RFK Plans To Take On Big Pharma. Easier Said Than Done

But the administration is likely to face legal challenges if it proposes more restrictions or an outright ban on pharmacy ads, said Jim Potter, executive director of the nonpartisan Coalition for Healthcare Communications. “Courts view advertising as a form of commercial speech, and have ruled in a series of cases dating back to the 1970s that banning advertising violates the First Amendment’s protection of free speech,” he said. “If the administration wanted to make new laws independently, they would be more legal today than years ago.”

That’s because the US Supreme Court last summer struck down the long-standing Chevron doctrine, which allowed federal agencies some leeway in how they interpreted ambiguous laws. The Supreme Court decision shifts power from agencies like the FDA to the courts.

Ballreich and Weissman are concerned that Kennedy’s support for raw milk, vitamins, and unapproved treatments for Covid-19, including ivermectin and hydroxychloroquine, could lead the agency to approve drugs without scientific evidence.

“I think when Robert Kennedy talks about fighting corruption and Big Pharma monopolies, that will translate into lowering FDA standards to approve and promote ineffective and questionable treatments, drugs, cures, whatever,” Weissman said.

As HHS secretary, Kennedy will not be directly responsible for approving new drugs or treatments. That task falls to the FDA’s Centers for Drug Evaluation and Research, which often approves drugs based on the recommendations of independent advisory committees. But in a few controversial cases, the agency has approved drugs against this expert advice, such as when it greenlit Exondys 51, a drug for Duchenne muscular dystrophy, in 2016. real clinical benefits.

RFK also called for a broader review of the vaccine, which must already be tested on thousands of healthy volunteers for several years before being licensed. This skepticism may be reflected in fewer vaccines making it onto the market and more monitoring of approved vaccines.

Working with Mehmet Oz, Trump’s pick to lead the Centers for Medicare and Medicaid Services, Kennedy could push to get questionable treatments or medical devices covered by Medicare, the federal health insurance program for people age 65 and older and those with disabilities.

But Kennedy’s anti-pharmacy stance could be influenced by congressional Republicans, who have been tight-lipped about more regulations, and other Trump appointees. The incoming president made the usual choice for FDA commissioner in Marty Makary, a pancreatic surgeon and public policy researcher at Johns Hopkins. Meanwhile, Vivek Ramaswamy, the founder of pharmaceutical company Roivant Sciences and a Republican presidential nominee, has been tapped to lead the Department of Government Operations, or DOGE, a presidential advisory commission set up under Trump’s second administration.

“There are big question marks about the Trump administration and their approach to medicine in general,” Ballreich said. “It’s hard to know exactly how this is going to go.”