Tuesday, April 16, 2013

The newly unveiled Health & Human Services budget proposal allocates $4.7 billion to the FDA, with more than half of that to be dedicated to medical product safety.

Mass Device
Aril 11, 2013

The 2014 budget proposal for the Dept. of Health & Human Services contains some important boosts in the FDA's coffers, including a $59 million increase the agency's medical device review arm compared with 2012.

The new budget would provide the Dept. of Health & Human Services a total of $967.3 billion in outlays and $80.1 billion in discretionary spending, and it includes initiatives that aim to save $361.1 billion over a decade.

The budget sets aside $4.7 billion for FDA's medical device, drug and biologic oversight, an increase of 21%, or $821 million, over 2012, according to the report.

Of that total, $2.6 billion is dedicated to medical product safety, including authority over medical devices, drugs and biologics.

Broken down further, the proposal allocates a total of $435 million for the FDA's medical device program, $1.29 billion for human drugs and $338 million for biologics. Those budgets are meant to be supplemented by the FDA's user fee programs through which the agency collects payment for reviewing new products.

The budget further recommends a $15 million "medical products reinspection" user fee that would put the full cost of a reinspection and associated follow-up squarely on a manufacturer should the review turn up health and safety violations.

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