The industry’s mRNA alliance is demanding steady FDA leadership, warning that the current “unprecedented turmoil” at the agency is eroding Americans' trust and threatening public health.
As biomedical innovation speeds ahead, public trust in health institutions is still strained, a dynamic that requires clear and consistent federal leadership, according to Clay Alspach, co-founder and executive director of the Alliance for mRNA Medicines.
“Sadly, that is not what we have today,” Alspach said in a Dec. 5 media statement.
The coalition is speaking out after recent staff shake-ups, most notably the appointment of known vaccine critic Tracy Beth Høeg, M.D., Ph.D., as head of the FDA’s Center for Drug Evaluation and Research (CDER) after the rapid retirement of Richard Pazdur, M.D. After reports of Pazdur's retirement broke, John Crowley, CEO of the industry group Biotechnology Innovation Organization, said that the “constant turmoil is undermining America's leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China.”
The Alliance for mRNA Medicines’ statement also comes on the heels of abrupt vaccine policy changes from the CDC’s Advisory Committee on Immunization Practices. Today, the panel weakened the federal recommendation for at-birth hepatitis B vaccination—a vaccine that's resulted in a 99% drop in infections since its introduction.
“Abrupt shifts in vaccine policy—introduced without transparent, evidence-based deliberation—risk undermining the rigorous framework that has long guided vaccine development and approval,” Alspach said.
The mRNA coalition leader argued that changes of such a large magnitude should occur in an open and public process.
“Circumventing this process will weaken public confidence and impair the ability to develop lifesaving vaccines in a timely manner,” Alspach added. “Declining public trust could also hinder efforts to address major unmet medical needs using platform innovations that are proven successful in vaccines.”
Just two days ago, 12 former FDA leaders banded together to express concerns related to a leaked internal memo by Vinay Prasad, M.D., director of the agency’s Center for Biologics Evaluation and Research, which oversees vaccines. The memo revealed plans to tighten vaccine regulations and claimed that COVID-19 vaccines “killed American children.”
The proposed changes would “disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections,” the former FDA leaders wrote in a Dec. 3 article in The New England Journal of Medicine.
The 12 commissioners collectively guided the FDA for more than 35 years during both Republican and Democratic administrations. The astounding unanimity in such a short turnaround underscores the urgency and severity of the matter, as both U.S. vaccine policies and the FDA suffer from significant turbulence.
“When a dozen former FDA commissioners from across the political spectrum—including those who served during President Trump’s first term—warn of a threat to public health, everyone should stop and take notice,” Alliance for mRNA Medicines’ Alspach said.
The coalition describes itself as a global organization committed to advancing and advocating for mRNA and RNA therapeutics for the ultimate benefit to patients and public health. The group’s members include companies like BioNTech, CSL, CureVac, Moderna, Merck & Co., and Thermo Fisher Scientific, among many others.
“We support President Trump’s desire to make America healthy again, and we believe mRNA medicines are an important part of the solution,” Alspach concluded. “However, an FDA in disarray and that few trust only hurts our ability to achieve the president’s goal.”
The mRNA space has endured deep scrutiny under President Donald Trump’s pick to lead the U.S. Department of Health and Human Services, Robert F. Kennedy Jr. The lawyer has made a career out of anti-vaccine conspiracy and has targeted vaccines extensively. Since taking office, he has cut all federal funding for mRNA vaccine work from Biomedical Advanced Research and Development Authority.
The administration has cited numerous reasons for its step back from mRNA vaccines, including a lack of safety information and knowledge around the technology. Multiple studies conducted so far have concluded that the vaccines are safe and effective, and the research underlying the science goes back to the discovery of mRNA in the early 1960s.
Even biotech leaders outside of the mRNA space have expressed concern regarding the FDA's recent volatility. In November, hundreds of biopharma CEOs wrote to FDA Commissioner Marty Makary, M.D., voicing worry that the added volatility in an already high-risk industry will discourage overall investment in biotech innovation or will drive it to other countries.