FDA credibility hurting due to budget issues, commissioner says

Federal budget cuts and budget uncertainty are hurting the credibility of the Food and Drug Administration, agency Commissioner Dr. Margaret Hamburg said Tuesday.

At a conference hosted by Bloomberg Government, Hamburg said the stakeholders regulated by the FDA expect predictability and transparency in how the agency conducts its oversight. And that's been hard to deliver given the continuing federal budget wars.

One problem has been the freeze on user fees paid by manufacturers who want their products approved for safety and efficacy. Because of the budget sequestration cuts, the FDA is set to lose $85 million in user fees in fiscal 2013, even though that money comes from regulated businesses, not from taxpayers.

“You can't run agency as important as the FDA if you don't have predictability, if you don't know what budget you'll be given during the year, or if you don't know whether you can draw from certain resources or not,” she said.

Increased responsibilities, such as regulating medical mobile apps, also have made the agency's work more challenging. She said the FDA has been “stretched thin for decades.”

Hamburg said as early next week Congress will vote a bill that would increase her agency's authority to regulate compounding pharmacies, following the more than 60 fungal infection-related deaths that occurred as the result of contaminated drugs made at the New England Compounding Center in Framingham, Mass.

“While more responsibility has been given to us, our budget has only expanded a little bit,” she said.

A former FDA official expressed skepticism about Hamburg's complaints.

“The FDA does have increased responsibility, but it is responsibility that it fought aggressively to get,” said Marc Scheineson, who served as associate commissioner from 1992-93 and now is a partner at Alston & Bird. “So it's not like it's been thrust upon them.” He said he has seen no evidence of drugmakers or device makers receiving less predictable oversight.