Prescribing a change to the FDA's drug labeling rules after the 21st Century Cures Act

• Published in: Duke law journal Vol. 72; no. 4; pp. 861 - 901
• Main Author: Engle, P. Sydney
• Format: Journal Article
• Language: English
• Published: Durham, NC USA Duke University School of Law 01.01.2023; Duke University, School of Law
• Subjects: Drug development; Drugs; Economic aspects; Ethical aspects; Gene therapy; Labeling; Law and legislation; Laws, regulations and rules; Pharmaceutical industry; Safety measures; Therapeutics; United States. Food and Drug Administration; Warning labels; UNITED STATES
• ISSN: 0012-7086; 1939-9111

Signed into law in 2016, the 21st Century Cures Act offers new hope to patients by empowering the FDA to expedite review of innovative, potentially lifesaving drugs. But these expedited approvals raise the risk that pivotal drug safety and efficacy data will not arise until after the drug is already on the market. The Cures Act failed to respond to two key aspects of shifting the discovery of safety and efficacy data to the postmarket phase. First, the Cures Act did not correspondingly enhance the FDA's authority to require manufacturers to generate and disclose postmarket information. Second, it did not guard against the potential rise in postmarket failure-to-warn liability for manufacturers, which could discourage them from investing in the development of lifesaving drugs. As interpreted by the Supreme Court, the FDA's current brand-name labeling rules exacerbate these two issues by discouraging meaningful postmarket disclosures to the FDA and enabling costly failure-to-warn suits against manufacturers. This Note discusses these two postmarket issues and proposes new drug labeling rules that would minimize their impact while maintaining the Cures Act's efforts to promote patient access to potentially lifesaving treatments.