Summary
Several high-ranking officials left the Food and Drug Administration (FDA), causing concerns about delays in drug approvals and the stability of the agency. Richard Pazdur, a noted oncologist who recently led the FDA's drug center, unexpectedly stepped down, sparking debate about the agency's future. Industry leaders and former FDA commissioners fear that political interference could affect drug review processes and America's biotech leadership.
Key Facts
- A high-level FDA official, Richard Pazdur, resigned soon after taking charge of the drug center.
- The FDA has seen four different directors for its drug center this year.
- Concerns have been raised that these changes might slow down drug approval processes.
- Health Secretary Robert F. Kennedy Jr. met with Pazdur to acknowledge his work.
- John Crowley, CEO of a biotech group, warned that the FDA's instability might benefit international competitors like China.
- Twelve former FDA commissioners shared their worries about the agency's current situation in a medical journal.
- The departures are linked to claims of political appointees excluding career scientists from discussions.
- Some say a new expedited drug review program lacks clear guidelines and legal authority.
