FDA appoints veteran Pazdur to replace Tidmarsh
New CDER director Richard Pazdur, who will retain his role at the FDA's Oncology Center of Excellence while a successor is sought.
After a period of chaos and instability among the leadership of the FDA, the agency has opted to steady the ship by appointing oncology head Richard Pazdur as head of the Center for Drug Evaluation and Research (CDER).
Pazdur, who currently leads the FDA's Oncology Center of Excellence (OCE) and has been with the agency for more than 25 years, is replacing George Tidmarsh, who resigned after just a few weeks as CDER chief earlier this month following concerns about his personal conduct.
Tidmarsh has been accused of using the regulatory powers afforded by his position to financially harm Kevin Tang – one of his former business associates – and Aurinia Pharma, a company in which Tang is an investor. However, he claims he was ousted after raising concerns about a new FDA fast-track programme for some drugs.
His departure from CDER also came after the resignation of Vinay Prasad, his counterpart at the Center for Biologics Evaluation and Research (CBER), who was then reinstated just a few days later. Prasad's predecessor at CBER, Richard Marks, resigned in protest at what he said was a downgrading of scientific principles at the FDA under HHS Secretary Robert F. Kennedy Jr.
In Pazdur, the FDA has turned to a seasoned regulatory expert who has been with the FDA since 1999 and quickly rose to head up the Office of Oncology Drug Products in 2005. He is credited with implementing streamlined processes to speed up the review of novel cancer drugs, allowing them to reach patients more quickly.
Among the achievements highlighted by the FDA in the announcement of his new role is the launch of Project Orbis, which allows new drugs to be simultaneously submitted and reviewed by international regulatory agencies, as well as frameworks to make it easier to request early access to experimental medicines and to make sure the clinical information about older drugs is kept up to date.
FDA-focused newsletter The Pink Sheet said last week that Pazdur turned down the position when first asked, reportedly after Kennedy made assurances that the CDER would not be subjected to political pressure.
"Dr Pazdur is a true regulatory innovator who will help guide our broader agenda to modernise the agency and streamline the approval process," said FDA Commissioner Marty Makary in a statement.
"He has a track record of success and is an impressive forward-thinking scientist."
Pazdur will continue to serve as director of the OCE until a successor is named. He said that he is "honoured to lead CDER at a time when the FDA is achieving long-sought regulatory reforms."
