Stiffer FDA user fees are on the horizon as well. The Obama administration has requested a $4.3 billion budget for the agency
in 2012, a reasonable increase given the tight funding environment in Washington. But most of the gain would come from higher
user fees on medical product manufacturers, and most of any added appropriations would fund a huge expansion in food safety
oversight authorized by Congress, but without support from food industry fees.
Any extra money for FDA's Center for Drug Evaluation and Research is designated to support development of medical countermeasures
and biosimilars, to expand monitoring of imported medical products, and to improve the safety of certain high-risk products
such as vaccines and human tissue. New generic-drug user fees, which at long last appear to be moving toward reality, would
improve the review of generic drugs, while other proposed fees would support more field inspections. There's a small amount
of money earmarked for improving regulatory science at FDA, which would primarily complete work on a new laboratory complex
for drugs and biologics at the agency's White Oak, Maryland campus. Without an extra $24 million to get the new laboratory
operational, FDA would have a new facility with no equipment, and still have to pay rent on an old, obsolete laboratory.
FDA is negotiating with manufacturers on its next five-year plan for collecting fees from industry under by the Prescription
Drug User Fee Act (PDUFA). Meanwhile, the agency wants drug and biotech firms to ante up some $850 million in PDUFA fees in
2012, up more than $275 million over 2010. About $600 million will fund drug oversight, and $125 million will support regulatory
activities involving vaccines and other biologics. Combined with all the added costs imposed by healthcare reform, and apparent
threats to expanding healthcare coverage to some 30 million uninsured Americans, manufacturers have to worry about the erosion
of resources to support new drug development.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, firstname.lastname@example.org