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Food and Drug Law
Seton Hall Unversity School of Law
Paradise, Jordan

Food and Drug Law (prof. Jordan Paradise)

Spring 2014

I. The Food & Drug Administration

A. General Themes

1. Long history of FDCA; & it is still evolving. FDCA amended over 100 times.

2. FDA interacts with various other agencies, laws

3. Life cycle analysis of products is necessary

4. Number of stakeholders involved in decisions

5. Intersection of law, science, public policy, medicine, ethics and politics

6. Ongoing conflicts:

a) Risk v. benefit, especially in the face of new information or new technologies

b) Consumer protection v. industry ally (e.g. user fees)

c) Speed of innovation v. protection from harm

B. FDA Mission Statement

1. The 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 nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. (FDA Website)

2. Compare to FDCA 1003(b).

C. Core FDA Duties

1. Product review & approval/clearance

2. Rulemaking

3. Standard setting

4. Public education & communication

5. Enforcement

D. FDA Regulatory Scope

1. Products FDA regulates account for approximately 25 percent of consumer spending in the U.S (~$1.5 trillion/year).

a) ~$466 billion in food sales

b) ~$275 billion in drugs

c) ~$60 billion in cosmetics

d) ~$18 billion in vitamin supplements

e) FDA is responsible for monitoring a third of all imports

2. FDA has a FY 2011 requested budget of $2.51 billion in budget authority and $4 billion in total program resources (up from $3.2 billion total resources for 2010).

E. FDA as Administrative

1. Old-line administrative agency

a) One of the first consumer protection agencies

2. Helped develop administrative law and procedure

3. Long institutional memory impacts decisions

a) Poison Squad

b) Thalidomide and Dr. Kelsey

c) Generic drug scandal

4. FDA & Health Care Policy

5. FDA gets involved (dragged?) into many political and policy debates

a) Life style and personal choice issues (e.g., tobacco, obesity)

b) 1st Amendment rights (e.g., promotion restrictions)

c) Abortion rights (e.g., RU 486, Plan B, now Ella)

d) Right to treatment (e.g., access to unapproved products – AIDS and cancer therapies)

e) Health care cost (e.g., drug importation, generics)

f) Economic fraud (e.g., quack cures, inaccurate claims)

g) Safety (e.g., Avandia)

h) Product liability (e.g., Vioxx)

i) Development of FDA Law

F. Development of FDA Law

1. Two key drivers for new FDA laws

a) Health crisis

b) Political pressures

2. Major statutory developments have been crisis driven

3. Congress and FDA often reactive

4. Role of congressional oversight

5. Rise of consumerism

6. Role of stakeholders

a) Industry

b) “Public interest” groups

c) Issue specific advocacy groups

7. FDA regulatory systems have followed key social, political and scientific movements

a) Urbanization

b) Industrialization

c) Health and life expectations

i. Longer life spans

ii. Life style choices

8. New technologies, new health care capabilities

9. Interface with computers and online systems

10. Globalization

11. Patient autonomy and control

G. FDA Internal Organization

1. 1 of 11 agencies within DHHS.

2. FDA Commissioner serves under DHHS Secretary

3. FDA Commissioner: Margaret Hamburg, M.D.

a) Since 1988, FDA Commissioner appointed by the President with advice and consent of Senate.

4. 6 centers under the Office of the Commissioner, including:

a) Center for Drug Evaluation and Research—CDER

b) Center for Devices and Radiological Health—CDRH

c) Center for Biologics Evaluation and Research—CBER

5. 5 regional “field offices” (Pacific, SW, Central, NE, SE)

H. Legal hierarchy & the FDA

1. U.S. Constitution

a) Commerce Clause (Art. 1. sec. 8, cl. 3)

b) 1st Amendment

2. Statutes

a) FDCA, 21 U.S.C. § 301 et seq.

b) Note FDA enforces approx. 45 statutes, FDCA only one of them.

3. Regulations/Rulemaking

a) Typically notice and comment rulemaking (“informal”)

4. Guidance documents

5. Informal statements and advice (warning letters, opinion letters)

I. Food Drug & Cosmetic Act (FDCA)

1. Codified in 21 U.S.C.§301 et seq. (FDCA Sec. 1 et seq.)

2. Now 10 chapters after June 2009 tobacco legislation

3. Major substantive history:

a) 1906 Pure Food & Drugs Act

b) 1938 FDCA

c) 1962 Kefauver-Harris Amendments

d) 1976 Medical Device Amendments

e) 2007 FDAAA

J. 1906 Pure Food & Drugs Act

1. Established manufacturing and labeling requirements for food and drugs (adulteration & misbranding)

2. No provisions for safety or efficacy requirements prior to marketing of a drug

3. Supreme Court subsequently held that this required that manufacturers were knowingly fraudulently representing their products on the market (U.S. v. Johnson, 1911)

a) Sherley Amendment in 1912

K. 1938 Food, Drug & Cosmetic Act

1. Expanded federal authority to regulate therapeutic devices and cosmetics along with drugs

2. Response to the “elixir of sulfanilamide” that killed ~100-200 people

s most to FDA Commissioner; Secretary need only approve regulations that affect an entire class of products or involve a serious public health issue.

E. Legal Effect of a Final Rule

1. A Final Agency Rule adopted through notice and comment rulemaking sets forth substantive, binding requirements and may be challenged in court as a final agency action on a topic.

2. A Citizen Petition can be submitted to FDA by anyone under established regulations in CFR to challenge a Final Rule. FDA has 180 days to respond. If the FDA does not respond, petitioner can file suit (creates standing).

3. Judicial review under APA is that agency action is unlawful if:

a) Contrary to law

b) Arbitrary and capricious

c) Abuse of discretion, and/or

d) Unreasonably withheld

F. Advisory Opinions

1. Set forth matters of general applicability, not specific to a single product

2. They do not go through notice and comment rulemaking

3. They bind the agency, not others. If FDA changes opinion, they must state that and issue a revised Advisory Opinion or higher action on the matter.

G. Good Guidance Practices

1. Set forth FDA’s current view of a regulatory issue (increasingly addressing scientific questions)

2. Not legally binding on FDA or industry

3. Not considered a final agency action that can be challenged in court

H. Compliance Policy Guide Manual

1. This is another type of advisory opinion, so it is binding on FDA

2. Consists of advice to inspection and compliance staff in the field regarding FDA’s standards and procedures

3. Lays out how the standards should be applied to determine regulatory compliance by industry members

4. FDA can be challenged on the enforcement of this

I. Staff Manuals and Guides

1. Manuals and guides for FDA employees explaining responsibilities and scope of duties , including Investigations Operations Manuals (IOM), Regulatory Procedures Manuals, (RPM) and Center-specific manuals re: policies and procedures (e.g., CDER’s MaPPs)

2. These are not binding like the compliance manuals; more procedural than substantive

J. Interactions with other Agencies

1. Both within DHHS (NIH, CMMS, CDC) and others:

a) USDA, DEA, EPA, U.S. Customs, FTC, CPSC, SEC, DOJ, Homeland Security