''Representatives from the FDA and industry expressed serious concerns about the potential impact of sequestration Monday, saying it's not a good time to shortchange the agency when it's under so much pressure to help bring innovative new drugs to market.
"We are always operating under some kind of fiscal problems or other at FDA, just shortages of resources to do the multiple jobs we’re asked to do," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said at POLITICO Pro's "Future of the FDA" panel discussion.
Woodcock said that if Congress doesn't reach a deal to prevent sequestration, the cuts could affect the FDA’s user fees.
"There’s been many conversations going on … but that is my understanding," she said.
Sara Radcliffe of the Biotechnology Industry Organization said that from her industry's perspective, “the financial situation that FDA is facing is a very, very serious one."
"Sequestration could result in $319 million off FDA's budget. That’s $112 million in user fees," Radcliffe said. "It’s really hard to overstate our concerns from the industry perspective about potential impact of the budget situation on the regulator of our industry."
The Pew Charitable Trusts's Allan Coukell said cuts would affect the FDA’s staffing as well.
"The FDA needs to hire 200 device reviewers, they need to hire new reviewers to clear generic drug applications, they need to hire inspectors to increase the inspections overseas. That will be difficult under any circumstances, but with budgetary uncertainty, that becomes very difficult," he said.
"FDA, more than many agencies, the budget goes to staff and personnel. … To tackle the challenges ahead of us, this budgetary uncertainty certainly isn’t helpful," Coukell added.
Jeff Allen, executive director of Friends of Cancer Research, said cuts to the FDA would have far-reaching effects. "This is an agency that regulates over a quarter of the economy," Allen said.
Radcliffe said that although congressional negotiators won't be focused on potential cuts to the FDA when they debate how to prevent sequestration, it's up to industry stakeholders to raise the profile of the issue on the Hill.
"Job No. 1 is to do what we can to avert sequestration," she said."
- Date added:
- Oct 2, 2012
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