennifer A., Mandatory Computerized Patient Information Program for Prescription Drugs (1994)

Rowe, Howard M., Patient Package Inserts: The Proper Prescription?, 50 Food & Drug L.J. 95 (1995)

Server, Alfred C., Patient Package Inserts Revisited (1994)

Schluster, Daniel H., FDA's Experience with Patient Package Inserts: A Program That Just Won't Go Away (1995)

Schuman, Brett M., FDA Regulation of Patient Package Inserts (1995)

Weiner, Janice L., Political Constraints on the Regulatory Process: The Attempt to Regulate Content and Distribution of Prescription Drug Information for Patients (1996)

Edmonson, Elizabeth, Beyond Rosaries, DialPaks, and Even Doctors: Improving Effectiveness-Related Patient Labeling for Oral Contraceptives (2007)

Hashmi, Maliha, To Take or Not to Take: Bioethical Conflicts with Non-adherence to Medications due to Religious Beliefs (2010).

3. Physician Advertising

*Tseng, Elaine H., The FDA's Draft Policy Statement on Industry-Supported Scientific and Educational Activities: A Policy Assessment (1996)

*Chen, Peggy S., Education or Promotion?: Industry-Sponsored Continuing Medical Education (CME) as a Center for the Core/Commercial Speech Debate, 58 Food & Drug L.J. 473 (2003)

*Gelbwasser, Lara N., "Ain't Misbehavin"?: An Analysis of Prescription Drug Promotions by Pharmaceutical Manufacturers and the Regulatory Response of the Food and Drug Administration (2003)

Ginn, Clifford M., Pre-Approval of Prescription Drug Advertisements in the Shadow of Central Hudson (2003)

Sullivan, Katherine M., IMS v. Sorrell--Implications for Federal Regulation of Pharmaceutical Marketing (2011)

Liu, Kassity Y., FDA and Social Media: The Impact of Social Media on Prescription Drug Advertising (2011)

4. Patient Advertising

Rowe, Howard M., The Regulation of Direct-to-Consumer Advertising of Prescription Drugs (1994)

Hammerman, Joel M., A New Prescription?: A Study of the Regulations Governing Direct-to-Consumer Advertising for Prescription Drugs (1996)

*Brooks, Tama Beth, The Economic Impact of Direct-to-Consumer Television Advertising of Prescription Drugs on the Healthcare Market (1999)

*Hartgraves, Tiffany, DTC Prescription Drug Advertising: The History and Impact of FDA Regulation (2002)

Trento, Andrea W., American Exceptionalism and Direct-to-Consumer Advertising: Structural and Philosophical Impediments to Reform in Europe (2002)

*Hackworth, Nekia, Back to Basics: Proposing a New Regime for Direct-to-Consumer Prescription Drug Advertising (2004)

Babic, Boris, A Logical-Historical Assessment of DTC Advertising, and Critical Analysis of the FDAAA Amendments (2010).

5. Information on Unapproved Uses

Miller, Kimberle M., FDA Control of Prescribing: Unapproved Uses of FDA Approved Drugs (1994)

Banasik, Kevin A., Balancing Public and Private Needs in Off-Label Prescriptions: Aggressive Application of Treatment INDs (1995)

Bradshaw, Karen M., FDA Regulation of the Promotion of Drugs for Unapproved Uses (1997)

*Weiner, Janice L., Regulation of the Dissemination of Off-Label Use Information in the Modern Pharmaceutical Marketplace (1997)

*Bradshaw, Karen M., The Food and Drug Administration Modernization Act of 1997: Is it the Answer to the Off-Label Advertising Debate? (1998)

Hamlin, Keith M., Products Liability Law and the Off-Label Promotion of Prescription Drugs: Addressing Concerns That New FDA Provisions Endanger Public Health (1998)

*Legath, R. Jeffrey, Prescription Drug Injuries: A Proposal for Change to Cure the Limits of FDA Regulation, Medical Malpractice, and Manufacturer Products Liability Law (1998)

Norbin, Carrie Louise, After Washington Legal Foundation v. Friedman: The FDAMA, Dissemination of Information on New Uses, and The First Amendment (1999)

Schooley, Heather H., Off-Label Marketing of Prescription Drugs: The State of the Art (2000)

*Ruiz, Erika, Off-Label Drug Prescribing by Physicians: Its Origins and Ramifications [Redacted Version] [Unredacted Version] (2002)

*Hoffman, Matthew A., The Military's Need for "Speed": A Case Study on the FDA's Regulation of Off-Label Prescriptions (2003)

Tiwary, A. Off-Label Use of Prescription Drugs Should Be Regulated by the FDA (2003)

*Alperowicz, Maya, A Case at a Crossroad: United States ex rel. Franklin v. Parke-Davis and the Intersection of Regulating Promotion of Off-Label Uses and Medicaid Fraud and Abuse(2004)

*Kaufman, Robert, The Neurontin Controversy: The Saga of Off-Label Drug Regulation Continues (2004)

Kelly, Carly, Government Regulation of Off-Label Drug Prescriptions: Balancing Healthcare Innovation with Public Safety and Fiscal Responsibility (2004)

*Evan, Jonathan, Approved Drugs for Unapproved Uses: A Cooperative Approach to Off-Label Prescriptions (2007)

Kenneth, Michael, Off-Label Enforcement: Does Congress Take Note When the FDA Expands its Enforcement Authority? [redacted version][unredacted version] (2007)

Lee, Brenda, The Wrinkle Wars: A Comparison of the Off-Label Promotions for Botox and Retin-A (2007)

Almo, Cari Sara, Achieving Equilibrium: An Examination of the FDA's Attempt to Balance Patient Safety with Access to Innovative Treatments through the Off-Label Marketing Regulations (2008).

Foster, Suzanne, FDA's Position on Off-Label Use and Promotion of Drugs and Devices and Recent Enforcement Efforts by the Department of Justice (2009).

*Lopez, Miguel A., The Informational and Institutional Theories of Off-Label Promotion, 49 San Diego L. Rev. 913 (2012)

Wang, Yuanheng (Sally), Adding Shades of Gray to Black and White: Proposal for a Tiered Pharmaceutical Labeling Scheme (2011).

6. Cost-Effectiveness Claims

Stranne, Steven K., Cost-Effectiveness Determinations and the FDA (1994)

Shohet, Zion, Identifying Cost-Effective Regulations to Cost-Effectiveness Studies: An Economic Analysis of a Proposed Set of Regulations (1995)

*Scarborough, Ryan T., Will Health Care Economic Information Lead to Therapeutic-Class Warfare or Welfare?, 111 Harvard L. Rev. 2384 (1998).

7. Comparative Effectiveness

Jeans, Megan E., Comparative Effectiveness Research at the FDA: Taking the "Person" Out of Personalized Medicine? (2010).

*Francis, Margaret H., Beyond "Safe and Effective": The Role of the Federal Government in Supporting and Disseminating Comparative-Effectiveness Research (2011).

C. Prescription Drug Licensure

1. Drug Testing (IND)

Bolland, Katharine S., AIDS Buyers Clubs (1994)

Kaufman, Patricia F., A Critique of the Food and Drug Administration's 1993 Guideline Concerning the Inclusion of Fertile Women in Early Clinical Testing of New Drug Therapies (1994)

Roskes, Jonathan A., The Inclusion of Women in Clinical Studies: Yesterday and Today (1994)

Grow, Julie A., Expanding Access to New AIDS Drugs: Wise Policy or Wrong Direction? (1996)

*Kosowsky, Daniel E., Placebo Control in Clinical Trials: A Communitarian Defense (1996)

Taft, Kingsley L., Deregulation of Investigational New Drug Applications (1996)

Jarrell, Brenda Herschbach, FDA Regulation and the Military: Is There a Compromise in the Battle Over Investigational Drugs?(1997)

Lovrien, Christopher J., Investigational Drug Use Among the Troops: The Waiver of Informal Consent in Cases of Military Combat Exigenciess (1997)

Lamb, Kristen A., Bridging the Gap between Drug Discovery and Market Introduction: The Rise of Contract Research Organizations (1998)

*Taitsman, Julie K., Regulation of Informed Consent in Human Subject Research: Past, Present, and Future (1998)

*Ciccone, Robert V., Medical Research and the Protection of Individuals Incapable of Providing Consent (1999)

*Plaue, Gina M. Third Party Reimbursement for Participation in Cancer Clinical Trials: A Proposal for Legislation (1999)

Patterson, Staci E., Adopting the Therapeutic Orphan: An Examination of FDA and Congress' Efforts to Promote the Inclusion of Children in Clinical Drug Studies (2001)

*Quittell, Robin M., "Informed" Consent and Human Experimentation: Present Status, Pitfalls, and the Need for Reform (2001)

*Wandler, Michelle R., The History of the Informed Consent Requirement in United States Federal Policy (2001)

*Williams, Christi J., A History of Institutional Review at the U.S. Food and Drug Administration (2001)

*Pauker, Stacey E., From Protectionism to Access: Women's Participation in Clinical Trials - Conflict, Controversy and Change(2002)

*Williams, Kevin W., Managing Physician Financial Conflicts of Interest in Clinical Trials Conducted in the Private Practice Setting, 59 Food and Drug L.J. 45 (2004).

*Flannery, Mary M., Research on the Terminally Ill: A Balancing Act between Facilitating Access to Innovative Therapies and Protecting Vulnerable Subjects in Search of One Last Hope for Survival (2003)

Strom, Julie L., The Cure at a Crossroads: The Intersection of Ethics and Ambition in AIDS Research (2003)

Anonymous, Better Fighting Through Chemistry? The Role of FDA Regulation in Crafting the Warrior of the Future (2004)

Corkery, Joseph, Primum Non Nocere: The Continuing Evolution of Safety Monitoring In Human Subjects Research (2005)

*Schott, Markus, Medical Research on Humans: Regulation in Switzerland, the European Union, and the United States of America, 60 Food & Drug L.J. 45 (2005)

Sclar, David, Registration in the Name of Patient Safety: The Food and Drug Administration and the Past, Present, and Future of Clinical Trials Registration [redacted version][unredacted version] (2007)

*Gordon, Matthew P., A Legal Duty to Disclose Individual Research Findings to Research Subjects?, 64 Food & Drug L.J. 225 (2009).

*Rossen, Benjamin R., FDA's Proposed Regulations to Expand Access to Investigational Drugs for Treatment Use: The Staus Quo in the Guide of Reform, 64 Food & Drug L.J. 183 (2009)

*Bernando, April E., The Evolution of the Clinical Trials Database: A Study in Pharmaceutical Industry Resistance and Congresional Inefficiency (2009).

Afifi, Laila, Pregnant Women Get Sick Too: Why Pregnant Women Require Meaningful Access to Clinical Research (2010).

Aidenbaum, Whitney Lee, Herein of Scandal and Advancement: A Chronical of Human Experimentalism in the United States (2011).

*Atanassaova, Mira, Clinical Trial 2.0: Can Health 2.0 Transform the FDA Drug Approval Process? (2011)

Heck, Lindsay, Clinical Trials Conducted Abroad (2011)

Schuman, Jacob, An Extraterritorial FDA: Could the Food and Drug Administration Apply Its Informed Consent Requirement Abroad with International Law? (2011).

2. FDA Review (NDA)

Barr, Lisa P., N2 Universal: A Case Study of an NDA (1994)

Mitchell, Sandra R., Tightening the Belt on the Weight-Loss Industry (1994)

Derzko, Natalie, The Effect of FDA's Policies on the Decreasing Effectiveness of Antibiotics (1995)

Rubenstein, Corey B., The Price We Pay: The Efficacy Requirement for New Drugs Under the Federal Food, Drug, and Cosmetic Act (1995)

Adams, Meredith A., An Examination of FDA's Drug Review Process (1996)

Curry, Cassandra L., Preserving Access for Pregnable Women to Medically Valuable Teratogenic Drugs (1996)

*Grow, Julie A., The Legislative History of the 1962 Drug Amendments: A Failure to Forget or A Lesson to Learn From? (1997)

Mitchell, Elizabeth L., Miracle Drugs and Teratogens: An Exercise in Risk Management (1997)

Yeon, Howard B., Thalidomide Revisited (1998)

*Greenberg, Michael D., AIDS, Experimental Drug Approval, and the FDA New Drug Screening Process 3 J. Legislation & Public Policy 295 (2000)

*Lutz, Kristina E., From Tragedy to Triumph: The Approval of Thalidomide (1999)

Frug, Emily A., No Miracle Pills: An Analysis of FDA Regulation of Prescription Weight Loss Medicine (2000)

Katz, Gail A., Protecting the Ignorant, the Unthinking and the Credulous: Are the FDA's Efforts to Accelerate the Drug Approval Process Compromising Public Public Safety (2000)

Green, Julia, Babies, Blemishes and FDA: A History of Accutane Regulation in the United States (2002)

*Lee, Steve C., The Controversy Surrounding Accutane: Regulation, Litigation, and Dangerous Side Effects (2003)

Petrovic, Emily S., Is the FDA Sexist?: Sex and the FDA Approval Process (2003)

Campbell, Carrie, No Humans Have Been Injured in the Testing of this Drug: The New Animal Efficacy Rule (2004)

*Stahl, Jacob, A History of Accelerated Approval: Overcoming the FDA’s Bureaucratic Barriers in order to Expedite Desperately Needed Drugs to Critically Ill Patients (2005)

*Steenburg, Charlie, The FDA's Use of Postmarketing (Phase IV) Study Requirements: Exception to Rule and Promise to Problem?, 61 Food & Drug L.J. 295 (2006)

Falit, Benjamin P., Curbing Industry Sponsors' Incentive to Design Post-Approval Trials That are Suboptimal for Informing Prescribers but More Likely than Optimal Designs to Yield Favorable Results, 37 Seton Hall L.Rev. 969 (2007).

Darrow, Jonathan J., Me-Too Drugs and the Regulatory Enviornment (2009).

Wolpin, Joseph B., The New Generation of Performance Enhancement: The Use and Regulation of Cognitive Enhancers (2009).

3. Specific Drug Products

*Kim, Sandra, Atypical Antipsychotic Drugs for Schizophrenia: Access, Reimbursement and the Struggle for Parity (2002)

Robinson, Kristin, Past, Present and Future in the Search for the Perfect Anti-epileptic Drug (2002)

*Hron, Benjamin M., Placebo or Panacea: the FDA's Rejection of ImClone's Erbitux Licensing Application (2003)

Bonanni, Marina, The Invasion of Ritalin: A Call for Federal Regulation (2004)

*Lombardo, Marguerite R., Through the Correct Lens: Understanding Overprescription of Stimulant Drugs, Their Abuse, and Where the Remedies Lie (2004)

Neuman, Ariel, GHB's Path to Legitimacy: An Administrative and Legislative History of Xyrem (2004)

*Sands, Darin M., Out of Control: The Flawed Regulation of Schedule II Drugs and Its Impact on Pain and Addiction (2004)

*Wray, Katherine, Combating Depression: A History and Analysis of FDA Regulation of Selective Serotonin Reuptake Inhibitors (2004)

*Gottfried, Joseph, History Repeating? Avoiding a Return to the Pre-Antibiotic Age (2005)

*Rothenburg, Carla J., The Rise and Fall of Estrogen Therapy: The History of HRT (2005)

*Shaitelman, Kenneth, Overload: Regulating the Sources of Information about Attention-Deficit/Hyperactivity Disorder (2005)

*Sung, Andrew J., Expediting Oncology Drug Approvals: The Public Backlash Against the FDA and Opportunities to Reform (2005)

*Tran, Lan, Untangling the Vioxx-Celebrex Controversy: A Story about Responsibility (2005)

*Zahler, Daniel, Preventing the Next Public Health Crisis: New Drug Approval after Vioxx (2005)

*Gupta, Alpana, Emerging Field of Race-Based Genetic Research: Can We Trust It? (2006)

*Lin, Richard, From Pre-Market Approval to Post-Market Removal The Implications of Lifestyle Drugs for the Regulation of Herbal Remedies (2006)

Mancinelli, Sarah M., Placing Blame for the Vioxx Debacle (2006)

*Quasha, Devon R., Intrinsa: An Inquiry into Female Sexual Dysfunction and Testosterone (2006)

Yonker, Stephanie A., FDA Drug Approval: A Black and White Issue? (2006)

*Kim, Douglas Y., Modafinil: The Journey to Promoting Vigilance and its Consideration by the Military in Sustaining Alertness (2007)

Broder, Jennifer M., Understanding Antibiotic Resistance: Challenges and Opportunities to Overcome the Growing Public Health Crisis (2011)

Canton, Allison N., The Elusive Silver Bullet: FDA Failures, Rejected New Drug Applications, and the Search for an Obesity Cure (2011).

Kraus, Erica J. Hemphill, A Heavy Burden: Rethinking the FDA's Safety Balancing in the Evaluation of Weight Loss Medications (2011).

Lewin, Carly S., Lifting the Fog: The Problem of Antipsychotic Drug Use in Nursing Homes (2011).

Rostoker, Jessica D., The Truth About Pediatric Antidepressant Use (2011).

4. Generic Drugs

Reines, Emily B., Litigating the Drug Price Competition and Patent Term Restoration Act of 1984 (2000)

*Range, Brian D., The ANDA Patent Certification Requirement and Thirty-Month Stay Provision: Is It Necessary? (2001)

Halstead, David P., One of These Things Is Not Quite the Same: A Comparison of the Patent Doctrine of Equivalents with Suitability for Filing an Abbreviated New Drug Applicationn (2002)

*Kunstling, Claire G., The Anticompetetive Impact of Patent Settlements in the Pharmaceutical Industry: The Need for Revisions to the Drug Price Competition and Patent Term Restoration Act of 1984 (2002)

*Lee, David D., A "Lighthearted" Look at the Drug Price Competition and Patent Term Restoration Act of 1984 (2002)

*Jorgenson, Matthew S., Sham INDs and the Hatch-Waxman Act of 1984 (2003)

Karbalai, Hasneen, The Hatch-Waxman (Im)Balancing Act (2003)

McPhie, David C., Old Drugs, New Uses: Solving a Hatch-Waxman Patent Predicament, 59 Food & Drug L.J. 155 (2004).

Rosen, Valarie B., The Real Fountain of Youth: How Old Drugs Get Covered by New Patents (2003)

*Morey, Candace J., A Patent-Based Perspective on the Hatch-Waxman Act: Remaining Incentives for Patent Evergreening and Proposals for Reform [Redacted Version] [Unredacted Version Version] (2004)

Sayeed, Hassen A. A Summary of Recent Changes to the Drug Price Competition and Patent Term Restoration Act of 1984 [Redacted Version][Unredacted Version] (2004)

Sabel, Nathan, Irrational Choice: A Study of Brand-Name and Generic Drug Purchasing Patterns [redacted version: graphics deleted] [unredacted version] (2005)

*Gorlin, Daniel, Staving Off Death: An Assessment of the Pharmaceutical Industry’s Strategies to Protect Blockbuster Franchises Upon the Loss of Marketing Exclusivity, 63 Food & Drug L.J. 823 (2008).

Bailin, Paul S., A Reverse Perspective on Reverse Payment Settlements (2010).

*Kelly, Colleen A., The Balance Between Innovation and Competition: The Hatch-Waxman Act, the 2003 Amendments, and Beyond (2011).

5. Risk Management

*Berniker, Jessamyn S., Spontaneous Reporting Systems: Achieving Less Spontaneity and More Reporting (2001)

*Cave, Neil G., Post Approval Testing by Pharmaceutical Manufacturers (2002)

*Petrocelli, Gina M., Accutane: Post-Approval Drug Regulation in a Risk Management Framework (2002)

Walker, Petal P., Considering the New REMS Legislation of the 2007 Amendments (2008).

6. Drug Manufacturing

Goldstein, Beth F., Current Good Manufacturing Practices (1995)

Schildkraut, Peter J., The Regulation of Drug Manufacturing Changes: Past, Present, and Foreign (1997)

7. Pharmacy Compounding

Fairfax, Roger A., Phederalism The Regulation of Pharmacy Compounding and Two Years in the Regulatory Tu War Between Pharmacy and the Food and Drug Administration (1998)

*Riley, Rebecca J., The Regulation of Pharmaceutical Compounding and the Determination of Need: Balancing Access and Autonomy with Patient Safety (2004)

8. Patents

Stanton, David, Longjohn, The Influence of Patents Over Patient Access to Pharmaceuticals: Arguments In Favor of Compulsory Licensing (1999)

Concannon, Sarah Heaton, Mapping the Contours of the Experimental Use Exemption: 35 U.S.C. § 271(E)(1)'s Past, Present, and Future (2000)

*Bassan, Daniela, In Cipro We Trust: But How Do We Feel About Our Drug Patent Laws? (2002)

*Keller, Lauren, Ciprofloxacin and Compulsory Licensing of Pharmaceutical Patents (2002)

Sun, Yi, From Drug-Purchasing Trips to Canada to Fighting AIDs in Africa -- Reform Patent Protection to Reduce Drug Prices (2003)

*Lipton, Alissa K., Biopharmaceuticals: The Patent System and Incentives for Innovation (2004)

*Bradley, Patrick, Patents – the Starting Gun in the Race for the Human Genome (2005)

*Laughlin, Catherine, Incrementalism in Pharmaceutical Research: Incentives and Policy Implications (2006)

Hong, Samantha N., Two Faces on Access to Pharmaceutical Patents: A Look into U.S. Policies on Compulsory Licensing During Public Health Emergencies (2010).

Kuan, Nelson, Legislative Proposals Regarding Patent Settlements Between Brand-Name and Generic Drug Makers (2010).

Ross, Caitlyn J., The Future of Gene Patenting and the Biotechnology Industry after Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office et al. (2010).

Gaudry, Katherine S., Unchartered Territories of the Patent-Restoration Due-Diligence Challenge, 66 Food & Drug L.J. 121 (2011).

9. Financial Investment

Dueker, Kenneth Sutherlin, Hard Science: Trends in Financing Start-Up Biomedical Companies (1996)

10. Use of Academic Research

*Solt, Christine G., Conflicts of Interest in Industry-Sponsored Pharmaceutical Research at Academic Institutions: The Need for a Regulatory Approach to Conflict Management (1995)

*Dueker, Kenneth Sutherlin, Biobusinesses on Campus: Commercialization of University-Developed Biomedical Technologies, 52 Food & Drug L.J. 453 (1997)

*Michaelson, Andrew Z., The Law of the Lab: Using Zerit to Inform Technology Transfer (2002)

*Klein, Peter J., An Empirical Analysis of Technology Transfer from U.S. Academic Medical Centers [redacted version] (2005) [unredacted version] (2005)

Ali, Mayssam H., Ownership of Federally Funded Biomedical Inventions (2009).

11. Regulatory Reform

*Oliver, Kevin P., Drug Approval in the United States: Problems and Solutions (1995)

*Ruger, Theodore W., The European Medicines Evaluation Agency and FDA Reform, 108 Harv. L. Rev. 2009 (1995)

Price, Elizabeth C., Teaching the Elephant to Dance: Privatizing the FDA Review Process, 51 Food & Drug L.J. 651 (1996)

Revellino, Tracey M., What Do We Have To Lose?": An Analysis of the FDA's Policy Regarding the Development of AIDS Drugs (1996)

*Wood, H. Maria, Learning from Prozac: A Case Study on Reforming the FDA Drug Approval Process (1997)

12. Laetrile and Cancer Quackery

Drescher, Gregory P., What's in an Apricot?: The Seeds of Life and Death (1995)

Groothuis, Erik S., Laetrile: The Power of Hope (1996)

Blohm, Lindsay, Dr. Koch: A Cancer Quack? (2006)

13. Unapproved Drugs

*Bachman, Bryson, Political Legitimacy and the FDA: A New Approach to the Debate over the Right to Life-saving Drugs (2007)

Muccio, Tammy M., Guaifenesinand FDA Approval of Marketed Unapproved Drugs: Protecting the Public or Protecting Profits? (2007)

*Shimada, Tomomi, Do Terminally Ill Patients Have the Right to Use Investigational Drugs? – The Analysis of Abigail Alliance v. von Eschenbach and the Suggestion for Japanese System for Expanded Access to Drugs (2007)

14. Incentives for Development

Qadrud-Din, Javed B., Market Exclusivity Extensions as a Means to Increase the Pace of Useful Drug Enhancement (2010)

D. Regulation of Nonprescription Drugs

1. Switch from Prescription to Nonprescription Status

Kisloff, Michelle A., The H2 Blockers' Rx-to-OTC Switch: For Whom Will It Spell Relief? (1995)

Price, Leland L., Sweetening the Bitter Pill: Rx to OTC Switches via a Third Class of Drugs (1995)

Rowley, Fred A., Switching Drugs from Prescription to Over-the-Counter: A Comparative Analysis (1996)

Dekhtyar, Ada, A Difficult Proposition: Oral Contraceptives' Switch from Prescription to Over-the-Counter Status (1997)

Lewis, Susan R., Oral Contraceptives: The Road to Over-the-Counter Availability (1999)

*Reilly, Gregory W., The FDA and Plan B: The Legislative History of the Durham-Humphrey Amendments and the Consideration of Social Harms in the Rx-OTC Switch (2006)

Lydon, Amanda, The FDA’s Decision to Make Emergency Contraception Available Without a Prescription: Guaranteed Access for Women or Just the First Step? (2007)

Wright, Sarah C., Controlling Contraception: The Case for Over-the-Counter Availability of Nonemergency Oral Contraceptives (2010).

2. OTC Drug Monographs

Gorji, Perham, OTC Sunscreen Drug Products: Toward Greater Protection (1997)

Sandier, Michael B., The Regulation of Toothpaste (1997)

Matlack, Sarah, From Tanning Accessory to Health Necessity: History of the OTC Sunscreen Monograph in Light of the Sunscreen Revolution (2009).

Boychenko, Lisa A., A Real Burn: Sunscreen Labeling in the Face of FDA Inaction (2011).

3. OTC Drug Labeling

Yahr, Kimberly A., Foreign-Language Labeling of Food and Drugs in the Wake of Ramirez v. Plough Inc.: Is an Official Language the Solution for America? (1994)

Legree, Keila, O No Seas: A Non-Prescription Drug Manufacturers Duty to Warn in a Foreign Language (1996)

*Arai, Ryan, English is Not Enough: The Language of Food and Drug Labels (2002)

E. Pediatric Testing and Labeling

Burns, Amy C., Pediatric Use Labeling: Regulatory Developments, Reactions, Further Reform (1996)

Gendell, Stephanie, Jill, A Dose of Your Own Medicine?: Drug Testing on Children and Labeling Drugs for Pediatric Use --Essential Needs (1997)

Brown, Nathan A., Baby Steps Toward Better Pharmaceutical Care: Market Exclusivity Incentives to Research Pediatric Drug Uses Under the FDA Modernization Act of 1997 (1998)

Ho, Derek T., Adopting the Therapeutic Orphan? A Legal and Regulatory Assessment of the FDA's Pediatric Testing Rule (2000)

*Breslow, Lauren Hammer, The Best Pharmaceuticals for Children's Act of 2002: The Rise of the Voluntary Incentive Structure and Congressional Refusal to Require Pediatric Testing, 40 Harvard Journal on Legislation 133 (2003)

Claiborne, Anne B., Researching and Regulating Prescription of Psychotropic Drugs in Adolescents (2003)

Doerner, Kristina M., What about the Children?: FDA's Response to Pediatric Drug Testing (2003)

Cohen, I. Glenn, Therapeutic Orphans, Pediatric Victims? The Best Pharmaceuticals for Children Act and Existing Pediatric Human Subject Protection, 58 Food & Drug L.J. 661 (2003).

F. Geriatric Testing and Labeling

G. Orphan Drugs

Gardner, John S., Profit Windfall or Patient Windfall? The Orphan Drug Act and Proposals for Its Reform (1994)

*Garcia, Anton Leis, Is the Copy Better than the Original? The Regulation of Orphan Drugs: a US-EU Comparative Perspective (2004)

*Fu, Helen C., Incentives to Innovate and Compete under the Orphan Drug Act: An Industry Profile and Analysis (2009)

H. Contraceptive Drugs

Ramirez, Vernadet, RU-486: A Lesson in Responsibility and Accountability (1994)

Stairs, Elizabeth, FDA Regulation of RU-486 (1994)

*Albert, Randi M., Providing Incentives to Industry to Develop New Contraceptives (1995)

Sheffron, Michelle L., FDA Regulation of Norplant (1997)

*Field, Heather M., Increasing Access to Emergency Contraceptive Pills Through State Law Enabled Dependent Pharmacist Prescribers, 11 U.C.L.A. Women's L.J. 141 (2000)

*Hogan, Julie A., The Life of the Abortion Pill in the United States (2000)

Wilson, Lisa A., Waiting for Mifepristone (2000)

*Pinho, Elizabeth, The Story of RU-486 in the United States (2001)

*Capiello, Laura A., A Matter of Necessity: The Case for Mandating Health Insurance for Contraception (2002)

*Hayenga, Matthew A., Oral Contraceptives and the Learned Intermediary Doctrine (2002)

*Kaufmann, Laura Amy, The Politics of Steroid Contraceptives: The FDA's Impact on Birth Control in the United States (2002)

*Zolman, Robyn E., Insurance Coverage of Prescription Contraceptives (2002)

*Lee, Marian, When Plan A Fails, We Need Plan B (2004)

Prieto-Gonzalez, Mayelin, Empowering Women: A Feminist Argument for Over-the-Counter Sale of Oral Contraceptives (2005)

Carlson, Sarah, The Politics of Emergency Contraception: How Broad Refusal Clauses Are Unwise and “Against Medical Advice” (2007)

I. Controlled Substances

Hunn, Trina R., FDA and the Medical Use of Marijuana (1994)

Bunting, Stephanie L., Waiting to Exhale: Medical Marijuana and Its Uncertain Future (1995)

Edelson, Christopher P., Toward Rational Regulation of Marijuana in the United States: FDA's Role in Consumer Choice and Safety (1995)

LeCraw, Linda L., The Ongoing Interplay among Congress, Administrative Agencies, and Citizen Groups Surrounding Regulatory Issues: Medical Marijuana as a Case Study (1995)

Groen, Eric G., The FDA and DEA: A Proposal for Reform (1996)

*LeCraw, Linda L., Alternate Routes of Reformist Activism: Medical Marijuana as a Case Study of Initiatives Within and Beyond Statutorily Prescribed Channels (1996)

Doblin, Rick, Regulatory Limits on the Use of Prescription Drugs: Implications for the Medical Use of Marijuana and Psychedelics (1997)

Finch, E. Laurita, The History of Medical Marijuana in the United States and Its Implications for the Current Legal Impediments to the Medical Use of Marijuana in the States (1997)

*Leckie, Dean W., State Medical Marijuana Initiatives: A Justification and Analysis (1998)

*Ransom, Jesse J., "Anslingerian" Politics:  The History of Anti-Marijuana Sentiment in Federal Law and How Harry Anslinger's Anti-Marijuana Politics Continue to Prevent the FDA and Other Medical Experts from Studying Marijuana's Medical Utility (1998)

Boyle, Kevin, The Classless Drug Classification System (2000)

*Lewis, Donald D., Therapeutic MDMA (Ecstasy) and the Federal Government: A Cloudy Past and A Hopeful Future (2000)

*Dubin, Jessica M., Rapists Discover New Weapons: The Problem and Response to Drug-Facilitated Sexual Assault (2001)

Ferkel, Greg M., Stopping Traffic: An In-Depth Analysis of the Controversial New Film and What It Says About the United States' War on Drugs (2001)

Kalam, Murad, The Food and Drug Administration and Drug Legalization: A Brief Model of Regulation (2002)

*Margolin, Allison B., On the Right to Get High (2002)

*Pacheco, Richard J., The Use and Misuse of OxyContin (2002)

*Thomas, Aaron, Overdose: A Screenplay (2002)

*Wong, Brian J., Doping in Sport: An Overview and Analysis of Doping and Its Regulation in International Sport (2003)

Zusman, Mara Beth, New Approaches to the Methamphetamine Epidemic (2004)

*Lee, Yu-Hsuan, Performance Enhancing Drugs: History, Medical Effects & Policy (2006)

*Tohidi,, Ramin, Anabolic Steroids: A Look at Potential Drug Testing Legislation and its Constitutional Implications (2006)

*Morril, Jane Marion, Methadone: A History of the Federal Government’s Struggle to Balance Treatment and Regulation in the 20th Century (2007)

*Chang, Daniel D., Military Drug Use in the Literature of the Vietnam War (2008)

*Lee, Young, Methamphetamine: Our Nation's Chronic Illness (2008)

Washington, Whitney E., Federal Enforcement of the Controlled Substances Act: Striking a Balance Between Enforcement and the Regulation of Medical Practice (2009)

Grayson, Katherine E. Eubanks, Federal and State Regulations to Combat Methamphetamine: Where We've Been, Where We're Going, and What We Can Learn (2010).

J. Complementary and Alternative Medicine

1. Homeopathic Drugs

Lari, Ayla, FDA Regulation of Homeopathy: Past, Present, and Future (1996)

Gelfond, Rebecca J.,Regulating Homeopathic Drugs: Pragmatic Solutions for the Food and Drug Administration (1999)

*Huey, Joanna N., Improving Safety and Informing the Public: A Gradual Transition of the Regulation of Homeopathic Drugs (2010).

2. Traditional Chinese Medicine

DeGraff, Enoh T., FDA Regulation of Imported Non-Complaint Chinese Herbal Remedies (1997)

*Kim, Anna L., Searching for a Cure: The FDA's Regulatory Approach to Traditional Chinese Herbal Medicine (1997)

Hwang, Tricia M., FDA and the Challenge of Alternative Medicine: Realistic Assessments and Regulatory Flexibility (1997)

*McCray, Donyelle C., Systems Healing for the FDA: An Examination of the Conventional Obstacles and Holisitc Solutions to Herbal Medicine Regulation (1999)

Chan, Justin H. Y., Mixing the Old with the New: Chinese Traditional Medicine and The Regulation of Food and Drugs in the United States (2000)

Li, Weishi, A Future for Herbal Medicines, 19 Journal of Contemporary Health Law and Policy 117 (2002)

K. Regulation of Physician Prescribing

Corrigan, Kerry A., Physician Prescribing Practices and Adverse Drug Reactions: A Proposal for Further FDA Regulation of Prescription Drugs (1995)

Pritchard, Robert H., Off-Label Uses of Approved Drugs: A New Compromise is Needed (1995)

Berry, Carol R., The Dividing Line Between the Role of the FDA and the Practice of Medicine: A Historical Review and Current Analysis (1997)

Stennes, Matthew L., The Criminalization of Innovation: FDA Misdirection in the Najarian and Burzynski Cases (1997)

*Cohen, Jacqueline, The Government’s Role in the Growing Medical Domain (2007)

Skoumbis, Georgia, The Suitability of Federal Control Over the Practice of Medicine: Striking the Appropriate Balance Between Protecting Public Health and Patient Access to Medical Treatments (2007)

Weldon, Laura, An Historical Analysis of Aid in Dying: Understanding and Regulating the Relationship between Medicine and Death (2007)

Lin, ChingPin, Evidence-Based Guidelines and Their Influence on the Standard of Care (2011).

L. Regulation of Drug Distribution

*Gerber, Monica R., Restrictions on Distribution or Use of Prescription Drugs: Current Practices and Future Products (2003)

M. Drug Prices

1. The Cost of Drugs

Sun, George H., Should Prescription Drug Prices in the United States be Regulated? A Public Policy Debate (1996)

*Fiorenzo, Bradley J., Prescription Drug Pricing: How Much is Too Much? (2000)

*Shah, Tarak, Equitable Division of International Joint Costs in Pharmaceutical Research and Development (2004)

*Young, Patricia, Perfect Price Discrimination for the Global Drug Market: Applying Economic Principles to Drive Innovation and Ensure Global Access [redacted version: graphics deleted] [unredacted version] (2005)

*Benson, Eric, Prescription Drug based Strategies for Controlling Healthcare Costs: A Survey of Proposed Strategies (2007)

2. Government Reimbursement for Drug Costs

Lubinsky, Charles A., Coverage Issues in the Government Reimbursement of Drugs: Some Legal and Policy Issues (1995)

*Geertsma, Meleah A., Medicaid Pharmacy Benefits Waiver Programs: A Deference Argument for Process in Informal Agency Actions (2003)

*Berman, Stefanie, A Legislative History of the Medicaid Drug Rebate Law: The Drug Industry and the Crusade of Senator David Pryor (2004)

*Gonzalez, William, An Analysis of the Medicare Prescription Drug Improvement and Modernization Act of 2003: A Win-Win for the Elderly and the Prescription Drug Insdustry (2004)

*Zachary, Jennifer The Evolution and Future of the Medicare Chemotherapy Concession (2004)

*Shaw, Coral, Medicare Part D: Prescription For Continued Debate (2007)

3. Americans with Disabilities Act

*Kaminski, Stephen T., Must Employers Pay for Viagra?: An Americans with Disabilities Act Analysis Post Bragdon and Sutton, 4 DePaul J. of Health Care L. 73 (2000)

4. Patents and Developing Countries

*Anderson, Jonas, Pharmaceutical R&D and Neglected Diseases: How the International Intellectual Property Regime Can Be Leveraged to Assist Developing Nations (2006)

*Lau, Stacy J., The Illusory Promise: Patents’ (Lack of) Power to Incentivize Drug Development for Poor Countries (2006)

Ornelas, Ariana, PhRMA-Dynasty: How to Provide Antiretroviral Access to Developing Nations while Aligning Research Incentives for Pharmaceutical Companies in the Form of Profit and Intellectual Property Protection (2006)

Koo, Sang-Yeop, Comparative Study on the Organization and the Enforcement System of FDA and KFDA (2008).

Liu, Kuanling, Access to Medicine: Pharmaceutical Patents and Public Health Needs under the WTO Framework (2008).

Park, Jonghyuns, International Struggles for Drugs: How to Achieve Innovation and Accessibility in Drug Industry (2008)

N. Managed Care

Osvald-Mruz, Christine A., PBM and Pharmaceutical Company Mergers: Policy and Regulatory Implications (1995)

Wickersham, Jacqueline J., Managed Care and the Pharmaceutical Industry (1995)

Babiskin, Lisa M., The Need for FDA to Revisit Policy in Response to Managed Care (1996)

Janower, Cynthia R., Implications of the Transformation of the Health Care Marketplace on the Regulation of Ethical Pharmaceuticals (1996)

*Carson, Cheryl B., The Effect of Managed Care on the Pharmaceutical Industry (1997)

Ragade, Anjani R., Managing "Managed Care": The Changing Role of the FDA In Light of A Changing Mark (1997)

O. Pharmacy

Trivedi, Harit U., A Pharmacist's Duty to Warn: Sound Economics, Effective Medicine, and Consistent with Drug Regulation Theory (1995)

*Nunnelley, Michael, (2002)

P. Counterfeit Drugs

*Asamoah, Afia, Not As Easy As It May Appear: Using RFID to Fulfill PDMA's Elusive Pedigree Requirement, 61 Food & Drug L.J. 385 (2006)

*Lee, Jennifer A., Counterfeit Drugs: A Growing Public Health Risk in Need of a Multi-factored Solution [redacted version][unredacted version] (2005)

*Newman,Daniell, The Next Big Thing: Radiofrequency Identification Technology in Industries Regulated by the Food and Drug Administration (2005)

*Lazar, Simon, Progress Report: A Comprehensive Evaluation of the FDA’S Battle against Counterfeit Drugs (2006)

Gerasimchuk, Julia, Clicking to Health? A Look at Online Pharmacies, Countereit Medicine, and Drug Reimportation (2011).

Q. Health Privacy

Netter, Wendy J., Curing the Unique Health Identifier: A Reconciliation of New Technology and Privacy Rights 43 Jurimetrics J. 165 (2003)

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VII. Animal Feed and Drugs

Bendheim, Daniel M., FDA Regulation of Recombinant Bovine Somatotropin (1995)

Shanmugam, Kannon K., America and the BSE Scare: Near Misses, Future Lessons (1997)

Barclay, Elizabeth A., Subtherapeutic Use of Antibiotics in Animal Feed: In Light of an Unresolved Clash of Expert Paradigms Should We Punt to the Consumer in Decade Four? (1998)

Schlotthauer, Brent G., Bovine Spongiform Encephalopathy: The Past, Present, and Future of Mad Cow Disease in the United States (1998)

*Bigg, Michael J., Bovine Spongiform Encephalopathy: A Critique of the European Union Report (1999)

Cantor, Alison E., Adequacy of FDA's Response to Mad Cow Disease (1999)

Suit, Neal J., Antibiotic Resistance: Proposals to Deal with the New Wrinkles on an Old Problem (2000)

Tibbetts, Cody, FDA's Regulation of Animal Feed: Labeling and Branding Shortcomings (2002)

*Patrick, Justine S., Deconstructing the Regulatory Facade: Why Confused Consumers Feed their Pets Ring Dings and Krispy Kremes (2006)

Barrella, Nigel A., An Impossible Balance: Antibiotic Resistance, Profits, and Public Health (2011)

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VIII. Human Biological Patterns

A. Definition of Biological Product

B. Biological Product Licensure

Shen, Christopher K., The Food and Drug Administration's Proposed Changes to the Biologic Approval System: "A Bridge Too Far" or "So Close And Yet So Far?" (1996)

*Dudzinski, David M., Reflections on Historical, Scientific, and Legal Issues Relevant to Designing Approval Pathways for Generic Versions of Recombinant Protein-Based Therapeutics and Monoclonal Antibodies, 60 Food & Drug L.J. 143 (2005)

Jacobstein, Jacob M., FDA Regulation of Stem Cell Therapies (2009)

Sorscher, Sarah E., A Longer Monopoly for Biologics?: Considering the Implications of Data Exclusivity as a Tool for Innovation Policy, 23 Harvard Journal of Law & Technology 285 (2009).

Gaudry, Katherine S., Exclusivity Strategies and Opportunities in View of the Biologics Price Competition and Innovation Act, 66 Food & Drug L.J. 587 (2011).

C. Vaccines

Aaronson, William H. Tort Liability for Vaccine Manufacturers (1994)

Sheft, Mark A., The National Childhood Vaccine Act (1994)

*D'Annunzio, Michael A., The Anthrax Vaccine Immunization Program: History, Controversy, and Legal Issues (2000)

*Davenport, Katherine A., Vaccines and the National Vaccine Injury Compensation Program (2000)

*Kotzer, Natalie R., The Captive Audience: A Review of Public Information on the Safety of The Hepatitis B Vaccine, Especially as It is Being Mandated for Newborns and Young Children (2000)

*Corrigan, Shara L., Total Force Anthrax Vaccine Imunization Program: Controversy and Conflagration (2001)

Gelfand, Rebecca A., Ensuring a Consistent Supply of Anthrax Vaccine (2002)

*Greilsamer, Glenn J., Aiding AIDS: Hurdling the Obstacles to the Development of an Effective AIDS Vaccine (2002)

*McCarty, Catherine M., Mandatory Vaccines: Questionable Federal Policy Informing Questionable State Laws (2002)

*Millikin, Christopher E., Responding to First Responders: A Proposal for a Smallpox Vaccine Injury Compensation Program (2003)

*Pang, Betty C., The National Vaccine Injury Compensation Program: A Program Evaluation (2003)

*Ray, Amy W., The Vaccine Additive Thimerosal: Causation and Compensation for Children with Autism (2003)

*Balding, Ben, Mandatory Vaccination: Why We Still Got to Get Folks to Take Their Shots (2006)

*Young, Diane, Influenza since 1918: Pandemics and Preparation (2007)

Rubin, Jenna G., Our Daughters' Keepers?: An Overview of the Debate Regarding an HPV Vaccination for Men (2009).

Steinbrook, Hillary W., Midsguided Mandate: Why Pre-Adolescent and Adolescent Girls Should be Able to Choose Whether to Receive the Human Papillomavirus Vaccine (2010)

Su, Shi, Guilty Even After Proven Innocent: The Vaccine-Autism Myth and Its Consequences (2011)

D. Blood

Russell, Lisa S., The Inadequate Response of the FDA to the Crisis of AIDS in the Blood Supply (1995)

Yugaki, Janice R., Tainted Blood: A Political and Cultural Analysis of the HIV-Scandal in Japan, 1983-1998(1999)

*Wagner Partin, Sally M., Bad Blood: An Examination of the Ban on Gay Blood Donation (2010)

E. Organs

Johnson, Harry I., FDA Regulation and Organ Transplantation (1994)

*Crandall, Rhonda K., Xenotransplantation: Promise, Peril, and the Need for Regulatory Oversight (1999)

Chandler, Jennifer A., Procurement of Transplantable Organs from Executed Prisoners in China: Can Foreign States Prevent Their Nationals from Obtaining Transplants in China? (2002)

James, Christopher, Selling Organs: The Answer to the Burgeoning Organ Deficit (2002)

*Ortiz de Leon, Doraliz E., FDA Regulation of Tissue-Engineered Replacement Parts for Humans (2003)

Chern, Arthur S., Regulation of Organ Transplants: A Comparison Between the System in the United States and Singapore (2008)

Criswell, Phillip J., The FDA and the Regulation of Human Organs (2010)

F. Tissue

Austin, Susan A., A Policy Analysis of How FDA Should Regulate Human Bone Marrow Transplantation (1995)

Harbach, David V., II, Regulation of Human Tissue for Transplantation (1997)

Pariser, Daniel S., Manipulated Autologous Cell Products and the FDA: Culturing a Rational Regulatory Policy (1997)

Williams, Marc O., The Regulation of Human Tissue in the United States: A Regulatory and Legislative Analysis, 52 Food & Drug L.J. 409 (1997)

Wang, Mary H., FDA Oversight of the Tissue Bank Industry (2002)

Han, Aera, The Ethical and Regulatory Problems in the Stem Cell Scandal (2006)

Pierson, Anne Clark, Handling the Misalignment of Interests in Assisted Reproductive Technology Practices (2010)

G. Gene Therapy

Tang, Terry L., Germ-Line Gene Therapy and the Need for a Coordinated Regulatory Framework (1996)

Choi, Han W., Gene Therapy and the Law: An International Perspective (1997)

*Herdman, Karah S., Federal Regulation of Gene Therapy: Who Will Save Our Germline (2003)

*Woodruff, Michele Rose, Gene Therapy: Cure or Poison? The Proper Role of the FDA in the Bubble Boy Disease Question (2004)

H. Genetic Testing

*Yang, Tamara J., Predicting the Genetic Makeup of FDA (2000)

*Geetter, Jennifer S., Coding for Change: The Power of the Human Genome to Transform the American Health Insurance System, 28 American J. of Law & Medicine 1 (2002)

*Harrison, Margaret, Reaping the Full Health Benefits of the Human Genome: The Duty to Warn and the Need to Establish a Comprehensive Federal Regulatory Structure for Genetic Testing (2002)

Vorhaus, Dan, The $1,000 Challenge to Genomic Research (2007)

I. Cloning

Vosk, Ted, Human Cloning and FDA Regulation (1998)

Carmody, Allison R., Borrowing Trouble: Should the FDA Regulate Human Cloning? (2000)

Paul, Darcy A., The Historical Development of Cloning, Technology and the Role of Regulation in Ensuring Responsible Applications (2003)

Wu, Chun-Ying, A Hypothetical Case: United States of America, Plaintiff, v. Clonaid Company, a Biotechnology Corporation, Defendant (2003)

J. Assisted Reproductive Technology

Leef, Megan Rachelle, The Infertility Industry: Inspiring Technology Gives Birth to Complex Moral Uncertainties (2002)

*Lindstrom, Laura J., Reproduction in the Genetic Age: A Proposed Scheme for the Regulation of Assisted Reproductive Technologies (2002)

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IX. Medical Devices

A. Medical Device Amendments of 1976

1. Definition of Device

Moss, Nicole J., FDA Regulation of Health and Fitness Equipment (2000)

2. Labeling

Williams, S. Reginald, Regulation of Quack Devices: It's a Miracle . . . Or Is It? (1994)

Delacourt, John T., Labeling as Misbranding and Overwarning (1996)

Kohen, Jamie M., The History of the Regulation of Menstrual Tampons (2001)

*Samuel, Anand, FDA Regulation of Condoms: Minimal Scientific Uncertainty Fuels the Moral Conservative Plea to Rip a Large Hole in the Public’s Perception of Contraception (2005)

3. Safety

Solt, Christine G., Cardiac Catheter Reuse in an Era of Reform: Cost-Efficiency and Regulatory Policy in the Face of Scientific Uncertainty (1994)

Weiss, David S., FDA Regulation and Patient Assisted Suicides (1995)

*Kuo, Emily T., An Indecipherable Debate?: An Overview of Opposing Perspectives and the Search for a Coherent Regulatory Scheme for the Reprocessing and Reuse of Single-Use Medical Devices (2000)

*Joshi, Rayan, Artificial Heart Research: An Historical Perspective (2001)

Zepeda, Paloma A., Regulating Insanity: Football, Dementia and the Case for FDA Intervention (2009)

4. Premarket Review

Goldberger, Benjamin A., The Evolution of Substantial Equivalence in FDA’s Premarket Review of Medical Devices, 56 Food & Drug L.J. 317 (2001)

Zollinger, Geri T., Reassessing Pre-Market Regulation of Class III Medical Devices (2003)

5. Premarket Approval

*Mystal, Elie, Regulating Cochlear Implants: The Legal Response to a Scientific and Cultural Revolution (2003)

Tilleman, Tamara R., Cosmetic Use of Injection Silicone Oils; Approved Material with Unapproved Procedure. Time to Ban “Off-Label” Use? [redacted version] [unredacted version] (2005)

6. Home Use Diagnostic Products

Silliman, Amy L., AIDS Home Test Kits (1994)

Zablow, Sheila, The HIV Home Test Kit and the Quest for FDA Approval (1996)

*Zablow, Sheila, The LARS: A Proposed Approach for FDA Evaluation of Home Testing Products (1996)

Bair, Stephanie P., The Past, Present, and Future of Direct-to-Consumder Genetic Testing: What We Have Learned and Why Increased Regulation Is Warranted (2011)

7. Combination Products

*Schillinger, Danielle C., The Office of Combination Products: Its Roots, Its Creation, and Its Role (2005)

8. Pediatric Devices

*Warshauer-Baker, Esther, Encouraging Research and Development of Pedicatric Medical Devices Through Legistlative and regulatory Action: The Pediatric Medical Device Safety and Improvement Act of 2007 in Context, 64 Food & Drug L.J. 531 (2009)

B. Radiation Control for Health and Safety Act

Fraser, Leigh R., Should Tanning Salons Be Banned? (1995)

Damman, Kirk A., Dangerous Safety: The Failure of Medical Radiation Regulation to Protect the Patient (1999)

Wisz, Jamie, Potential Hazards of Cellular Phone Radiation: Responses to Fear and Uncertainty (2002)

*Tran, Vivi, The Radiation Control for Health and Safety Act of 1968: History, Accomplishments, and Future (2006)

C. Mammography

Jones, Michelle A., Regulating Mammograms (1998)

*Wheeler, Claire Daise, The Mammography Quality Standards Act: Misread Mammograms, Malpractice, and the Politics of Regulation (2003)

D. Technology Assessment

E. Reimbursement

Yeon, Susan B., The Scope of Medicare Reimbursement for New Medical Devices: Impact on Device Availability and the Standard of Care (1995)

F. [Reserved]

G. Breast Implants and Other Cosmetic Devices

Liao, Robert H., Breast Implants (1994)

Granoff, Susan N., Misplaced Mandate: An Examination of FDA's Silicone Breast Implant Policy (1995)

Simme, Jodi L., . . . And the Breast is History: Issues Surrounding FDA Regulation of Silicone Breast Implants (1995)

Simonian, Leonard A., The Breast Implant Debacle (1996)

Friedland, Shelly L., FDA's Role in the Silicone Breast Implant Story (1997)

Webb, M. Sharon, Cleopatra's Needle: The History and Legacy of Silicone Injections (1997)

*Connelly, Ellen, From Regulation to Litigation: An Analysis of the Silicone Breast Implant Controversy (2000)

*Abrams, Karen, The Silicone Gel-Filled Breast Implant Controversy: Testing the Bounds of Regulatory Intervention (2004)

*Kim, Angela E., “Wine, Cheese and a Dash of Poison in the Forehead”: Exploring the Evolution of the Injectable Filler Industry and the Consequent Implications for Regulatory Action (2006)

H. Telemedicine

*Harris, Gregory A., The Future of Telemedicine: Overcoming the Barriers to Distance Learning, Diagnosis, and Treatment (1999)

Labadie-Jackson, Glenda, FDA Regulation of Telemedicine (1999)

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X. Cosmetics

Liang, Bryan A., It's Only Skin Deep: FDA Regulation of Skin Care Cosmetics Claims 8 Cornell J. of L. & Public Policy 249 (1999)(with Kurt M. Hartman)

Hensel, Donald P., FDA Regulation and the New Anti-Aging Products (1995)

Grow, Lisa Anne, Cosmeceuticals: A Proposal for Regulatory Reform (1996)

Heymann, Laura A.,The Cosmetic/Drug Dilemma: FDA Regulation of Alpha-Hydroxy Acids, 52 Food & Drug L.J. 357 (1997)

Davis, William L., The Hidden Costs of Sexier Lipstick: Animal Testing in the Cosmetic Industry (1999)

*Menechios, Anatasia, Sixty Years Later: The Survival of the 1938 Coal and Tar Hair Dye Exemption (2000)

Griffin, Carrie, Henna Tattooing: Cultural Tradition Meets Regulation, 62 Food & Drug L.J. 779 (2007)

Youngerwood, Aron, From Creams to Lasers: Regulating the Beauty Industry in the New Millenium (2002)

Brown, Laurel, Examining the FDA’s Under-sight of Celebrity Dermatologists in the Cosmeceuticals Industry (2005)

*Daum, Casey, Self-Regulation in the Cosmetic Industry: A Necessary Reality or a Cosmetic Illusion? (2006)

*Elliott, Nakia, Cosmetic Regulation: The Case for Reform (2006)

*Schaffer, Sarah, Reading Our Lips: The History of Lipstick Regulation in Western Seats of Power, 62 Food & Drug L.J. 165 (2007)

Lee, Minsun, The Expanding "Cosmeceutical" Conundrum: The Growing Need for Heightened FDA Regulations in the Face of Modern Day Cosmeceuticals (2011)

Panis, Sarah, Stem Cells Intended for Cosmetic Use Only: Regulation in Belgium, Europe and the United States (2011)


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XI. Regulation of Carcinogens

Feinberg, David M., Cookbook for a Consistent Food Safety Standard for Carcinogenic Foods: Looking to the Ingredients of Food Rather than its Recipe (1995)

*Klimko, Katheryn E., FDA's Contradictory Decisions Related to the Delaney Clause (2011)

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XII. Biotechnology

A. General

Israelsen, R. Burns, Portrait of a Professional Plaintiff: Jeremy Rifkin's Crusade Against Biotechnology (1997)

*Naik, Paul S., Jeremy Rifkin: An Examination of the Efforts of an Anti-Biotechnology Activist (1999)

*Stepp, David L., The History of FDA Regulation of Biotechnology in the Twentieth Century (2000)

Winickoff, David E., Governing Population Genomics: Law, Bioethics, and Biopolitics in Three Case Studies, 43 Jurimetrics J. 187 (2003)

Wu, Chuan-Feng, Regulations on Biotechnological Research and Biologically Modified Products (2002)

Lumelsky, Anna E., Genetic Testing and Government Regulation: The Growing Significance of Pharmacogenomics (2003)

*Hong, Kristy, Breakthrough Biotechnologies: Can the FDA Keep Up with the Speed of Science? (2004)

B. Food

Bolce, Margaret E., FDA Regulation of Food Biotechnology (1994)

McGraw, Donna E., The FDA Should Revise Their 1992 Policy Statement to Require Labeling on Certain Genetically Altered Fruits and Vegetables (1994)

Rabinowitz, Stephen S., Anti-Sense and Common-Sense: Regulation of Food From Genetically Engineered Plants (1994)

Badros, Mark J., Regulation of Genetically Engineered Food Products: A Market-Oriented Perspective (1995)

Thelen, Jennifer A. FDA Regulation of Food and Drug Biotechnology (1995)

*Yoelson, Allana, USDA and FDA Regulations: "The Attack of the Killer Tomato" (1996)

Kleinberg, Rachel D., European and American Attitudes Toward Genetically Modified Foods: The Effect that Public Opinion Has and Should Have in Regulation (1997)

*Moncrief, Aliki, Genetically Engineered Foods: Labeling to Protect Human Health and the Environment (1999)

Winn, Lara Beth Sheer, Special Labeling Requirements for Genetically Engineered Food: How Sound Are the Analytical Frameworks Used by FDA and Food Producers?, 54 Food & Drug L.J. 667 (1999)

Nyereyegona, Christine J., Alice and the Frankenfoods: A Well Regulated Wonderland? (2003)

Lincicum, Matthew V., Synthetic Meat: An Ethical, Environmental, and Regulatory Analysis (2010)

Dickos, Peter G., The Next Frontier in Food: FDA Regulation of Genetically Engineered Animals (2011)

Goubau, Alain, The AquAdvantage Salmon Controversy--A Tale of Aquaculture, Genetically Engineered Fish and Regulatory Uncertainty (2011)

C. Drugs

Colodny, Mark M., The Capital Crisis in Biotech and the Invisible Costs of Regulation (1995)

*McWilliams, Douglas E., Reforming Drug Approval in the United States: Measures Necessary to Alleviate the Cash Crunch Faced by Small Biotechnology Companies (1995)

Cha, Myoungil, Pharma-Biotech Alliances: A Case Study [Redacted Version][Unredacted] (2004)

*Guo, Karen, Biopharming: Unique Challenges and Policy Proposals (2004)

*Quisel, John D., Regulating Transgenic “Pharm” Plants: Pre-Commercialization Review and Post-Commercialization Monitoring (2004)

Fahnestock, Derek, Accomodating Pharmacogenomics: Fulfilling the Promise of Individualized Medicine (2005)

*Gutmann, Valerie, A New Era in Drug Development: Legal and Ethical Implications of Pharmacogenomics (2005)

D. Animal Drugs

*Bendheim, Daniel M., The FDA and RBST: How the Milk Debate Turned Sour (1996)

*Bartholomew, Jamie Lynn, The Off-Label Use of Acepromazine Maleate (2006)

E. Ethical Considerations

*Lee, Susan S., A Due Process for Bioethics (2002)

XIII. Nanotechnology

*MacDonald, Brianna, Perspectives on FDA’s Regulation of Nanotechnology: Emerging Challenges and Potential Solutions, 8 Comprehensive Reviews in Food Science and Food Safety 375 (October 2009)

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XIV. Regulation of Tobacco

Prabhu, Jayant V., The Food and Drug Administration and the Proposed Regulation of Cigarettes (1994)

Brooks, David C., Fred, Joe, and Me: A Call for FDA Regulation of Cigarettes (1996)

New, Jonathan B., Smoke and Mirrors: The FDA's Proposed Regulation of Cigarettes as "Combination Products (1996)

Watson, Damon C., Right for the Job?: The Food and Drug Administration Takes on the Tobacco Empire (1996)

Friedman, Andrew D., What the FDA Doesn't Want You to Hear: Regulation of Tobacco Advertising and Disease-Specific Health Claims (A Hypothetical and a Fictional Discussion) (1997)

Liu, Levi, Advertising, the FDA, and the Tobacco Settlement: As Hopes for Settlement Dim, Challenges of FDA Authority and First Amendment Concerns are Rekindled (1998)

Szubin, Adam J., Leveling the Playing Field: The FDA's Regulation of Nicotine Dependence Products (1999)

Fogel, Joshua L., Tobacco and the FDA: Conflict, Controversy and Closure (2001)

Brooks, Angela, A Retrospective Review of FDA v. Brown & Williamson Tobacco Corporation and the Issue of Congressional Intent (2004)

*Varnum, Ronald M., SHOOT, DON’T SMOKE: A Political and Legal Explanation For Why the Tobacco Industry Settled the Public Entity Lawsuits And the Gun Industry Has Not (2005)

*Lee, Edward J., What is Soft Paternalism, and the Best it has to Offer in the Battle to Quit Smoking (2006)

Friend, Stephen N., FDA Regulation of Tobacco: Can Smokers Really Consent? (2008)

*Chadwell, Seth N., Smokeless Tobacco Regulation (2010)

Weiner, Stephanie R., The Family Smoking Prevention and Tobacco Control Act: An Early Evaluation (2010)

XV. Miscellaneous

Hom, Jonady R., The Seclusion and Restraint of the Mentally Ill Child (1994)

Bramson, Jeffrey S., Tightening Your Belt: Inequities and Inconsistencies Regarding the Treatment of Food, Prescription Drugs, and Cigarettes in the United States Bankruptcy Code (2011)

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XVI. Appendix

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Title Page · Introduction · Outline of Contents · Appendix

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