That’s because the U.S. Supreme Court struck down the long-standing rule last summer Chevron Doctrinewhich gave federal agencies some latitude in interpreting ambiguous regulations. The Supreme Court’s ruling shifts power from agencies like the FDA to the courts.
Ballreich and Weissman worry that Kennedy’s support for raw milk, vitamins and disproven Covid-19 treatments, including ivermectin and hydroxychloroquine, could lead to the agency’s approval of drugs that lack scientific evidence.
“I think that when Robert Kennedy talks about fighting corruption and Big Pharma monopolies, that will translate into lowering the standards at the FDA to allow the authorization and promotion of ineffective and questionable therapies, drugs, herbs, whatever,” Weissman says.
As HHS secretary, Kennedy would not be directly responsible for approving fresh drugs or treatments. This task falls to the FDA’s Center for Drug Evaluation and Research, which most often approves drugs based on recommendations from independent advisory committees. However, in several controversial cases, the agency has approved drugs against expert recommendations, such as the 2016 green featherlight for Exondys 51, a drug for Duchenne muscular dystrophy. FDA advisers said there was insufficient evidence to show the drug had a therapeutic effect. real clinical benefits.
RFK also called for closer scrutiny of vaccines, which already must be tested on thousands of well volunteers for several years before they are approved for apply. This skepticism could translate into fewer vaccines coming to market and more monitoring of approved vaccines once they are launched.
Working with Mehmet Oz, Trump’s pick to head the Centers for Medicare and Medicaid Services, Kennedy can push for questionable treatments or medical devices to be covered by Medicare, the federal health insurance program for people 65 or older and people with disabilities.
But Kennedy’s anti-pharmacology stance may be softened by Republicans in Congress, who have been reticent in the past on more regulation, and other Trump appointees. The future president made a more conventional choice for FDA commissioner: Marty Makary, a pancreatic surgeon and public policy researcher at Johns Hopkins. Meanwhile, Vivek Ramaswamy, founder of the pharmaceutical company Roivant Sciences and Republican presidential candidate, has been tapped to lead the Department of Government Effectiveness, or DOGE, a planned presidential advisory commission under the second Trump administration.
“There are huge question marks about the Trump administration and its overall approach to pharmaceuticals,” Ballreich says. “It’s hard to say how this will actually play out.”