Landmark 21st Century Cures Act Receives FDA, NIH Checkup


Rep. Gus Bilirakis (R-FL) takes a moment to visit with Max before the hearing started.

WASHINGTON, DC – The Health Subcommittee, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing to receive a status update on the implementation of the 21st Century Cures Act (Cures), landmark legislation to accelerate the discovery, development, and delivery of new treatments and cures, in order to maintain America’s global status as the leader in biomedical innovation.

The law also includes funding for the Precision Medicine Initiative, bolsters former Vice President Biden’s “Cancer Moonshot,” invests in the BRAIN initiative to help improve our understanding of diseases like Alzheimer’s, and fosters development and utilization of promising approaches to regenerative medicine.

Kicking off the hearing, #SubHealth Chairman Burgess stated, “Today’s hearing marks the Health Subcommittee’s first look into the implementation of what many in the health care community called a transformational bill that would positively impact not only the researchers and scientists who are developing the latest breakthrough therapies, but physicians seeking treatments for their patients – giving hope to them, their loved ones, and other advocates.”

FDA Commissioner Gottlieb and NIH Director Collins listen to member opening statements.

U.S. Food and Drug Administration (FDA) Commissioner, Dr. Scott Gottlieb, provided important updates on several aspects of Cures, including: the Oncology Center of Excellence, regenerative medicine, digital health, the breakthrough devices program, patient-focused drug development, drug development tools, clinical trial designs, combination products, and real world data and real world evidence.

Speaking to FDA’s role in implementing Cures, Dr. Gottlieb stated, “The aim of these policies is to improve patient access to innovative medical products while continuing to protect those who rely on these products. The provisions help FDA in its commitment to continue taking a fresh look at how we regulate products developed through truly novel medical advances to ensure that FDA is encouraging their development and creating efficient, risk-based pathways.”

National Institutes of Health (NIH) Director, Dr. Francis Collins, also shared an update on the implementation of provisions of Cures under his scope, including: sharing data while also protecting privacy, strengthening our biomedical workforce, NIH’s Innovation Fund, the Precision Medicine Initiative, the BRAIN Initiative, and the Cancer Moonshot.

“The Cures Act touches on so many important issues,” stated Dr. Collins. “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.”

Authors of the Cures legislation, Rep. Diana DeGette (D-CO) and #SubEnergy Chairman Fred Upton (R-MI) visit with Max.

#SubHealth also had a special guest in the audience, #CuresNow all-star advocate, Max.

During Energy and Commerce Committee Chairman Greg Walden’s (R-OR) opening statement, he took a moment to highlight Max’s critical role in the Cures effort, saying, “…We are so very glad that you’re here to share in this special birthday appearance of the 21st Century Cures legislation. It’s because of people like you that inspire us to do the best that this committee has to offer… because we know human lives are at stake.”

Today also marks the one year anniversary of the 21st Century Cures Act’s House passage (for the second time). A happy birthday, indeed.

“Time and time again we heard our former chairman proclaim that we were ‘on the cusp of something special’ – the Path to Cures – and Fred, your words are just as true today,” said #FullCmte Chairman Walden. “With Cures being law, it’s of the utmost importance we get implementation right so this groundbreaking law can yield promising developments for patients across the country.”

For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click here.