Heads of NIH and FDA Update Congress on 21st Century Cures Act

By | December 7, 2017

Image Source: Oregon Health & Science University, click to view original image.

On November 30, the House Committee on Energy and Commerce Committee held a hearing on implementation of the 21st Century Cures Act, signed into law a year ago. Scott Gottlieb, MD, Commissioner of the Food and Drug Administration (FDA), and Francis Collins, MD, PhD, Director of the National Institutes of Health (NIH), offered testimony about how the law has aided the work of their agencies.

In opening remarks, Drs. Gottlieb and Collins both praised the law for provisions that are advancing biomedical science and accelerating the development and deployment of new therapies and cures. Dr. Gottlieb described how recent scientific breakthroughs are transforming treatments for many diseases, including cancer. He went on to describe how FDA is using the framework created by the Cures Act to expedite approval of some of these new cancer drugs.

Dr. Collins homed in on provisions of the law aimed at reducing administrative burdens, offering prizes for revolutionary new research ideas, and safeguarding patient privacy. He also highlighted several scientific initiatives being supported by the Cures Act Innovation fund: the BRAIN Initiative, the Cancer Moonshot, the Regenerative  Medicine Innovation Project, and the Personalized Medicine Initiative (PMI).

During a lengthy discussion period following their statements, Drs. Gottlieb and Collins fielded questions from the committee on efforts to combat antibiotic-resistant microbes, the high cost of prescription drugs, patient privacy concerns related to the PMI, and research and clinical progress in areas such as Alzheimer’s and Parkinson’s diseases. There were also inquiries about NIH policies that affect students and the research workforce.

During one exchange, Rep. Greg Walden (R-OR) asked Dr. Collins about efforts to aid young and mid-career investigators. He responded that NIH has noted the aging of the research workforce and has begun to make policy changes to increase the funding rate for both early-stage investigators, who bring renewed  “energy and creativity” into the biomedical research enterprise, and mid-career scientists, who are at risk of losing funding at the time of their first grant renewal. He cautioned that NIH does have constraints on its resources and will have to redirect money from established investigators in order to fund younger scientists.

Regarding graduate education, several Democrats expressed concerns about the taxation of tuition waivers included in the Tax Cuts and Jobs Act (HR 1). Rep. Frank Pallone (D-NJ) asked Dr. Collins if he worried that taxing tuition waivers would make graduate school unaffordable for many students and threaten the future of the U.S. biomedical research workforce. While he did not comment specifically on HR 1, Dr. Collins affirmed that graduate students are “absolutely critical” to the future of the research enterprise and that any policies that hinder the “best and the brightest” from pursuing research careers are of great concern.

Additional information: Full written testimony for Dr. Gottlieb and Dr. Collins.