Political Pressure at the FDA
Current and former FDA staff report that political officials are increasingly involved in regulatory matters, an unprecedented level of involvement.
In August, scientists at the FDA received an unusual inquiry about leucovorin, a generic drug used to alleviate side effects of cancer therapies. The leader of the center that regulates prescription medicines suggested exploring its potential as an autism treatment, citing promising studies.
The request would have seemed completely random if not for health secretary Robert F. Kennedy Jr.'s longstanding interest in autism.
Autism is a challenging condition to treat with medication, and for the FDA to push for a significant change to a drug's label based on a handful of small studies would be unheard of, according to officials.
Author's summary: FDA staff face political pressure.