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Inside Health Policy – Upton, Pallone Bill Would Require FDA Cross-Center, Disease-Specific Institutes

Inside Health Policy – Upton, Pallone Bill Would Require FDA Cross-Center, Disease-Specific Institutes

House Energy and Commerce Committee Chair Fred Upton (R-MI) and Ranking Member Frank Pallone (D-NJ) introduced legislation Wednesday (June 8) that calls on FDA to establish disease-specific intercenter institutes to streamline the review of of drugs and devices. The bill mirrors language in provisions of the Senate health committee’s innovation legislation. It also follows a Friends of Cancer Research proposal that the agency should replace its current drug, biologic and device centers with disease-specific centers.

Upton and Pallone’s bill, the FDA Cross-Center Collaboration Act, would require the agency to establish at least one intercenter institute focused om a major disease area and work across FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologic Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH).

FDA would have at one year after enactment of the measure to establish at least one institute, and would be required to take public comments on the proposed institute before it is established. Additionally, the agency could shut down a disease-specific institute if it determines the institute no longer benefits the public health.

“With this bipartisan effort, each Intercenter Institute would be primed to coordinate activities and convene the right scientific and regulatory experts to help solve challenges that are unique to specific conditions and diseases,” Upton and Pallone said in a joint statement. “Throughout the 21st Century Cures process, we’ve seen that success is possible when we work together. This commonsense bill encourages centers to working together to help accelerate the discovery, development, and delivery of cures.”

The bill is nearly identical to provisions of an FDA and National Institutes of Health workforce bill passed by the Senate Health, Education, Labor, and Pensions Committee’s as part of its parallel legislation to the House-passed 21st Century Cures Act.

In February, Friends of Cancer Research said FDA’s internal structure needs to be changed to include Centers of Excellence that focus on a disease-oriented approach rather than the current regime that is separated into drugs, devices and biologics to bring the agency in line with the rapid progression of medical science.

Ellen Sigal, chair and founder of Friends of Cancer Research, suggested starting with three or four pilot programs that include a center for oncology and could also include centers on neurodegenerative, cardiovascular and infectious diseases. She said changes should be done thoughtfully and in a stepwise approach with the appropriate resources allocated to the agency.

Additionally Friends of Cancer Research joined 27 other cancer patient advocacy groups in a letter Monday (June 6) calling for an Oncology Center of Excellence at the agency designed to bring together cancer experts from CDER, CBER and CDRH into their own center to regulate oncology products.

The Obama Administration’s Cancer Moonshot Initiative headed by Vice President Joe Biden calls for a Virtual Oncology Center of Excellence at FDA to work across the agency’s drug, biologic and device centers. The president’s 2017 budget request earmarks $75 million to set up the virtual center.…;