FDA's Drug Regulator Steps Down After Just Three Weeks Amid Turmoil and Rebellion Against Commissioner Makary's Plans.
Dr. Richard Pazdur, the newly appointed head of the FDA's Center for Drug Evaluation and Research, has decided to leave his position just three weeks after taking the role. His departure comes amidst a backdrop of controversy and rebellion against FDA Commissioner Marty Makary's plans to overhaul and expedite agency operations.
Pazdur, an oncologist who has worked at the FDA since 1999, was seen as a stabilizing force for the agency, which has been plagued by turmoil during the Trump administration. His appointment was viewed positively by agency insiders, industry representatives, and patient advocacy groups, but he quickly clashed with Makary over issues related to the legality and public health risks of his plans.
Pazdur expressed deep concerns about Makary's proposals, including a plan to reduce the number of studies needed for drug-related decisions and shorten review times. He also pushed back on Makary's plan to exclude agency career scientists from certain drug review processes deemed political priorities. These disagreements led Pazdur to consider retirement last month.
According to reports by Stat News and The Washington Post, Pazdur has now filed paperwork to retire at the end of this month. While he may still change his mind, a source told the Post that such a reversal is unlikely. Ellen Sigal, chairperson and founder of advocacy group Friends of Cancer Research, described Pazdur's departure as a "sad day for science and patients" and called him their "guiding light."
Dr. Richard Pazdur, the newly appointed head of the FDA's Center for Drug Evaluation and Research, has decided to leave his position just three weeks after taking the role. His departure comes amidst a backdrop of controversy and rebellion against FDA Commissioner Marty Makary's plans to overhaul and expedite agency operations.
Pazdur, an oncologist who has worked at the FDA since 1999, was seen as a stabilizing force for the agency, which has been plagued by turmoil during the Trump administration. His appointment was viewed positively by agency insiders, industry representatives, and patient advocacy groups, but he quickly clashed with Makary over issues related to the legality and public health risks of his plans.
Pazdur expressed deep concerns about Makary's proposals, including a plan to reduce the number of studies needed for drug-related decisions and shorten review times. He also pushed back on Makary's plan to exclude agency career scientists from certain drug review processes deemed political priorities. These disagreements led Pazdur to consider retirement last month.
According to reports by Stat News and The Washington Post, Pazdur has now filed paperwork to retire at the end of this month. While he may still change his mind, a source told the Post that such a reversal is unlikely. Ellen Sigal, chairperson and founder of advocacy group Friends of Cancer Research, described Pazdur's departure as a "sad day for science and patients" and called him their "guiding light."