In an article published by Law360, Bass, Berry & Sims attorney Clint Hermes provided insight on President-Elect Donald Trump’s nomination of Robert F. Kennedy, Jr. as Secretary of the Department of Health and Human Services (HHS). While Kennedy has been outspoken about his views about vaccines, his opinions about other health policies remain unclear which makes planning for the upcoming administration difficult. Clint commented that there is often not a lot of legal advice, or even practical business advice, one can give about the impact of a prospective nominee before the nominee is in position and the administration is actually doing things.
One area of concern involves life sciences companies and research organizations, which fall under the umbrella the Food and Drug Administration (FDA) and National Institutes of Health (NIH), both under HHS control. Clint said a “significant area of apprehension for life sciences companies relates to the FDA’s user fee programs,” which involve regulations around companies seeking approval for new products, such as drugs or medical devices.
“Industry is concerned that if those programs are disrupted or not reauthorized, the corresponding product review timeline commitments would go away, which would in turn create real uncertainty in companies’ clinical development plans,” Clint said.
Clint said he’s also getting questions about the implications of the nomination for international research collaborations. HHS agencies are working on guidance under Executive Order 14117 — President Joe Biden’s data security executive order — on sharing certain types of data with “countries of concern,” like China, Clint said.
“Will a Kennedy-led HHS impose more restrictions on such collaborations, either in connection with that executive order or otherwise as part of the growing body of national security regulation of biomedical research?” he asked.
The full article, “Despite Vaccine Spotlight, RFK Jr. A Health Policy ‘Unknown’,” was published by Law360 on November 15 and is available online.