Joe Rogan on fda: what the evidence says · JRE #2223

What the evidence says 01 / RECORD

The one-third figure conflates two different things: the rate of any postmarket safety event and the rate of actual market withdrawal. A JAMA study of 222 novel therapeutics approved by the FDA from 2001 to 2010 found that 71 (32.0%) were affected by a postmarket safety event over a median 11.7-year follow-up, but only 3 of the 222 drugs (about 1.4%) were actual market withdrawals; the rest of the postmarket events were boxed warnings or safety communications. The FDA's own postmarket safety monitoring program reflects this same distinction: ongoing surveillance typically leads to labeling changes or warnings, with outright withdrawal being a rare outcome rather than a routine one. Current evidence therefore shows that while roughly a third of newly approved drugs eventually receive some kind of safety flag, outright market withdrawal happens to a small single-digit percentage of approved drugs, far below the one-third figure Rogan cites.