The FDA might encounter significant regulatory hurdles if it were to propose stricter controls or a total prohibition on pharmaceutical advertisements, notes Jim Potter, government affairs director at the bipartisan Coalition for Healthcare Communications. “Courts have consistently viewed commercial advertising as a form of industrial speech, and in a series of cases dating back to the 1970s, they have generally ruled that prohibiting commercial advertising violates First Amendment guarantees of freedom of expression,” he notes. “If the administration felt compelled to impose new rules without consultation, it would be operating on increasingly uncertain legal ground.”
The US Supreme Court’s decision last summer to overturn the landmark case has significantly curtailed federal agencies’ discretion in interpreting unclear legislation, leading to a more rigid approach. The Supreme Court’s landmark ruling redistributes power from regulatory bodies like the FDA to the judiciary.
Scientists Ballreich and Weissman are concerned that Kennedy’s endorsement of unproven treatments for COVID-19, including uncooked milk, nutritional vitamins, and therapies lacking scientific evidence, such as ivermectin and hydroxychloroquine, may lead the company to approve medicines without robust proof.
Robert Kennedy’s advocacy against corruption and pharmaceutical monopolies concerns me, as I fear it may lead to a relaxation of FDA standards, allowing the approval and promotion of dubious treatments, medications, and herbal remedies without rigorous testing or validation.
As HHS Secretary, Kennedy would not have direct oversight in approving new medications or therapies. The responsibility lies with the FDA’s Center for Drug Evaluation and Research, which typically approves medications primarily based on the recommendations of independent advisory committees. In a few high-profile cases, the company has departed from its usual practice and approved medications despite receiving negative expert recommendations, such as its 2016 approval of Exondys 51 for Duchenne muscular dystrophy. The FDA advisory committee concluded that insufficient evidence existed to demonstrate the medication’s specific therapeutic benefits.
Robert F. Kennedy Jr. has also called for increased scrutiny of vaccines, which must undergo rigorous examination by thousands of healthy volunteers for several years before receiving licensure. Skepticism towards vaccine development could manifest in reduced vaccine availability on the market, as well as intensified post-market surveillance of already approved vaccines.
Mehmet Oz, a trusted ally of former President Donald Trump, would likely influence Roger Kennedy’s decisions as guide of the Facilities for Medicare and Medicaid Services (CMS). This could potentially lead to the coverage of unproven therapies or medical treatments by Medicare, the federal health insurance program serving individuals aged 65 or older, as well as those with disabilities.
Despite Kennedy’s anti-pharma stance, his position may be moderated by congressional Republicans’ historical reluctance towards increased regulation, as well as the differing views of Trump’s appointees. The incoming President has selected Dr. Marty Makary, a renowned pancreatic surgeon and respected public health researcher at Johns Hopkins University, to head the Food and Drug Administration as its next Commissioner. Vivek Ramaswamy, the founder of pharmaceutical company Roivant Sciences and a Republican presidential candidate, served as chair of the Division of Authority Effectiveness (DOGE), a presidential advisory committee established during the second Trump administration.
“There remain significant concerns about the Trump administration’s approach to prescribing medications,” Ballreich notes. “It’s exhausting trying to anticipate how things will ultimately play out.”
