RFK plans to take on Big Pharma. It’s easier said than done

But the administration would likely face legal challenges if it proposed additional restrictions or an outright ban on pharmaceutical ads, says 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 First Amendment free speech protections,” it says. . “If the administration wanted to unilaterally impose new rules, it would be on shakier legal ground today than in previous years.”

This is because last summer the United States Supreme Court overturned the old Chevron Doctrinewhich allowed federal agencies some freedom in how they interpreted ambiguous laws. The Supreme Court ruling transfers power from agencies like the FDA to the courts.

Ballreich and Weissman fear that Kennedy’s support for raw milk, vitamins and disproven treatments for Covid-19, including ivermectin and hydroxychloroquine, could lead to the agency approving drugs that lack scientific evidence.

“I believe that when Robert Kennedy talks about fighting corruption and Big Pharma monopolies, that will result in lowering standards at the FDA to allow the authorization and promotion of ineffective and ineffective therapies, drugs, herbs or whatever. doubtful,” says Weissman.

As HHS secretary, Kennedy would not be directly responsible for approving new drugs or treatments. That task falls to the FDA’s Center for Drug Evaluation and Research, which in most cases approves drugs based on the recommendations of independent advisory committees. But in a handful of controversial cases, the agency approved drugs against this expert’s advice, such as when it gave the green light to Exondys 51, a drug for Duchenne muscular dystrophy, in 2016. FDA advisers said there was no sufficient evidence to show that the drug had real clinical benefits.

RFK has also called for greater scrutiny of the vaccines, which already must be tested on thousands of healthy volunteers over several years before being authorized. This skepticism could translate into fewer vaccines reaching the market and increased post-market monitoring of approved vaccines.

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

But Kennedy’s anti-pharmaceutical stance could be tempered by congressional Republicans, who have historically been resistant to greater regulation, and by other Trump appointees. The incoming president has chosen Marty Makary, a pancreatic surgeon and public policy researcher at Johns Hopkins, as FDA commissioner, more conventionally. 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 during the second Trump administration.

“There are big questions about the Trump administration and its approach to pharmaceuticals in general,” Ballreich says. “It’s hard to know how this will really end.”