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LEGISLATION

Obama Signs User Fee Bill

Legislation expands the resources at FDA’s disposal and cuts review time for generics.

MICHAEL FITZHUGH

The Burrill Report

“This Administration should recognize the broad, bipartisan support this bill has earned and implement it without delay.”

President Barack Obama has signed bipartisan legislation reauthorizing the Prescription Drug and Medical Device User Fee Acts along with new fees to support the review of generic drugs and biosimilars.

The Food and Drug Administration Safety and Innovation Act, enacted July 9, will provide the agency with $6.4 billion in fees over the next five years, starting in 2013, money that will pay the salaries of some FDA review staff and fund about 45 percent of the agency’s overall budget.

“By signing the FDA Safety and Innovation Act, President Obama has ensured that the FDA will have the resources and authority it needs to promote the development of safe, effective and innovative medical products that Americans need,” says Allan Coukell, director of medical programs at the Pew Health Group.

“This Administration should recognize the broad, bipartisan support this bill has earned and implement it without delay.”

The generic drug industry, which fills 80 percent of the prescriptions dispensed in the United States, welcomed passage of the legislation as well. They anticipate a reduction in the average review time for most generic drug applications to two years from more than 30 months today, and to just 10 months by the end of the program’s fifth year, says the Generic Pharmaceutical Association.

The legislation lays the groundwork for improved communication between the FDA and drug developers through earlier and more frequent meetings and also renews mechanisms for ensuring children’s medicines are appropriately tested and labeled, and expedites the development and review of drugs for rare diseases.

Additionally, the law will require manufacturers of certain drugs to notify the FDA when they experience circumstances that could lead to a potential drug shortage and increase incentives for the development of new antibiotics.

Passage of the law also mandates the development of FDA guidance on the review and approval of “breakthrough therapies”—those that treat a serious or life-threatening disease—and on the use of social media to promote FDA-regulated medical products.



July 10, 2012
http://www.burrillreport.com/article-obama_signs_user_fee_bill.html

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