With big budget cutbacks under way at both the NIH and the FDA, drug developers as well as researchers and patient groups are scrambling to lobby the government to protect grants as well as keep all of the industry's user fees committed to drug reviews.
There appears to be considerable activity at the NIH right now, where all of its subsidiary institutes are taking advantage of a mandate to cut 5% in spending as they see fit, according to The New York Times. Researchers as well as patient advocacy groups are making their voices heard, trying to protect ongoing research and avoid the sequestration ax.
At the FDA, regulators are working with an order from the Obama administration not to spend $83 million in user fees paid by the industry to accelerate drug reviews. Any drop in funding at the agency could be felt for some time if reviews begin to slow now. And that would mean a longer path to market--a turn of events that the biopharma industry would bitterly resent.
"By law, prescription drug user fees cannot be used for any purpose other than to support the F.D.A.'s human drug review program," Josephine C. Martin, an executive vice president of the Pharmaceutical Research and Manufacturers of America, tells the Times. "The sequestration of user fees exacerbates the already severe budgetary constraints on the agency."
Of course, one of the purposes of the administration's order is to spread the pain among many people and industries in an effort to spur a political resolution to the showdown in D.C. It's certainly captured the attention of biopharma.
- here's the story from The New York Times