FDA's Top Drug Regulator Signals Possible Exit Amid Turmoil at Agency
Richard Pazdur, the top drug regulator in the US, has hinted at his possible retirement just weeks after taking on the position. The move comes as the FDA is reeling from a series of high-profile departures and internal conflicts.
Pazdur, a seasoned expert in oncology, was expected to bring much-needed stability to the agency after a tumultuous year marked by leadership turnover and tension among officials. His appointment was seen as a positive development for the FDA, but his early exit has raised concerns about the agency's ability to function effectively.
According to sources, finding a suitable replacement for Pazdur will be challenging due to the mounting political pressure and internal conflict at the FDA. Janet Woodcock, former acting commissioner of the agency, described the situation as "turmoil" with multiple departures and departures of top leaders.
The previous chief of the Center for Drug Evaluation and Research (CDER), George Tidmarsh, was pushed out after a lawsuit alleged he was retaliating against a business partner. Tidmarsh denied the allegations, claiming he was removed due to his opposition to a new system for quickly making regulatory decisions.
Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER) and chief medical and scientific officer at the FDA, also faced brief removal and subsequent reinstatement over disagreements with other officials. The situation has created an "orderly process" environment, according to Woodcock.
Pazdur's departure has raised concerns about the agency's ability to function effectively, particularly when it comes to making rapid approval decisions for new drugs. A new program aimed at streamlining the review process has been criticized for lacking planning and thoroughness.
The lack of stability at the FDA is likely to have a lasting impact on public trust and the future of drug creation. As Woodcock noted, pharmaceutical and other industries rely on predictable decision-making from regulatory agencies, which Pazdur's exit may jeopardize.
Richard Pazdur, the top drug regulator in the US, has hinted at his possible retirement just weeks after taking on the position. The move comes as the FDA is reeling from a series of high-profile departures and internal conflicts.
Pazdur, a seasoned expert in oncology, was expected to bring much-needed stability to the agency after a tumultuous year marked by leadership turnover and tension among officials. His appointment was seen as a positive development for the FDA, but his early exit has raised concerns about the agency's ability to function effectively.
According to sources, finding a suitable replacement for Pazdur will be challenging due to the mounting political pressure and internal conflict at the FDA. Janet Woodcock, former acting commissioner of the agency, described the situation as "turmoil" with multiple departures and departures of top leaders.
The previous chief of the Center for Drug Evaluation and Research (CDER), George Tidmarsh, was pushed out after a lawsuit alleged he was retaliating against a business partner. Tidmarsh denied the allegations, claiming he was removed due to his opposition to a new system for quickly making regulatory decisions.
Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER) and chief medical and scientific officer at the FDA, also faced brief removal and subsequent reinstatement over disagreements with other officials. The situation has created an "orderly process" environment, according to Woodcock.
Pazdur's departure has raised concerns about the agency's ability to function effectively, particularly when it comes to making rapid approval decisions for new drugs. A new program aimed at streamlining the review process has been criticized for lacking planning and thoroughness.
The lack of stability at the FDA is likely to have a lasting impact on public trust and the future of drug creation. As Woodcock noted, pharmaceutical and other industries rely on predictable decision-making from regulatory agencies, which Pazdur's exit may jeopardize.