Press Release

#SubHealth Hears from FDA and NIH on Implementation of Landmark 21st Century Cures Act


07.25.18

WHAT:

The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), held a hearing continuing its review of the implementation of the landmark 21st Century Cures Act (Cures), with a focus on the work being done at the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).

WHY:

“The 21st Century Cures Act provides hope to those who need it the most – individuals and families suffering from life-altering, often life-threatening illnesses,” said #SubHealth Chairman Burgess. “Whether it be cancer, a rare disease, or Alzheimer’s, there are countless conditions that are costly to Americans of all ages and their families. Sadly, we each know too well the financial and human toll that diseases place on our friends and communities.”

WHO:

  • Francis Collins, Director, NIH (Opening Statement)
  • Stephanie Devaney, Deputy Director, All of Us Research Program, NIH
  • Scott Gottlieb, Commissioner, FDA (Opening Statement)
  • Norman Sharpless, Director, National Cancer Institute, NIH

KEY MOMENTS:

Dr. Gottlieb highlighted a number of provisions within Cures, including the use of real world evidence to improve patient care and ways to increase feedback from patients.

“Consistent with the Cures Act, FDA is also actively working to elevate patient voices in developing new medical products to treat their diseases. We learn through scientific advances, but also by listening to patients,” said Dr. Gottlieb. “We must make the science of medical product development and review more modern and more patient-centered, so that approved products successfully address the aspects of disease that concern real-world patients and families the most.”

#SubEnergy Chairman Fred Upton (R-MI), who championed the game-changing bill, spoke to the importance of the All of Us Research Program led by NIH. Dr. Collins provided an update on the program in his opening statement, and Dr. Stephanie Devaney gave additional details about their efforts.

#SubOversight Ranking Member Diana DeGette (D-CO), who led Cures with #SubEnergy Chairman Upton, asked Dr. Collins about NIH’s efforts to develop alternatives to opioids for pain management. Dr. Collins touted the March 2018 omnibus that provided new resources for the NIH to develop such medicines, and explained the work they are doing to prioritize these efforts in the midst of the opioid crisis. Watch the exchange here.

Rep. Billy Long (R-MO) spoke about his daughter, who is a cancer survivor, and asked Dr. Sharpless to provide an update on the work being done in conjunction with the Cancer Moonshot. Watch the exchange here.

RESOURCES:

Dr. Gottlieb and Dr. Collins previously provided a status update on the implementation of Cures during a November 2017 #SubHealth hearing. Last week, #SubHealth received an update from Dr. Elinore McCance-Katz, Assistant Secretary, Substance Abuse and Mental Health Services Administration (SAMHSA) regarding Cures’ mental health provisions.

For more information on Cures, click here.

The Majority Memorandum, witness testimony, and an archived webcast are available online HERE.  

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Press Release