Grassley questions FDA's 'Safety First'
Sen. Charles Grassley (R-IA) says he is concerned that the FDA's Safety First initiative is merely cosmetic and will not make fundamental changes he says are needed to improve FDA's oversight of approved drugs. In a letter to FDA commissioner Andrew von Eschenbach, Grassley asked that his Finance Committee staff be briefed on the initiative.
In addition to obtaining more details of Safety First and implementation timeframes, Grassley asked for an explanation of the agency's decision to maintain what appears to be the status quo by having the Office of Surveillance and Epidemiology (OSE) play a consulting role to the Office of New Drugs (OND) on post-marketing safety matters.
When Safety First was announced in February, FDA drugs center director Janet Woodcock said the effort would strengthen and modernize FDA's post-market drug oversight.
Grassley said his investigations into how the FDA handles post-market surveillance of drugs, biologics, medical devices, and veterinary medicines “have shown repeatedly that serious adverse events that emerge after a drug is on the market do not necessarily get prompt attention from OND. Further, safety concerns raised by OSE were sometimes ignored by OND, which is responsible for determining what, if any, regulatory actions will be taken to address a post-marketing drug safety issue.”