Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders. This week’s updates:
- CDER Director Dr. Pazdur to Retire, Dr. Høeg Named as Replacement and Other CDER Leadership Changes
- U.S. House of Representatives Passes Rare Pediatric Disease Voucher Bill
- FDA’s Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies
More CDER Leadership Changes: Current Director Dr. Pazdur to Retire, Dr. Høeg Named as Replacement and Other Key Changes
Last week, it was reported that the recently named leader of the Center for Drug Evaluation and Research (CDER), Dr. Richard Pazdur, M.D., plans to retire from the Agency by the end of December. Dr. Pazdur was named CDER director on November 11 following the resignation of Dr. George Tidmarsh, M.D., Ph.D. On December 3, FDA announced that Dr. Tracy Beth Høeg, M.D., Ph.D., will serve as the acting director of CDER. In the same press release announcing Høeg’s appointment, FDA announced Dr. Karen Murry, M.D., as the new director of CDER’s Office of Nonprescription Drugs (ONPD). According to STAT News, FDA transferred the previous ONPD director, Dr. Theresa Michele, M.D., to a new role within the Agency.
U.S. House of Representatives Passes Bill Reauthorizing Rare Pediatric Disease Voucher Program
On December 1, the House of Representatives passed H.R. 1262, the Mikaela Naylon Give Kids a Chance Act, which would reauthorize the rare pediatric disease priority review voucher (PRV) program that began to sunset after December 20, 2024, through September 30, 2029. In addition to reauthorizing the rare pediatric disease PRV program, the act would also authorize FDA “to direct companies to study combinations of cancer drugs and therapies in pediatric trials,” according to a press release by the bill’s sponsor. As of December 2, the bill has been received in the Senate.
FDA’s Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal Antibodies
As part of FDA’s efforts to reduce animal testing, the Agency announced on December 2 the release of draft guidance outlining certain monoclonal antibody products for which the Agency believes six-month non-human primate toxicity testing can be reduced or is not needed. Specifically, this draft guidance “provides broadly applicable recommendations for streamlined approaches to assess long-term safety from monospecific antibodies; describes when general toxicology studies are not warranted or may be limited to a short-term study; and addresses alternative approaches for reproductive, developmental, and juvenile toxicity assessments.” Stakeholders have until February 2, 2026, to provide comments to the Agency on the draft guidance.
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