Political Pressure at FDA
Current and former FDA staff members report that political officials are increasingly involved in regulatory matters, a level of involvement that is unprecedented.
In August, an unusual inquiry was made to scientists at the Food and Drug Administration regarding leucovorin, a generic drug used to alleviate side effects of cancer therapies. The leader of the center that regulates prescription medicines asked for their thoughts on potentially approving it 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 due to its broad spectrum of symptoms. The FDA's consideration of such a significant change to a drug's label, based on a handful of small studies, is unheard of, according to officials.
Author's summary: FDA staff report unusual political pressure in regulatory matters.
- Unprecedented level of political involvement in FDA regulatory matters
- Inquiry about leucovorin as a potential autism treatment
- Health secretary Robert F. Kennedy Jr.'s interest in autism may be a factor