Health-Reform Controversies - Pharmaceutical Technology

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Health-Reform Controversies
Courts and Congress seek to reshape policies and programs.


Pharmaceutical Technology
Volume 35, Issue 4, pp. 30-36

Funding FDA

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 Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,
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