But Jim Potter, executive director of the nonpartisan Coalition for Healthcare Communications, says the administration could face legal challenges if it proposes additional restrictions or a complete ban on pharma ads. He says, “Courts view advertising as a form of commercial speech, and they have ruled in several cases dating back to the 1970s that banning advertising violates First Amendment protections of free speech.” “If the Administration were to unilaterally impose new rules, they would be on a more shaky legal basis today than in years past.”
That's because the US Supreme Court last summer overturned a long-standing decision chevron principleThat gave federal agencies some leeway in interpreting ambiguous laws. The Supreme Court's decision has handed over power from agencies like the FDA to the courts.
Ballreich and Weissman worry that Kennedy's support of raw milk, vitamins and unproven treatments for COVID-19, including ivermectin and hydroxychloroquine, could lead the agency to approve drugs that lack scientific evidence.
Weissman says, “I think of Robert Kennedy when he talked about fighting corruption and Big Pharma monopoly, enabling the authorization and promotion of ineffective and questionable treatments, drugs, herbals, whatever. “That's going to translate into lowering of standards at the FDA.”
As HHS Secretary, Kennedy will not be directly responsible for approving new drugs or treatments. This job falls to the FDA's Center for Drug Evaluation and Research, which often approves drugs based on recommendations from independent advisory committees. But in some controversial cases, the agency has approved drugs against this expert's advice, such as when it greenlighted Exondis 51, a drug for Duchenne muscular dystrophy, in 2016. FDA advisers said there was not enough evidence to show that the drug had real clinical benefit.
RFK has also called for greater scrutiny of vaccines, which must be tested on thousands of healthy volunteers for several years before they can be licensed. This skepticism could result in fewer vaccines coming to market and more postmarket surveillance of approved vaccines.
Working with Mehmet Oz, whom Trump chose to lead the Centers for Medicare and Medicaid Services, Kennedy dubious treatments covered by Medicare, the federal health insurance program for people age 65 and older and those with disabilities. Or may exert pressure to obtain medical equipment.
But Kennedy's anti-pharma stance could be softened by congressional Republicans, who have historically been reticent about more regulation, and Trump's other appointees. The incoming president has chosen a more traditional candidate, Marty Macri, a pancreatic surgeon and public policy researcher at Johns Hopkins, as FDA commissioner. Meanwhile, Vivek Ramaswamy, founder of pharmaceutical company Roivant Sciences and 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 big question marks over the Trump administration and its approach to pharmaceuticals in general,” Ballreich says. “It's hard to know how this is really going to shake out.”