Blog | 4/25/2025
Trump Administration Healthcare News
Health Advances weekly healthcare tracker focused on top level government administration news.
KEY FEDERAL GOVERNMENT NEWS
FDA
With Dr. Marty Makary in power, the FDA’s future comes slightly more into view
- Makary’s plan for the agency — and the extent to which he’ll be influenced by HHS Secretary Robert F. Kennedy, Jr. — has yet to fully unfold. But he did hint at some of his plans in an interview with former Fox News journalist Megyn Kelly last week.
- For one, Makary proposed rolling out a new pathway for rare disease approvals that could get drugs into the hands of patients faster.
- If there’s a new treatment for a rare disease that makes sense physiologically — meaning the mechanism is scientifically plausible — the proposed pathway would allow patients to get on the treatment if they wanted to, even in the absence of a randomized controlled trial.
- Makary also touched on the burgeoning anti-vaccine efforts taking shape under Kennedy’s helm, noting that “there’s been an epidemic of distrust [in the FDA] and part of it is warranted.”
- In response to a question posed by Kelly about negative side effects from the COVID-19 vaccine, however, Makary claimed the FDA will conduct “intense, comprehensive research” on the safety and efficacy of vaccines and emphasized the use of real-world data in doing so.
- He also said that Marks’ former position as the agency’s top vaccine regulator will be filled, and that a lot of “talented people” were applying for the job.
- Finally, Makary announced last week that the FDA would implement a new policy that would prevent individuals employed at pharma companies from serving as official members of FDA advisory committees, all in the name of boosting transparency and reducing conflicts of interest.
- and more . . .