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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

NIH and FDA Leaders Update House Committee on 21st Century Cures Act Implementation

December 1, 2017—The House Energy and Commerce Health Subcommittee Nov. 30 held a hearing titled, “Implementing the 21st Century Cures Act: An Update from FDA and NIH.”

Members of the subcommittee asked National Institutes of Health (NIH) Director Francis Collins, MD, PhD, and Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD,  to provide a status update on various provisions included in the 21st Century Cures Act (P.L. 114-255) [see Washington Highlights, Dec. 9, 2016].

Subcommittee Chair Michael Burgess, MD, (R-Texas) began the hearing by calling the 21st Century Cures Act a “monumental achievement,” citing the broad bipartisan support for the legislation. Committee Chair Greg Walden (R-Ore.) also shared high praise, saying that the 21st Century Cures Act is “a transformational law intended to modernize the nation’s biomedical innovation infrastructure.” He added that he wanted to hear more about how the law was being implemented to “deliver hope to millions of patients living with untreatable diseases.”

Dr. Collins began his testimony thanking lawmakers by saying, “From providing support for four cutting edge research priorities, to enhancing privacy protections to inclusion of various communities in research trials, to reducing administrative burden to expanded prize authority, we at NIH appreciate your leadership and dedication in enacting new authorities to speed the pace of research and improve how science is conducted to transform the way we translate discovery into therapies.”

Dr. Collins focused most of his oral testimony on initiatives under the NIH Innovation Fund, and members of the subcommittee inquired how his agency is supporting younger researchers. Dr. Collins highlighted the Next Generation Researchers Initiative, which is focused on “strengthening the biomedical workforce with a focus on early career investigators or investigators who are at an early stage in their career.”

In his testimony, Dr. Gottlieb discussed FDA’s new Oncology Center for Excellence, minimal risk clinical investigations, and regenerative medicine, among other topics. Rep. Larry Buschon, MD, (R-Ind.) also asked Dr. Gottlieb about his take on the Diagnostic Accuracy and Innovation Act (DAIA), a draft bill he and Rep. Diana DeGette (D-Colo.) have released that would provide an alternative path to market for clinical diagnostic tests. Expressing his willingness to work with Congress, Dr. Gottlieb said the “traditional medical device approval process is a poor fit for the regulation of [lab developed tests] and we think there is an opportunity to fashion a regulatory framework through legislation that can provide a more appropriate fit.”

Meanwhile, the Senate has teed up a similar hearing in the Senate Health, Education, Labor, and Pensions Committee, scheduled for Dec. 7. Drs. Collins and Gottlieb are both expected to testify.

Contact:

Tannaz Rasouli
Sr. Director, Public Policy & Strategic Outreach
Telephone: 202-828-0525
Email: trasouli@aamc.org

Joseph Bañez
Legislative Analyst
Telephone: 202-739-2995
Email: jbanez@aamc.org

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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.


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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org