How H.R. 6800 Might Impact the FDA

Sometimes legislation that is described as “dead on arrival” is truly without consequence. Other times, the effort to set a legislative position is highly meaningful, even if the bill itself is never going to become law.Such is the case with H.R. 6800, the ‘‘Health and Economic Recovery Omnibus Emergency Solutions Act,’’ which is being referred to as the “HEROES Act” (text here; summary here). While it will not become law in its current form, its provisions affecting FDA are ones that are likely to be under consideration for the foreseeable future and may be in the next coronavirus package that the House and Senate agree upon.While not exhaustive of every reference to FDA in the bill, here are five sections of H.R. 6800 that will require FDA action:National Centers of Excellence in Continuous Pharmaceutical Manufacturing (pages 464 to 476 of the bill text). The bill summary says:Section 30519 ... Directs FDA to designate National Centers of Excellence in Continuous Pharmaceutical Manufacturing (NCEs). NCEs will work with FDA and industry to craft a national framework for the implementation of continuous manufacturing of drugs, including supporting additional research and development of this technology, workforce development, standardization, and collaborating with manufacturers to support adoption of continuous manufacturing of drugs.GAO Report on Diagnostic Tests (pages 499 to 502 of the bill text). The bill summary says:Section 30547 ... Requires a GAO report on the response of laboratories, diagnostic test manufacturers, state, local, Tribal, and territorial governments, and relevant federal agencies, related to the COVID-19 epidemic with respect to the development, regulatory evaluation, and deployment of diagnostic tests.Research and development (pages 533 to 535 of the bill text). The bill summary says:Section 30565 ... Requires CDC, in collaboration with the National Institutes of Health (NIH), the Agency for Healthcare Research and Quality (AHRQ), FDA, and CMS to support research and development on efficient and effective testing, contact tracing, and surveillance strategies.Federal Modernization for Health Inequities Data (pages 558 to 559 of the bill text). The bill summary says:Section 30573 ... Authorizes funding to AHRQ, CDC, CMS, FDA, the Office of the National Coordinator for Health Information Technology, and NIH to modernize their data collection methods and infrastructure in order to increase data collection related to health inequities.COVID-19 Emergency Medical Supplies Enhancement (pages 906 to 934 of the bill text). The bill summary says:Sec. 110101 ... This section would expand the use and oversight of Defense Production Act (DPA) authorities to: increase the production and supply of critical medical supplies and equipment, such as diagnostic tests and personal protection equipment; focus efforts on supply chain mobilization; decrease the disruption of critical deliveries to state and local governments; and require assessments for both immediate and longer term needs and plans to meet those needs, as well as requiring longer-term planning to ensure that the United States is better prepared for future pandemics.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.