FDA sends user-fee recommendations to Congress

January 16, 2012 7:57 AM

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.

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


Source: Reuters, 13 January 2012

Leave a Reply

Twitter ID
(ID only. No links or "@" symbols)

Latest News on Biosimilar News

Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?


Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!