US FDA Chief May Be Leaving Amid Turmoil: Is It A Done Deal?
Richard Pazdur, a veteran FDA official with 26 years of experience, may be set to retire from his position as head of the Center for Drug Evaluation and Research (CDER), sparking further uncertainty at the agency. His decision comes weeks after he accepted the role, which was seen as an attempt to bring stability to the troubled organization.
Pazdur's departure has created a power vacuum at the CDER, with insiders describing it as a "very hard problem" for his successor to fill. The agency is currently embroiled in internal conflicts and mounting pressure from politicians, which could make it challenging to find a suitable replacement.
Critics point to the recent departures of several high-ranking officials, including George Tidmarsh, who was pushed out after questioning a new system for quickly making regulatory decisions. Another official, Vinay Prasad, was briefly fired before being brought back on board.
Pazdur's own tenure has been marked by controversy, particularly with regards to the FDA's rapid approval program, which is meant to streamline the process but has raised concerns about politicization and lack of thoroughness in decision-making.
Janet Woodcock, a former acting commissioner of the FDA, warns that finding a suitable replacement for Pazdur will be a challenge. "There's lots of conflict going on... Being asked to manage through that and do all these new things in the time when a lot of people have left, resigned, been forced out โ it's a very hard problem."
Pazdur has filed papers indicating his intention to retire, but some speculate he may be playing a long game. Filing for retirement from the US government can be a lengthy and bureaucratic process, so he may have filed his papers in an effort to keep his options open.
The uncertainty surrounding Pazdur's departure has significant implications for public trust and the future of drug creation. As Woodcock notes, "Members of the public want to be confident that predictable decisions are being made... Pharmaceutical and other industries need predictability because they're investing or taking huge risks."
Richard Pazdur, a veteran FDA official with 26 years of experience, may be set to retire from his position as head of the Center for Drug Evaluation and Research (CDER), sparking further uncertainty at the agency. His decision comes weeks after he accepted the role, which was seen as an attempt to bring stability to the troubled organization.
Pazdur's departure has created a power vacuum at the CDER, with insiders describing it as a "very hard problem" for his successor to fill. The agency is currently embroiled in internal conflicts and mounting pressure from politicians, which could make it challenging to find a suitable replacement.
Critics point to the recent departures of several high-ranking officials, including George Tidmarsh, who was pushed out after questioning a new system for quickly making regulatory decisions. Another official, Vinay Prasad, was briefly fired before being brought back on board.
Pazdur's own tenure has been marked by controversy, particularly with regards to the FDA's rapid approval program, which is meant to streamline the process but has raised concerns about politicization and lack of thoroughness in decision-making.
Janet Woodcock, a former acting commissioner of the FDA, warns that finding a suitable replacement for Pazdur will be a challenge. "There's lots of conflict going on... Being asked to manage through that and do all these new things in the time when a lot of people have left, resigned, been forced out โ it's a very hard problem."
Pazdur has filed papers indicating his intention to retire, but some speculate he may be playing a long game. Filing for retirement from the US government can be a lengthy and bureaucratic process, so he may have filed his papers in an effort to keep his options open.
The uncertainty surrounding Pazdur's departure has significant implications for public trust and the future of drug creation. As Woodcock notes, "Members of the public want to be confident that predictable decisions are being made... Pharmaceutical and other industries need predictability because they're investing or taking huge risks."