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FDA Reform Bill Heading Towards Obama

The 2012 FDA reform bill, which includes a fifth, five-year reauthorization of the Prescription Drug User Fee Act (PDUFA V), is set to make its way to President Obama before July 4th. In May, the House and Senate produced two very similar versions to the FDA reform bill, H.R. 5651 FDA Reform Act and S.2292 PATIENT’S FDA Act respectively. According to Rep. Fred Upton, chairman of the House Energy and Commerce Committee, “We need to enact this user fee bill by the end of June. We are on track to accomplish this goal”. The similarities between the House and Senate version of the bill are promising indicators for the successful and timely passage of the bill.

The FDA collects user fees from companies in order to pay for the regulatory review of new drugs and technologies. The FDA reform bill reauthorizes prescription drug and medical device user fees and authorizes new user fees for generic small molecule drugs and biosimilars. The new fees for generic small molecule drugs and biosimilars in the Senate bill are estimated to generate over $1.7 billion of additional revenue. The increase in user fees will enable the FDA to review new drugs and biological products more quickly. Once the bill is enacted, the FDA will be committed to reviewing and acting on 90% of standard applications within 10-12 months of being filed and 90% of priority submissions within 6-8 months of being filed. [1]

On April 18, 2012, David E. Wheadon, M.D. of PhRMA strongly endorsed PDUFA V’s goals. PDUFA V aims to enhance the New Molecular Entity review program with more communication between the FDA and companies, advance regulatory science by engaging with stakeholders involved in drug development, develop a systematic approach to benefit-risk assessment, and modernize the FDA drug safety system by standardizing risk evaluation and mitigation studies. Most are in agreement that PDUFA V, effective until 2017, will strengthen the FDA’s regulatory review process for New Drug Applications and Biologic License Applications. [2]

The House and Senate’s proposed FDA reform bills are also a victory for the rare disease community. Both bills will improve the Accelerated Approval Pathway for rare diseases and life threatening diseases by allowing for the use of a surrogate endpoint or biomarker to indicate whether or not a drug is working during a clinical trial. This significantly decreases the cost and time to develop a treatment. In addition, both bills will require the FDA to expedite the development and review of “breakthrough” drugs that treat a serious or life-threatening disease and have demonstrated substantial treatment effects early on. Moreover, both bills will increase staffing of the FDA’s rare disease programs and train FDA reviewers on issues specific to rare diseases. The FDA hopes to integrate its rare disease programs into the drug application review process.

The FDA reform bill reflects the U.S. government’s ongoing commitment to improving its regulatory review process. User fees collected by the FDA from companies will be used to facilitate the development of new drugs and technologies so that they can move to the market more quickly and reach patients in need.

Tags: Strategy & Compliance