FDA ‘Like Flat Earthers Taking Over NASA’: Woodcock
Former FDA acting commissioner and CDER director Janet Woodcock says the situation at FDA in the Trump administration is “like the flat earthers taking over NASA.” Speaking on 4/7 at the Biopharma Congress on a panel on “The Future of FDA: Where Do We Go From Here?”, the agency veteran didn’t pull any punches in describing the challenges the agency faces from the staff cuts and reorganization being pursued by HHS secretary Robert F. Kennedy, Jr., and FDA commissioner Martin Makary through the so-called Department of Government Efficiency led by Elon Musk.
Woodcock used her analogy to describe a situation in which people who believe their beliefs and opinions have been ignored come to power and fire anyone who disagrees with them.
“It’s really beyond the pale,” she 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 purported reorganizations, this is not about management or leadership. There are hundreds of articles in Harvard Business Review about how to manage an organization. This wouldn’t be in the top 10.
“Maybe the flat earthers want that destruction because they’re angry. OK, they’ve been left out, nobody honored their views. So I think we have to be, we really have to look that in the face and understand that is actually what’s happening.”
Joining Woodcock on the panel were retired CDRH director Jeffrey Shuren and former regulatory counsel Frank Sasinowski, now a director at Hyman, Phelps & McNamara.
Shuren said it would not be surprising to see longer review times, at least in the near term. Speaking about the firing of thousands of employees, he said that even in the best of times there will be attrition, but FDA had worked hard to develop an environment in which attrition was low. “We want people to stay,” he said. “We know how disruptive it is when people do leave.”
Sasinowski predicted the reorganization will have a “disproportionate effect” on rare disease drug development, citing the role that agency technical supervisors have in resolving internal disagreements. “If you lose that kind of granularity,” he said, “you lose the ability to move forward.” He also wondered who will develop new guidances as the fate of the CDER Office of Regulatory Policy remains uncertain. “I could go through a whole list of rare disease communities, fellow Americans who have benefited because of the guidance documents that CDER was able to promulgate,” he said.
But Woodcock was the most direct in discussing issues facing FDA. “I don’t know what the administration’s rationale for all these cuts was,” she said. She described any notion that the cuts won’t adversely affect reviews as a “naïve conception. I would expect 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 [scientific] disputes.”
Sasinowski said the agency campus now “looks like a movie zombie set, with cars parked on every inch of grass available and card tables set up in the halls so that people have someplace to put their laptops to work.”
“Morale is absent,” Woodcock added, “because, of course, people have been treated very disrespectfully.”
The panelists said there has been little information forthcoming on the new administration’s strategy and areas of focus.
“It’s tough to discern exactly where they’re coming from,” Sasinowski said, citing mixed messages such as reestablishing the gold standard and reducing regulations on stem cell clinics.
They said that for the time being, the agency’s attention will remain centered on clinical trials, but those efforts will slow in response to reduced resources and staff. “You’re not going to see everything come to a stop in the actual review of documents and development programs,” Woodcock said. “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.”