The Hill News

The Food and Drug Administration (FDA) released last week a proposed agreement on the federal review process for new drugs. We must now ensure that all efforts to approve this agreement lead to the ultimate goal of better serving the needs of patients and consumers. We need Congress to pass legislation that returns the FDA review process to its original mission: getting safe and effective lifesaving medicines to people as quickly as possible.
 
The Prescription Drug User Fee Act (PDUFA), passed in 1992, authorizes the FDA to collect user fees from drug makers to help pay for the staffing and resources necessary for the agency to conduct thorough and timely reviews of potential new treatments. In the beginning, PDUFA worked â€" the time it took to review a new drug decreased by 63%. Unfortunately, those review times have been creeping upward over the past several years, delaying access to potentially life-saving medicines for Americans. In 2008, 40% of the appli! cations for major therapeutic advances did not receive a timely review, based on FDA’s own goals.
 
We have a window of opportunity this year to enhance the approval process. PDUFA is up for reauthorization in 2012, and stakeholders like the National Consumers League and the National Health Council have proposed recommended improvements. While our two organizations address the issue from different perspectives, we agree two things must be integrated in PDUFA.

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