Monday, 30 July 2018 11:55

House Committee Holds Latest Hearing on 21st Century Cures

On July 25, the Health Subcommittee of the House Energy and Commerce Committee held a hearing on implementation of the “21st Century Cures Act (Cures Act).” National Institutes of Health (NIH) Director Francis Collins and U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb were among the witnesses. Several issues raised during the hearing are of interest to ASM membership:

Rep. Gene Green (D-TX) expressed concern with antibiotic resistance and asked what has changed since passage of the Cures Act. Commissioner Gottlieb responded that the FDA will take added steps to look at antibiotic use in animal feed and that a guidance document will soon be issued on the topic. He also spoke about the importance of new pathways for getting countermeasures to market. He spoke about “pull incentives.” A pull creates an incentive for private sector engagement by creating viable market demand or reward for success.

Rep. Green also asked about the potential for FDA approval of Ebola vaccine. Dr. Collins noted that the NIH began working on an Ebola vaccine in the 1990s and the vaccine was developed in record time, but not in time for the West Africa Ebola outbreak of 2013-2016. With regard to the recent outbreak in the Democratic Republic of Congo (DRC), Collins said that the vaccine was distributed and administered to healthcare workers and that The World Health Organization had declared the epidemic over the day before. Dr. Gottlieb remarked the Ebola vaccine is a “game changer” and applauded Merck’s efforts (vaccines were provided free in DRC). Gottlieb revealed Merck is working toward a licensed product in the US.

Rep. Anna Eshoo (D-CA) asked about the priority review process for medical countermeasures (MCM). Specifically, she asked if the FDA was concerned with the number of products that qualify for priority review. Gottlieb responded that the first MCM (treatment for smallpox) was just approved by the FDA. He added that he wouldn’t argue that FDA anticipates too many MCMs competing for priority review.

The Cures Act was signed into law in December 2016 (PL: 114-255), and was designed to help accelerate medical product development and bring new innovations and advances to patients in a more efficient manner. See all the relevant documents and view this hearing.  ASM will continue to monitor these issues and any Congressional actions coming out of the hearing.