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] [unredacted version] (2007)

*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)

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] [unredacted version] (2001)

*Ting, Andrew Sing Huo, 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)

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 Ian, 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)

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)

3. The Environmental Protection Agency

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] [Unredacted Version] (2003)

*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] [unredacted version] (2007)

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

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] [unredacted version] (2007)

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)

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 [Redacted Version] [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)

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

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)

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 E., 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, forthcoming, 38 Inter-American Law Review ___ (2006).

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)

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 June, 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] [Unredacted Version] (2003)

*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 Eurpoean Union, and Japan: The ICH Initiative (2003)

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] [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 (June 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))

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)

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, The Project BioShield Act of 2004: An Innovative Failure (2006)

Kasper, Sara, The 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)

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 (2007)

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)

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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)

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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 (2007)

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 A., 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, Olivette, 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)

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  J., 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, The 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 [in press]

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

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)

G. Medical Food

H. Food Sanitation

1. Good Manufacturing Practices

*Axelrod, 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., FDA Regulation of 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)

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, Resistance to FDA Regulation of Raw Milk (2005)

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).

4. Color Additives

*Burrows, Adam, The Palette of Our Palates: A brief history of food coloring and its regulation [Redacted Version] [Undredacted Version] (2006)

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)

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 R., Regulate This: The Politics and Practice of Poo Farming (2006)

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 Irradiaiton: Too Many Risks, Too Few Benefits (1998)

Browning, Paul W., Food Irradiation Labeling (1999)

*Prejean, Jonathan E., Food 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)

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 Shante, From the Farm to the Factory: An Overview of the American and European Approaches to Regulation of the Beef Industry (2004)

*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)

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 (2006)

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

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)

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)

Return to top

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)

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 (2003)

*Gelbwasser, Lara N., "Aint 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)

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)

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. Devesh, 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)

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).

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 Exigencies (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. Mazzariello, 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)

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 Safety? (2000)

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

*Lee, Steve C.,