Political Pressure at FDA
Current and former FDA staff report that political officials are increasingly involved in regulatory matters, an unprecedented level of involvement.
A recent inquiry about leucovorin, a generic drug used to alleviate cancer therapy side effects, struck FDA scientists as unusual. The center leader suggested approving it as an autism treatment, despite limited 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 the FDA's push for a label change based on a handful of small studies is unheard of, according to officials.
Author's summary: FDA staff face political pressure in regulatory matters.