The recent decision by Commissioner Dr. Martin Makary to appoint Dr. Vinay Prasad as the head of the Center for Biologics Evaluation and Research has sparked a wave of controversy within the FDA. Prasad, known for his outspoken criticism of traditional FDA policies, aligns with the broader MAHA agenda of scrutinizing industry ties, questioning scientific norms, and taking a critical stance on vaccines.
Prasad’s appointment comes on the heels of other controversial shakeups at the FDA, including HHS Secretary Robert F. Kennedy Jr.’s decision to cut thousands of FDA jobs, followed by reports of some terminated workers being rehired. This trend of appointing agency heads who are critical of their respective departments has been consistent under the Trump administration.
As the new head of CBER, Prasad will oversee regulations for vaccines, cell and gene therapies, areas he has previously criticized. Despite his past criticisms, Prasad has taken a more moderate tone since assuming his new role, according to reports. However, he faces the challenge of navigating the FDA’s vaccine division amid increased scrutiny from HHS, particularly regarding placebo testing for new vaccine approvals.
Upcoming decisions on Moderna’s next-gen COVID jab and Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy will shed light on the FDA’s evolving stance in these therapeutic areas. Meanwhile, Commissioner Makary has been advancing his agenda of increasing transparency, reducing industry influence, and streamlining approvals. However, some approvals have slowed under his watch, raising questions about the impact of FDA staffing cuts.
Key leadership positions within the FDA remain vacant or are filled by acting directors, signaling potential instability within the agency. The positions to watch include the FDA chief counsel, the director of the Center for Drug Evaluation and Research, and the director of the Center for Veterinary Medicine. These vacancies and changes in leadership reflect a period of transition and uncertainty within the FDA.
In conclusion, the FDA under Commissioner Makary and CBER Director Prasad is undergoing significant changes that could reshape the agency’s future direction. As they navigate challenges and controversies, the FDA’s leadership will play a critical role in shaping the agency’s policies and decisions in the coming years.
