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Harkin, Enzi Express Commitment to Bipartisan Reauthorization of FDA User Fee Legislation

WASHINGTON – In advance of tomorrow’s Senate Health, Education, Labor and Pensions (HELP) Committee first hearing on FDA User Fee legislation, the Committee’s Chairman and Ranking Member Senators Tom Harkin (D-IA) and Mike Enzi (R-WY) released the following joint statement expressing their commitment to a bipartisan reauthorization process:

“These laws authorize the FDA to collect fees from manufacturers to expedite the process of approving drugs and medical devices, and play a critically important role in ensuring that they reach the American public in a timely way.  We are committed to working together in a bipartisan fashion to reauthorize the drug and device user fees acts as well as authorize generic and biosimilar user fees if the industry can reach a user fee agreement with FDA. We also believe it is important to reauthorize the pediatric drug testing laws in the same legislative package.

“The package will likely include a small number of additional policy changes related to the FDA, potentially including supply chain integrity measures and measures related to the medical device review process.   We have asked Commissioner Hamburg and the industry to deliver the user fee agreements to Congress by the end of 2011, so that our Committee can be prepared to markup the legislation early next spring.”