President Obama Signs into Law Three Bills Affecting FDA

Posted 27 September 2012 | By Alexander Gaffney, RAC 

US President Barack Obama has signed into law three pieces of legislation that affect-directly or indirectly-the activities of the US Food and Drug Administration.

User Fees Front and Center

The first, and perhaps the most important, bill  was House Joint Resolution 117, the Continuing Appropriations Resolution of 2013. The bill would maintain funding for US government agencies at fiscal year 2012 levels. While not specifically aimed at FDA, without the legislation, FDA and other government agencies would for the second year in a row be facing the prospect of a government shutdown.

The bill would postpone at least part of the FDA Safety and Innovation Act, a 2012 piece of legislation that granted FDA the authority to collect and spend additional user fees for pharmaceutical and medical device products, as well as new fees for biosimilar and generics products. User fees under the reauthorized Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) would continue to be collected as planned, but short of a legislative fix would be unable to be spent.

(For Regulatory Focus' previous explanation of the bill, please see "Budget Passes Senate, Leaving User Fees at 2012 Levels.")

A second piece of legislation signed on 26 September by Obama would fix at least one oversight related to the funding of FDA operations through user fees. Under FDASIA, FDA is scheduled to receive approximately $250 million in fees from the Generic Drug User Fee Act (GDUFA) to finance the hiring of new review and inspection staff to both clear an existing backlog of Abbreviated New Drug Applications (ANDAs) and ensure new applications are cleared expeditiously.

Though the continuing resolution would have postponed the collection of these fees, the FDA User Fee Corrections Act (FDAUFC) would allow FDA to collect fees for generic medicines. Left out by the legislation: The Biosimilar User Fee Act (BSUFA), which allows for the collection of user fees for an emerging class of biosimilar medicines that are theoretically interchangeable for a referenced biologic product.

BioCentury,  meanwhile, reports that FDA believes it will still be able to collect and spend fees for biosimilar products, saying "no further congressional action is needed."

(For Regulatory Focus' previous explanation of the bill, please see "Congress Scrambles to Pass User Fee Fix for Generics, Leaving Others in Limbo.")

Enhanced Penalties for Counterfeiters

A third and final piece of legislation, the SAFE DOSES Act, would crack down on counterfeiters and thieves of medical products, including pharmaceuticals and medical devices. The act would also make it considerable easier to disrupt counterfeiting networks, granting US agents the authority to detain and imprison those found to be guilty of knowingly possessing fraudulent products or anyone counterfeiting using aggravated methods.

The legislation, introduced by Rep. James Sensenbrenner (R-WI), passed both houses of Congress unanimously.

(For Regulatory Focus' previous explanation of the bill, please see "Bill to Enhance Fines, Penalties for Falsifying Medical Products Passes Congress.")

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