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  • Washington Highlights

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

    Tannaz Rasouli, Sr. Director, Public Policy & Strategic Outreach
    Christa Wagner, Manager, Government Relations

    The House Energy and Commerce Health Subcommittee July 25 held a hearing titled, “21st Century Cures Implementation: Updates 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]. Dr. Collins was joined by Ned Sharpless, MD, Director of the National Cancer Institute, and Stephanie Devaney, PhD, Deputy Director of the NIH's All of Us Research Program.

    Subcommittee Chair Michael Burgess, MD, (R-Tex.) began the hearing by calling the 21st Century Cures Act “one of the most substantial legislative accomplishments in the space of biomedical innovation” passed with strong bipartisan support in both chambers. Subcommittee Ranking Member Gene Green (D-Tex.) highlighted his view that “the promise of the 21st Century Cures is to advance the discovery and development of new treatments and cures through increased research and improved drug approval processes … and demonstrates what we [the committee] can accomplish when we work across the aisle.”

    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 advancements in precision medicine, including updates on the All of Us Research Program. He noted that the program has enrolled 86,000 volunteers, with almost half from historically underrepresented racial and ethnic groups, a goal of the program to better understand health disparities. Several subcommittee members posed questions about volunteer enrollment, data security, and future research opportunities with data collected through All of Us. Drs. Collins and Devaney both commented that data security has been a high priority in implementing the program, as well as the code of conduct that has been developed to regulate the use of program data in future research.

    In his opening questioning, Chairman Burgess asked for a progress update in condensing duplicative regulations in order to reduce administrative burden for investigators. Dr. Collins reported that work is ongoing between NIH and the Department of Health and Human Services (HHS) in a variety of ways, including to adjust the “unduly onerous” reporting mechanisms for financial conflicts of interests and financial expenditure reporting. NIH also has made simplifications to subrecipient monitoring. Additionally, inefficiencies in animal care and use oversight currently are being examined as NIH considers the 19,000 responses to a recent request for information (RFI). Dr. Collins reported that NIH’s formal response to these comments is expected late this year or early in 2019.

    In his testimony, Dr. Gottlieb discussed FDA’s work in developing innovative clinical trial designs, including “encouraging the use of state-of-the-art innovations such as adaptive trials, modeling, and simulations.” Dr. Gottlieb noted that FDA will be publishing a guidance soon on how product developers can conduct innovative clinical trials. Rep. Larry Buschon, MD, (R-Ind.) asked Dr. Gottlieb for an update on the Diagnostic Accuracy and Innovation Act (DAIA), a draft bill he and Rep. Diana DeGette (D-Colo.) co-authored and summarized. It would provide an alternative path to market for clinical diagnostic tests. In response to Rep. Buschon’s interest in passing the bill this Congress, Dr. Gottlieb said FDA is “very close” to completing its review of the draft bill.