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FOOD AND DRUG LAWAND REGULATION

SECOND EDITION

Edited by

DaviD G. aDams

Partner, Venable LLPAdjunct Proessor, George Washington University School o Law

RichaRD m. coopeR

Partner, Williams & Connolly LLP

maRtin J. hahn

Partner, Hogan Lovells LLP

Jonathan s. Kahan

Partner, Hogan Lovells LLP


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2011 FDLI. All rights reserved. ISBN 978-1-935065-44-9

Authorization to photocopy items or internal or personal use o specic clients is granted by theFood and Drug Law Institute, provided that the base ee o US $.75 per page is paid directly to the

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To order additional copies of this publication, please visit our website at www.fdli.org.

1155 15th St. NW, Suite 800, Washington, DC 20005Tel: (202) 371-1420 Fax: (202) 371-0649

email: [email protected]: www.dli.org


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CONTENTS

Preface vi

About the Editors vii

About the Authors viii

Chapter 1: Introduction

Richard M. Cooper, Williams & Connolly LLP 1

Chapter 2: Food Safety

Fred H. Degnan, King & Spalding, LLP 23

Chapter 3: Food Labeling

Mel Drozen and Eve Pelonis, Keller and Heckman LLP 101

Chapter 4: Food and Drug Packaging

Devon Wm. Hill and Rachel A. Bond, Keller and Heckman LLP 127

Chapter 5: Food: Meat and Poultry Inspection

Brett T. Schwemer and Jolyda O. Swaim, Olsson Frank Weeda

Terman Bode Matz PC 157Chapter 6: Dietary Supplements

William R. Pendergast, Brian P. Waldman and Marsha C.

Wertzberger, Arent Fox LLP 201

Chapter 7: Veterinary Food and Drugs

Eugene Lambert and Jeannie Perron, Covington & Burling LLP 247

Chapter 8: Cosmetic Regulation Revisited

Gary L. Yingling and Suzan Onel, K&L Gates LLP 283

Chapter 9: Drugs: General Requirements

Daniel Kracov, Arnold & Porter LLP 317

Chapter 10: Drugs: INDs and Full NDAs

James N. Czaban, Wiley Rein LLP and Georey M. Levitt, Pfzer 355

Chapter 11: Generic Drugs, ANDAs, Section 505(b)(2)

Applications, Patents and Exclusivities

Lisa Barclay, Zuckerman Spaeder LLP 393


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iv Food and drug Lawand reguLation

Chapter 12: Prescription Drug Promotion and Marketing

Kathleen M. Sanzo and Stephen Paul Mahinka,

Morgan Lewis 425

Chapter 13: Over-the-Counter Drugs

Daniel R. Dwyer and Stacy L. Ehrlich, Kleineld,

Kaplan & Becker LLP 461

Chapter 14: Human Biologics

Edward L. Korwek and Michael N. Druckman,

Hogan Lovells US LLP 485

Chapter 15: Biosimilars

Erika Lietzan and Emily Alexander, Covington & Burling LLP 531

Chapter 16: Medical Devices

Jonathan S. Kahan and Edward C. Wilson, Jr.,


Chapter 17: Radiological Health

Edward C. Wilson, Jr. and Michael S. Heyl,


Chapter 18: Combination Products and Jurisdictional IssuesJerey K. Shapiro, Hyman, Phelps, & McNamara, P.C. 641

Chapter 19: Tobacco Products

Joseph A. Page, Georgetown University Law Center 659

Chapter 20: FDA Regulation of Healthcare Professionals

David G. Adams, Venable LLP 705

Chapter 21: FDA Administrative Procedures

Ann H. Wion, U.S. Food and Drug Administration 721

Chapter 22: FDA Enforcement Powers

Scott Bass, Sidley Austin, LLP 769

Chapter 23: Medical Countermeasures: Emergency Preparedness

and Response Roles and Authorities

Brooke Courtney and Elizabeth Sadove, U.S. Food and Drug Administration 829

Chapter 24: FDA at the International Level

Linda R. Horton, Elizabethann Wright, Fabien Roy and

Alexander Roussanov, Hogan Lovells US LLP 851


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Foodand drug Lawand reguLation v

Chapter 25: FTC Regulation of Advertising

Anne V. Maher, Kleineld, Kaplan & Becker LLP

and Lesley Fair, Federal Trade Commission 923

Chapter 26: DEA Regulation of Controlled Substances

and Listed Chemicals

John A. Gilbert, Jr., Hyman, Phelps & McNamara, P.C. 965

Chapter 27: Reimbursement, Fraud and Abuse

Joseph W. Metro, Gail L. Daubert and Gordon B. Schatz, Reed Smith LLP 981

Index 1017


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vi Food and drug Lawand reguLation

PREFACE

Food and drug law occupies a unique position in American jurisprudence: it governs saety,ecacy, labeling and availability o products that are central to health and well being, and

that account or 20-25 percent o consumer spending in the United States. From the elegant

simplicity o the Pure Food and Drugs Act o 1906 to the technically elaborate FDA Food

Saety Modernization Act o 2011, the body o ood and drug regulatory law has grown into

a vast and complex array o statutes, regulations, interpretive documents and judicial deci-

sions, or 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 rom all areas o ood 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 o ood and drug law and

regulation, including ve chapters on drugs, our on ood, and chapters on dietary supple-

ments, cosmetics, veterinary ood and drugs, combination products, biologics and biosimi-

lars, medical devices, radiological health, combination products and tobacco products. Five

additional chapters detail the purposes, methods and inner workings o the Food and Drug

Administration, including regulation o healthcare proessionals; administrative proce-

dures; enorcement authority; the agencys role in emergenciesmedical countermeasures,

emergency preparedness and response roles and authorities; and its role at the international

level. The nal three chapters address the related regulatory missions o other agencies andgovernmental entities: the Federal Trade Commissions regulation o advertising, the Drug

Enorcement Administrations regulation o controlled substances and ederal regulation o

reimbursement, raud and abuse.

Each chapter was written by one or more attorneys selected or their special expertise in

their respective subject matters. Although the authors are attorneys aliated with ederal

agencies, a university law school, a pharmaceutical manuacturer and private law rms,

they have sought to be objective in the treatment o their subjects.

The book provides discussions that are practical, thorough and supported by citations toguide urther research. It is intended as a resource or practicing attorneys who want to learn

about ood and drug law or gain greater expertise in a particular area. It is also intended to

complement law school casebooks and as a general reerence or law libraries, practitioners

in other elds, and those interested in how oods, medical products and cosmetics are regu-

lated by the U.S. government.

We thank FDLI or its dedication to publishing this book and the authors or their generos-

ity in sharing their expertise with our readers.

David G. AdamsRichard M. Cooper

Martin J. Hahn

Jonathan S. Kahan


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Food and drug Lawand reguLation vi i

ABOUT THE EDITORS

David G. Adams is Chair othe FDA Practice Group at Venable LLP. Mr. Adams previouslyheld senior positions at the Food and Drug Administration (FDA) in the Ofce o the

Commissioner and Ofce othe ChieCounsel. He has served as Chair otheAmerican Bar

Association Food and Drug Law Committee and as Chair othe Editorial Board othe Food

and Drug Law Journal. Mr. Adams also teaches ood and drug law as an adjunct proessor at

the GeorgeWashington University School oLaw.

Richard M. Cooper is a partner in the Washington, D.C. law rm o Williams & Connolly

LLP. He has written extensively on ood and drug law and has taught that subject at

Georgetown University Law Center. He was Chie Counsel o FDA during 1977-1979.Earlier in 1977, he was a special assistant toJames R. Schlesinger and a senior member o

the Ofce o Energy Policy and Planning, Executive Ofce othe President. He was a law clerk

to Hon.WilliamJ. Brennan,Jr., U.S. Supreme Court, in 1969-70.

Martin J.Hahn is a partner at Hogan Lovells. His practice ocuses on a wide variety o

regulatory issues aecting the ood and dietary supplement industries. Mr. Hahn monitors

new developments and has co-authored a manual on the regulation o oods derived rom

biotechnology and a manual on the issues presented by allergens in oods. He has presented

numerous speeches on ood labeling and ood saety and is a requent speaker or programs

sponsored by the Food and Drug Law Institute and the FoodAllergy Research and Resource

Program.

Jonathan S. Kahan is a Co-director o Hogan Lovells ood, drug, medical device and

agriculture group. His practice ocuses primarily on assisting medical device companies in

navigating the FDA regulatory process. Mr. Kahan is the author oMedical Device Development:

Regulation and Law (Parexel 2009), and Medical Devices: Obtaining FDA Market Clearance

(Parexel 1995). He is the Chair o the DeansAdvisory Board o the George Washington

University Law School. He is the ormer Chairman othe Federal BarAssociation Section

on Health and Human Services. He is a member oPhi Beta Kappa and Order othe Coi.


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viii Food and drug Lawand reguLation

ABOUT THE AUTHORS

Emily Alexander is an associate in the ood and drug practice group in the Washington,D.C. oce o 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 ederal, state and local law. At this time she

ocuses on, among other things, the regulation o biosimilars and biologics in the United

States and oreign 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 o 2009 and was involved in various types o advocacy leading up to

the passage o the act.

Lisa Barclay is a partner at the law rm Zuckerman Spaeder LLP in Washington, D.C. Ms.

Barclay practices in the areas o complex civil litigation, ood and drug law, proessional

responsibility and legal ethics. During her time at Zuckerman Spaeder, Ms. Barclay has

drawn rom her experience at the U.S. Food and Drug Administration (FDA) in representing

a range o clients on ood and drug issues. She has represented generic pharmaceutical

companies, nonprot organizations and individuals in litigation and has also counseled

these clients on regulatory matters. In the spring o 2011, Ms. Barclay was an adjunct

proessor at Georgetown University Law Center. Prior to joining Zuckerman Spaeder, Ms.

Barclay clerked or Senior Judge William B. Bryant, U.S. District Court or the District o

Columbia and practiced civil litigation in the Washington, D.C. oce o Weil, Gotshal &

Manges, LLP. From 1995-2001, she worked in the Oce o the Commissioner at FDA. Ms.

Barclay is a graduate o Georgetown University Law Center and The George Washington

University.

Scott Bass heads Sidley Austins Global Lie Sciences Team, coordinating pharmaceutical,

medical device, ood and dietary supplement matters in the United States, Europe and

Asia. Mr. Bass served as an adjunct proessor at Georgetown University Graduate School,

where he co-taught ood saety with the Food and Drug Administration; as Co-Chair o the

American Bar Association Food and Drug Law Committee and Chairman o the New YorkState 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, enorcement and

dietary supplement elds.

Rachel A. Bond is an associate in the ood and drug practice group at Keller and

Heckman LLP. Ms. Bond advises domestic and oreign corporations in matters o FDA

and international regulatory compliance o ood and drug packaging materials. Her work

includes assisting clients in establishing clearances or ood contact materials under thelaws and regulations o the United States, the European Union and Canada. Ms. Bond

graduated rom the University o Delaware with a BA in Biology in 2003 and received her

JD rom the George Mason University School o Law in 2006.


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Food and drug Lawand reguLation ix

Brooke Courtney is Regulatory Counsel in the Oce o Counterterrorism and EmergingThreats in FDAs Oce o the Commissioner, where she works on legal, regulatory and

policy issues related to medical products or public health emergencies. Ms. Courtney was

previously the Director o the Oce o Public Health Preparedness and Response at the

Baltimore City Health Department and an associate at the Center or Biosecurity. She is

the recipient o the Public Health Law Associations Emerging Leader in Public Health Law

Award, a term member o the Council on Foreign Relations and a member o an Institute o

Medicine committee. She received her JD and Health Law Certicate rom the University

o Maryland and her MPH rom Yale University.

James N. Czaban is the Chairman o the Food & Drug Law Practice at Wiley Rein LLP

in Washington, D.C. where his practice broadly encompasses government regulation o

pharmaceutical, biotechnology, ood, medical device and other clients involved in the Lie

Sciences. Under his leadership, the rm represents such clients with respect to complex

regulatory strategies, compliance matters, and in administrative and judicial enorcement

actions and other proceedings involving FDA, FTC, DEA, HHS/OIG, DOJ, and other

ederal and state agencies. Mr. Czaban has a long history o service to the Food & Drug bar,

having served as Chair o the Legal Writing Awards Committee o the Food and Drug Law

Institute (FDLI) and regularly publishing on and teaching ood and drug law or FDLI and

other organizations. He is consistently recognized as a leading lawyer in ood and drug law,including by Chambers USAs Americas Leading Lawyers,Washingtonian magazine, PLC/

Which Lawyerand other publications. In 2011 Mr. Czaban received the Burton Award or

Legal Achievement as a result o his work in the eld o biosimilars regulation. Mr. Czaban

is a graduate o the University o Virginia School o Law and the University o Caliornia,

Berkeley.

Gail L. Daubert is a member o the Lie Sciences Health Industry Group at Reed

Smith, practicing in the area o healthcare regulatory law. She provides legal, regulatory

and legislative counsel to a variety o proessional associations and manuacturers opharmaceutical drug products and medical devices. She has creatively resolved issues

related to Medicare reimbursement o new medical technology or the rms clients. Ms.

Daubert has assisted clients with Medicare coverage issues, working directly with the

Centers or 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 or new medical technologies. She has worked with device

manuacturers and specialty societies to obtain CPT codes or new technology procedures.

She has also successully restructured and created new DRGs and APCs to improve

Medicare payment or procedures.


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x Food and drug Lawand reguLation

Fred H. Degnan joined King & Spaldings ood and drug practice in 1988 ater an

11-year career in FDAs Oce o General Counsel. Since 1989 he has taught ood and drug

law at the Catholic University o America where he serves as a Distinguished Lecturer. Hisnumerous 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 ood and drug lawyers.

Mel Drozen is a partner at Keller and Heckman LLP. Mr. Drozen advises clients on a

broad spectrum o FDA, Federal Trade Commission, U.S. Department o Agriculture and

Environmental Protection Agency (pesticides) regulatory matters involving ood 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

Oce o FDA or seven years. With his partners, Mr. Drozen regularly teaches seminars

on ood law, labeling and advertising. He earned his BA rom Georgetown University and

graduated rom Brooklyn Law School.

Michael N. Druckman is a partner in the Washington, D.C. oce o Hogan Lovells US

LLP. He counsels pharmaceutical and biotechnology companies on FDA law and regulation.

Previously Mr. Druckman worked in FDAs Oce o Chie Counsel. He served as co-team

leader or biologics, advising on legal issues involving vaccines, blood products, cellular

and tissue products, and public health emergency and pandemic planning. Prior to joiningFDA, he was a litigation partner at a Washington, D.C. law rm. Mr. Druckman clerked or

U.S. District Judge John H. Pratt (D.D.C.). He received his AB rom Harvard College and

his JD rom the University o Pennsylvania Law School.

Daniel R. Dwyer is a partner in the law rm o Kleineld, Kaplan and Becker LLP, o

Washington, D.C. His practice concentrates on law and regulation aecting ood, drugs,

cosmetics, dietary supplements, medical devices and other products regulated by FDA.

He requently advises on regulatory matters, advertising and promotional rules, recalls

and saety issues, corporate compliance, clinical trial compliance and good manuacturingpractice. He is a requent writer and speaker on FDA topics. Mr. Dwyer is a 1984 graduate o

Georgetown University Law Center and is admitted to practice in the District o Columbia

and Maryland.

Stacy L. Ehrlich is a partner in the Washington, D.C. law rm o Kleineld, Kaplan &

Becker LLP, which specializes in ood and drug law. Her practice ocuses on representing

pharmaceutical, ood, dietary supplement, tobacco, cosmetic and medical device companies

on a variety o 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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Food and drug Lawand reguLation xi

tobacco product regulation and enorcement. She currently serves on the FDLI Tobacco

Committee. Ms. Ehrlich received her BA with high honors in English rom Emory University

and her JD, cum laude, rom Harvard Law School.

Lesley Fair is a Senior Attorney with the Federal Trade Commissions (FTCs) Bureau o

Consumer Protection, where she has represented the FTC in numerous investigations o

deceptive advertising or health-related products. Ms. Fair has been on the adjunct aculty

o the Catholic University o America School o Law since 1984 and is a Proessorial Lecturer

at George Washington University Law School. A graduate o the University o Notre Dame

and the University o Texas School o Law, she clerked or U.S. District Judge Fred Shannon

and served as a sta counsel to the U.S. Court o Appeals or the Fith 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 o 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 Enorcement Administrations (DEAs) Oce o

Chie Counsel and served as a law clerk in the DEA Oce o Administrative Law Judges.

Mr. Gilbert graduated rom Westeld State College and received his law degree rom the

Catholic University o America, where he was an associate editor o the Catholic University

Law Review.

Michael S. Heyl, Catholic University, Columbus School o Law (magna cum laude), isa partner in the Washington, D.C. oce o the law rm o Hogan Lovells US LLP. His

practice is in the medical device area with an emphasis on postmarket enorcement

matters. He ocuses extensively on postmarket compliance issues, including the Quality

System Regulation (QSR), adverse event reporting and recalls. Mr. Heyl is a requent

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

o specialty chemical producers beore the U.S. Congress and numerous administrative

agencies.

Devon Wm. Hill is a partner in the ood 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 o ood, animal eed, cosmetics,

and ood and drug packaging materials in various jurisdictions around the world. Mr.

Hill is a requent speaker on the regulation o ood 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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xii Food and drug Lawand reguLation

Linda R. Horton, BA, JD, LLM, served FDA as legislative director, deputy chie counsel

or 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 rmsinternational lie sciences regulatory practice or eight years, retiring in 2010. Earlier she

chaired the Food and Drug Law JournalsEditorial Board and received FDLIs Leadership and

Meritorious Service Award as well as several FDA awards. She also taught ood 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 rm

o Hogan Lovells US LLP. Dr. Korwek has practiced in the FDA area or more than 30 years

and has a special expertise in the regulation o 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 o

Biotechnology Law Report. He is a past member o the editorial board o the Food and Drug

Law Journal and twice served on the FDLI Board o Directors.

Daniel Kracov is a Partner and Chair o the FDA and Healthcare Practice at Arnold &

Porter LLP. He assists clients in addressing challenges relating to the development, approval

and marketing o drugs, biologics and medical devices. Mr. Kracov has extensive experience

in product and compliance-related investigations, the development o regulatory corporate

compliance programs, enorcement matters, due diligence in nancings, mergers and

acquisitions, and biomedical product-related public policy matters, including congressionalinvestigations. He is a graduate o the University o Maryland and the University o Virginia

School o Law.

Eugene Lambert joined Covington & Burling LLP in 1961, ater graduation rom Yale Law

School and a clerkship on the D.C. Circuit, and embarked on ood and drug law through the

Drug Amendments o 1962 and the peanut butter standard. Since working on the passage

o the Animal Drug Amendments o 1968, he has been intimately involved in the legislative

and regulatory issues conronting the animal drug and pet ood industries. Now a Senior

Counsel at C&B, this is his tenth essay on animal drug or eed issues.

Geoffrey M. Levitt is Senior Vice President and Associate General Counsel or Regulatory

and Policy Law at Pzer, where he is responsible or managing global legal support or

regulatory, saety, policy and environmental operations. Prior to joining Pzer in October

2009, Mr. Levitt served as Vice President and Chie Regulatory Counsel at Wyeth. He has

published and lectured extensively on regulatory law, and is a past member o the editorial

board o the Food and Drug Law Journal and a current member o the editorial board o

the FDA Advertising and Promotion Manual. Mr. Levitt is Chairman o the Board o 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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Food and drug Lawand reguLation xiii

The Drugs/Biologics Approval Process in A Practical Guide to Food and Drug Law and

Regulation (3d ed. 2008). He earned his JD rom Harvard Law School and his BA rom

Columbia University.

Erika Lietzan is a partner in the ood and drug group at Covington & Burling LLP, specializing

in U.S. and ex-U.S. regulation o drugs and biological products. She was deeply involved

in the stakeholder process that led to development o the Biologics Price Competition

and Innovation Act, and she has been working with companies since its enactment on

the legal, scientic and policy issues surrounding FDA implementation. She also works

with companies developing global positions and lie-cycle strategies relating to biosimilars,

including coordination o regulatory and patent strategies, and she assists with their

advocacy beore oreign regulators. She speaks and publishes regularly on issues relating

to biosimilars. Her other areas o 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., countereiting, pedigrees, importation, shortages

and online pharmacy); drug saety (e.g., risk management and pharmacovigilance); and

interactions with healthcare proessionals.

Anne V. Maher is a partner at Kleineld, Kaplan & Becker LLP, a ood and drug law rm.

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 beore the FTC, the state Attorneys General and the NAD. Shewas Chairman o the Editorial Advisory Board o the Food and Drug Law Journal. Ms.

Maher was ormerly Assistant Director o Advertising Practices at the FTC, where she was

the designated FDA and USDA liaison. She requently speaks at conerences involving

advertising law and policy. Ms. Maher received her BA rom Boston University and her JD

rom Northeastern University School o Law.

Stephen Paul Mahinka, BA, JD, is the chair o Morgan Lewis global Lie Sciences &

Healthcare interdisciplinary group, resident in the rms Washington, D.C. oce. His

practice ocuses on both FDA regulatory and antitrust issues throughout the product liecycle, concerning pharmaceuticals, biologics, medical devices and ood additives, and FTC

and state consumer protection matters. Mr. Mahinka is widely published, is a co-author o

Life Sciences Mergers and Acquisitions (2008) and Winning Antitrust Strategies (2004), a

contributing author o the Pharmaceutical Industry Antitrust Handbook, (2009), and is a

past member o the editorial board o the Food and Drug Law Journal. He is a graduate o

Johns Hopkins University, Phi Beta Kappa, and o the Harvard Law School.

Joseph W. Metro is a partner in the Washington, D.C. oce o Reed Smith LLP. Mr.

Metro is a member o the rms Lie Sciences and Health Industry group, and represents

pharmaceutical, biologic and medical device industry clients on matters relating

to reimbursement, raud and abuse and government pricing. His practice includes


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xiv Food and drug Lawand reguLation

transactional, counseling and investigational aspects, and he is a requent speaker on

matters relating to the Medicaid rebate program and the Veterans Health Care Act. Mr.

Metro is a 1986 graduate o Dickinson College and received his law degree in 1989 romthe George Washington University National Law Center.

Suzan Onel is a partner in the FDA Practice o K&L Gates. Ms. Onels practice covers all

issues related to FDA-regulated products with a particular ocus on cosmetics, over-the-

counter drugs, dietary supplements, oods, medical devices and related consumer products.

Ms. Onel is a requent author and lecturer on topics relating to FDA regulatory compliance

and enorcement. She received her bachelors degree with honors in neurobiology and

history rom the University o Pennsylvania and her law degree rom the University o

Virginia.

Joseph A. Page is a proessor at the Georgetown University Law Center, where he has been

teaching ood and drug law since 1980. He has written about aspects o ood 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 Eects

Study Advisory Panel o the Oce o Technology Assessment o the U.S. Congress, and was

a member o the Board o Directors o Public Citizen rom 1972 to 2009. A 1955 graduate

o Harvard College (magna cum laude), where he majored in classics, Proessor Page holds

both an LLB and an LLM rom the Harvard Law School.

Eve C. Pelonis is a Food and Drug Counsel at Keller and Heckman LLP. Ms. Peloniss

practice ocuses on all regulatory and compliance matters o the U.S. Food and Drug

Administration and the U.S. Department o Agriculture. Ms. Pelonis graduated rom the

Johns Hopkins University with a BA in International Studies in 1999 and received her JD

rom the Catholic University o America in 2003.

William Pendergast is a retired partner and ounding member o the Food and Drug Group

o Arent Fox LLP. While serving as a trial attorney with FDA in the mid-1960s, Mr. Pendergast

was responsible or the conduct o some 100 trials and adjudicatory hearings involvingprincipally the pharmaceutical, cosmetic and ood 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 o leading manuacturers o

human and animal drugs, cosmetics and ood ingredients. Mr. Pendergast is the author o

more than 20 articles published in FDA-related proessional journals.


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Foodand drug Lawand reguLation xv

Jeannie Perron, JD, DVM, is a partner at the law rm o Covington & Burling LLP in

Washington, D.C. Her practice emphasis is ood and drug law, particularly animal ood and

drug law, and animal welare cases. She has authored or co-authored numerous articles andchapters in various publications. She is a member o a number o state and ederal bars and

the U.S. Patent and Trademark Oce. Dr. Perron received her JD rom George Washington

University and her DVM rom Texas A&M University.

Alexander Roussanov concentrates on pharmaceutical and medical devices matters, with

a particular ocus on the European Union (EU) regulatory ramework. Mr. Roussanov

advises in the areas o EU and national regulatory regimes regarding medicinal products

and medical devices, including promotion and marketing o products, compliance o

communication and interactions with stakeholders, regulatory obligations related to

authorization, and placing on the market. He has also worked in the eld o national pricing

and reimbursement systems. Prior to joining Hogan & Hartson (now Hogan Lovells),

Mr. Roussanov worked at the European Public Aairs oce o a leading international

pharmaceutical company.

Fabien Roys practice ocuses 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 conerences. He ocuses

particularly on the dierent stages o the medical device CE marking process. Mr. Roy alsoadvises 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 Oce o Counterterrorism and

Emerging Threats in FDAs Oce o the Commissioner. She is responsible or advancing

FDAs statutory, regulatory, and policy ramework to support the development and

availability o FDA-regulated medical products or public health and national securityemergencies. Ms. Sadove joined FDA in 2003 as Regulatory Counsel in the Center or

Drug Evaluation and Research. Prior to joining FDA, she handled public policy issues and

legislative aairs both in private practice law and or a Subcommittee o the U.S. House

o Representatives. She earned her BA rom Franklin & Marshall College and her JD rom

George Washington University, National Law Center.


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xvi Food and drug Lawand reguLation

Kathleen M. Sanzo is a partner in and leader o Morgan Lewis FDA & Healthcare Practice,

representing drug, device, ood and cosmetic manuacturers in regulatory, transactional,

enorcement and compliance matters. She graduated rom Emory Law School and receivedher LLM rom the George Washington University National Law Center, as the Food and

Drug Law Institute Fellow. Ms. Sanzo is the author or co-author o 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 Lie Sciences Integration partner in China. He works

with device, drug and diagnostic manuacturers establishing new operations in China,

seeking product approvals, to ensure regulatory compliance. Along with Dean Wang

Chenguang (Tsinghua School o 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

or innovative medical products. An honors graduate o Haverord College, he received the

Barristers Award rom Temple University School o Law.

Brett T. Schwemer is a principal at Olsson Frank Weeda Terman Bode Matz PC. He received

his BBA in 1989 rom the James Madison University and his JD rom Ohio Northern University

School o Law in 1992, graduating with distinction. Mr. Schwemer concentrates his practice

in regulatory and enorcement matters beore the Food Saety and Inspection Service, the

Packers and Stockyards Administration, and the Animal and Plant Health Inspection Service

o the U.S. Department o Agriculture. He has spoken extensively on a variety o meat and

poultry inspection issues and is a certied HACCP trainer.

Jeffrey K. Shapirohas represented healthcare companies on FDA-related matters since 1994.

He advises companies in the areas o medical devices, combination products and human

tissue products, including product approvals, marketing, clinical studies, jurisdictional

issues, recalls and enorcement. Mr. Shapiro has written and lectured extensively on FDA-

related topics. He is co-editor oPromotion of Biomedical Products (FDLI 2006) and co-author oCombination Products: How to Develop the Optimal Strategic Path for Approval

(FDA News 2005). He is a Director in the law rm o Hyman, Phelps, & McNamara, a rm

ocused exclusively on FDA law and regulation.

Jolyda O. Swaim is a principal in the Washington, D.C. law rm o Olsson Frank Weeda

Terman Bode Matz PC, ocusing on USDA-FSIS regulatory matters related to meat and

poultry production. Prior to becoming an attorney, she had extensive experience in the

ood industry. Her last position was with Sara Lee Corporation as Corporate Food Saety

Director with oversight o meat and poultry plants in the United States and Mexico. Ms.Swaim received her BS rom Mercyhurst College in Erie, Pennsylvania, and her JD cum

laude rom Thomas M. Cooley Law School in Lansing, Michigan.


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Food and drug Lawand reguLation xvii

Brian P. Waldman is a member o Arent Fox LLPs Executive Committee, and co-manager

o the rms Regulatory Department. Mr. Waldman concentrates his practice in the areao ood and drug law and advertising law, counseling manuacturers and distributors o

pharmaceuticals, medical devices, oods (including dietary supplements and medical oods)

and cosmetics, with particular emphasis on developing eective strategies or introducing

and promoting new products. He received his JD degree rom the University o Caliornia

at Los Angeles and his MBA and BA rom the University o Chicago.

Marsha Wertzberger is the senior ood and dietary supplement attorney at Arent Fox. Ms.

Wertzberger practices in the areas o ood and drug law and biotechnology, with a ocus

on regulatory and enorcement matters, advertising and marketing issues, and product

development. She is active in mentoring activities within the rm and is a ounding

member o the women in ood and drug law group o the Food and Drug Law Institute.

She is a pharmacist and is a graduate o Georgetown Law Center.

Edward C. Wilson, Jr. (Ted), JD, University o Virginia School o Law, AB, Davidson

College (cum laude, Phi Beta Kappa), is a partner at Hogan Lovells US LLP in Washington,

D.C. His practice ocuses on a wide variety o regulatory and enorcement issues aecting

the medical device industry. Mr. Wilson is a certied 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 inthe deense o government investigations, conducting internal investigations o alleged

company misconduct and providing legal advice on a variety o device-related issues.

Ann H. Wion is Deputy Chie Counsel or Program Review in the Oce o the General

Counsel, Department o Health and Human Services (HHS), Food and Drug Division.

She received a PhD rom Cornell University and a JD rom Stanord Law School. Ater

joining the HHSs Oce o 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 inChapter 21 are the authors and do not necessarily represent those o HHS/FDA.

Elisabethann Wright ocuses on European Union (EU) law relating to lie sciences, with

particular emphasis on pharmaceutical law, medical devices, ood law and the environment.

This includes assisting clients in classication o their products, establishment o a pathway

to authorization and marketing o their products in the EU (including related regulatory

obligations), pharmacovigilance obligations, promotion and marketing o products, sales

agreements, clinical trial agreements, adverse event reporting, product withdrawals and

challenges to national authority and EU Institution decisions concerning classication and

marketing o medicinal products and medical devices. Prior to joining Hogan & Hartson


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xviii Food and drug Lawand reguLation

(now Hogan Lovells), she served as Senior Legal Ocer and Hearing Ocer at the EFTA

Surveillance Authority.

Gary L. Yingling, a partner with K&L Gates, is the rms FDA Practice Groups Coordinator.

Beore entering private practice, Mr. Yingling was president o the Food and Drug Law

Institute. He was in the government or 10 years serving in FDAs Oce o the General

Counsel and was director o the OTC Drug Review or two years, or which he received

FDAs Award o Merit. Beore attending law school, he practiced community pharmacy and

is a registered pharmacist in Maryland and D.C. He received a BS rom the University o

North Carolina, MS rom Purdue University and JD rom Emory University School o Law.


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CHAPTER 1

INTRODUCTION

RICHARD M. COOPER

The Focus of the Law

Food and drug law is about certain types o physical things. Most o these things are put

into or onto, or are used with, the bodies o humans or animalsoods, drugs, medical

devices, cosmetics, and, since June 22, 2009, tobacco products. Food and drug law also

concerns aspects o radiation-emitting products (e.g., microwave ovens, laser lights) that

relate to saety. The principal requirements and prohibitions o the law are about things:

they shall not be adulterated or misbranded; they shall be manuactured and tested in ac-

cordance with certain standards; on their labels and in their labeling, certain disclosures

shall be made, and certain kinds o claims shall not be made; certain kinds o things shall

not be introduced into interstate commerce until their distribution has been authorized by

the regulatory agency; and so on.

During the rst ew decades o modern ood and drug law, the laws characteristic orm o

enorcement action was an in rem seizure action against physical objects that were in viola-

tion o the law.1 The purpose o this type o action was to protect patients or other consum-ers rom 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 ood and drug law regulates people and what

they do, it regulates them only in relation to the physical things that are within the jurisdic-

tion o the law, through injunctive, criminal, debarment, civil-penalty or certain other types

o proceedings.

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


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2 Food and drug Lawand reguLation

Some products within the jurisdiction o the Food and Drug Administration (FDA)e.g.,

drugs and medical devicesare discovered or invented ater substantial research. Such a

product undergoes a developmental process that includes testing in a laboratory and thenin animals and humans; creation and validation o processes or manuacturing and quality

control on a commercial scale; and development o labeling that sets orth conditions o use.

It then goes through some orm o review by FDA and is approved, cleared or otherwise

permitted to be distributed in interstate commerce. Next, the product is manuactured in

packaged and labeled orm, is advertised and promoted, and is shipped commercially. Dur-

ing its lie on the market, the product is rom time to time the subject o reports o adverse

events experienced by consumers and o complaints by consumers, which are reviewed by

the products manuacturer and possibly by FDA. Medical devices may undergo engineer-

ing changes. The labeling o drugs and medical devices changes as inormation on how touse them most eectively and saely accumulates. Additional uses or such products may

be discovered, tested and included in product labeling. Food and drug law addresses most

stages o this product lie cycle.

This ocus on physical things sets the ramework or regulation by FDA. The agencys most

labor-intensive activities include: 1) review o applications to test potential new medi-

cal products in human subjects; 2) review o applications or permission or commercial

marketing o new products or ingredients or use in products, and or changes in already

marketed products; 3) review o reports and other data bearing on the saety o marketed

products; 4) inspections o actories and o goods oered or importation, and testing o

samples obtained in such inspections; 5) review o advertising and marketing o products;

6) regulatory and enorcement actions that result rom such inspections and reviews; and 7)

development and publication o regulations and guidance documents relating to products

and activities within its jurisdiction.

FDA regulates products that account or more than 20 percent o consumer spending in

the United States.2 Whereas other administrative agencies have gone through periods o

deregulation, in recent years Congress has expanded FDAs jurisdiction and its regulatory

authorities.

2 Margaret A. Hamburg, M.D., Commissioner o Food and Drugs, Remarks at Generic Pharmaceutical Association

Annual Meeting (Feb. 18, 2010), available at http://www.da.gov/NewsEvents/Speeches/ucm201833.htm. See also

Sean Silverthorne, The FDA: What Will the Next 100 Years Bring?, Harvard Bus. scH. Working knoWledge (Sept. 24,

2007), available at http://hbswk.hbs.edu/item/5753.html; Alastair J.J. Wood, M.D., Playing Kick the FDARisk-reeto Players But Hazardous to Public Health, 358 n. eng. J. Med. 1774, 1774-75 (Apr. 24, 2008), available at http://www.

nejm.org/doi/ull/10.1056/NEJMp0802227.


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CHAPTER 1 introduction 3

A Little History

Although there were antecedents in the 19th century in America and even earlier inEngland,3 the modern history o ood and drug regulation begins with the Pure Food and

Drugs Act o 1906.4 That legislation, which had long been championed by Dr. Harvey W.

Wiley, Chie Chemist o the U.S. Department o Agriculture (USDA), nally resulted rom

the sensational disclosures by the muckrakers o corruption, raud and improper conditions

in many areas o economic activity, including ood processing and the manuacture and

marketing o patent medicines.5

The law specied conditions under which oods and drugs would be considered adulterated

or misbranded (and thereore barred rom interstate commerce), and authorized USDAsBureau o Chemistry to recommend enorcement actions to the U.S. Department o Justice

(DoJ). The law did not provide or governmental review o products prior to their marketing,

and was limited in other ways.

Many o the recognized deects in the 1906 act were remedied by the Federal Food, Drug,

and Cosmetic Act o 1938 (FDCA), FDAs organic statute and the principal authority or

its regulatory activities.6 This statute greatly expanded FDAs authority by providing or

premarket review o drugs under a requirement o saety, or standards o identity and qual-

ity or ood, or regulation o medical devices and cosmetics, and or inspections by FDA

employees o actories, warehouses and other places where regulated products are made,

tested or held. This statute remains the basic ood 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 o which have been subsequently amended) have

included the ollowing:

3 See, e.g., Peter Barton Hutt, The Basis and Purpose o Government Regulation o Adulteration and Misbranding o 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 o biologi-

cal origin. Pub. L. No. 57-244, 32 Stat. 728 (1902).5 See generally Richard M. Cooper, The Struggle or the 1906 Act, in Fda: a centuryoF consuMer Protection25-69

(Wayne Pines ed., FDLI 2006). The phenomenon o enacting ood and drug legislation in response to harm, or a per-

ceived threat o harm, to the public health (perceived as resulting rom a lack o adequate regulation) was repeated

in 1938, when the modern ood 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 urther

major amendments to the drug law and other parts o the FDCA were enacted.6

Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codied as amended at 21 U.S.C. 301-904). Section 408 o the FDCA,21 U.S.C. 346a, relating to tolerances and exemptions or pesticide chemical residues, is administered by the

Environmental Protection Agency.


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Aseriesofamendmentsprovidingforregulationofinsulinandvariousantibiotics7;

MillerAct,whichaddedtotheFDCAsection301(k)(adulteratingormisbrandingareg-

ulated product ater it has been shipped in interstate commerce) and correspondinglyamended section 304(a) (relating to seizure)8;

Durham-Humphrey Amendment (providing a statutory basis for a prescription

requirement)9;

Pub.L.No.83-217(strengtheningFDAsinspectionalauthority)10;

FoodAdditivesAmendmentof195811;

ColorAdditiveAmendmentsof196012;

DrugAmendmentsof196213;

AnimalDrugAmendmentsof196814;

DrugListingActof197215

; MedicalDeviceAmendmentsof197616;

VitaminsandMineralsAmendments17;

InfantFormulaActof198018;

OrphanDrugAct19;

DrugPriceCompetitionandPatentTermRestorationActof1984(Hatch-WaxmanAct)20;

DrugExportAmendmentsActof198621;

PrescriptionDrugMarketingActof198722;

FoodandDrugAdministrationActof1988(statutoryestablishmentofFDA)23;

GenericAnimalDrugandPatentTermRestorationAct24;

NutritionLabelingandEducationActof199025;

SafeMedicalDevicesActof199026;

7 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 o 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).


23/39


FoodandDrugAdministrationRevitalizationAct27;

GenericDrugEnforcementActof199228;

PrescriptionDrugAmendmentsof199229; MedicalDeviceAmendmentsof199230;

PrescriptionDrugUserFeeActof199231;

AnimalMedicinalDrugUseClaricationActof199432;

DietarySupplementHealthandEducationActof199433;

FDAExportReformandEnhancementActof199634;

FoodQualityProtectionActof199635;

AnimalDrugAvailabilityActof199636;

FoodandDrugAdministrationModernizationActof199737;

BestPharmaceuticalsforChildrenAct38

; PublicHealthSecurityandBioterrorismPreparednessandResponseActof200239;

MedicalDeviceUserFeeandModernizationActof200240;

AnimalDrugUserFeeActof200341;

PediatricResearchEquityActof200342;

TitleXIoftheMedicarePrescriptionDrug,Improvement,andModernizationActof2003

(relating to generic drugs)43;

MinorUseandMinorSpeciesAnimalHealthActof200444;

FoodAllergenLabelingandConsumerProtectionActof200445;

DietarySupplementandNonprescriptionDrugConsumerProtectionAct46;

FoodandDrugAdministrationAmendmentsActof200747;

QIProgramSupplementalFundingActof2008(sectionrelatingtocertainantibiotic

drugs)48;

27 Pub. L. No. 101-635, 104 Stat. 4583 (1990).28 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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FamilySmokingPreventionandTobaccoControlAct49;

PatientProtectionandAffordableCareActof2010(sectionrelatingtonutritionlabeling

o standard menu items at chain restaurants)50; and FDAFoodSafetyModernizationAct.51

Although FDA is the agency principally responsible or regulation o oods, drugs, medical

devices, cosmetics and tobacco products, certain regulatory unctions relating to some o

those products are also perormed by USDA, the Drug Enorcement Administration in DoJ,

the Federal Trade Commission and the states. In addition, the system or ederal reimburse-

ment or therapeutic products is administered by the Centers or Medicare & Medicaid

Services in the Department o Health and Human Services (HHS).

FDAs Place in the Executive Branch

FDA is, and always has been, an agency in the executive branch.52 Thereore, its budget,

legislative proposals, congressional testimony and major regulatory proposals are subject to

approval by the Oce o Management and Budget (OMB) on behal o the President.

Like other executive branch agencies, FDA is subject to a wide variety o 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 itsel in

court, but is represented by DoJ.55 All litigationcivil and criminalinvolving the agency,

and including litigation brought against the agency, is supervised on behal o the agency

49 Pub. L. No. 111-31, 123 Stat. 1776 (2009).50 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 Saety Commission, or example, are inde-

pendent agencies.53 See Chapter 21, inra.54 E.g., Administrat ive Procedure Act, Pub. L. No. 79-404, 60 Stat. 237 (1946) (codied as amended at 5 U.S.C. 551-

559, 701-706); Freedom o Inormation Act, Pub. L. No. 89-554, 80 Stat. 383 (1966) (codied as amended at 5 U.S.C.

552); Federal Advisory Committee Act, Pub. L. No. 92-463, 86 Stat. 770 (1972) (codied as amended at 5 U.S.C.

app. 2); National Environmental Policy Act o 1969, Pub. L. No. 91-190, 83 Stat. 852 (1969) (codied as amended

at 42 U.S.C. 4321, 4331-4335); Regulatory Flexibility Act, Pub. L. No. 96-354, 94 Stat. 1164 (1980) (codied as

amended at 5 U.S.C. 601-612); Government Perormance and Results Act o 1993, Pub. L. No. 103-62, 107 Stat.

285 (1993); Ununded Mandates Reorm Act o 1995, Pub. L. No. 104-4, 109 Stat. 48 (1995) (codied as amended

at 2 U.S.C. 1501-1504, 1511-1616, 1531-1538, 1551-1556, 1571); Paperwork Reduction Act o 1995, Pub. L. No.

104-13, 109 Stat. 163 (1995) (codied at 44 U.S.C. 3501-3520). These statutes have been amended rom time totime.55 See 28 U.S.C. 516, 519 (2006). The agency is also bound by opinions o the Attorney General.


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by the Oce o Consumer Litigation (OCL) in the Civil Division o DoJ. In practice, re-

sponsibility or the actual conduct o litigation on behal o the agency is divided between

the OCL and the Oces o the United States Attorneys throughout the country. In general,DoJ permits lawyers in FDAs Oce o Chie Counsel to assist in the representation o the

agency in litigation.

FDA originated as the Bureau o Chemistry in USDA beore the enactment o the Pure

Food and Drugs Act o 1906.56 The agency remained part o USDA (under various names)

until 1940, when it was transerred to the Federal Security Agency, which later became the

Department o Health, Education and Welare, and then HHS.57 The agency was ormally

established by law in 1988.58

As part o 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 o other important

actions, including certain types o regulatory actions,59 internal reorganizations and impor-

tant personnel actions. Issues o integrity or eciency with respect to FDA are investigated

by HHSs Oce o Inspector General.

Although not legally independent, FDA is culturally independent o HHS. FDAs principal

oces are located on a campus in White Oak, Marylanda substantial distance rom 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 o deerring

to superior legal authority only to the extent necessary, and o acting as independently as

circumstances permit.

FDA and Congress

Despite the movement o FDA rom USDA to HHS, FDAs annual appropriation is still parto the agricultural appropriations process, and is reviewed and determined by the Subcom-

mittees on Agriculture o the House and Senate Appropriations Committees. FDAs autho-

rizing committees are the Senate Committee on Health, Education, Labor, and Pensions and

56 The Bureau o Chemistry began in 1862 with President Lincolns appointment o a chemist in the Department o

Agriculture. U.S. Department o Health and Human Services, Histor ical Highlights, available at http://www.hhs.gov/

about/hhshist.html. The name Food and Drug Administration rst ocially appeared in the Agricultural Appro-

priat ion Act o 1931, Pub. L. No. 71-272, 46 Stat. 392 (1930).57 See generally Michael Brannon, Organizing and Reorganizing FDA, inFoodand drug laW 113-63 (Richard M. Cooper

ed., FDLI 1991).58 See supra note 23.59 See inra notes 86-87 and accompanying text.


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the House o Representatives Committee on Energy and Commerce. Within the latter, the

Subcommittee on Oversight and Investigations and the Subcommittee on Health histori-

cally have taken a strong interest in the agency. The House o Representatives Committee onOversight and Government Reorm also has responsibilities with respect to FDA. From time

to time, other committees also have conducted investigations and hearings relating to FDA.

FDA requently has been the subject o reports issued by congressional committees and by

the Government Accountability Oce (ormerly known as the General Accounting Oce).60

FDAs Internal Organization and Budget

FDAs internal organization is set orth in Part 5 o Title 21 o the Code o Federal Reg-

ulations. The head o the agency is a single Commissioner,61 who, under a stat-

ute enacted in 1988, is appointed by the President with the advice and consent o the

Senate.62 Under the Commissioner, FDA units with agency-wide responsibilities are:

Oce o Policy, Planning and Budget;OfceofPolicy;

OfceofPlanning;

OfceofBudget;

OfceofWomensHealth;

OfceofLegislation;

OfceoftheChiefCounsel63;

OfceoftheCounselortotheCommissioner;

OfceofCrisisManagement;

OfceoftheAdministrativeLawJudge64;

OfceoftheChiefofStaff

60 See Peter Barton Hutt, Investigations and Reports on the Food and Drug Administration, in Foodand drug laW 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 Secre-

tary without Senate conrmation.63 FDAs Oce o Chie Counsel is, technically, part o the Oce o the General Counsel o HHS, which, in turn,

is part o the Oce o the Secretary. The FDA Chie Counsel is ocially an Associate General Counsel o HHS.

See HHS, Oce o the General Counsel, Key Personnel, Food and Drug Division, available at http://www.hhs.

gov/ogc/personnel/index.html#FoodandDrugDivisionStaContactInormation (last updated Dec. 27, 2010). Al-

though the Chie Counsel advises the Commissioner o Food and Drugs, the Chie Counsel ormally reports to the

General Counsel o HHS. Description o the Oce o Chie Counsel, available at http://www.da.gov/AboutFDA/

CentersOces/OrganizationCharts/ucm229420.htm (last updated Jan. 10, 2011).64

FDAs Administrative Law Judge ormally reports directly to the Secretary o Health and Human Services. FDA web-site, available at http://www.da.gov/AboutFDA/CentersOces/OrganizationCharts/ucm229424.htm (last updated

Jan. 14, 2011).


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OfceofSpecialMedicalPrograms;

OfceofGoodClinicalPractice;

OfceofCombinationProducts;OfceofOrphanProductsDevelopment;

OfceofPediatricTherapeutics;

OfceofExternalAffairs;

OfceofExternalRelations;

OfceofPublicAffairs;

OfceofSpecialHealthIssues;

OfceofFoods;

OfceoftheChiefScientist;

OfceofCounter-TerrorismandEmergingThreats;OfceofCriticalPathPrograms;

OfceofScienticIntegrity;

OfceofScienceandInnovation;

OfceofInternationalPrograms;

OfceofAdministration;

OfceofAcquisitionsandGrantsServices;

OfceofExecutiveOperations;

OfceofFinancialOperations;

OfceofFinancialManagement;

OfceofFinancialServices;

OfceofInformationManagement;

OfceofManagement;

OfceofSharedServices;

EmployeeResourceInformationCenter;

OfceofPublicInformationandLibraryServices;

OfceofRealPropertyServices;

OfceofWhiteOak Services;

OfceofBusinessOperationsandHumanCapitalPrograms;

OfceofManagementPrograms; OfceofSecurityOperations;and

OfceofEqualOpportunityandDiversityManagement.

The organization o the Oce o the Commissioner changes rom time to time to suit the

preerences o particular Commissioners.

FDAs Oce o Regulatory Aairs (under an Associate Commissioner or Regulatory Aairs)

and its Oces o Resource Management, Regional Operations, Enorcement and Criminal


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Investigations also have agency-wide responsibilities.65 Under the Oce o Regulatory A-

airs, FDAs eld sta is divided into ve regions (Northeast, Southeast, Central, Southwest

and Pacic), which have district oces and other oces at numerous locations. FDA alsohas an ombudsman,66 and a National Center or Toxicological Research.67

FDAs principal regulatory programs are administered by six Centers:

CenterforBiologicsEvaluationandResearch;

CenterforDevicesandRadiologicalHealth;

CenterforDrugEvaluationandResearch;

CenterforFoodSafetyandAppliedNutrition;

CenterforTobaccoProducts;and CenterforVeterinaryMedicine.

Extensive inormation about the Centers and about other aspects o FDAs structure and

activities is available on FDAs website, www.da.gov.

As o early 2011, FDA had 49 advisory committees and panels, principally or drugs and

biological products.68

Despite extensive cuts elsewhere in the ederal budget or scal 2011 (ending September

30, 2011), FDAs appropriated budget authority or that year increased approximately $107

million over scal 2010 to $2.5 billion (apart rom unds or repair o buildings and acili-

ties, and excluding user ees).69 For scal 2012, the President requested a total o $4.4 billion

(rounded) in budget authority and user ees, o which $2.7 billion is budget authority and

$1.6 billion is user ees; despite urther cuts elsewhere, the actual appropriated budget au-

thority or scal 2012 is $2.5 billion (an increase o nearly $50 million is not shown in the

total compared to that or scal 2011 due to rounding).70

65 See generally the description o the Oce o Regulatory Aairs, available at http://www.da.gov/AboutFDA/Centers

Oces/ORA/deault.htm (last updated Apr. 12, 2011).66 See generally the description o the Oce o the Ombudsman, available at http://www.da.gov/AboutFDA/Centers O-

ces/OC/OceoScienticandMedicalPrograms/ucm197508.htm (last updated Apr. 8, 2011).67 See generally the description o the National Center or Toxicological Research, available at http://www.da.gov/

AboutFDA/CentersOces/NCTR/deault.htm ( last updated Mar. 3, 2011).68 See http://www.da.gov/AdvisoryCommittees/deault.htm (last updated May 2, 2011) (or lists o committees, under

Get Inormation by Committee, click on individual subject matter areas).69 Alliance or a Stronger FDA, One Battle Done, But More to Come (Apr. 15, 2011) (click on the chart), available at

http://strengthenda.org/2011/04/15/one-battle-done-but-more-to-come.70 See HHS, Fiscal Year 2012 FDA Justication o Estimates or Appropriations Committees 83 (undated, but 2011),

available at http://www.da.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/ucm243370.

pd. See also Testimony o Margaret A. Hamburg, M.D., Commissioner o Food and Drugs on the Presidents Fiscal

Year 2010 Budget Request or FDA, Beore the Subcommittee on Agriculture, Rural Development, Food and Drug Ad-

mini stration, andRelatedAgenciesoftheH.Comm.OnAppropriat ions(Mar.11,2011),available at http://www.da.

gov/NewsEvents /Testimony/ucm246902.htm; Alliance or a Stronger FDA, FDA Budget Authority Appropriations or

FY 2012 (updated Nov. 15, 2011), available at http://daalliance.les.wordpress.com/2009/11/y-12-da-house-senate-

con-approps-by-center1.pd.


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In scal 2010, FDAs authorized stang o ull-time-equivalent positions was as ollows:

Food 3,486Human Drugs 2,085

Biologics 858

Animal Drugs/Feed 636

Devices & Radiological Health 1,494

Natl Center or Toxicological Research 210

Oce o Commissioner & Other HQ 644

TOTAL 9,41371

Although FDA has received budget increases in recent years, there is reason to believe thatthe resources provided by Congress to FDA chronically have been, and remain, inadequate

to enable the agency to ulll its statutory responsibilities.72

FDAs Statutory Authorities

All authority exercised by FDA is derived rom congressional delegations to the Secretary o

Health and Human Services (the Secretary), and redelegations by the Secretary to the Com-

missioner o 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 Stan-

dards Act o 1992,75 certain provisions o 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 or a Stronger FDA, supra note 69.72 See, e.g., FDA Subcommittee on Science and Technology, FDA Science and Mission at Risk (Nov. 2007), available

at http://www.da.gov/ohrms/dockets/ac/07/brieng/2007-4329b_02_01_FDA%20Report%20on%20Science%20

and%20Technology.pd.73 The delegations are set orth in 2 FDA staFF Manual guides 1410.10 (2005), available at http://www.da.gov/

AboutFDA /ReportsManualsForms/StaManualGuides/ucm080711.htm(Authorities Delegated), which lists the au-thorities delegated by the Secretary to FDA. See also Removal o Delegations o Authority and Conorming Changes

to Regulations, 69 Fed. Reg. 17,285 (Apr. 2, 2004) (removing list o delegated authorities rom the Code o Federal

Regulations).74 The Commissioner is directly authorized by FDCA 904, 21 U.S.C. 394, to establish technical and scientic

review groups and to appoint and pay their members.75 Pub. L . No. 102-539, 106 Stat. 3547 (1992).76 See 2 FDA staFF Manual 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 o laws relating to controlled substances and drug abuse,80 and has important

unctions under the Federal Caustic Poison Act,81 the Lead-Based Paint Poisoning Preven-

tion Act82 and the Fair Packaging and Labeling Act.83 The agency also has certain unctionsunder statutes administered principally by USDA.84 The unctions that FDA perorms under

statutes other than the FDCA are ancillary to its unctions 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 o oods,

drugs, cosmetics, medical devices, or other subjects o regulation;or

2. Present highly signicant public issues involving the quality,

availability, marketability, or cost o one or more oods, drugs,

cosmetics, medical devices, or other subjects o regulation.87

This reservation o authority was not intended to create any private right or benet, 88 al-

though, as a practical matter, it does invite lobbying at the department with respect to

regulations to which it applies.

FDAs internal redelegations o authority are available at http://www.da.gov/AboutFDA/Re-

portsManualsForms/StaManualGuides/ucm136380.htm (last updated Apr. 6, 2011).

80 Comprehensive Drug Abuse Prevention and Control Act o 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(), 84 Stat. 1242, 1253, 1255 (1970) (codied as

amended at 21 U.S.C. 823()).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) (codied as amended at 42 U.S.C. 4831(a)).83 15 U.S.C. 1451-1461 (2006).84 Federal Meat Inspection Act 409(b) (codied as amended at 21 U.S.C. 679(b)); Poultry Products Inspection Act

24(b) (codied as amended at 21 U.S.C. 467(b)); Egg Products Inspection Act (codied as amended at 21 U.S.C.

1031-1056).85 For a list o other statutes FDA considers itsel aected by, see http://www.da.gov/RegulatoryInormation/Legisla-

tion/ucm153119.htm.86 Reservation o Rulemaking Authority o the Food and Drug Admini stration in Matters Involving Signicant Public

Policy: Revision, 47 Fed. Reg. 16,318 (Apr. 16, 1982).87 See 2 FDA staFF Manual guides 1410.10 2 (Reservation o Authority) (2005), supra note 73.88 Id. 2.C.


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An Overview of the Federal Food, Drug, andCosmetic Act

The FDCA is organized into ten chapters:

ShortTitle,

Denitions,

ProhibitedActsandPenalties,

Food,

Drugs,Devices,andElectronicProducts,89

Cosmetics,

GeneralAdministrativeProvisions, ImportsandExports,

TobaccoProducts,and

Miscellaneous.

The statute is codied in Title 21 o the United States Code. The critical terms o the statute

are dened in section 201.90 Among the terms dened are the jurisdictional terms (ood,

drug, device (the term device reers to a medical device), cosmetic and tobacco prod-

uct), and other terms critical to the operation o the statute (e.g., interstate commerce,

label and labeling, new drug, ood additive and color additive). Section 201(u) spec-

ies that, or purposes o ood additives, new animal drugs and color additives, the term

sae reers to the health o man or animal91; but the statute contains no general denition

o sae or saety, and consequently the denitions o those terms or particular regulatory

purposes must be derived rom other legal and regulatory materials.

The general strategy o the statute consists o three steps. First, the statute species circum-

stances in which an article (ood, drug, device, cosmetic or tobacco product) is adulterated

89 The provisions relating to electronic products, including denitions, substantive, administrative, and enorcement

provisions, and a list o prohibited acts, appear in FDCA sections 531-542, 21 U.S.C. 360hh-360ss. FDA origi-

nally regulated radiation-emitting electronic products under the Radiation Control or Health and Saety Act o

1968, Pub. L. No. 90-602, 82 Stat. 1173 (1968), which was originally codied as part o the Public Health Service

Act. Responsibi lity or administrat ion o this statute was t ranserred to FDA by Redelegation o Authority, 36 Fed.

Reg. 12,803 ( July 7, 1971); and the statute, itsel , was recodied 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 de-

nes a set o prohibited acts with respect to such an article.94 Third, the statute authorizes

a set o enorcement actions in response to a prohibited act.95 With respect to ood, drugs,devices, cosmetics and tobacco products the adulteration and misbranding provisions use

terms elaborated on in other substantive provisions o the statute, located in Chapter IV

(Food),ChapterV(DrugsandDevices),ChapterVI(Cosmetics)andChapterIX(Tobacco

Products). Under FDCA section 701(a),96 FDA has exercised general authority to elaborate

by regulation the statutory standards or adulteration and misbranding, and those or ap-

provals and other authorizations or marketing o 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 reerence to adulteration or misbranding)prohibits the introduction into interstate commerce o any new drug or which an approval

92 See FDCA 402 (adulterated ood), 403 (misbranded ood), 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 or certain oods), 505 (new drugs or human use), 21 U.S.C. 344, 355.

Other requirements or authorization or distribution, including id. 409 (ood 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) (ood additives), 402(a)(2)(C)(ii) (oods containing

a new animal drug), 501(a)(5)-(6) (new animal drugs), 351() (Class III medical devices), 402(c) (ood containing

a color additive), 501(a)(4)(A) (drug or device containing a color additive), 501(a)(4)(B) (color additive or use on adrug 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 reer to actions by FDA to permit the distribution o dierent

kinds o 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 o a notication under sec-

tion 510(k), 21 U.S.C. 360(k). See, e.g., FDA, 510(k) Clearances, available at http://www.da.gov/MedicalDevices/

ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/deault.htm (last updated June

18, 2009). Under section 404, 21 U.S.C. 344, FDA issues permits or interstate distribution o certain oods.

With respect to a new tobacco product rev iewed 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

or introduction into interstate commerce Most authorizations or marketing are by letter (which constitutes an

order or purposes o the Administrative Procedure Act, 5 U.S.C. 551(6)), but an authorization or the marketing

and use o a ood additive or color additive is in the orm o a regulation, see FDCA 409(c), 21 U.S.C. 348(c) (ood

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 enorcement actions are authorized in

substantive provisions o the statute. For example, FDCA 505(e), 21 U.S.C. 355(e), authorizes withdrawal o

approval o a new drug application on certain specied grounds.96 21 U.S.C. 371(a).97 See, e.g., 21 C.F.R. pts. 101 (ood labeling), 110 (current good manuacturing practices or human ood), 201 (drug

labeling), 210-211 (good manuacturing practices or drugs), 314 (premarket approvals o new drugs), 801 (device

labeling), 814 (premarket approvals o devices) and 820 (quality system regulation or devices).98

21 U.S.C. 331.99 Id. 331(a).100Id. 331(d).


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required by section 505(a)101 is lacking and o any ood subject to section 404102 or 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 or sale ater shipment

in interstate commerce, or that lacks a required authorization or distribution, is subject to

seizure.103 Commission o acts prohibited by section 301 may be enjoined under section

302,104 and may be the basis or a criminal prosecution and/or, in certain circumstances, an

action or civil penalties under section 303.105 Other remedies or certain kinds o prohibited

acts are available to FDA under other provisions o the statute.106

FDAs Mission

FDAs mission is stated in section 1003(b) o the FDCA:

The Administration shall

(1) promote the public health by promptly and eciently reviewing clinical

research and taking appropriate action on the marketing o regulated prod-

ucts in a timely manner;

(2) with respect to such products, protect the public health by ensuring that

(A) oods are sae, wholesome, sanitary, and properly labeled;

(B) human and veterinary drugs are sae and eective;

(C) there is reasonable assurance o the saety and eectiveness o devices

intended or human use;

(D) cosmetics are sae and properly labeled; and

(E) public health and saety are protected rom electronic product radiation;

(3) participate through appropriate processes with representatives o other

countries to reduce the burden o regulation, harmonize regulatory re-

quirements, 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

101Id. 355(a).102Id. 344.103Id. 334.104Id. 332.105Id. 333.106See generally Chapter 22, inra.


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health, and in cooperation with consumers, users, manuacturers, import-

ers, packers, distributors, and retailers o regulated products.107

Here is FDAs statement o what it does:

FDA is responsible or protecting the public health by assuring the saety, e-

cacy and security o human and veterinary drugs, biological products, medical

devices, our nations ood supply, cosmetics, and products that emit radiation.

FDA is also responsible or advancing the public health by helping to speed in-

novations that make medicines more eective, saer, and more aordable and

by helping the public get the accurate, science-based inormation they need to

use medicines and oods to maintain and improve their health. FDA also hasresponsibility or regulating the manuacturing, marketing and distribution

o tobacco products to protect the public health and to reduce tobacco use by

minors.

Finally, FDA plays a signicant role in the Nations counterterrorism capabil-

ity. FDA ullls this responsibility by ensuring the security o the ood supply

and by ostering development o medical products to respond to deliberate and

naturally emerging public health threats.108

FDA states that it strives to:

EnforceFDAlawsandregulations,usingallappropriatelegalmeans.

Baseregulatorydecisionsonastrongscienticandanalyticalbaseandthelaw;and

understand, conduct, and apply excellent science and research.

Beapositiveforceinmakingsafeandeffectiveproductsavailabletotheconsumer,and

ocus special attention on rare and lie-threatening diseases.

Provideclearstandardsofcompliancetoregulatedindustry,andadviseindustryonhow

to meet those standards.

IdentifyandeffectivelyaddresscriticalpublichealthproblemsarisingfromuseofFDA-regulated products.

IncreasetheFDAseffectivenessthroughcollaborationandcooperationwithstateandlocal

governments; domestic, oreign, and international agencies; industry; and academia.

Assistthemedia,consumergroups,andhealthprofessionalsinprovidingaccurate,cur-

rent inormation about regulated products to the public.

Work consistently toward effective and efficient application of resources to our

responsibilities.

107 21 U.S.C. 393(b).108 FDAs Mission Statement, available at http://www.da.gov/opacom/morechoices/mission.html (last updated Nov. 18,

2010). A statement o FDAs mission also appears in the 2007-2008 u.s. governMent Manual 224, available at http://rwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2007_government_manual&docid=211657tx_xxx-41.pd.


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Providesuperiorpublicservicebydeveloping,maintainingandsupportingahigh-quality,

diverse workorce.

Behonest,fair,andaccountableinallofouractionsanddecisions.109

FDAs International Activities

Under Chapter VIII o the FDCA, FDA long has had responsibilities with respect to import

and export o articles within its jurisdiction. In connection with imports, FDA, in coopera-

tion with the U.S. Customs and Border Protection, conducts inspections o oreign goods

presented or entry into the United States110

; the agency also has responsibility to inspect, orarrange or inspection o, oreign acilities that manuacture or process goods or importa-

tion into the United States.111 In connection with exports, the agency reviews applications

or export approval where required,112 and provides export certicates.113 The agency also

has active programs to achieve harmonization o its regulatory requirements with those o

other countries with sophisticated regulatory systems.114

Food and Drug Law and Regulation, and Medicine

Although the ood and drug laws and FDAs regulations apply to articles that aect health

and to articles that are used to protect, promote and restore health, they do not apply di-

rectly to the practice o medicine or other healing arts. In general, physicians, dentists,

pharmacists and other providers o healthcare are regulated by their respective proessional

societies and by state governmental agencies; and, in general, FDA does not regulate medical

proessionals except when they engage in clinical research, and when they manuacture,

prepare, dispense or market products within FDAs jurisdiction.115

Food and drug laws and regulations do directly aect the practice o the healing arts. FDAsregulation o drugs (including biological products), medical devices and medical oods

109 FDA investigations oPerati

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