The Burrill Report

Bills reauthorizing and expanding user fee programs for drugs and medical devices have cleared the House and Senate, securing essential funding for the U.S. Food and Drug Administration and a new fast-track pathway for the approval of drugs for life-threatening illnesses.

The legislation renews the Prescription Drug User Fee Act, which permits the FDA to collect user fees from industry to fund the review of new drugs. The bills also extend the FDA's user-fee program, allowing the agency to collect fees from the generic drug companies and drugmakers seeking approval of biosimilar therapies.

“The user fee agreement reached between FDA and industry and implemented by this legislation is a potential game-changer that could help accelerate the development and approval of safe and effective treatments and diagnostics,” says Stephen Ubl, president and CEO of the Advanced Medical Technology Association.

In addition, the legislation creates a new accelerated approval pathway that will help expedite the development of personalized therapies for patients suffering from serious and life-threatening diseases. The bills also include provisions to improve safety monitoring of FDA-approved medical devices and to address the growing issue of drug shortages.

The House approved it version of the legislation, the Food and Drug Administration Reform Act, May 30, in a 387-5 vote. The Senate passed its version, the Food and Drug Administration Safety and Innovation Act, with similar bi-partisan support May 24.

The legislation will now be reconciled in a conference with the Senate and is on track to be signed into law by President Barack Obama well before the current version of the law expires at the end of September.






June 01, 2012
http://www.burrillreport.com/article-user_fee_packages_win_congressional_approval.html