RFK plans to take on Big Pharma. It’s easier said than done
Jim Potter, Executive Director of the nonpartisan Coalition for Healthcare Communications, said that the administration could face legal challenges should it propose additional restrictions, or even an outright ban, on pharma advertisements. He says that courts have ruled, in cases dating back to 1970s, that banning advertisements violates First Amendment rights of freedom of expression. “If the administration wanted to unilaterally impose new rules, they would be on shakier legal ground today than in past years.”
That’s because the US Supreme Court last summer overturned the longstanding Chevron doctrine, which allowed federal agencies some latitude in how they interpreted ambiguous laws. The Supreme Court ruling shifts power from agencies like the FDA to the courts.
Ballreich and Weissman worry that Kennedy’s support of raw milk, vitamins, and disproven treatments for Covid-19, including ivermectin and hydroxychloroquine, could lead to the agency approving medicines that lack scientific evidence.
“I think when Robert Kennedy talks about fighting corruption and Big Pharma monopolies, that is going to translate into reducing standards at FDA to enable the authorization and promotion of ineffective and dubious therapies, drugs, herbs, whatever,” Weissman says.
As HHS secretary, Kennedy would not be directly responsible for approving new drugs or treatments. The FDA’s Center for Drug Evaluation and Research is responsible for approving new drugs and treatments. In a few controversial cases, however, the FDA has approved drugs against expert advice. For example, when it approved Exondys 51 in 2016, a drug to treat Duchenne muscular Dystrophy. This skepticism could lead to fewer vaccines being approved and more postmarket monitoring of approved vaccines. This skepticism could play out in fewer vaccines making it to the market and more postmarket 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 aged 65 or older and those with disabilities.
But Kennedy’s anti-pharma stance could be tempered by congressional Republicans, who have been historically reticent about more regulation, and Trump’s other appointees. Marty Makary is a Johns Hopkins public policy researcher and pancreatic surgeon who has been appointed by the incoming president as FDA commissioner. Meanwhile, Vivek Ramaswamy, founder of the pharmaceutical company Roivant Sciences and a Republican presidential candidate, has been tapped to lead the Department of Government Efficiency, or DOGE, a planned presidential advisory commission under the second Trump administration.
“There are huge question marks with the Trump administration and its approach to pharmaceuticals in general,” Ballreich says. It’s difficult to predict how the situation will unfold.
