Sequester Threatens FDA Mission

One aspect of sequestration isn’t doing anything to reduce the deficit, but could be delaying patient access to new drugs and medical devices, according to the FDA’s Janet Woodcock at a House subcommittee hearing on Friday. The FDA is being denied access to some of the user fees paid by the drug and device industries, which are intended to fund FDA’s review and oversight programs and ensure timely patient access to new and effective treatments.

BioWorld’s Mari Serebrov has an excellent account of the hearing:

One of the areas impacted is rare diseases. The FDA’s Center for Drug Evaluation and Research (CDER) works with drugmakers on a case-by-case basis to design clinical trials involving diseases that affect small patient populations. As part of its FDASIA commitment, CDER set up a rare disease staff, but Woodcock said sequestration has hampered efforts to get that staff fully up and running.

CDER isn’t the only FDA unit suffering under sequestration. Jeffrey Shuren, director of the agency’s medical device center, testified that the sequester will keep the Center for Devices and Radiological Health (CDRH) from meeting its FDASIA user fee goals. Many device programs already have been affected by the across-the-board cuts, and it’s getting to the point of turning lights off in some of CDRH’s labs, he said.

While sequestration was intended to reduce the deficit, prescription drug user fees cannot, by law, be used for anything other than funding FDA’s human drug review program. However, the FDA will be unable to spend the fees until Congress re-appropriates them. BIO strongly supports the FDA Safety Over Sequestration Act, which would exempt user fees from sequestration and allow the FDA to spend the money on the critically important programs they are intended to fund.

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