Dr. Pazdur’s New Role at CDER: More Than Just Adding Stable Leadership
Dr. Pazdur’s appointment to lead FDA’s Center for Drug Evaluation and Research (CDER) has been widely acclaimed....and rightly so.
It is particularly pertinent to last week’s FDA Matters column about the direction of employee morale at FDA (here). If the situation improves, Dr. Pazdur’s appointment might be the turning point.
In response to media inquiries, I made four statements that I am reiterating here with additional commentary:
No one has a longer history of public decisions on the safety and efficacy of drugs. That makes Dr. Pazdur the ultimate “known quantity.”
Turnover in senior FDA leadership usually occurs as one-offs, rather than clustered or timed to external events, such as a change of Administration. Thus, the agency has no prior experience with the level of uncertainty that has come from: the replacement of the entire leadership team, the lack of continuity in policies, the influx of people with little experience with FDA process, and a seeming disregard for prior agency commitments to stakeholders.
In that context, it is a relief to have the appointment of someone who is a “known quantity.” Dr. Pazdur’s appointment provides the ultimate assurance that future changes--at least at CDER--will be anchored by awareness of what has happened at FDA over the last 25 years,
His appointment will be welcomed by patients, sponsors, and investors, all of whom are hungry for consistent and scientifically sound direction that will benefit from his experience and wisdom on drug development.
So far this year, Center for Biologics Evaluation and Research (CBER) Director, Dr. Vinay Prasad, has preached continuity in drug decision-making policies, but — at least to many stakeholders — he has actually practiced the opposite. As the agency’s chief medical and scientific officer and CBER Director, it has been his voice and actions that have been the most concerning to patients, sponsors, and investors.
With a leadership vacuum at CDER, Dr. Prasad has been able to charge forward without engaging in the traditional director-level coordination between CBER and CDER.
The stakes are now reset. Dr. Pazdur has a no-nonsense reputation. It will be far more difficult, if not impossible, for CBER to act on drug development issues without some coordination with CDER and, of course, vice versa.
The CDER Director’s responsibilities extend far beyond new drugs. I am glad he took the extra few days to decide that he wanted to take on that challenge.
As reported in several publications, Dr. Pazdur’s hesitation stemmed from concerns about his decision-making authority and independence from politically driven interference. I have no reason to doubt that narrative.
However, much of the news coverage has made it seem like the move to CDER Director was just about becoming the uber-authority over new drug approvals--effectively overseeing the Office of New Drugs, the Oncology Center of Excellence, and the Office of Therapeutic Biologics and Biosimilars (which is rumored to be split off from OND soon).
The scope of CDER responsibilities is much larger. In addition to new drugs, Dr. Pazdur will be overseeing and managing CDER activities in generics, biosimilars, and OTC products, as well as pharmaceutical quality, inspections and compliance, medical policy, translational sciences, and epidemiology and surveillance. The organization chart is here.
Unless Dr. Pazdur dramatically increases his working hours (if that is possible), he will spend less time on new drugs than he does now. That may be a net/net good for the agency and provide greater professional fulfilment for Dr. Pazdur. However, his responsibilities won’t be the “all new drugs, all the time” focus that many news stories have implied.
As a well-respected pioneer and advocate for change, Dr. Pazdur has the bona fides to selectively draw on the past while joining the Commissioner in forging new directions and embracing new opportunities for the future.
Dr. Pazdur understands that--in this Administration---his becoming CDER director is not an endorsement of the status quo or a mere mandate to stabilize CDER leadership. He will have to deliver on the promises Commissioner Makary has made, including substantially reducing review times, integrating generative and performative AI into all CDER activities, invigorating orphan drug development, and embracing the National Priority Review Vouchers.
None of this is beyond Dr. Pazdur’s experience or prodigious leadership skills. The challenge will be to demonstrate to Commissioner Makary that “continuity and carefully-chosen precedent” are the friend, not the enemy, of the Commissioner’s ambitious agenda.
I am optimistic about Dr. Pazdur’s success. However, this should be seen as a work in progress, not a certainty.
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