SARS-CoV-2 Spike Protein Vaccine(Recombinant)(Novavax, Inc.)

“This is like the flat Earthers taking over NASA,” Janet Woodcock, M.D., said about the current FDA.\n As President Donald Trump’s massive overhaul of federal agencies continues, several former FDA officials spoke about the potential ramifications for drug reviews and provided a look inside current FDA conditions.“Leadership in the agency’s been decapitated, and I think that was somewhat deliberate,” Janet Woodcock, M.D., former acting FDA commissioner and former principal deputy commissioner of food and drugs, said during an April 7 session of the Biopharma Congress.The panel—titled “The Future of FDA: Where Do We Go From Here”—was part of an event hosted by Prevision Policy and Friends of Cancer Research in Washington, D.C.Woodcock, who retired from the agency in February 2024, was joined by two other former FDA officials: Jeff Shuren, M.D., longtime director of the FDA’s Center for Devices and Radiological Health (CDRH), and Frank Sasinowski, who joined the FDA in 1983 as regulatory counsel and helped establish several modern drug laws, such as the Orphan Drug law. Sasinowski is currently the director of Hyman, Phelps & McNamara, a law firm that specializes in FDA practices. \'A slow-moving catastrophe\' Since Trump took office again, his administration has taken the ax to federal health agencies, ousting thousands of workers and numerous leaders.Notably, Peter Marks, M.D., Ph.D., the former leader of the agency\'s Center for Biologics Evaluation and Research (CBER), resigned late last month. A few days after his resignation, reports broke that new FDA Commissioner Marty Makary, M.D., signed off on Department of Health and Human Services (HHS) head Robert F. Kennedy Jr.’s efforts to push him out. Marks had been targeted by RFK Jr. over his approach to vaccines at the CBER, according to Politico. While the broader cuts are ostensibly designed to save cash and increase efficiency, Woodcock doesn’t see the logic in the changes—and she believes the targeted removal of health agency leaders will have catastrophic consequences for drug development.“I don\'t know what the administration\'s rationale for all these cuts were,” said Woodcock, who spent more than 38 years at the FDA. “For example, CBER was about 70% funded by user fees,” she explained. “Therefore, if you ran a pro rata calculation, you\'d only be cutting out of the 30% that was paid for by taxpayers a month.”Woodcock also said the claim that the cuts made won’t impact drug reviews is a “naive conception.”When explaining FDA reviews, Woodcock detailed routine disputes between different disciplines at the agency, noting that varying opinions arise “because there\'s a lot of uncertainty in development of medical products.” Supervisors and leaders generally help quell these disagreements, hearing out all sides and determining the best course of action.“So, I would expect that you\'ll see that you\'ll see mysterious slowdowns and you won\'t know what it\'s about, but it\'s about the agency doesn\'t have any more smooth mechanism to sort out all these disputes,” Woodcock said.The former agency leader compared the current FDA restructuring to retaining only doctors at a hospital, while letting go of all nurses and phlebotomists.“Doctors can\'t just walk in and perform surgery all by themselves,” she said. “The reviewer is the same.”As an example, she pointed to the “timekeeper” position at the FDA, or those who are responsible for recording and maintaining data related to employee time worked and taken off, travel plans, payments and reimbursements.“If you don\'t get paid because there are no timekeepers there, it may cause you to have second thoughts about your job,” she explained.“There seems to be a belief that the people at FDA invented all this paperwork,” the former FDA official continued. “No, you know why this paperwork is there? ... To prevent waste, fraud and abuse.”Shuren, who retired from his spot leading the FDA’s CDRH in 2024, said last week that the recent loss of 3,500 full-time positions would definitely impact the pace of the center’s work.“It would not be surprising if we saw longer review times, at least in the near term,” Shuren said. For the time being, the panelists said the agency\'s attention will remain centered on clinical trials, but those efforts will dwindle as resources and workers also decrease.“You’re not going to see everything come to a stop in the actual review of documents and development programs,” Woodcock explained. “But the whole apparatus to get a drug on the market, a lot of that is missing, and you\'re going to see mistakes.”“So, I would expect this is a slow-moving catastrophe, not an immediate catastrophe,” she said in summation.Already, the FDA has missed its deadline for deciding on approval of Novavax’s COVID-19 shot.Novavax expected to hear back from the FDA about a full, traditional approval for its protein-based COVID-19 vaccine by April 1. Instead, senior leaders at the FDA said they need more data, The Wall Street Journal first reported.Novavax said in a statement that the company “had responded to all of the FDA’s information requests” and felt its application was ready for approval.Rare disease drug developers may be hit harder The restructuring will have a “disproportionate effect” on rare disease development, according to Sasinowski, who cited the role that technical supervisors have in resolving internal disagreements.“If you lose that kind of granularity, you lose the ability to move forward,” he explained, emphasizing the greater need for more flexibility and special pathways, such as the accelerated approval pathway, in rare disease drug development.Sasinowski wondered who would develop new guidelines as the fate of the Office of Regulatory Policy and Center for Drug Evaluation and Research (CDER) remain uncertain.“I could go through a whole list of whole communities of rare disease, fellow Americans who have benefited because of the guidance documents that CDER was able to promulgate,” Sasinowski said.\'A zombie movie set\': A look inside the current FDA  Under Trump’s Department of Government Efficiency, the federal government plans on terminating 676 leases, including several FDA sites.Meanwhile, HHS’ RFK. Jr. shared plans to downsize the agency—which houses the FDA—by 20,000 staff members. A few days later, he said about 2,000 of the job cuts were done in error, adding that reinstatements were \"always part of the plan.\"“The campus looks like a zombie movie set, with cars parked on every inch of grass available and card tables set up in the halls so that people have some place to put their laptop to work,” Sasinowski said during the Biopharma Congress panel.“Morale is … absent,” Woodcock added. “Because, of course, people have been treated very disrespectfully.”Despite this, some FDA workers remain with the agency, something Woodcock credits to their dedication to serving the agency’s mission, which is ensuring that safe and effective products are available to Americans.“They want to keep doing that,” Woodcock said. “However, I will say, because of some of the cuts, it\'s going to be increasingly difficult over time for people to function.”  “Even in the best of times, you lose people—there\'s always attrition,” Shuren added, noting that the agency has worked to foster an environment where attrition is low. “We want people to stay. We know how disruptive it is when people do leave.”“And unless you have the mechanisms to invest not only in the environment for people to stay in, but you have active recruitment so you can continue to bring in the talent that you need, you\'ll just progressively fall behind,” he said.Zooming out, the panelists pointed to a dearth of information from the new administration regarding strategy and areas of focus.“It is tough to discern exactly where they\'re coming from,” Sasinowski said, citing mixed messages from the administration, such as “reestablishing the gold standard” and reducing regulations on stem cell clinics. “This is like the flat Earthers taking over NASA,” Woodcock said. In the analogy, she describes a group of people who feel that their beliefs and opinions have been ignored, and, once in power, fire anyone who disagrees with them.“It\'s really beyond the pale,” Woodcock said. “It is not science. And this is [a] science-based regulatory agency, which means legal science. And the messages they are getting are not about science.”“These purges, these proposed reorganizations—this is not about management or leadership,” the former FDA official continued. “There are hundreds of articles in Harvard Business Review about how to manage an organization—this wouldn\'t be in the top 10.”“This might be in one of the top 10 [ways] of how not to run a business or an organization,” she added.“Maybe the flat Earthers want that destruction because they\'re angry. Okay, they\'ve been left out—nobody honored their views,” Woodcock said. “So, I think we have to be … we really have to look that in the face and understand that is actually what\'s happening.”Fierce Biotech has reached out to the HHS for comment and will update this article if more information becomes available.