With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
On Nov. 28, Center for Biologics Evaluation and Research chief Vinay Prasad issued a memo to the FDA. In it, he said that because of 10 deaths allegedly linked to COVID-19 vaccinations, FDA frameworks around vaccines were going to be changed.
It was as if he was issuing a decree “by fiat,” as Dorit Reiss, professor at UC Law San Francisco put it to me a few days later. Prasad did not share any data nor appear to consult experts at the FDA. He did not seem to be going through any sort of bureaucratic process at all. Memo issued, that was that.
Anyone who has worked at a large organization—especially one as vast and unwieldy as the federal government—knows that there are typically many levels of bureaucracy required to institute a significant change. This is by design. Government agencies function on coherent administrative processes to institute strategy. They do not and cannot function by fiat.
Large organizations also thrive under steady leadership—another thing the FDA has been sorely lacking this year, as nearly 90% of senior-level directors from a year ago have since left the agency.
Writing for BioSpace, regulatory expert Steven Grossman expressed concerns about the FDA’s future: “The agency’s history and culture enshrine predictability and expertise as core values. In my opinion, those values are antithetical to Trump’s norm-breaking approach to policymaking.”
It’s tough headwinds, then, for those who rely on the health regulatory body. With top FDA officials seemingly lacking an understanding of or regard for bureaucracy, the biopharma industry is left with an unreliable and unpredictable regulatory partner. Ultimately, that will only hurt patients.
Bureaucratic Dysfunction Run Amok
The sidestepping of bureaucratic norms runs up and down the Department of Health and Human Services. At the CDC, members of the agency’s Advisory Committee on Immunization Practices like Vicky Pebsworth asked mid-meeting what the ramifications of their votes are and the group repeatedly delayed votes because they had never before seen the voting language presented.
And CDC leadership has fared no better than that at the FDA. Former chief Susan Monarez was fired August 28 after being confirmed by Senate because, she told senators, Health Secretary Robert F. Kennedy Jr. told her to pre-approve ACIP recommendations, perhaps the administration’s most egregious example of bureaucratic overreach.
Several of the FDA’s leaders have left in similarly dramatic fashion. The agency’s Center for Drug Evaluation and Research has gone through five separate leaders this year alone. One, George Tidmarsh, was forced out after criticizing a company in a LinkedIn post in a serious breach of bureaucratic professionalism.
Most recently, the FDA lost a well-respected veteran in Richard Pazdur, who decided to retire a scant three weeks into his new role as CDER director. CBS News reported that FDA Commissioner Marty Makary was conducting interviews for positions Pazdur oversaw despite having promised Pazdur that he wouldn’t intervene in CDER’s work.
Beyond the unprecedented leadership turnover are unusual and sometimes uncontrolled channels of communication. Prasad’s memo is par for the course. Instead of carefully considered policies shaped in draft guidances with input from stakeholders, caregivers and patients, agencies have made announcements of new decisions via social media, media interviews and in editorials published by medical journals—often without consulting advisors or internal experts.
This is simply no way to run a large and critically important bureaucratic agency. Biopharma companies and patients need predictability and consistency, not shoot-from-the-hip policy making. Indeed, the industry has already begun to suffer the consequences.
Some Bureaucracy, Please
Perhaps the clearest examples of how bureaucratic dysfunction at the FDA is affecting biopharma companies are the stories of regulatory reversals. Biohaven, uniQure, Capricor and others were hit with surprise rejections after having previously aligned with the agency on approval requirements.
Describing the impact of such an experience for Replimmune’s advanced melanoma candidate RP1, BMO Capital Markets analyst Evan Seigerman said at a BioSpace event this fall, “It throws everything into a tailspin.”
And it’s not just pending approvals; drugs already on the market may be subject to the moving goalposts. This week, the FDA has begun relitigating approvals of other anti-viral treatments, like anti-RSV antibodies made by Merck, Sanofi and AstraZeneca, for reasons not made clear to the public.
Bureaucracy can be frustrating to deal with but it exists for a reason. When the FDA makes changes to regulatory processes and standards, it cannot be because Vinay Prasad made a decision based on data that few are privy to. Democratic governments are of the people, by the people, for the people—not just one person. These are extremely complex issues and regulations that are beyond the expertise of any one individual.
Bureaucratic processes allow important decisions to be well informed, appropriately communicated and understandable. Without them, the pharmaceutical industry and ultimately patients are at a loss.
