Richard Pazdur’s New FDA Post

By: David Ostrowsky

The Center for Drug Evaluation and Research (CDER), charged with regulating most prescription drugs and over-the-counter medicines, is quite possibly the most high-powered regulatory division of the U.S. Food and Drug Administration (FDA). Indeed, tens of millions depend on the CDER’s review decisions for new drug applications—which cover basically everything except vaccines and gene and cell therapies. Recently, the division has been riddled with great turnover and staffing cuts, subsequently triggering an uptick in review delays, much to the consternation of the American public. However, earlier this month, there was a promising development when the FDA announced that its chief cancer drug regulator and founding director of the agency’s Oncology Center of Excellence, Dr. Richard Pazdur, will be spearheading the CDER going forward. This change came in the aftermath of the resignation of Dr. Pazdur’s predecessor, Dr. George Tidmarsh, a biotech executive who was a faculty member at Stanford.

Dr. Pazdur, whom the FDA considers a “renowned regulatory innovator” following his work streamlining the approval of new cancer medications, is widely expected to stabilize an agency of which he has been a prominent member since 1999. Among Pazdur’s many soaring achievements, he notably championed the use of measures known as surrogate endpoints, such as shrinking tumors, to assess whether a cancer drug should be authorized. Reportedly, this methodology expedites the process by which drugs reach the market and has been applied not just to cancer drugs, but also to those for rare diseases and neurological conditions. Conversely, in 2021, amidst criticism of approvals of drugs that did not enhance patients’ quality of life or prolong their lives, Dr. Pazdur urged some companies to remove drugs that had been authorized via a conditional approval program. Pazdur’s also one of only two center leaders who has remained at the FDA amidst the agency’s recent significant leadership shakeup.

“Dr. Pazdur is a true regulatory innovator who will help guide our broader agenda to modernize the agency and streamline the approval process,” FDA Commissioner Marty Makary said in a news release issued after The Washington Post reported Pazdur’s selection. “He has a track record of success and is an impressive forward-thinking scientist.”

Ellen Sigal, chair and founder of Friends of Cancer Research, a Washington, D.C.-based non-profit cancer research think tank and advocacy organization, echoed Makary’s sentiment by recently telling Reuters, “Rick Pazdur has been a tireless public servant and one of the most trusted leaders in biomedical innovation. At a time when the agency faces extraordinary opportunity and complexity, Rick’s steady leadership and commitment to scientific integrity make him exactly the right person to lead CDER.”

Pazdur’s pledge of helping “our country reach its peak in drug development” has tremendous significance for Americans suffering from a vast array of health conditions, many of which are life-jeopardizing such as myeloma, melanoma, and lung cancer. While an onrush of breakthrough therapy drugs in the ensuing years would certainly mark a tremendous advancement in treating said diseases, Pazdur’s upcoming tenure as head of the CDER augurs well for efforts to bolster transparency in the FDA. During a 2021 interview with the Journal of the American Cancer Society, Pazdur shared, “I really do believe that academic investigators and pharmaceutical companies need to have a thorough understanding of what the FDA wants—that there shouldn’t be any guessing games. I’ve told our staff to communicate to our stakeholders exactly what their plans are.”

Pazdur’s plans for future drug approvals may be unknown to the American public, but his track record of instituting novel oncology drug programs is noteworthy: Project Orbis facilitated a collaborative review process between the United States, Canada, Australia, the United Kingdom, and Brazil for oncology drugs to be approved much earlier in those nations than they would be otherwise; Project Facilitate helped guide practitioners through the process of obtaining compassionate use approval for certain drugs in treating individual patients; Project Community focused on supporting underserved populations; and Project Equity examined means for improving participation of underrepresented populations in clinical trials.

Meanwhile, regarding the interface between pharmaceutical innovation and commercial priorities, Pazdur also told the Journal of the American Cancer Society that, “I really question whether there needs to be more national leadership on how our drugs are developed and where our resources are dedicated.”

It would appear that now is his opportunity to provide such leadership.