SKAPP on User Fees in the FDA

SKAPP issued an open letter [PDF] a few weeks ago advocating for abandonment or changes in the user fee-based system set up for drug review at the FDA.

“User fees may appear to save the taxpayers money, but at an unacceptable cost to public health,” the letter warns, citing findings of a panel of experts recently convened by the Institute of Medicine (IOM) to address drug safety at the FDA.  Four of the letter’s signers served on that IOM panel, and six signers are former top staff of FDA or the Department of Health and Human Services.

Glancing through the signatories, I recognize at least four or five as having served as plaintiffs’ experts in litigation involving the FDA.

(And as a reminder, I do a small amount of work for pharmaceutical companies.)