FOOD AND DRUG LAW AND REGULATION

SECOND EDITION
Edited by David G. Adams Partner, Venable LLP Adjunct Professor, George Washington University School of Law Richard M. Cooper Partner, Williams & Connolly LLP Martin J. Hahn Partner, Hogan Lovells LLP Jonathan S. Kahan Partner, Hogan Lovells LLP

 2011 FDLI. All rights reserved. ISBN 978-1-935065-44-9 Authorization to photocopy items for internal or personal use of specific clients is granted by the Food and Drug Law Institute, provided that the base fee of US $.75 per page is paid directly to the Copyright Clearance Center (CCC), 222 Rosewood Drive, Danvers, MA 01923, USA. For those organizations that have been granted a photocopy license by CCC, a separate system of payment has been arranged. The fee code for users of the Transactional Reporting Service is: 978-1-935065-44-9/02.75 To order additional copies of this publication, please visit our website at www.fdli.org. 1155 15th St. NW, Suite 800, Washington, DC 20005 Tel: (202) 371-1420 Fax: (202) 371-0649 email: comments@fdli.org website: www.fdli.org

CONTENTS
Preface About the Editors About the Authors Chapter 1: Introduction vi vii viii

Richard M. Cooper, Williams & Connolly LLP

Chapter 2: Food Safety

1 23 101 127

Fred H. Degnan, King & Spalding, LLP

Chapter 3: Food Labeling

Mel Drozen and Eve Pelonis, Keller and Heckman LLP

Chapter 4: Food and Drug Packaging

Devon Wm. Hill and Rachel A. Bond, Keller and Heckman LLP
Chapter 5: Food: Meat and Poultry Inspection

Brett T. Schwemer and Jolyda O. Swaim, Olsson Frank Weeda Terman Bode Matz PC
Chapter 6: Dietary Supplements

157

William R. Pendergast, Brian P. Waldman and Marsha C. Wertzberger, Arent Fox LLP
Chapter 7: Veterinary Food and Drugs

201 247 283 317 355

Eugene Lambert and Jeannie Perron, Covington & Burling LLP

Chapter 8: Cosmetic Regulation Revisited

Gary L. Yingling and Suzan Onel, K&L Gates LLP

Chapter 9: Drugs: General Requirements

Daniel Kracov, Arnold & Porter LLP

Chapter 10: Drugs: INDs and Full NDAs

James N. Czaban, Wiley Rein LLP and Geoffrey M. Levitt, Pfizer

Chapter 11: Generic Drugs, ANDAs, Section 505(b)(2) Applications, Patents and Exclusivities

Lisa Barclay, Zuckerman Spaeder LLP

393

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Chapter 12: Prescription Drug Promotion and Marketing

Kathleen M. Sanzo and Stephen Paul Mahinka, Morgan Lewis Daniel R. Dwyer and Stacy L. Ehrlich, Kleinfeld, Kaplan & Becker LLP
Chapter 14: Human Biologics

425

Chapter 13: Over-the-Counter Drugs

461

Edward L. Korwek and Michael N. Druckman, Hogan Lovells US LLP

Chapter 15: Biosimilars

485 531

Erika Lietzan and Emily Alexander, Covington & Burling LLP

Chapter 16: Medical Devices

Jonathan S. Kahan and Edward C. Wilson, Jr., Hogan Lovells US LLP

Chapter 17: Radiological Health

569

Edward C. Wilson, Jr. and Michael S. Heyl, Hogan Lovells US LLP

Chapter 18: Combination Products and Jurisdictional Issues

621 641 659 705 721 769

Jeffrey K. Shapiro, Hyman, Phelps, & McNamara, P.C.

Chapter 19: Tobacco Products

Joseph A. Page, Georgetown University Law Center

Chapter 20: FDA Regulation of Healthcare Professionals

David G. Adams, Venable LLP

Chapter 21: FDA Administrative Procedures

Ann H. Wion, U.S. Food and Drug Administration

Chapter 22: FDA Enforcement Powers

Scott Bass, Sidley Austin, LLP

Chapter 23: Medical Countermeasures: Emergency Preparedness and Response Roles and Authorities

Brooke Courtney and Elizabeth Sadove, U.S. Food and Drug Administration
Chapter 24: FDA at the International Level

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Linda R. Horton, Elizabethann Wright, Fabien Roy and Alexander Roussanov, Hogan Lovells US LLP

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Chapter 25: FTC Regulation of Advertising

Anne V. Maher, Kleinfeld, Kaplan & Becker LLP and Lesley Fair, Federal Trade Commission
Chapter 26: DEA Regulation of Controlled Substances and Listed Chemicals

923

John A. Gilbert, Jr., Hyman, Phelps & McNamara, P.C.

Chapter 27: Reimbursement, Fraud and Abuse

965 981 1017

Joseph W. Metro, Gail L. Daubert and Gordon B. Schatz, Reed Smith LLP
Index

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PREFACE
Food and drug law occupies a unique position in American jurisprudence: it governs safety, efficacy, labeling and availability of products that are central to health and well being, and that account for 20-25 percent of consumer spending in the United States. From the elegant simplicity of the Pure Food and Drugs Act of 1906 to the technically elaborate FDA Food Safety Modernization Act of 2011, the body of food and drug regulatory law has grown into a vast and complex array of statutes, regulations, interpretive documents and judicial decisions, for which treatment in an authoritative text is needed. In the last several decades, the Food and Drug Law Institute (FDLI) has met this need by developing texts authored and edited by experts from all areas of food and drug law. This book carries on that important mission in greater scope and depth. The books 27 chapters are intended to cover every major aspect of food and drug law and regulation, including five chapters on drugs, four on food, and chapters on dietary supplements, cosmetics, veterinary food and drugs, combination products, biologics and biosimilars, medical devices, radiological health, combination products and tobacco products. Five additional chapters detail the purposes, methods and inner workings of the Food and Drug Administration, including regulation of healthcare professionals; administrative procedures; enforcement authority; the agencys role in emergenciesmedical countermeasures, emergency preparedness and response roles and authorities; and its role at the international level. The final three chapters address the related regulatory missions of other agencies and governmental entities: the Federal Trade Commissions regulation of advertising, the Drug Enforcement Administrations regulation of controlled substances and federal regulation of reimbursement, fraud and abuse. Each chapter was written by one or more attorneys selected for their special expertise in their respective subject matters. Although the authors are attorneys affiliated with federal agencies, a university law school, a pharmaceutical manufacturer and private law firms, they have sought to be objective in the treatment of their subjects. The book provides discussions that are practical, thorough and supported by citations to guide further research. It is intended as a resource for practicing attorneys who want to learn about food and drug law or gain greater expertise in a particular area. It is also intended to complement law school casebooks and as a general reference for law libraries, practitioners in other fields, and those interested in how foods, medical products and cosmetics are regulated by the U.S. government. We thank FDLI for its dedication to publishing this book and the authors for their generosity in sharing their expertise with our readers. David G. Adams Richard M. Cooper Martin J. Hahn Jonathan S. Kahan

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ABOUT THE EDITORS

David G. Adams is Chair of the FDA Practice Group at Venable LLP . Mr. Adams previously held senior positions at the Food and Drug Administration (FDA) in the Office of the Commissioner and Office of the Chief Counsel. He has served as Chair of the American Bar Association Food and Drug Law Committee and as Chair of the Editorial Board of the Food and Drug Law Journal. Mr. Adams also teaches food and drug law as an adjunct professor at the George Washington University School of Law. Richard M. Cooper is a partner in the Washington, D.C. law firm of Williams & Connolly LLP . He has written extensively on food and drug law and has taught that subject at Georgetown University Law Center. He was Chief Counsel of FDA during 1977-1979. Earlier in 1977, he was a special assistant to James R. Schlesinger and a senior member of the Office of Energy Policy and Planning, Executive Office of the President. He was a law clerk to Hon. William J. Brennan, Jr., U.S. Supreme Court, in 1969-70. Martin J. Hahn is a partner at Hogan Lovells. His practice focuses on a wide variety of regulatory issues affecting the food and dietary supplement industries. Mr. Hahn monitors new developments and has co-authored a manual on the regulation of foods derived from biotechnology and a manual on the issues presented by allergens in foods. He has presented numerous speeches on food labeling and food safety and is a frequent speaker for programs sponsored by the Food and Drug Law Institute and the Food Allergy Research and Resource Program. Jonathan S. Kahan is a Co-director of Hogan Lovells food, drug, medical device and agriculture group. His practice focuses primarily on assisting medical device companies in navigating the FDA regulatory process. Mr. Kahan is the author of Medical Device Development: Regulation and Law (Parexel 2009), and Medical Devices: Obtaining FDA Market Clearance (Parexel 1995). He is the Chair of the Deans Advisory Board of the George Washington University Law School. He is the former Chairman of the Federal Bar Association Section on Health and Human Services. He is a member of Phi Beta Kappa and Order of the Coif.

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ABOUT THE AUTHORS

Emily Alexander is an associate in the food and drug practice group in the Washington, D.C. office of Covington & Burling LLP. She provides regulatory advice and strategic guidance to pharmaceutical, biotechnology and medical device companies, as well as related trade organizations, on applicable federal, state and local law. At this time she focuses on, among other things, the regulation of biosimilars and biologics in the United States and foreign jurisdictions, including issues related to data exclusivity, naming and labeling. She has published articles and given speeches on the Biologics Price Competition and Innovation Act of 2009 and was involved in various types of advocacy leading up to the passage of the act. Lisa Barclay is a partner at the law firm Zuckerman Spaeder LLP in Washington, D.C. Ms. Barclay practices in the areas of complex civil litigation, food and drug law, professional responsibility and legal ethics. During her time at Zuckerman Spaeder, Ms. Barclay has drawn from her experience at the U.S. Food and Drug Administration (FDA) in representing a range of clients on food and drug issues. She has represented generic pharmaceutical companies, nonprofit organizations and individuals in litigation and has also counseled these clients on regulatory matters. In the spring of 2011, Ms. Barclay was an adjunct professor at Georgetown University Law Center. Prior to joining Zuckerman Spaeder, Ms. Barclay clerked for Senior Judge William B. Bryant, U.S. District Court for the District of Columbia and practiced civil litigation in the Washington, D.C. office of Weil, Gotshal & Manges, LLP. From 1995-2001, she worked in the Office of the Commissioner at FDA. Ms. Barclay is a graduate of Georgetown University Law Center and The George Washington University. Scott Bass heads Sidley Austins Global Life Sciences Team, coordinating pharmaceutical, medical device, food and dietary supplement matters in the United States, Europe and Asia. Mr. Bass served as an adjunct professor at Georgetown University Graduate School, where he co-taught food safety with the Food and Drug Administration; as Co-Chair of the American Bar Association Food and Drug Law Committee and Chairman of the New York State Bar Association Section on Food, Drug and Cosmetic Law; as an expert in a European Union Commission study and as an advisor on new China drug and device legislation. Mr. Bass has published many articles and books in the pharmaceutical, enforcement and dietary supplement fields. Rachel A. Bond is an associate in the food and drug practice group at Keller and Heckman LLP. Ms. Bond advises domestic and foreign corporations in matters of FDA and international regulatory compliance of food and drug packaging materials. Her work includes assisting clients in establishing clearances for food contact materials under the laws and regulations of the United States, the European Union and Canada. Ms. Bond graduated from the University of Delaware with a BA in Biology in 2003 and received her JD from the George Mason University School of Law in 2006.

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Brooke Courtney is Regulatory Counsel in the Office of Counterterrorism and Emerging Threats in FDAs Office of the Commissioner, where she works on legal, regulatory and policy issues related to medical products for public health emergencies. Ms. Courtney was previously the Director of the Office of Public Health Preparedness and Response at the Baltimore City Health Department and an associate at the Center for Biosecurity. She is the recipient of the Public Health Law Associations Emerging Leader in Public Health Law Award, a term member of the Council on Foreign Relations and a member of an Institute of Medicine committee. She received her JD and Health Law Certificate from the University of Maryland and her MPH from Yale University. James N. Czaban is the Chairman of the Food & Drug Law Practice at Wiley Rein LLP in Washington, D.C. where his practice broadly encompasses government regulation of pharmaceutical, biotechnology, food, medical device and other clients involved in the Life Sciences. Under his leadership, the firm represents such clients with respect to complex regulatory strategies, compliance matters, and in administrative and judicial enforcement actions and other proceedings involving FDA, FTC, DEA, HHS/OIG, DOJ, and other federal and state agencies. Mr. Czaban has a long history of service to the Food & Drug bar, having served as Chair of the Legal Writing Awards Committee of the Food and Drug Law Institute (FDLI) and regularly publishing on and teaching food and drug law for FDLI and other organizations. He is consistently recognized as a leading lawyer in food and drug law, including by Chambers USAs Americas Leading Lawyers, Washingtonian magazine, PLC/ Which Lawyer and other publications. In 2011 Mr. Czaban received the Burton Award for Legal Achievement as a result of his work in the field of biosimilars regulation. Mr. Czaban is a graduate of the University of Virginia School of Law and the University of California, Berkeley. Gail L. Daubert is a member of the Life Sciences Health Industry Group at Reed Smith, practicing in the area of healthcare regulatory law. She provides legal, regulatory and legislative counsel to a variety of professional associations and manufacturers of pharmaceutical drug products and medical devices. She has creatively resolved issues related to Medicare reimbursement of new medical technology for the firms clients. Ms. Daubert has assisted clients with Medicare coverage issues, working directly with the Centers for Medicare & Medicaid Services, Coverage and Analysis Group as well as local Medicare Administrative Contractors (MACs). She also handles issues related to CPT and HCPCS coding and payment for new medical technologies. She has worked with device manufacturers and specialty societies to obtain CPT codes for new technology procedures. She has also successfully restructured and created new DRGs and APCs to improve Medicare payment for procedures.

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Fred H. Degnan joined King & Spaldings food and drug practice in 1988 after an 11-year career in FDAs Office of General Counsel. Since 1989 he has taught food and drug law at the Catholic University of America where he serves as a Distinguished Lecturer. His numerous publications include the book FDAs Creative Application of the Law (2d ed., 2006). While at FDA he received the agencys highest awards and in 2002 received the FDLI Distinguished Leadership award. He has consistently been recognized in numerous independently conducted surveys as being among the nations top food and drug lawyers. Mel Drozen is a partner at Keller and Heckman LLP. Mr. Drozen advises clients on a broad spectrum of FDA, Federal Trade Commission, U.S. Department of Agriculture and Environmental Protection Agency (pesticides) regulatory matters involving food labeling, ingredients and advertising issues. Prior to joining Keller and Heckman, he was an Assistant District Attorney in Brooklyn, New York, and then an attorney in the General Counsels Office of FDA for seven years. With his partners, Mr. Drozen regularly teaches seminars on food law, labeling and advertising. He earned his BA from Georgetown University and graduated from Brooklyn Law School. Michael N. Druckman is a partner in the Washington, D.C. office of Hogan Lovells US LLP. He counsels pharmaceutical and biotechnology companies on FDA law and regulation. Previously Mr. Druckman worked in FDAs Office of Chief Counsel. He served as co-team leader for biologics, advising on legal issues involving vaccines, blood products, cellular and tissue products, and public health emergency and pandemic planning. Prior to joining FDA, he was a litigation partner at a Washington, D.C. law firm. Mr. Druckman clerked for U.S. District Judge John H. Pratt (D.D.C.). He received his AB from Harvard College and his JD from the University of Pennsylvania Law School. Daniel R. Dwyer is a partner in the law firm of Kleinfeld, Kaplan and Becker LLP, of Washington, D.C. His practice concentrates on law and regulation affecting food, drugs, cosmetics, dietary supplements, medical devices and other products regulated by FDA. He frequently advises on regulatory matters, advertising and promotional rules, recalls and safety issues, corporate compliance, clinical trial compliance and good manufacturing practice. He is a frequent writer and speaker on FDA topics. Mr. Dwyer is a 1984 graduate of Georgetown University Law Center and is admitted to practice in the District of Columbia and Maryland. Stacy L. Ehrlich is a partner in the Washington, D.C. law firm of Kleinfeld, Kaplan & Becker LLP, which specializes in food and drug law. Her practice focuses on representing pharmaceutical, food, dietary supplement, tobacco, cosmetic and medical device companies on a variety of matters. Ms. Ehrlich has spoken and published on various topics related to FDA law and regulation, including over-the-counter and prescription drug marketing, dietary supplement labeling and advertising, corporate compliance, drug exclusivity, and

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tobacco product regulation and enforcement. She currently serves on the FDLI Tobacco Committee. Ms. Ehrlich received her BA with high honors in English from Emory University and her JD, cum laude, from Harvard Law School. Lesley Fair is a Senior Attorney with the Federal Trade Commissions (FTCs) Bureau of Consumer Protection, where she has represented the FTC in numerous investigations of deceptive advertising for health-related products. Ms. Fair has been on the adjunct faculty of the Catholic University of America School of Law since 1984 and is a Professorial Lecturer at George Washington University Law School. A graduate of the University of Notre Dame and the University of Texas School of Law, she clerked for U.S. District Judge Fred Shannon and served as a staff counsel to the U.S. Court of Appeals for the Fifth Circuit. John A. Gilbert, Jr. is a Director at Hyman, Phelps & McNamara, P.C. in Washington, D.C. Mr. Gilbert advises clients on the regulation of controlled substances in the United States and under the international drug control treaties. Prior to joining HPM in 1995, Mr. Gilbert was an attorney in the Drug Enforcement Administrations (DEAs) Office of Chief Counsel and served as a law clerk in the DEA Office of Administrative Law Judges. Mr. Gilbert graduated from Westfield State College and received his law degree from the Catholic University of America, where he was an associate editor of the Catholic University Law Review. Michael S. Heyl, Catholic University, Columbus School of Law (magna cum laude), is a partner in the Washington, D.C. office of the law firm of Hogan Lovells US LLP. His practice is in the medical device area with an emphasis on postmarket enforcement matters. He focuses extensively on postmarket compliance issues, including the Quality System Regulation (QSR), adverse event reporting and recalls. Mr. Heyl is a frequent speaker at medical device seminars and has authored articles on device regulations. Prior to joining Hogan & Hartson (the predecessor to Hogan Lovells), he represented the interests of specialty chemical producers before the U.S. Congress and numerous administrative agencies. Devon Wm. Hill is a partner in the food and drug practice group at Keller and Heckman LLP where he has worked since 1996. Mr. Hill represents clients and trade associations on compliance and testing issues surrounding the regulation of food, animal feed, cosmetics, and food and drug packaging materials in various jurisdictions around the world. Mr. Hill is a frequent speaker on the regulation of food contact materials in the United States, Canada, Europe, South America and Asia. Prior to attending law school, Mr. Hill obtained his Masters Degree in chemistry and worked as a university research chemist and in industry.

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Linda R. Horton, BA, JD, LLM, served FDA as legislative director, deputy chief counsel for regulations, and international policy director, among other positions (1968-2002). In 2002, she joined Hogan & Hartson (now Hogan Lovells) as a partner and led the firms international life sciences regulatory practice for eight years, retiring in 2010. Earlier she chaired the Food and Drug Law Journals Editorial Board and received FDLIs Leadership and Meritorious Service Award as well as several FDA awards. She also taught food and drug law classes at both legal alma maters, the George Washington and Georgetown law schools. Edward L. Korwek, PhD (biochemistry), JD, is a partner in the Washington, D.C. law firm of Hogan Lovells US LLP. Dr. Korwek has practiced in the FDA area for more than 30 years and has a special expertise in the regulation of drugs, including biologics, and has written and spoken extensively on biotechnology issues concerning FDA regulation. He has served on several governmental advisory committees and is on the Editorial Advisory Board of Biotechnology Law Report. He is a past member of the editorial board of the Food and Drug Law Journal and twice served on the FDLI Board of Directors. Daniel Kracov is a Partner and Chair of the FDA and Healthcare Practice at Arnold & Porter LLP. He assists clients in addressing challenges relating to the development, approval and marketing of drugs, biologics and medical devices. Mr. Kracov has extensive experience in product and compliance-related investigations, the development of regulatory corporate compliance programs, enforcement matters, due diligence in financings, mergers and acquisitions, and biomedical product-related public policy matters, including congressional investigations. He is a graduate of the University of Maryland and the University of Virginia School of Law. Eugene Lambert joined Covington & Burling LLP in 1961, after graduation from Yale Law School and a clerkship on the D.C. Circuit, and embarked on food and drug law through the Drug Amendments of 1962 and the peanut butter standard. Since working on the passage of the Animal Drug Amendments of 1968, he has been intimately involved in the legislative and regulatory issues confronting the animal drug and pet food industries. Now a Senior Counsel at C&B, this is his tenth essay on animal drug or feed issues. Geoffrey M. Levitt is Senior Vice President and Associate General Counsel for Regulatory and Policy Law at Pfizer, where he is responsible for managing global legal support for regulatory, safety, policy and environmental operations. Prior to joining Pfizer in October 2009, Mr. Levitt served as Vice President and Chief Regulatory Counsel at Wyeth. He has published and lectured extensively on regulatory law, and is a past member of the editorial board of the Food and Drug Law Journal and a current member of the editorial board of the FDA Advertising and Promotion Manual. Mr. Levitt is Chairman of the Board of the Food and Drug Law Institute and received the Institutes 2009 Distinguished Service and Leadership Award. His recent publications include the book Competitive Challenges in the Drug Approval Process: Generics, Hybrids and Follow-on Biologics (2005) and the chapter

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The Drugs/Biologics Approval Process in A Practical Guide to Food and Drug Law and Regulation (3d ed. 2008). He earned his JD from Harvard Law School and his BA from Columbia University. Erika Lietzan is a partner in the food and drug group at Covington & Burling LLP, specializing in U.S. and ex-U.S. regulation of drugs and biological products. She was deeply involved in the stakeholder process that led to development of the Biologics Price Competition and Innovation Act, and she has been working with companies since its enactment on the legal, scientific and policy issues surrounding FDA implementation. She also works with companies developing global positions and life-cycle strategies relating to biosimilars, including coordination of regulatory and patent strategies, and she assists with their advocacy before foreign regulators. She speaks and publishes regularly on issues relating to biosimilars. Her other areas of expertise include the Hatch-Waxman Amendments to the FDCA; orphan and pediatric exclusivity; preemption doctrine; First Amendment issues; supply and supply chain issues (e.g., counterfeiting, pedigrees, importation, shortages and online pharmacy); drug safety (e.g., risk management and pharmacovigilance); and interactions with healthcare professionals. Anne V. Maher is a partner at Kleinfeld, Kaplan & Becker LLP, a food and drug law firm. She specializes in advertising law. Her expertise includes health, environmental, childrens, online and social media marketing claims, including ad meaning and substantiation issues. She represents clients before the FTC, the state Attorneys General and the NAD. She was Chairman of the Editorial Advisory Board of the Food and Drug Law Journal. Ms. Maher was formerly Assistant Director of Advertising Practices at the FTC, where she was the designated FDA and USDA liaison. She frequently speaks at conferences involving advertising law and policy. Ms. Maher received her BA from Boston University and her JD from Northeastern University School of Law. Stephen Paul Mahinka, BA, JD, is the chair of Morgan Lewis global Life Sciences & Healthcare interdisciplinary group, resident in the firms Washington, D.C. office. His practice focuses on both FDA regulatory and antitrust issues throughout the product life cycle, concerning pharmaceuticals, biologics, medical devices and food additives, and FTC and state consumer protection matters. Mr. Mahinka is widely published, is a co-author of Life Sciences Mergers and Acquisitions (2008) and Winning Antitrust Strategies (2004), a contributing author of the Pharmaceutical Industry Antitrust Handbook, (2009), and is a past member of the editorial board of the Food and Drug Law Journal. He is a graduate of Johns Hopkins University, Phi Beta Kappa, and of the Harvard Law School. Joseph W. Metro is a partner in the Washington, D.C. office of Reed Smith LLP. Mr. Metro is a member of the firms Life Sciences and Health Industry group, and represents pharmaceutical, biologic and medical device industry clients on matters relating to reimbursement, fraud and abuse and government pricing. His practice includes

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transactional, counseling and investigational aspects, and he is a frequent speaker on matters relating to the Medicaid rebate program and the Veterans Health Care Act. Mr. Metro is a 1986 graduate of Dickinson College and received his law degree in 1989 from the George Washington University National Law Center. Suzan Onel is a partner in the FDA Practice of K&L Gates. Ms. Onels practice covers all issues related to FDA-regulated products with a particular focus on cosmetics, over-thecounter drugs, dietary supplements, foods, medical devices and related consumer products. Ms. Onel is a frequent author and lecturer on topics relating to FDA regulatory compliance and enforcement. She received her bachelors degree with honors in neurobiology and history from the University of Pennsylvania and her law degree from the University of Virginia. Joseph A. Page is a professor at the Georgetown University Law Center, where he has been teaching food and drug law since 1980. He has written about aspects of food and drug law in the UCLA Law Review, the Food and Drug Law Journal, Books-on-Line, the Washington Monthly, The New Republic and Commonweal. He has also served on the Drug Effects Study Advisory Panel of the Office of Technology Assessment of the U.S. Congress, and was a member of the Board of Directors of Public Citizen from 1972 to 2009. A 1955 graduate of Harvard College (magna cum laude), where he majored in classics, Professor Page holds both an LLB and an LLM from the Harvard Law School. Eve C. Pelonis is a Food and Drug Counsel at Keller and Heckman LLP. Ms. Peloniss practice focuses on all regulatory and compliance matters of the U.S. Food and Drug Administration and the U.S. Department of Agriculture. Ms. Pelonis graduated from the Johns Hopkins University with a BA in International Studies in 1999 and received her JD from the Catholic University of America in 2003. William Pendergast is a retired partner and founding member of the Food and Drug Group of Arent Fox LLP. While serving as a trial attorney with FDA in the mid-1960s, Mr. Pendergast was responsible for the conduct of some 100 trials and adjudicatory hearings involving principally the pharmaceutical, cosmetic and food additive industries. Following his work at FDA, Mr. Pendergast worked in private practice, serving as lead counsel in more than 40 litigated cases involving FDA, including the representation of leading manufacturers of human and animal drugs, cosmetics and food ingredients. Mr. Pendergast is the author of more than 20 articles published in FDA-related professional journals.

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Jeannie Perron, JD, DVM, is a partner at the law firm of Covington & Burling LLP in Washington, D.C. Her practice emphasis is food and drug law, particularly animal food and drug law, and animal welfare cases. She has authored or co-authored numerous articles and chapters in various publications. She is a member of a number of state and federal bars and the U.S. Patent and Trademark Office. Dr. Perron received her JD from George Washington University and her DVM from Texas A&M University. Alexander Roussanov concentrates on pharmaceutical and medical devices matters, with a particular focus on the European Union (EU) regulatory framework. Mr. Roussanov advises in the areas of EU and national regulatory regimes regarding medicinal products and medical devices, including promotion and marketing of products, compliance of communication and interactions with stakeholders, regulatory obligations related to authorization, and placing on the market. He has also worked in the field of national pricing and reimbursement systems. Prior to joining Hogan & Hartson (now Hogan Lovells), Mr. Roussanov worked at the European Public Affairs office of a leading international pharmaceutical company. Fabien Roys practice focuses on European Union (EU) and national regulatory matters involving pharmaceutical, and medical device laws and guidelines. Mr. Roy is a keen writer and regularly publishes articles concerning developments in the medical device and pharmaceutical sectors. He is also a regular speaker at dedicated conferences. He focuses particularly on the different stages of the medical device CE marking process. Mr. Roy also advises on questions regarding marketing authorization procedures, variation procedures, and clinical trials, promotional and marketing activities in the pharmaceutical sector. Mr. Roy joined Hogan Lovells International in 2007 (at that time Hogan & Hartson LLP). He was called to the Brussels Bar in early 2011. Elizabeth Sadove is Senior Regulatory Counsel in the Office of Counterterrorism and Emerging Threats in FDAs Office of the Commissioner. She is responsible for advancing FDAs statutory, regulatory, and policy framework to support the development and availability of FDA-regulated medical products for public health and national security emergencies. Ms. Sadove joined FDA in 2003 as Regulatory Counsel in the Center for Drug Evaluation and Research. Prior to joining FDA, she handled public policy issues and legislative affairs both in private practice law and for a Subcommittee of the U.S. House of Representatives. She earned her BA from Franklin & Marshall College and her JD from George Washington University, National Law Center.

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Kathleen M. Sanzo is a partner in and leader of Morgan Lewis FDA & Healthcare Practice, representing drug, device, food and cosmetic manufacturers in regulatory, transactional, enforcement and compliance matters. She graduated from Emory Law School and received her LLM from the George Washington University National Law Center, as the Food and Drug Law Institute Fellow. Ms. Sanzo is the author or co-author of numerous speeches and publications, including How to Work with the FDA, Food and Drug Law Settlements and Negotiation, and Pharmaceutical Industry Compliance Practices Forum: Enforcement Theories and Compliance Responses for the Pharmaceutical Industry. Gordon Schatz serves as Reed Smiths Life Sciences Integration partner in China. He works with device, drug and diagnostic manufacturers establishing new operations in China, seeking product approvals, to ensure regulatory compliance. Along with Dean Wang Chenguang (Tsinghua School of Law, Health Law Research Center Beijing), Mr. Schatz co-edited FDLIs Compilation of Selected Chinese SFDA Laws and Regulations on drugs and medical devices. He is a recognized expert in the U.S. on coding, coverage and payment for innovative medical products. An honors graduate of Haverford College, he received the Barristers Award from Temple University School of Law. Brett T. Schwemer is a principal at Olsson Frank Weeda Terman Bode Matz PC. He received his BBA in 1989 from the James Madison University and his JD from Ohio Northern University School of Law in 1992, graduating with distinction. Mr. Schwemer concentrates his practice in regulatory and enforcement matters before the Food Safety and Inspection Service, the Packers and Stockyards Administration, and the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture. He has spoken extensively on a variety of meat and poultry inspection issues and is a certified HACCP trainer. Jeffrey K. Shapiro has represented healthcare companies on FDA-related matters since 1994. He advises companies in the areas of medical devices, combination products and human tissue products, including product approvals, marketing, clinical studies, jurisdictional issues, recalls and enforcement. Mr. Shapiro has written and lectured extensively on FDArelated topics. He is co-editor of Promotion of Biomedical Products (FDLI 2006) and coauthor of Combination Products: How to Develop the Optimal Strategic Path for Approval (FDA News 2005). He is a Director in the law firm of Hyman, Phelps, & McNamara, a firm focused exclusively on FDA law and regulation. Jolyda O. Swaim is a principal in the Washington, D.C. law firm of Olsson Frank Weeda Terman Bode Matz PC, focusing on USDA-FSIS regulatory matters related to meat and poultry production. Prior to becoming an attorney, she had extensive experience in the food industry. Her last position was with Sara Lee Corporation as Corporate Food Safety Director with oversight of meat and poultry plants in the United States and Mexico. Ms. Swaim received her BS from Mercyhurst College in Erie, Pennsylvania, and her JD cum laude from Thomas M. Cooley Law School in Lansing, Michigan.

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Brian P. Waldman is a member of Arent Fox LLPs Executive Committee, and co-manager of the firms Regulatory Department. Mr. Waldman concentrates his practice in the area of food and drug law and advertising law, counseling manufacturers and distributors of pharmaceuticals, medical devices, foods (including dietary supplements and medical foods) and cosmetics, with particular emphasis on developing effective strategies for introducing and promoting new products. He received his JD degree from the University of California at Los Angeles and his MBA and BA from the University of Chicago. Marsha Wertzberger is the senior food and dietary supplement attorney at Arent Fox. Ms. Wertzberger practices in the areas of food and drug law and biotechnology, with a focus on regulatory and enforcement matters, advertising and marketing issues, and product development. She is active in mentoring activities within the firm and is a founding member of the women in food and drug law group of the Food and Drug Law Institute. She is a pharmacist and is a graduate of Georgetown Law Center. Edward C. Wilson, Jr. (Ted), JD, University of Virginia School of Law, AB, Davidson College (cum laude, Phi Beta Kappa), is a partner at Hogan Lovells US LLP in Washington, D.C. His practice focuses on a wide variety of regulatory and enforcement issues affecting the medical device industry. Mr. Wilson is a certified quality systems auditor who helps companies worldwide attain regulatory compliance. He has taught numerous courses on FDAs premarket and postmarket requirements. His experience includes assisting in the defense of government investigations, conducting internal investigations of alleged company misconduct and providing legal advice on a variety of device-related issues. Ann H. Wion is Deputy Chief Counsel for Program Review in the Office of the General Counsel, Department of Health and Human Services (HHS), Food and Drug Division. She received a PhD from Cornell University and a JD from Stanford Law School. After joining the HHSs Office of General Counsel in 1979, she specialized primarily in drug and biologics law. Since 1993, she has held her present position, in which she oversees the attorneys providing legal counsel in HHS on FDA-related matters. The views expressed in Chapter 21 are the authors and do not necessarily represent those of HHS/FDA. Elisabethann Wright focuses on European Union (EU) law relating to life sciences, with particular emphasis on pharmaceutical law, medical devices, food law and the environment. This includes assisting clients in classification of their products, establishment of a pathway to authorization and marketing of their products in the EU (including related regulatory obligations), pharmacovigilance obligations, promotion and marketing of products, sales agreements, clinical trial agreements, adverse event reporting, product withdrawals and challenges to national authority and EU Institution decisions concerning classification and marketing of medicinal products and medical devices. Prior to joining Hogan & Hartson

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(now Hogan Lovells), she served as Senior Legal Officer and Hearing Officer at the EFTA Surveillance Authority. Gary L. Yingling, a partner with K&L Gates, is the firms FDA Practice Groups Coordinator. Before entering private practice, Mr. Yingling was president of the Food and Drug Law Institute. He was in the government for 10 years serving in FDAs Office of the General Counsel and was director of the OTC Drug Review for two years, for which he received FDAs Award of Merit. Before attending law school, he practiced community pharmacy and is a registered pharmacist in Maryland and D.C. He received a BS from the University of North Carolina, MS from Purdue University and JD from Emory University School of Law.

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INTRODUCTION
RICHARD M. COOPER

The Focus of the Law

Food and drug law is about certain types of physical things. Most of these things are put into or onto, or are used with, the bodies of humans or animalsfoods, drugs, medical devices, cosmetics, and, since June 22, 2009, tobacco products. Food and drug law also concerns aspects of radiation-emitting products (e.g., microwave ovens, laser lights) that relate to safety. The principal requirements and prohibitions of the law are about things: they shall not be adulterated or misbranded; they shall be manufactured and tested in accordance with certain standards; on their labels and in their labeling, certain disclosures shall be made, and certain kinds of claims shall not be made; certain kinds of things shall not be introduced into interstate commerce until their distribution has been authorized by the regulatory agency; and so on. During the first few decades of modern food and drug law, the laws characteristic form of enforcement action was an in rem seizure action against physical objects that were in violation of the law.1 The purpose of this type of action was to protect patients or other consumers from things that might harm or deceive them. In recent decades, seizure actions have largely (though not completely) been replaced by recalls, which serve the same purpose without intervention by a court. To the extent food and drug law regulates people and what they do, it regulates them only in relation to the physical things that are within the jurisdiction of the law, through injunctive, criminal, debarment, civil-penalty or certain other types of proceedings.

Federal Food, Drug, and Cosmetic Act (FDCA) 304, 21 U.S.C. 334 (2006 & Supp. III 2009).

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Some products within the jurisdiction of the Food and Drug Administration (FDA)e.g., drugs and medical devicesare discovered or invented after substantial research. Such a product undergoes a developmental process that includes testing in a laboratory and then in animals and humans; creation and validation of processes for manufacturing and quality control on a commercial scale; and development of labeling that sets forth conditions of use. It then goes through some form of review by FDA and is approved, cleared or otherwise permitted to be distributed in interstate commerce. Next, the product is manufactured in packaged and labeled form, is advertised and promoted, and is shipped commercially. During its life on the market, the product is from time to time the subject of reports of adverse events experienced by consumers and of complaints by consumers, which are reviewed by the products manufacturer and possibly by FDA. Medical devices may undergo engineering changes. The labeling of drugs and medical devices changes as information on how to use them most effectively and safely accumulates. Additional uses for such products may be discovered, tested and included in product labeling. Food and drug law addresses most stages of this product life cycle. This focus on physical things sets the framework for regulation by FDA. The agencys most labor-intensive activities include: 1) review of applications to test potential new medical products in human subjects; 2) review of applications for permission for commercial marketing of new products or ingredients for use in products, and for changes in already marketed products; 3) review of reports and other data bearing on the safety of marketed products; 4) inspections of factories and of goods offered for importation, and testing of samples obtained in such inspections; 5) review of advertising and marketing of products; 6) regulatory and enforcement actions that result from such inspections and reviews; and 7) development and publication of regulations and guidance documents relating to products and activities within its jurisdiction. FDA regulates products that account for more than 20 percent of consumer spending in the United States.2 Whereas other administrative agencies have gone through periods of deregulation, in recent years Congress has expanded FDAs jurisdiction and its regulatory authorities.

Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, Remarks at Generic Pharmaceutical Association Annual Meeting (Feb. 18, 2010), available at http://www.fda.gov/NewsEvents/Speeches/ucm201833.htm. See also Sean Silverthorne, The FDA: What Will the Next 100 Years Bring?, H arvard Bus. Sch. Working K nowledge (Sept. 24, 2007), available at http://hbswk.hbs.edu/item/5753.html; Alastair J.J. Wood, M.D., Playing Kick the FDARisk-free to Players But Hazardous to Public Health, 358 N. Eng. J. Med. 1774, 1774-75 (Apr. 24, 2008), available at http://www. nejm.org/doi/full/10.1056/NEJMp0802227.

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A Little History
Although there were antecedents in the 19th century in America and even earlier in England,3 the modern history of food and drug regulation begins with the Pure Food and Drugs Act of 1906.4 That legislation, which had long been championed by Dr. Harvey W. Wiley, Chief Chemist of the U.S. Department of Agriculture (USDA), finally resulted from the sensational disclosures by the muckrakers of corruption, fraud and improper conditions in many areas of economic activity, including food processing and the manufacture and marketing of patent medicines.5 The law specified conditions under which foods and drugs would be considered adulterated or misbranded (and therefore barred from interstate commerce), and authorized USDAs Bureau of Chemistry to recommend enforcement actions to the U.S. Department of Justice (DoJ). The law did not provide for governmental review of products prior to their marketing, and was limited in other ways. Many of the recognized defects in the 1906 act were remedied by the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), FDAs organic statute and the principal authority for its regulatory activities.6 This statute greatly expanded FDAs authority by providing for premarket review of drugs under a requirement of safety, for standards of identity and quality for food, for regulation of medical devices and cosmetics, and for inspections by FDA employees of factories, warehouses and other places where regulated products are made, tested or held. This statute remains the basic food and drug law; and it has been amended many, many times, in most instances in ways that expand and strengthen the regulatory scheme. The principal amendments (some of which have been subsequently amended) have included the following:

See, e.g., Peter Barton Hutt, The Basis and Purpose of Government Regulation of Adulteration and Misbranding of Food, 33 Food Drug Cosm. L.J. 505, 506-09 (1978). 4 Pub. L. No. 59-384, 34 Stat. 768 (1906). Congress previously had enacted legislation to regulate products of biological origin. Pub. L. No. 57-244, 32 Stat. 728 (1902). 5 See generally Richard M. Cooper, The Struggle for the 1906 Act, in FDA: A Century of Consumer P rotection 25-69 (Wayne Pines ed., FDLI 2006). The phenomenon of enacting food and drug legislation in response to harm, or a perceived threat of harm, to the public health (perceived as resulting from a lack of adequate regulation) was repeated in 1938, when the modern food and drug statute was enacted; in 1962, when major amendments to the drug law were enacted; in 1976, when major amendments to the medical device law were enacted; and in 2007, when further major amendments to the drug law and other parts of the FDCA were enacted. 6 Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. 301-904). Section 408 of the FDCA, 21 U.S.C. 346a, relating to tolerances and exemptions for pesticide chemical residues, is administered by the Environmental Protection Agency.

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A series of amendments providing for regulation of insulin and various antibiotics7; Miller Act, which added to the FDCA section 301(k) (adulterating or misbranding a regulated product after it has been shipped in interstate commerce) and correspondingly amended section 304(a) (relating to seizure)8; Durham-Humphrey Amendment (providing a statutory basis for a prescription requirement)9; Pub. L. No. 83-217 (strengthening FDAs inspectional authority)10; Food Additives Amendment of 195811; Color Additive Amendments of 196012; Drug Amendments of 196213; Animal Drug Amendments of 196814; Drug Listing Act of 197215; Medical Device Amendments of 197616; Vitamins and Minerals Amendments17; Infant Formula Act of 198018; Orphan Drug Act19; Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)20; Drug Export Amendments Act of 198621; Prescription Drug Marketing Act of 198722; Food and Drug Administration Act of 1988 (statutory establishment of FDA)23; Generic Animal Drug and Patent Term Restoration Act24; Nutrition Labeling and Education Act of 199025; Safe Medical Devices Act of 199026;

Pub. L. No. 77-366, 55 Stat. 851 (1941) (insulin); Pub. L. No. 79-139, 59 Stat. 463 (1945) (penicillin); Pub. L. No. 80-16, 61 Stat. 11 (1947) (streptomycin); Pub. L. No. 81-164, 63 Stat. 409 (1949) (aureomycin, chloramphenicol, bacitracin); Pub. L. No. 83-201, 67 Stat. 389 (1953) (chlortetracycline). 8 Pub. L. No. 80-749, 62 Stat. 582 (1948). 9 Pub. L. No. 82-215, 65 Stat. 648 (1951). 10 67 Stat. 476 (1953). 11 Pub. L. No. 85-929, 72 Stat. 1784 (1958). 12 Pub. L. No. 86-618, 74 Stat. 397 (1960). 13 Pub. L. No. 87-781, 76 Stat. 780 (1962). 14 Pub. L. No. 90-399, 82 Stat. 342 (1968). 15 Pub. L. No. 92-387, 86 Stat. 559 (1972). 16 Pub. L. No. 94-295, 90 Stat. 539 (1976). 17 Pub. L. No. 94-278, 90 Stat. 410, 410-13 (1976). 18 Pub. L. No. 96-359, 94 Stat. 1190 (1980). 19 Pub. L. No. 97-414, 96 Stat. 2049 (1983). 20 Pub. L. No. 98-417, 98 Stat. 1585 (1984). 21 Pub. L. No. 99-660, 100 Stat. 3743 (1986). 22 Pub. L. No. 100-293, 102 Stat. 95 (1988). 23 Health Omnibus Programs Extension of 1988, Pub. L. No. 100-607, tit. V, 102 Stat. 3048, 3120-22 (1988). 24 Pub. L. No. 100-670, 102 Stat. 3971 (1988). 25 Pub. L. No. 101-535, 104 Stat. 2353 (1990). 26 Pub. L. No. 101-629, 104 Stat. 4511 (1990).

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Food and Drug Administration Revitalization Act27; Generic Drug Enforcement Act of 199228; Prescription Drug Amendments of 199229; Medical Device Amendments of 199230; Prescription Drug User Fee Act of 199231; Animal Medicinal Drug Use Clarification Act of 199432; Dietary Supplement Health and Education Act of 199433; FDA Export Reform and Enhancement Act of 199634; Food Quality Protection Act of 199635; Animal Drug Availability Act of 199636; Food and Drug Administration Modernization Act of 199737; Best Pharmaceuticals for Children Act38; Public Health Security and Bioterrorism Preparedness and Response Act of 200239; Medical Device User Fee and Modernization Act of 200240; Animal Drug User Fee Act of 200341; Pediatric Research Equity Act of 200342; Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (relating to generic drugs)43; Minor Use and Minor Species Animal Health Act of 200444; Food Allergen Labeling and Consumer Protection Act of 200445; Dietary Supplement and Nonprescription Drug Consumer Protection Act46; Food and Drug Administration Amendments Act of 200747; QI Program Supplemental Funding Act of 2008 (section relating to certain antibiotic drugs)48;

27

Pub. L. No. 101-635, 104 Stat. 4583 (1990). Pub. L. No. 102-282, 106 Stat. 149 (1992). 29 Pub. L. No. 102-353, 106 Stat. 941 (1992). 30 Pub. L. No. 102-300, 106 Stat. 238 (1992). 31 Pub. L. No. 102-571, 106 Stat. 4491 (1992). 32 Pub. L. No. 103-396, 108 Stat. 4153 (1994). 33 Pub. L. No. 103-417, 108 Stat. 4325 (1994). 34 Pub. L. No. 104-134, tit. II, ch. 1A, 110 Stat. 1321-313 through 1321-320 (1996). 35 Pub. L. No. 104-170, 110 Stat. 1489 (1996). 36 Pub. L. No. 104-250, 110 Stat. 3151 (1996). 37 Pub. L. No. 105-115, 111 Stat. 2296 (1997). 38 Pub. L. No. 107-109, 115 Stat. 1408 (2002). 39 Pub. L. No. 107-188, 116 Stat. 594 (2002). 40 Pub. L. No. 107-250, 116 Stat. 1588 (2002). 41 Pub. L. No. 108-130, 117 Stat. 1361 (2003). 42 Pub. L. No. 108-155, 117 Stat. 1936 (2003). 43 Pub. L. No. 108-173, 117 Stat. 2066, 2448 (2003). 44 Pub. L. No. 108-282, tit. I, 118 Stat. 891, 891-905 (2004). 45 Pub. L. No. 108-282, tit. II, 118 Stat. 905, 905-11 (2004). 46 Pub. L. No. 109-462, 120 Stat. 3469 (2006). 47 Pub. L. No. 110-85, 121 Stat. 823 (2007). 48 Pub. L. No. 110-379, 4, 122 Stat. 4075, 4076 (2008).
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Family Smoking Prevention and Tobacco Control Act49; Patient Protection and Affordable Care Act of 2010 (section relating to nutrition labeling of standard menu items at chain restaurants)50; and FDA Food Safety Modernization Act.51 Although FDA is the agency principally responsible for regulation of foods, drugs, medical devices, cosmetics and tobacco products, certain regulatory functions relating to some of those products are also performed by USDA, the Drug Enforcement Administration in DoJ, the Federal Trade Commission and the states. In addition, the system for federal reimbursement for therapeutic products is administered by the Centers for Medicare & Medicaid Services in the Department of Health and Human Services (HHS).

FDAs Place in the Executive Branch

FDA is, and always has been, an agency in the executive branch.52 Therefore, its budget, legislative proposals, congressional testimony and major regulatory proposals are subject to approval by the Office of Management and Budget (OMB) on behalf of the President. Like other executive branch agencies, FDA is subject to a wide variety of executive orders issued by the President.53 It is also subject to general statutes that bear on its regulatory activities.54 Also like other agencies in the executive branch, FDA has no authority to represent itself in court, but is represented by DoJ.55 All litigationcivil and criminalinvolving the agency, and including litigation brought against the agency, is supervised on behalf of the agency
49 50

Pub. L. No. 111-31, 123 Stat. 1776 (2009). Pub. L. No. 111-148, 4205, 124 Stat. 119 (2010). 51 Pub. L. No. 111-353, 124 Stat. 3885 (2011). 52 By contrast, the Federal Trade Commission and the Consumer Product Safety Commission, for example, are independent agencies. 53 See Chapter 21, infra. 54 E.g., Administrative Procedure Act, Pub. L. No. 79-404, 60 Stat. 237 (1946) (codified as amended at 5 U.S.C. 551559, 701-706); Freedom of Information Act, Pub. L. No. 89-554, 80 Stat. 383 (1966) (codified as amended at 5 U.S.C. 552); Federal Advisory Committee Act, Pub. L. No. 92-463, 86 Stat. 770 (1972) (codified as amended at 5 U.S.C. app. 2); National Environmental Policy Act of 1969, Pub. L. No. 91-190, 83 Stat. 852 (1969) (codified as amended at 42 U.S.C. 4321, 4331-4335); Regulatory Flexibility Act, Pub. L. No. 96-354, 94 Stat. 1164 (1980) (codified as amended at 5 U.S.C. 601-612); Government Performance and Results Act of 1993, Pub. L. No. 103-62, 107 Stat. 285 (1993); Unfunded Mandates Reform Act of 1995, Pub. L. No. 104-4, 109 Stat. 48 (1995) (codified as amended at 2 U.S.C. 1501-1504, 1511-1616, 1531-1538, 1551-1556, 1571); Paperwork Reduction Act of 1995, Pub. L. No. 104-13, 109 Stat. 163 (1995) (codified at 44 U.S.C. 3501-3520). These statutes have been amended from time to time. 55 See 28 U.S.C. 516, 519 (2006). The agency is also bound by opinions of the Attorney General.

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by the Office of Consumer Litigation (OCL) in the Civil Division of DoJ. In practice, responsibility for the actual conduct of litigation on behalf of the agency is divided between the OCL and the Offices of the United States Attorneys throughout the country. In general, DoJ permits lawyers in FDAs Office of Chief Counsel to assist in the representation of the agency in litigation. FDA originated as the Bureau of Chemistry in USDA before the enactment of the Pure Food and Drugs Act of 1906.56 The agency remained part of USDA (under various names) until 1940, when it was transferred to the Federal Security Agency, which later became the Department of Health, Education and Welfare, and then HHS.57 The agency was formally established by law in 1988.58 As part of HHS, FDA is subject to oversight by the department on the same matters as to which it is subject to oversight by OMB. FDA is subject to review by HHS of other important actions, including certain types of regulatory actions,59 internal reorganizations and important personnel actions. Issues of integrity or efficiency with respect to FDA are investigated by HHSs Office of Inspector General. Although not legally independent, FDA is culturally independent of HHS. FDAs principal offices are located on a campus in White Oak, Marylanda substantial distance from HHSs headquarters near the U.S. Capitol in Washington, D.C. The agency perceives its statutory and regulatory systems as complex and highly technical, and its expertise in administering them as unmatched by any group outside the agency. FDA has a long history of deferring to superior legal authority only to the extent necessary, and of acting as independently as circumstances permit.

FDA and Congress

Despite the movement of FDA from USDA to HHS, FDAs annual appropriation is still part of the agricultural appropriations process, and is reviewed and determined by the Subcommittees on Agriculture of the House and Senate Appropriations Committees. FDAs authorizing committees are the Senate Committee on Health, Education, Labor, and Pensions and
56

The Bureau of Chemistry began in 1862 with President Lincolns appointment of a chemist in the Department of Agriculture. U.S. Department of Health and Human Services, Historical Highlights, available at http://www.hhs.gov/ about/hhshist.html. The name Food and Drug Administration first officially appeared in the Agricultural Appropriation Act of 1931, Pub. L. No. 71-272, 46 Stat. 392 (1930). 57 See generally Michael Brannon, Organizing and Reorganizing FDA, in Food and Drug L aw 113-63 (Richard M. Cooper ed., FDLI 1991). 58 See supra note 23. 59 See infra notes 86-87 and accompanying text.

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the House of Representatives Committee on Energy and Commerce. Within the latter, the Subcommittee on Oversight and Investigations and the Subcommittee on Health historically have taken a strong interest in the agency. The House of Representatives Committee on Oversight and Government Reform also has responsibilities with respect to FDA. From time to time, other committees also have conducted investigations and hearings relating to FDA. FDA frequently has been the subject of reports issued by congressional committees and by the Government Accountability Office (formerly known as the General Accounting Office).60

FDAs Internal Organization and Budget

FDAs internal organization is set forth in Part 5 of Title 21 of the Code of Federal Regulations. The head of the agency is a single Commissioner,61 who, under a statute enacted in 1988, is appointed by the President with the advice and consent of the Senate.62 Under the Commissioner, FDA units with agency-wide responsibilities are:

Office of Policy, Planning and Budget;

Office of Policy; Office of Planning; Office of Budget; Office of Womens Health; Office of Legislation; Office of the Chief Counsel63; Office of the Counselor to the Commissioner; Office of Crisis Management; Office of the Administrative Law Judge64; Office of the Chief of Staff

60

See Peter Barton Hutt, Investigations and Reports on the Food and Drug Administration, in Food and Drug L aw 41-60 (Richard M. Cooper ed., FDLI 1991). 61 There is no corresponding commission. 62 FDCA 903, 21 U.S.C. 393(b); see supra note 23. Previously, the Commissioner had been appointed by the Secretary without Senate confirmation. 63 FDAs Office of Chief Counsel is, technically, part of the Office of the General Counsel of HHS, which, in turn, is part of the Office of the Secretary. The FDA Chief Counsel is officially an Associate General Counsel of HHS. See HHS, Office of the General Counsel, Key Personnel, Food and Drug Division, available at http://www.hhs. gov/ogc/personnel/index.html#FoodandDrugDivisionStaffContactInformation (last updated Dec. 27, 2010). Although the Chief Counsel advises the Commissioner of Food and Drugs, the Chief Counsel formally reports to the General Counsel of HHS. Description of the Office of Chief Counsel, available at http://www.fda.gov/AboutFDA/ CentersOffices/OrganizationCharts/ucm229420.htm (last updated Jan. 10, 2011). 64 FDAs Administrative Law Judge formally reports directly to the Secretary of Health and Human Services. FDA website, available at http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ucm229424.htm (last updated Jan. 14, 2011).

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Office of Special Medical Programs; Office of Good Clinical Practice; Office of Combination Products; Office of Orphan Products Development; Office of Pediatric Therapeutics; Office of External Affairs; Office of External Relations; Office of Public Affairs; Office of Special Health Issues; Office of Foods; Office of the Chief Scientist; Office of Counter-Terrorism and Emerging Threats; Office of Critical Path Programs; Office of Scientific Integrity; Office of Science and Innovation; Office of International Programs; Office of Administration; Office of Acquisitions and Grants Services; Office of Executive Operations; Office of Financial Operations; Office of Financial Management; Office of Financial Services; Office of Information Management; Office of Management; Office of Shared Services; Employee Resource Information Center; Office of Public Information and Library Services; Office of Real Property Services; Office of White OakServices; Office of Business Operations and Human Capital Programs; Office of Management Programs; Office of Security Operations; and Office of Equal Opportunity and Diversity Management. The organization of the Office of the Commissioner changes from time to time to suit the preferences of particular Commissioners. FDAs Office of Regulatory Affairs (under an Associate Commissioner for Regulatory Affairs) and its Offices of Resource Management, Regional Operations, Enforcement and Criminal

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Investigations also have agency-wide responsibilities.65 Under the Office of Regulatory Affairs, FDAs field staff is divided into five regions (Northeast, Southeast, Central, Southwest and Pacific), which have district offices and other offices at numerous locations. FDA also has an ombudsman,66 and a National Center for Toxicological Research.67 FDAs principal regulatory programs are administered by six Centers: Center for Biologics Evaluation and Research; Center for Devices and Radiological Health; Center for Drug Evaluation and Research; Center for Food Safety and Applied Nutrition; Center for Tobacco Products; and Center for Veterinary Medicine.

Extensive information about the Centers and about other aspects of FDAs structure and activities is available on FDAs website, www.fda.gov. As of early 2011, FDA had 49 advisory committees and panels, principally for drugs and biological products.68 Despite extensive cuts elsewhere in the federal budget for fiscal 2011 (ending September 30, 2011), FDAs appropriated budget authority for that year increased approximately $107 million over fiscal 2010 to $2.5 billion (apart from funds for repair of buildings and facilities, and excluding user fees).69 For fiscal 2012, the President requested a total of $4.4 billion (rounded) in budget authority and user fees, of which $2.7 billion is budget authority and $1.6 billion is user fees; despite further cuts elsewhere, the actual appropriated budget authority for fiscal 2012 is $2.5 billion (an increase of nearly $50 million is not shown in the total compared to that for fiscal 2011 due to rounding).70
65

See generally the description of the Office of Regulatory Affairs, available at http://www.fda.gov/AboutFDA/Centers Offices/ORA/default.htm (last updated Apr. 12, 2011). 66 See generally the description of the Office of the Ombudsman, available at http://www.fda.gov/AboutFDA/Centers Offices/OC/OfficeofScientificandMedicalPrograms/ucm197508.htm (last updated Apr. 8, 2011). 67 See generally the description of the National Center for Toxicological Research, available at http://www.fda.gov/ AboutFDA/CentersOffices/NCTR/default.htm (last updated Mar. 3, 2011). 68 See http://www.fda.gov/AdvisoryCommittees/default.htm (last updated May 2, 2011) (for lists of committees, under Get Information by Committee, click on individual subject matter areas). 69 Alliance for a Stronger FDA, One Battle Done, But More to Come (Apr. 15, 2011) (click on the chart), available at http://strengthenfda.org/2011/04/15/one-battle-done-but-more-to-come. 70 See HHS, Fiscal Year 2012 FDA Justification of Estimates for Appropriations Committees 83 (undated, but 2011), available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/ucm243370. pdf. See also Testimony of Margaret A. Hamburg, M.D., Commissioner of Food and Drugs on the Presidents Fiscal Year 2010 Budget Request for FDA, Before the Subcommittee on Agriculture, Rural Development, Food and Drug Administration,and Related Agencies of the H. Comm. On Appropriations (Mar. 11, 2011), available at http://www.fda. gov/NewsEvents/Testimony/ucm246902.htm; Alliance for a Stronger FDA, FDA Budget Authority Appropriations for FY 2012 (updated Nov. 15, 2011), available at http://fdaalliance.files.wordpress.com/2009/11/fy-12-fda-house-senateconf-approps-by-center1.pdf.

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11

In fiscal 2010, FDAs authorized staffing of full-time-equivalent positions was as follows: Food Human Drugs Biologics Animal Drugs/Feed Devices & Radiological Health Natl Center for Toxicological Research Office of Commissioner & Other HQ TOTAL 3,486 2,085 858 636 1,494 210 644 9,41371

Although FDA has received budget increases in recent years, there is reason to believe that the resources provided by Congress to FDA chronically have been, and remain, inadequate to enable the agency to fulfill its statutory responsibilities.72

FDAs Statutory Authorities

All authority exercised by FDA is derived from congressional delegations to the Secretary of Health and Human Services (the Secretary), and redelegations by the Secretary to the Commissioner of Food and Drugs.73 FDA has no independent regulatory authority delegated directly to it by Congress.74 FDA administers the FDCA, and other statutes, including the Mammography Quality Standards Act of 1992,75 certain provisions of the Public Health Service Act,76 the Filled Milk Act,77 the Federal Import Milk Act,78 the Saccharin Study and Labeling Act79 and certain

71

Alliance for a Stronger FDA, supra note 69. See, e.g., FDA Subcommittee on Science and Technology, FDA Science and Mission at Risk (Nov. 2007), available at http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20 and%20Technology.pdf. 73 The delegations are set forth in 2 FDA Staff M anual Guides 1410.10 (2005), available at http://www.fda.gov/ AboutFDA/ReportsManualsForms/StaffManualGuides/ucm080711.htm (Authorities Delegated), which lists the authorities delegated by the Secretary to FDA. See also Removal of Delegations of Authority and Conforming Changes to Regulations, 69 Fed. Reg. 17,285 (Apr. 2, 2004) (removing list of delegated authorities from the Code of Federal Regulations). 74 The Commissioner is directly authorized by FDCA 904, 21 U.S.C. 394, to establish technical and scientific review groups and to appoint and pay their members. 75 Pub. L. No. 102-539, 106 Stat. 3547 (1992). 76 See 2 FDA Staff M anual Guides 1410.10 (2005) 1, supra note 73. 77 21 U.S.C. 61-64 (2006). 78 Id. 141-149 (2006). 79 Pub. L. No. 95-203, 91 Stat. 1451 (1977).
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provisions of laws relating to controlled substances and drug abuse,80 and has important functions under the Federal Caustic Poison Act,81 the Lead-Based Paint Poisoning Prevention Act82 and the Fair Packaging and Labeling Act.83 The agency also has certain functions under statutes administered principally by USDA.84 The functions that FDA performs under statutes other than the FDCA are ancillary to its functions under the FDCA.85 Moreover, despite the broad delegations by the Secretary to the Commissioner, the Secretary in 198286 reserved, and continues to reserve, authority to approve regulations promulgated by FDA that: 1. Establish procedural rules applicable to a general class of foods, drugs, cosmetics, medical devices, or other subjects of regulation; or 2. Present highly significant public issues involving the quality, availability, marketability, or cost of one or more foods, drugs, cosmetics, medical devices, or other subjects of regulation.87 This reservation of authority was not intended to create any private right or benefit,88 although, as a practical matter, it does invite lobbying at the department with respect to regulations to which it applies. FDAs internal redelegations of authority are available at http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/ucm136380.htm (last updated Apr. 6, 2011).

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Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513, tit. I, 4, 84 Stat. 1236, 1241 (1970); Controlled Substances Act, Pub. L. No. 91-513, tit. II, 303(f), 84 Stat. 1242, 1253, 1255 (1970) (codified as amended at 21 U.S.C. 823(f)). 81 Pub. L. No. 69-783, 44 Stat. 1406 (1927). 82 Pub. L. No. 91-695, tit. IV, 401, 84 Stat. 2078, 2079 (1971), as amended by Pub. L. No. 94-317, tit. II, 90 Stat. 695, 705 (1976) (codified as amended at 42 U.S.C. 4831(a)). 83 15 U.S.C. 1451-1461 (2006). 84 Federal Meat Inspection Act 409(b) (codified as amended at 21 U.S.C. 679(b)); Poultry Products Inspection Act 24(b) (codified as amended at 21 U.S.C. 467(b)); Egg Products Inspection Act (codified as amended at 21 U.S.C. 1031-1056). 85 For a list of other statutes FDA considers itself affected by, see http://www.fda.gov/RegulatoryInformation/Legislation/ucm153119.htm. 86 Reservation of Rulemaking Authority of the Food and Drug Administration in Matters Involving Significant Public Policy: Revision, 47 Fed. Reg. 16,318 (Apr. 16, 1982). 87 See 2 FDA Staff M anual Guides 1410.10 2 (Reservation of Authority) (2005), supra note 73. 88 Id. 2.C.

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An Overview of the Federal Food, Drug, and Cosmetic Act

The FDCA is organized into ten chapters: Short Title, Definitions, Prohibited Acts and Penalties, Food, Drugs, Devices, and Electronic Products,89 Cosmetics, General Administrative Provisions, Imports and Exports, Tobacco Products, and Miscellaneous. The statute is codified in Title 21 of the United States Code. The critical terms of the statute are defined in section 201.90 Among the terms defined are the jurisdictional terms (food, drug, device (the term device refers to a medical device), cosmetic and tobacco product), and other terms critical to the operation of the statute (e.g., interstate commerce, label and labeling, new drug, food additive and color additive). Section 201(u) specifies that, for purposes of food additives, new animal drugs and color additives, the term safe refers to the health of man or animal91; but the statute contains no general definition of safe or safety, and consequently the definitions of those terms for particular regulatory purposes must be derived from other legal and regulatory materials. The general strategy of the statute consists of three steps. First, the statute specifies circumstances in which an article (food, drug, device, cosmetic or tobacco product) is adulterated

89

The provisions relating to electronic products, including definitions, substantive, administrative, and enforcement provisions, and a list of prohibited acts, appear in FDCA sections 531-542, 21 U.S.C. 360hh-360ss. FDA originally regulated radiation-emitting electronic products under the Radiation Control for Health and Safety Act of 1968, Pub. L. No. 90-602, 82 Stat. 1173 (1968), which was originally codified as part of the Public Health Service Act. Responsibility for administration of this statute was transferred to FDA by Redelegation of Authority, 36 Fed. Reg. 12,803 (July 7, 1971); and the statute, itself, was recodified in the FDCA by Pub. L. No. 101-629, 19(a)(3), (4), 104 Stat. 4511, 4529-4530 (1990). 90 21 U.S.C. 321. 91 21 U.S.C. 321(u).

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or misbranded,92 or lacks required permission to be marketed.93 Second, the statute defines a set of prohibited acts with respect to such an article.94 Third, the statute authorizes a set of enforcement actions in response to a prohibited act.95 With respect to food, drugs, devices, cosmetics and tobacco products the adulteration and misbranding provisions use terms elaborated on in other substantive provisions of the statute, located in Chapter IV (Food), Chapter V (Drugs and Devices), Chapter VI (Cosmetics) and Chapter IX (Tobacco Products). Under FDCA section 701(a),96 FDA has exercised general authority to elaborate by regulation the statutory standards for adulteration and misbranding, and those for approvals and other authorizations for marketing of products.97 Section 301 prohibits certain acts with respect to an article that is adulterated or misbranded.98 For example, section 301(a) declares it a prohibited act to introduce such an article into interstate commerce.99 Similarly, section 301(d)100 directly (i.e., without reference to adulteration or misbranding) prohibits the introduction into interstate commerce of any new drug for which an approval

92

See FDCA 402 (adulterated food), 403 (misbranded food), 501 (adulterated drugs and devices), 502 (misbranded drugs and devices), 601 (adulterated cosmetics), 602 (misbranded cosmetics), 902 (adulterated tobacco products) & 903 (misbranded tobacco products) 21 U.S.C. 342, 343, 351, 352, 361, 362, 387b & 387c. 93 See id. 404 (emergency permit control for certain foods), 505 (new drugs for human use), 21 U.S.C. 344, 355. Other requirements for authorization for distribution, including id. 409 (food additives), 512 (new animal drugs), 515 (Class III devices), 721 (color additives), & 910 (tobacco products), 21 U.S.C. 348, 360b, 360e, 379e, & 387j, operate through the adulteration provisions, id. 402(a)(2)(C)(i) (food additives), 402(a)(2)(C)(ii) (foods containing a new animal drug), 501(a)(5)-(6) (new animal drugs), 351(f) (Class III medical devices), 402(c) (food containing a color additive), 501(a)(4)(A) (drug or device containing a color additive), 501(a)(4)(B) (color additive for use on a drug or device), 601(e) (cosmetic containing a color additive), 902(6) (tobacco product), 21 U.S.C. 342(a)(2)(C)(i), 342(a)(2)(C)(ii), 351(a)(5)-(6), 342(c), 351(a)(4)(A), 351(a)(4)(B), 361(e), 402(c), & 387b(6). Food and drug law uses varying terminology to refer to actions by FDA to permit the distribution of different kinds of products in interstate commerce. For example, FDA may approve a new drug application under FDCA 505(c)(1)(A), 21 U.S.C. 355(c)(1)(A); and it may approve a device premarket approval application under section 515(d)(1), 21 U.S.C. 360e(d)(1). FDA may clear a device to enter the market by means of a notification under section 510(k), 21 U.S.C. 360(k). See, e.g., FDA, 510(k) Clearances, available at http://www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm (last updated June 18, 2009). Under section 404, 21 U.S.C. 344, FDA issues permits for interstate distribution of certain foods. With respect to a new tobacco product reviewed under FDCA 910, 21 U.S.C. 387j, FDA may, under section 910(c)(1)(A)(i), 21 U.S.C. 387j(c)(1)(A)(i), issue an order that the new product may be introduced or delivered for introduction into interstate commerce Most authorizations for marketing are by letter (which constitutes an order for purposes of the Administrative Procedure Act, 5 U.S.C. 551(6)), but an authorization for the marketing and use of a food additive or color additive is in the form of a regulation, see FDCA 409(c), 21 U.S.C. 348(c) (food additives); FDCA 721(b)(1), 21 U.S.C. 379e(b)(1). 94 FDCA 301, 21 U.S.C. 331. 95 FDCA 302-310, 21 U.S.C. 332-337. Certain additional, administrative enforcement actions are authorized in substantive provisions of the statute. For example, FDCA 505(e), 21 U.S.C. 355(e), authorizes withdrawal of approval of a new drug application on certain specified grounds. 96 21 U.S.C. 371(a). 97 See, e.g., 21 C.F.R. pts. 101 (food labeling), 110 (current good manufacturing practices for human food), 201 (drug labeling), 210-211 (good manufacturing practices for drugs), 314 (premarket approvals of new drugs), 801 (device labeling), 814 (premarket approvals of devices) and 820 (quality system regulation for devices). 98 21 U.S.C. 331. 99 Id. 331(a). 100 Id. 331(d).

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required by section 505(a)101 is lacking and of any food subject to section 404102 for which a permit required under that section is lacking. Under section 304, an article that was adulterated or misbranded when introduced into interstate commerce or while in interstate commerce or while held for sale after shipment in interstate commerce, or that lacks a required authorization for distribution, is subject to seizure.103 Commission of acts prohibited by section 301 may be enjoined under section 302,104 and may be the basis for a criminal prosecution and/or, in certain circumstances, an action for civil penalties under section 303.105 Other remedies for certain kinds of prohibited acts are available to FDA under other provisions of the statute.106

FDAs Mission
FDAs mission is stated in section 1003(b) of the FDCA: The Administration shall (1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner; (2) with respect to such products, protect the public health by ensuring that (A) foods are safe, wholesome, sanitary, and properly labeled; (B) human and veterinary drugs are safe and effective; (C) there is reasonable assurance of the safety and effectiveness of devices intended for human use; (D) cosmetics are safe and properly labeled; and (E) public health and safety are protected from electronic product radiation; (3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and (4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public

101

Id. 355(a). Id. 344. 103 Id. 334. 104 Id. 332. 105 Id. 333. 106 See generally Chapter 22, infra.
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health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.107

Here is FDAs statement of what it does: FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Finally, FDA plays a significant role in the Nations counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.108 FDA states that it strives to: Enforce FDA laws and regulations, using all appropriate legal means. Base regulatory decisions on a strong scientific and analytical base and the law; and understand, conduct, and apply excellent science and research. Be a positive force in making safe and effective products available to the consumer, and focus special attention on rare and life-threatening diseases. Provide clear standards of compliance to regulated industry, and advise industry on how to meet those standards. Identify and effectively address critical public health problems arising from use of FDAregulated products. Increase the FDAs effectiveness through collaboration and cooperation with state and local governments; domestic, foreign, and international agencies; industry; and academia. Assist the media, consumer groups, and health professionals in providing accurate, current information about regulated products to the public. Work consistently toward effective and efficient application of resources to our responsibilities.
107

108

21 U.S.C. 393(b). FDAs Mission Statement, available at http://www.fda.gov/opacom/morechoices/mission.html (last updated Nov. 18, 2010). A statement of FDAs mission also appears in the 2007-2008 U.S. Government Manual 224, available at http:// frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2007_government_manual&docid=211657tx_xxx-41.pdf.

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Provide superior public service by developing, maintaining and supporting a high-quality, diverse workforce. Be honest, fair, and accountable in all of our actions and decisions.109

FDAs International Activities

Under Chapter VIII of the FDCA, FDA long has had responsibilities with respect to import and export of articles within its jurisdiction. In connection with imports, FDA, in cooperation with the U.S. Customs and Border Protection, conducts inspections of foreign goods presented for entry into the United States110; the agency also has responsibility to inspect, or arrange for inspection of, foreign facilities that manufacture or process goods for importation into the United States.111 In connection with exports, the agency reviews applications for export approval where required,112 and provides export certificates.113 The agency also has active programs to achieve harmonization of its regulatory requirements with those of other countries with sophisticated regulatory systems.114

Food and Drug Law and Regulation, and Medicine

Although the food and drug laws and FDAs regulations apply to articles that affect health and to articles that are used to protect, promote and restore health, they do not apply directly to the practice of medicine or other healing arts. In general, physicians, dentists, pharmacists and other providers of healthcare are regulated by their respective professional societies and by state governmental agencies; and, in general, FDA does not regulate medical professionals except when they engage in clinical research, and when they manufacture, prepare, dispense or market products within FDAs jurisdiction.115 Food and drug laws and regulations do directly affect the practice of the healing arts. FDAs regulation of drugs (including biological products), medical devices and medical foods

109

FDA Investigations Operations M anual, FDA Principles 1.8.1 (2008), available at http://www.fda.gov/ICECI/Inspections/IOM/ucm122507.htm (last updated May 2, 2011). 110 See FDCA 801(a)-(d), 21 U.S.C. 381(a)-(d). 111 See FDCA 510(i)(3), 21 U.S.C. 360(i)(3); ORA Field Management Directive No. 13A: Foreign Inspection Program (rev. Oct. 5, 2010), available at http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/UCM056644. 112 See FDCA 801(e)(2), (4), 802, 21 U.S.C. 381(e)(2), (4), 382. 113 FDA, Guidance for Industry: FDA Export Certificates (July 2004) (Corr. copy Apr. 2005), available at http://www. fda.gov/downloads/RegulatoryInformation/Guidances/ucm125822.pdf. 114 See generally Chapter 24, infra. 115 See generally Chapter 20, infra.

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determines their availability to practitioners and patients. The FDA-approved labeling for such products influences the ways they are used. As a matter of food and drug law and regulation, practitioners are free to use such products outside the conditions stated in their labeling,116 but they are responsible for such use under state law. Thus, for example, FDA regulates devices used in surgical and other medical procedures, but does not regulate the procedures, themselves; and physicians are free to use such devices in ways not recommended in their FDA-approved labeling. FDA does regulate clinical trials conducted on unapproved drugs and devices in the United States, and clinical trials on approved drugs and devices (and clinical trials on unapproved drugs and devices outside the United States) where the sponsors of the trials intend to submit data from them to the agency in support of applications for approval.117 When practitioners participate in such trials, their participation is regulated by FDA.118 Moreover, when medical professionals step outside their normal therapeutic roles and misbrand or adulterate drugs or devices or engage in what FDA considers regulated activities indistinguishable from manufacturing and marketing drugs or devices, the agency may take regulatory action against them.119 Physicians and other healthcare practitioners play significant roles in FDAs activities. In recent decades, FDA Commissioners have been physicians or have had related academic credentials. Many senior and other officials of FDA, particularly those responsible for reviews of new medical products, are physicians. FDAs advisory committees, whose advice the agency usually accepts, consist principally of physicians, most with academic appointments. Moreover, physicians design, oversee and conduct virtually all of the clinical research on which FDA regulatory decisions about specific products are based.

116

FDCA 1006, 21 U.S.C. 396; 48 Fed. Reg. 26,720, 26,733 (June 9, 1983); Use of Approved Drugs for Unlabeled Indications, 12 FDA Drug Bull. 4 (1982); 37 Fed. Reg. 16,503 (Aug. 15, 1972). 117 See generally FDCA 505(i), 520(g), 21 U.S.C. 355(i), 360j(g). 118 See generally 21 C.F.R. pts. 50, 54, 56, 312, 812 (2011). 119 See, e.g., United States v. Sullivan, 332 U.S. 689 (1948) (criminal prosecution of retail pharmacist for misbranding drug after it had been shipped in interstate commerce); United States v. Diapulse Corp. of America, 514 F.2d 1097, 1098 (2d Cir. 1975) (per curiam) (devices in offices of medical practitioners for use in treatment of patients are held for sale within the meaning of FDCA section 301(k), 21 U.S.C. 331(k)); United States v. Kaadt, 171 F.2d 600 (7th Cir. 1948) (prosecution of physicians for distributing misbranded drugs); United States v. Sene X Eleemosynary Corp., 479 F. Supp. 970 (S.D. Fla. 1979) (enjoining compounding, promotion and distribution of certain drugs by pharmacist and others).

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State Regulation of Foods and Drugs

Most states have food and drug laws that are similar to the FDCA. States regulate intrastate products and activities, and work cooperatively with FDA on matters of mutual interest. State Attorneys General, from time to time, also have taken enforcement action with respect to matters within the general area of food and drug law and regulation.

Additional Sources of Information About FDA

FDAs website address is www.fda.gov. FDA regulatory documents are posted at www.regulations.gov. Other governmental agencies and congressional committees that interact with FDA have their own websites, on which materials relevant to FDA can be found. The Food and Drug Law Institute publishes the Food and Drug Law Journal, a magazine, books and an e-mail newsletter; conducts conferences and educational programs relating to food and drug regulation; maintains a directory of professional services; and provides other educational services; its activities cover the full range of products regulated by FDA. Its website is www.fdli.org. The Drug Information Association provides similar services with respect to drugs, medical devices and related products. Its website is http://www.diahome. org/DIAHome/Home.aspx. Both organizations are neutral and not-for-profit. Many trade publications report on FDAs activities, including: CCH (reporters on food, drugs, devices, cosmetics), http://health.cch.com/news/food-drugdevices/041211.asp; FDA Week, http://insidehealthpolicy.com; FDANews (a variety of newsletters, including Washington Drug Letter, The Food & Drug Letter, Drug GMP Report and the Drug Industry Daily), http://www.fdanews.com/ newsletters; FDC Reports (a variety of newsletters relating to drugs, medical devices, cosmetics, and healthcare), http://www.elsevierbi.com/index.html; Food Chemical News, http://www.agra-net.com/portal2/fcn/home.jsp; Supermarket News (has a legislation/regulation section), http://supermarketnews.com/ Legislation_Regulations; NewsRx (has a news section on food and drug law; offers pay-as-you-go and some free news stories/alerts), http://www.newsrx.com/alerts/b/Food-and-Drug-Law.html; and Rx Compliance Report, http://www.rxcompliancereport.com.

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FDA lists trade publications relating to cosmetics at http://www.fda.gov/Cosmetics /ResourcesForYou/CosmeticsManufacturersPackagersDistributors/ucm077674.htm. Many medical journals also publish, in addition to scientific reports, editorials and comments relating to food and drug law. Blogs relating to food and drug law include: FDA Law Blog, www.fdalawblog.net Drug and Device Law, druganddevicelaw.blogspot.com Orange Book Blog, www.orangebookblog.com Prescriptions, http://prescriptions.blogs.nytimes.com (from the New York Timesgeneral health/industry) WSJ Health Blog, http://blogs.wsj.com/health (from the Wall Street Journalgeneral health/ industry) Many trade associations, public interest groups and other organizations interact frequently with FDA or are otherwise involved in food and drug regulation, and thus may be useful sources of information on some matters relating to FDA. Here is a partial list (excluding the numerous medical professional colleges and societies and organizations focused on particular medical conditions): Abigail Alliance for Better Access to Developmental Drugs, www.abigail-alliance.org; AdvaMed, www.advamed.org; Alliance for a Stronger FDA, http://strengthenfda.org; American Clinical Laboratories Association, www.clinical-labs.org; American Herbal Products Association, www.ahpa.org; American Hospital Association, www.aha.org; American Public Health Association, www.apha.org; Association for the Advancement of Medical Instrumentation, www.aami.org; Association of Food Industries, Inc., www.afius.org; Association of Healthcare Journalists, www.healthjournalism.org; Association of Medical Diagnostics Manufacturers, www.amdm.org; Campaign for Tobacco-Free Kids, www.tobaccofreekids.org; Center for Public Integrity, www.publicintegrity.org; Center for Regulatory Effectiveness, www.thecre.com; Center for Science in the Public Interest, www.cspinet.org; Consumer Healthcare Products Association, www.chpa-info.org; Consumers Union, www.consumersunion.org; Council for Responsible Nutrition, www.crnusa.org; ECRI Institute, www.ecri.org; European Public Health Alliance, www.epha.org;

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Food Animals Concerns Trust, www.foodanimalconcerns.org; Generic Pharmaceutical Association, www.ghpalonline.org; Global Resources Action Center for the Environment, www.worldwatch.org; Grocery Manufacturers of America, www.gmaonline.org; Healthcare Distribution Management Association, www.healthcaredistribution.org; Institute for Agriculture & Trade Policy, www.iatp.org; Medical Device Manufacturers Association, www.medicaldevices.org; National Community Pharmacists Association, www.ncpanet.org; Natural Products Association, www.npainfo.org; Personalized Medicine Coalition, www.personalizedmedicinecoalition.org; Pharmaceutical Research and Manufacturers of America, www.phrma.org; Physicians for Social Responsibility, www.psr.org; Public Citizen Health Research Group, www.citizen.org; Regulatory Affairs Professionals Society, www.raps.org; Research! America, www.researchamerica.org; Union of Concerned Scientists, www.ucsusa.org; and Utah Natural Products Alliance, www.unpa.com.

A list by FDA of trade and professional associations of interest to the cosmetics industry is available at http://www.fda.gov/Cosmetics/ResourcesForYou/CosmeticsManufacturersPackagersDistributors/ucm077669.htm (last updated Feb. 14, 2011).