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Pallone’s Floor Remarks on FDA User Fee Reauthorization

Jul 12, 2017
Press Release
“The legislation before us today is the product of compromise and almost two years of work between FDA, Congress, industry, and other stakeholders.”

Energy and Commerce Ranking Member Frank Pallone, Jr. (D-NJ) delivered the following remarks on the House Floor today during consideration of the Food and Drug Administration Reauthorization Act (H.R. 2430):

Mr. Speaker, I rise in support of H.R. 2430, the Food and Drug Administration Reauthorization Act – a bill that will allow the FDA to continue its critical mission of reviewing and approving drugs and medical devices that save lives and improve the quality of life for many Americans.

The legislation before us today is the product of compromise and almost two years of work between FDA, Congress, industry, and other stakeholders. The Food and Drug Administration Reauthorization Act, or FDARA, reauthorizes FDA’s medical product user fee agreements, providing FDA with the resources the agency needs to continue its critical public health work, hire the necessary scientists and review staff, and improve the certainty and efficiency of the review process.

The sixth reauthorization of the Prescription Drug User Fee Act will maintain current review timelines, modernize the user fee structure, and build on the work of 21st Century Cures by investing resources in the development of biomarkers and innovative clinical trial designs.

The fourth reauthorization of the Medical Device User Fee Amendments includes some important new policies that will help to increase the consistency, efficiency and effectiveness of drug and medical device reviews. The bill advances the use of the patient perspective in the risk-benefit assessment of medical devices.  It establishes a system to utilize real world data for premarket approval of new uses and post-market safety monitoring.  And it improves pre-submission communication with manufacturers in an effort to expedite the review process.

This legislation also reauthorizes two of our newer user fee programs for generics and biosimilars. Both of these programs strive to expedite access to high quality, lower cost drugs for American families.

FDARA will also allow the agency to undertake new initiatives to create a category of over-the-counter hearing aids, advance the development of pediatric cancer treatments, and provide greater assistance and incentives to encourage additional competition from generic drugs.

Since this is a bipartisan compromise, it does not address every issue that I would have liked. It also includes troublesome language prohibiting FDA from making the investments the agency needs as part of future user-fee agreements. It’s important that the FDA maintain a work environment that allows the agency to recruit and retain the world’s best and brightest. I am concerned that this final agreement preserves language advanced in the Senate that will make it difficult in the future for FDA to make the investments needed to recruit personnel and meet the performance goals set out in the user fee reauthorizations.  This is a concern that I hope we can address in the future.

At the end of the day this final product represents all of the significant discussions and compromises that were made, and I am pleased that we are considering it in a timely fashion.

I strongly urge my colleagues to support H.R. 2430 so that we can continue to give the FDA the tools and resources it needs to continue doing the critical work of reviewing and approving lifesaving drugs and medical devices. Thank you.

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