FDA sends user-fee recommendations to Congress

	Tweet

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 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 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.

###

(Reuters)

RELATED STORIES:
Scientist to submit Vioxx study, attorney says   Pfizer planned reorganization will result in a “net reduction” of jobs   Use Caution with All Pain Medications   Banning “light” from cigarette packs falls short   Brand-name prescription drug prices rise   WHO warns of enormous burden of chronic disease: Non-Communicable Diseases   Experts advise elderly to continue exercising   House takes another step on healthcare reform   Pfizer Lipitor study has mixed results   Benzene toxic at levels below US standards   Doctors question safety of U.S. drugs   Cancer society begins Daffodil Days sale

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]