The Food and Drug Administration named its top cancer drug regulator, Dr. Richard Pazdur, on Tuesday to run its top center for regulating and approving new drugs after a tumultuous period.
Dr. Pazdur represents a stabilizing choice for the agency, given his 26 years there and his reputation as a highly respected veteran. The choice comes at a time of rapid turnover at the agency and sinking morale after rounds of staff cuts.
Dr. Pazdur has presided over an era that has brought a flurry of approvals of new cancer drugs that have helped patients and generated huge windfalls for their makers.
The division Dr. Pazdur will now lead, the Center for Drug Evaluation and Research, or CDER, is in charge of regulating most prescription drugs and over-the-counter medicines. The division has about 5,000 employees after losing about 1,000 this year amid dismissals, buyouts and stressful working conditions that spurred many to pursue jobs in the pharmaceutical industry. A different division at the agency, which has also been racked by turmoil, regulates vaccines and gene therapies.
“I’m honored to lead CDER at a time when the F.D.A. is achieving long-sought regulatory reforms,” Dr. Pazdur said in an agency news release on Tuesday. He said he was looking forward to helping “our country reach its peak in drug development.”
In recent weeks, federal officials accepted the resignation of Dr. Pazdur’s predecessor, Dr. George Tidmarsh, a biotech executive who was a faculty member at Stanford. He said in a previous interview that he had been put on leave pending an investigation by the inspector general of the Department of Health and Human Services related to criticism he aired publicly about a particular medication. He also said he had been critical of a new rapid-approval program that he said had opened the door to political interference with drug approval decisions.
Aurinia Pharmaceuticals, the company that makes the drug Dr. Tidmarsh critiqued as toxic, sued Dr. Tidmarsh soon after he had been placed on leave, claiming that he had vowed revenge against Kevin C. Tang, a San Diego investor who is the company’s board chairman. The lawsuit claimed that Dr. Tidmarsh had attempted to extort Mr. Tang. Dr. Tidmarsh denied the allegations, saying he had no interest in revenge against Mr. Tang.
Dr. Pazdur was once criticized by some as an obstructionist bureaucrat who had slowed down promising cancer medicines. But he came to play a key role in speeding up their approvals, a philosophical shift he attributed in part to the death of his wife, Mary, from cancer in 2015.
In particular, he embraced the use of measures known as surrogate endpoints, such as shrinking tumors, to gauge whether a cancer drug should be authorized. That allows drugs to reach the market much faster than if they were tested for whether they extended patients’ lives. The agency has increasingly allowed these measures beyond just cancer, using them for drugs for rare diseases and neurological conditions.
In 2021, amid criticism of approvals of drugs that did not ultimately improve patients’ quality of life or extend their lives, Dr. Pazdur urged some companies to withdraw drugs that had been authorized in a conditional approval program.
Dr. Pazdur is also known for being skeptical of clinical trial results from China, instead pushing companies to test their cancer drugs in American patients. His views on that issue will be closely watched by the industry at a time when China’s biotech sector is surging and U.S. drugmakers are increasingly turning to China to buy the rights to promising experimental drugs.
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
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