Preapproval Promises to Voluntarily Withdraw FDA-Approved Drugs
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.
Food and Drug Administration, FDA, Preapproval, Drug Approval, Drug Withdrawal
Holly Fernandez Lynch & Rachel E. Sachs, Preapproval Promises to Voluntarily Withdraw FDA-Approved Drugs, 328 JAMA 2392–2393 (2022).
Sachs, Rachel and Lynch, Holly Fernandez, "Preapproval Promises to Voluntarily Withdraw FDA-Approved Drugs" (2022). Scholarship@WashULaw. 61.