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Improving FDA Capacity, Promoting Precision Medicine, Accelerating Cell Therapies Key to Advancing Medical Innovation

Wednesday, April 6, 2016

Washington, D.C. – Today, the Senate HELP Committee held its third markup of bipartisan medical innovation legislation, paving the way for changes that will improve the medical product development process, increase regulatory clarity, increase investment in drugs that address public health needs, and strengthen the Food and Drug Administration’s (FDA) ability to carry out its mission. Legislation advanced by the Committee over the last two months contains provisions that align with the Bipartisan Policy Center’s recommendations released last summer in its report, FDA: Advancing Medical Innovation, developed under the guidance of co-chairs former Senate Majority Leader Bill Frist, MD, and former Rep. Bart Gordon. The Senate HELP Committee’s package is companion legislation to the House-passed 21st Century Cures Act.

Today’s markup included several provisions that are consistent with BPC’s recommendations:

The Food and Drug Administration and National Institutes of Health Workforce Authorities Modernization Act (S.2700), contains provisions that will improve scientific expertise and strengthen capacity at the FDA. It grants the FDA new authority to increase salaries, expand direct hires, permit greater staff attendance to scientific meetings, and improve coordination across centers.

The Advancing Precision Medicine Act of 2016 (S.2713), supports several activities to advance precision medicine similar to BPC recommendations, including bolstering the development and use of public-private partnerships, leveraging existing data sources, and using information voluntarily provided by individuals to better understand health and disease.

Additionally, Sen. Mark Kirk (R-IL) offered bipartisan legislation, introduced by Sens. Kirk, Collins, and Manchin—the Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act (S.2689)—as an amendment to the medical innovation package. This legislation also aligns with recommendations included in BPC’s report, Advancing Regenerative Cellular Therapy: Medical Innovation for Healthier Americans, and would modernize FDA’s current regulatory approach toward safe and effective cell therapies. Regenerative cell therapy, which involves the use of cells to restore healthy organ and tissue function, represents one of the most promising areas for the next generation of groundbreaking treatments. S.2700 also includes provisions that support the prioritization of standards for the development, evaluation, and review of regenerative medicine and advanced therapies.

“To accelerate the development of new, safe, and effective treatments and cures, FDA must have the ability to hire the best and brightest scientific minds, increase its staffing, and expand its resources to successfully keep pace with medical innovation,” said Janet Marchibroda, BPC health innovation director. “This legislation will also help translate scientific discovery into new treatments and therapies for patients. This final markup by the Help Committee is critical to advancing companion legislation to the House’s 21st Century Cures bill this year.”

Since last summer, BPC has been offering technical assistance to the committee on ways to improve the medical product development process, increase regulatory clarity, strengthen the ability of the FDA to carry out its mission, and increase investment in treatments for unmet and public health needs.

Read BPC’s blog that highlights ten ways to advance medical innovation this year.

Janet Marchibroda, BPC health innovation director, is available for comment.

KEYWORDS: 114TH CONGRESS, 21ST CENTURY CURES, BART GORDON, BILL FRIST, FOOD AND DRUG ADMINISTRATION, JANET MARCHIBRODA, JOE MANCHIN, MARK KIRK, SENATE HELP COMMITTEE, SUSAN COLLINS