Drug regulation (FDA)
Drug Regulation by the Food and Drug Administration (FDA)
Overview
The Food and Drug Administration (FDA) is the federal agency responsible for regulating food, drugs, medical devices, cosmetics, and tobacco products. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA oversees the safety, efficacy, labeling, and marketing of drugs.
The FDA’s drug regulatory authority includes:
Approval of new drugs through a rigorous New Drug Application (NDA) process.
Regulation of drug labeling to prevent misbranding.
Enforcement against adulterated or unsafe drugs.
Post-market surveillance and enforcement actions.
Key Legal Principles in FDA Drug Regulation
Pre-market approval: No drug can be marketed unless FDA approves it based on evidence of safety and effectiveness.
Labeling: Labels must not be false or misleading.
Enforcement: FDA can seize drugs, issue injunctions, and impose penalties for violations.
Balancing Public Health and Innovation: Courts often balance FDA’s regulatory goals with manufacturers’ rights.
Landmark Cases on FDA Drug Regulation
1. United States v. Sullivan (1919)
Facts: Early case involving the enforcement of the Pure Food and Drug Act of 1906.
Issue: Could the government prohibit false or misleading drug labeling?
Ruling: The Supreme Court upheld the government’s power to regulate drug labeling to protect consumers.
Significance: Affirmed the federal government’s role in preventing deceptive drug marketing.
2. FDA v. Brown & Williamson Tobacco Corp. (2000)
Facts: FDA sought to regulate tobacco products as drugs/devices under the FDCA.
Issue: Does the FDA have authority to regulate tobacco products?
Ruling: The Court ruled that Congress had not given FDA authority to regulate tobacco as a drug.
Significance: Limited FDA’s jurisdiction, emphasizing the need for clear congressional authorization.
Key takeaway: FDA authority is statutory and cannot be expanded beyond Congressional intent.
3. Buckman Co. v. Plaintiffs’ Legal Committee (2001)
Facts: Plaintiffs alleged fraud on the FDA during the approval process.
Issue: Could plaintiffs bring state law claims based on alleged fraud on FDA?
Ruling: The Court held that such claims were preempted by federal law because they conflicted with the FDA’s regulatory scheme.
Significance: Strengthened FDA’s centralized control and limited parallel state litigation.
Key takeaway: Federal law preempts certain state claims related to FDA approval processes.
4. Wyeth v. Levine (2009)
Facts: Plaintiff sued Wyeth for failure to warn about risks on drug labeling, despite FDA approval.
Issue: Are drug manufacturers shielded from state law claims if FDA approved labeling?
Ruling: The Court held that FDA approval does not preempt state law failure-to-warn claims.
Significance: Allowed state tort claims to coexist with FDA regulation, encouraging manufacturers to enhance warnings.
Key takeaway: FDA approval does not provide blanket immunity from state tort liability.
5. Kordel v. United States (1948)
Facts: Addressed the distinction between drugs and unapproved substances.
Issue: Can the government seize drugs distributed in interstate commerce without FDA approval?
Ruling: The Court upheld seizure and injunctions against drugs violating the FDCA.
Significance: Affirmed FDA’s enforcement authority over unapproved or misbranded drugs.
Key takeaway: FDA can act decisively to protect public health against unlawful drugs.
Summary Table
| Case | Issue | Holding / Significance |
|---|---|---|
| United States v. Sullivan (1919) | False/misleading drug labeling | Upheld government regulation to prevent deception |
| FDA v. Brown & Williamson (2000) | FDA authority over tobacco | Limited FDA authority; Congress must clearly authorize |
| Buckman Co. v. PLC (2001) | State claims based on FDA fraud | Preempted to preserve FDA’s regulatory scheme |
| Wyeth v. Levine (2009) | State tort claims vs. FDA approval | No preemption; manufacturers liable under state law |
| Kordel v. United States (1948) | Enforcement against unapproved drugs | FDA has authority to seize and enjoin unlawful drugs |
Additional Notes
The FDA’s authority is grounded in statutory law, and courts interpret it based on Congressional intent.
There is ongoing tension between federal regulatory authority and state tort claims.
The FDA balances public safety with promoting innovation and access to new drugs.
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