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FDA sends user-fee recommendations to Congress

WASHINGTON (Reuters) – U.S. health regulators said on Friday they have submitted to Congress new recommendations for how manufacturers will help fund their review of new branded drugs, conventional generic medicines and a new generation of generic biotech treatments.

At the same time, they have still not finalized how such “user fee” programs will apply to a review of medical devices.

Under a user fee program, manufacturers pay to fund part of the Food and Drug Administration’s review process, helping speed the decision of whether to bring new drugs to the U.S. market.

The FDA in return commits to certain performance goals, including the review of a certain percentage of drug applications in a set time.

“At a time of greater budgetary constraint, user fees provide a critical way for leveraging appropriated dollars, ensuring that the FDA has the resources needed to conduct reviews in a timely fashion,” FDA Commissioner Margaret Hamburg said in a statement.

The programs include the fifth authorization of the Prescription Drug User Fee Act, or PDUFA. PDUFA was enacted by Congress in 1992 and must be reauthorized every five years to govern the review of new prescription drugs.

Two new programs proposed for conventional generic drugs and for generic biotech drugs, or “biosimilars,” are modeled on the act. The FDA said it received 800 to 900 new generic-drug related applications annually. Drugmakers have sought clarity on the biosimilar guidelines before building up that new segment of the industry.

Medical device makers have clashed with the FDA over the agency’s request for higher user fees. FDA spokeswoman Karen Riley said the discussions were continuing, with a deadline set for Sunday.

The fees for devices and drugs provide about a third of the FDA’s funding.


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