Pharma Confronts ‘Moving Bar’ for Vaccines, Drugs Under RFK Jr.

US Health Secretary Robert F. Kennedy Jr.’s regulatory agenda is tugging the pharmaceutical industry in different directions as it seeks to both tighten and loosen oversight of drugs.

Kennedy, a longtime critic of immunizations and pharmaceutical corporations, has rolled out several measures in the last year overhauling vaccine policies. His team has pulled funds for mRNA vaccine development, sought to slash the number of recommended childhood vaccines, required that all new shots undergo placebo-controlled trials, and most recently, rejected then reversed course to review Moderna Inc.‘s flu shot.

But he also supports initiatives carried out by Food and Drug Administration Commissioner Marty Makary to hasten drug reviews, reduce clinical trial burdens, and streamline approvals for biosimilars and gene therapies.

The agenda is forming an uneven regulatory landscape as health officials seek to raise standards in some areas but reduce friction in others, manufacturers and industry groups say. Kennedy’s actions have stymied the development of some vaccines as drugmakers navigate his policies.

“When one product class appears to be getting a faster path while another is encountering added evidentiary demands or policy turbulence, companies start rethinking capital allocation, development timing, and market priorities,” said David Dodd, CEO of GeoVax Labs Inc., a biotech developing vaccines against infectious diseases and cancers. “Biopharma can operate under a high bar, but it struggles under a moving bar.”

Sanofi SA, one of the world’s largest vaccine makers, said in January that it expects its vaccine sales to slightly dip due to policy shifts. Moderna said it doesn’t plan to invest in new late-stage vaccine trials because of growing opposition to immunizations. Pfizer Inc. also shared concerns about Kennedy’s positions, saying they have “zero scientific merit.”

“This needs to be addressed,” said a spokesperson for the Biotechnology Innovation Organization, the chief lobbying group for biotech companies. “Shifting standards create confusion, curtail capital flows, harm patients, and have serious consequences, especially for our smaller and mid-sized biotech companies.”

Kennedy has stood by his decisions, arguing they re-establish public confidence in vaccine science. Makary has also said the FDA can demand data in areas where they view the scientific evidence as insufficient, such as vaccine oversight.

“FDA is working to reduce unnecessary burden and speed access to treatments, particularly where options are limited,” Emily Hilliard, a spokesperson for the US Department of Health and Human Services, said in an email. “When questions remain about safety or effectiveness, the agency may request additional data.”

‘Head Down, Patient Focused’

Industry concerns largely stem from whether regulatory decisions are consistent and based in science.

Many raised the alarm when the FDA in February refused to review Moderna’s flu vaccine. The agency, which said the application’s studies didn’t compare the experimental shot to the “best-available standard of care,” later granted review to the company.

Moderna’s response to the initial decision said it was “inconsistent” with previous communications.

At the same time, the FDA has granted approval to vaccines, including Novavax Inc.’s Covid-19 shot and GSK Plc’s RSV shot.

“Some of these decisions that have been issued have really led to a lot of doubts and concerns about consistency,” said Ron Peck, president and principal consultant at Veritas Oncology LLC.

The agency this year also introduced a new framework to accelerate the approval of ultra-rare disease drugs, but the pathway comes after issuing various letters to companies determining that it can’t approve the product in its current form.

“Inconsistencies are difficult to navigate,” said Eva Temkin, a former FDA acting policy director at the Center for Drug Evaluation and Research, now a partner at Arnold & Porter Kaye Scholer LLP. “The industry segments that I am working with stay head down, patient focused, trying to push through.”

Drugmakers could expect more regulatory changes as Vinay Prasad, the FDA’s vaccine and biologics chief, is departing in April. The FDA is also operating after losing some of its top scientists and agency veterans last year under Kennedy’s restructuring and reduction-in-force across the HHS.

“It is legitimate to ask whether things will pivot 180 degrees back to our old normal right of reliance on FDA,” said Paul Kim, a principal at Kendall Square Policy Strategies LLC. “I don’t think we know that until we start seeing new decisions being made about rare disease drugs.”

The Pharmaceutical Research and Manufacturers of America said while it appreciates the FDA’s efforts to modernize, “recent leadership turnover and inconsistent regulatory decision-making risk eroding trust in the agency’s gold-standard review,” according to Alex Schriver, the drug lobby’s senior vice president of public affairs.

Cutting Red Tape

Simultaneously, industry has embraced the FDA’s initiatives to accelerate drug reviews, phase out expensive animal studies, and implement a program to strengthen the domestic drug supply chain. The agency also introduced plans to reduce clinical trial requirements and use AI to modernize reviews.

“Pharma industry is looking at this and sees a lot of potential to reduce development costs and bring new products through,” said James Boiani, a member of Epstein Becker & Green PC. “It’s just there are these niches that seem to be getting hammered.”

Some companies have touted clear experiences with the agency, including CERo Therapeutics. The company is developing a novel and first-in-class cell therapy that initially targeted acute myeloid leukemia in adults, but modified its indication to target myelofibrosis and myelodysplastic syndrome.

“Our interactions with FDA staff have been very timely and constructive, allowing the company to safely explore two new indications without interruption of the ongoing clinical trial,” said Robert Sikorski, CERo’s chief medical officer.

Still, “whether a given policy is a benefit or detriment to industry will likely vary depending on a given company’s circumstances,” said Elizabeth Jungman, a former FDA chief of staff, now partner at Hogan Lovells US LLP. “Deregulatory efforts that benefit one company may be harmful to competitors.”