Political Pressure at the FDA
Current and former FDA staff report that political officials are increasingly involved in regulatory matters, an unprecedented level of interference.
A recent inquiry about the generic drug leucovorin, typically used to alleviate cancer therapy side effects, has raised concerns among scientists at the FDA.
The request would have seemed completely random if not for health secretary Robert F. Kennedy Jr.’s longstanding interest in autism.
The FDA's consideration of approving leucovorin as an autism treatment, based on a handful of small studies, is unusual and challenging due to the broad spectrum of autism symptoms.
Autism is one of the most difficult conditions to treat with medication, making the FDA's potential label change for leucovorin a significant and unexpected move.
Author's summary: FDA staff face political pressure in regulatory matters.