Political Pressure at FDA
Current and former FDA staff report that political officials are increasingly involved in regulatory matters, an unprecedented level of involvement.
In August, FDA scientists received an unusual inquiry about leucovorin, a generic drug used to alleviate cancer therapy side effects, with a suggestion to explore its potential as an autism treatment.
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 consideration of a label change for leucovorin based on a handful of small studies is unusual, according to officials.
Autor's summary: FDA staff face political pressure.