Regulatory Focus™ > News Articles > Legislation Corrects User Fee Oversight for Medical Devices, Generic Drugs

Legislation Corrects User Fee Oversight for Medical Devices, Generic Drugs

Posted 05 March 2013 | By Alexander Gaffney, RAC 

Legislators have introduced a piece of legislation in the US House of Representatives that would allow the US Food and Drug Administration (FDA) to spend user fees that it had previously been able to collect, but unable to spend.

The appropriations bill, introduced on 4 March 2013 by Rep. Hal Rogers, chairman of the House Appropriations Committee, would fund the government to the tune of $982 billion through 30 September 2013, when-in theory-legislators should be able to pass a regular budget covering the entire year.

Since 2011, US legislators have passed a series of six-month continuing resolution bills that have kept FDA's funding at stagnant levels. Of particular issue for regulators was the difference between what it was ordered to collect in user fees and what it was authorized to spend by legislators. FDA's funding has been stuck at fiscal year 2012 levels, even as legislators have passed the FDA Safety and Innovation Act (FDASIA), which directed the agency to collect hundreds of millions of dollars in additional revenue to fund expanded review and inspection activities.

User Fees to be Made Available

That will likely change-at least in part-under the new legislation. Section 1204 says that "medical device user fees shall be increased by the amounts by which the authorized levels of such fees for fiscal year 2013 exceed the authorized levels of such fees for fiscal year 2012."

In addition, "Fees authorized for fiscal year 2013 pursuant to section 744B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42) shall be credited to 'Department of Health and Human Services, Food and Drug Administration, Salaries and Expenses' and remain available until expended."

Section 744B of the FD&C Act covers FDA's authority to assess and use human generic drug fees.

In other words, FDA can spend the full amount of fees that it takes in, and will no longer be limited to FY2012 levels of spending.

ABC News reports that the bill could see passage in the House as early as Thursday, after which time the bill would be sent to the Senate for a vote. The government's current appropriations authority runs out on 27 March 2013.


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