Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Health Law & Business, in “FDA Science, Vaccine Policy to Face ‘Firm Hand’ in Trump Return,” by Nyah Phengsitthy. (Read the full version – subscription required.)
Following is an excerpt:
The FDA is susceptible to a reshuffle under President-elect Donald Trump, whose plans to “Make America Healthy Again” would have ramifications for an agency responsible for drug approvals and food and cosmetics safety. …
Trump hasn’t revealed details of his agenda, but his promise to allow vaccine skeptic Robert F. Kennedy Jr. to “go wild” on health care puts the focus on the FDA’s role in vaccine policy, abortion medication access, and even the science that underpins its work. …
Scientific Work
The agency could also face pressure in its every day practices, according to Richard Hughes, a member at Epstein Becker & Green P.C.
“At FDA, there are things that are set in stone for the Federal Food, Drug, and Cosmetic Act—basic activities that FDA has to carry out,” Hughes said. But “a lot of FDA policy is contained in those nonbinding guidances, which could all be changed very easily.”
“It remains to be seen on what he could do around food and tobacco,” Hughes added. “Also, the potential injection of very subjective views on evidence into an agency that is focused on safety and efficacy of the products it evaluates would be very concerning.”
