Scholarship@WashULaw
Preapproval Promises to Voluntarily Withdraw FDA-Approved Drugs
Document Type
Editorial
Publication Date
2022
Publication Title
JAMA
Abstract
The US Food and Drug Administration (FDA) faces a persistent tension between confidence and speed. The more stringent its gatekeeping requirements for drug approval, the better the evidence for treatment and coverage decisions, but the longer patients wait for products that may help. With urging from Congress, regulated industry, and patients, the FDA has increasingly prioritized speed, opening the gate based on less certain evidence often assuming that it can later be closed.
Keywords
Food and Drug Administration, FDA, Preapproval, Drug Approval, Drug Withdrawal
Publication Citation
Holly Fernandez Lynch & Rachel E. Sachs, Preapproval Promises to Voluntarily Withdraw FDA-Approved Drugs, 328 JAMA 2392–2393 (2022).
Repository Citation
Sachs, Rachel and Lynch, Holly Fernandez, "Preapproval Promises to Voluntarily Withdraw FDA-Approved Drugs" (2022). Scholarship@WashULaw. 61.
https://openscholarship.wustl.edu/law_scholarship/61