Via this week’s edition of Ad Age:
Drug Makers Brace for Possible Cuts to FDA
After Midterm Elections, Pharma Wary of Congressional Appetite for Reduced Spending on Federal Agency
The Nov. 2 elections that reshaped the structure of the U.S. House of Representatives are causing a headache in the pharmaceutical industry, which could lose millions as a hamstrung FDA leads to a clogged up drug pipeline.
With many congressional candidates riding into office on a platform of reduced spending, drug makers are bracing for what they believe could be cuts to government agencies, particularly to the Food and Drug Administration.
Astra Zeneca CEO David Brennan and FDA Commissioner Dr. Margaret Hamburg last week both told the Reuters Health Summit in New York that cuts to the agency would be detrimental. "I don't think that would be good for our industry. It doesn't look to me like that would speed things up," Mr. Brennan told Reuters, speaking of the time it takes the FDA to review new products, where delays of several months can cost pharma companies millions.
Ms. Hamburg cautioned the new Congress to think twice about FDA cuts.
"Not every function of government can be cut to the same degrees using the same tools. I think we should proceed with real care," she told Reuters. "It should be recognized if we can't do our job and do it well, there isn't any other entity that will backstop behind us. What we do really matters to health."
"I think the threat to cut FDA funding is real and it's a signal that FDA has to deliver on the promises that it made during the last PDUFA negotiations," said former FDA associate commissioner Peter Pitts, referring to the Prescription Drug User Fee Act, or the fees that pharmaceutical companies pay to the FDA. "It's a shot across the bow."
For the rest of the story, see here.
