Scientists, drugmakers brace for a Kennedy HHS after confirmation

Health scientists and drug industry executives around the world are on alert after the confirmation of Robert F. Kennedy Jr., who spreads antivaccine misinformation and has often derided the pharmaceutical and food industries, as secretary of the US Department of Health and Human Services (HHS).

As HHS head, Kennedy now has considerable influence over how drugs are approved, priced, and made available—or not—to the public. The department is a large umbrella that houses the Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services, Centers for Disease Control and Prevention (CDC), and National Institutes of Health (NIH), among other agencies.

Kennedy’s antivaccine sentiment is of particular concern to doctors, researchers, drug manufacturers, and patient advocates. During Senate hearings, he refused to testify outright about whether he believes vaccines are safe and effective, instead repeating the line that he is "prosafety." He also would not refute the notion that vaccines cause autism, a theory he has repeatedly promoted despite the fact that it has been discredited.

Shares of companies that produce vaccines dropped sharply on Feb. 4, the day Kennedy advanced past a key Senate committee that determined whether he would make it to a hearing in front of the full chamber. Mani Foroohar, a senior research analyst at Leerink Partners, wrote in a research note that day that Kennedy's advancement reflected an "evolving regulatory environment [that is] negative for primary care vaccine manufacturers—both on a fundamental and sentiment basis."

Moderna is particularly vulnerable, Foroohar noted, because its only FDA-approved product is its COVID-19 vaccine. 

The Senate vote on Kennedy's confirmation was split almost entirely along party lines. Every Senate Democrat voted against his appointment, and every Senate Republican voted for it, except one: Mitch McConnell, who survived polio as a child.

"In my lifetime, I've watched vaccines save millions of lives from devastating diseases across America and around the world," McConnell says in a statement. "I will not condone the re-litigation of proven cures, and neither will millions of Americans who credit their survival and quality of life to scientific miracles."

Some advocates are concerned that Kennedy may try to revoke existing vaccine authorizations and approvals or influence groups like the Advisory Committee on Immunization Practices, which recommends vaccine schedules for the CDC. In a statement emailed to C&EN, Infectious Diseases Society of America president Tina Tan says the group will "hold Secretary Kennedy to his promise to maintain our nation's vaccine approval and safety framework."

Meanwhile, Kennedy has also indicated he'd work to diminish some of the subagencies that fall within the HHS. He has said he would eliminate whole FDA departments and fire and replace 600 NIH employees. 

The NIH has already become a target of the new administration of President Donald J. Trump, who froze grants, loans, and study sections by way of executive orders and policy changes almost immediately upon taking office. Those freezes have been largely rescinded or temporarily blocked by judicial orders, but they've nonetheless sown chaos. The NIH’s second-in-command, Lawrence Tabak, abruptly retired Wednesday, and NIH extramural research deputy director Michael Lauer said Thursday that he'd leave the agency at the end of the week, Stat reported.

That kind of turnover, and the accompanying loss of institutional knowledge, could undermine Trump and Kennedy's goals, according to Stuart Pape, former associate chief counsel for food at the FDA, who now chairs the FDA practice at the law firm Polsinelli.

"If you have a diminished workforce, by definition, you have fewer people who can execute on any strategy, whether conventional or otherwise," Pape says. "The likelihood that you would succeed would also be diminished, because if you're going to try something unconventional, you need experienced people who can help you identify the traps so that you don't walk into them."

Beyond vaccines, Kennedy has spoken at length about ultraprocessed foods, which he believes should be probed for links to the growing prevalence of chronic health conditions in the US. Trump's nominee to head the FDA, Marty Makary, has made similar arguments, calling for an approach to "food as medicine."

As HHS head, Kennedy may pressure the FDA to close a loophole that allows food manufacturers to avoid needing to get premarket approval by using ingredients categorized as "generally recognized as safe," or GRAS. 

"I could see RFK Jr. or Makary coming in, identifying a couple of ingredients in the food supply that are out there on the basis of GRAS for which a notice has been submitted to FDA, and sort of deciding whether you want it to be an unapproved food additive," Pape says. "Suppose I took and put into an AI device all of the ingredient lists from all of the foods currently marketed in the United States, and then I compared those ingredient lists to a publicly available list of GRAS substances. . . . What I could do is come up with a list by product [and say], 'The following products made by the following companies contain ingredients that have not been reviewed by the Food and Drug Administration.' "

Makary is likely to be approved by the Senate in a few months' time, Pape says.

Despite potential impacts to their industry, biotech and pharmaceutical companies have taken a middle-of-the-road stance on Kennedy, at least on the record. Stephen J. Ubl, CEO of the trade group Pharmaceutical Research and Manufacturers of America (PhRMA), says in a statement emailed to C&EN that the industry is aligned with Kennedy's desire to "reduce the burden of chronic disease, improve health outcomes and make health care more affordable for the American people." The Biotechnology Innovation Organization (BIO) sent a similar statement to C&EN but also emphasized the importance of "maintaining our existing and long-established public health infrastructure for vaccines—one of the greatest tools available for making—and keeping—America healthy."

But Kennedy seems to disagree with drug manufacturers about what the country’s health issues are and what causes them.

"The industry will now shift to trying to make lemonade out of lemons," says a biotech executive and investor who insisted on anonymity to preserve relationships.