Drugs

FDA Taps Tracy Beth Høeg as Acting CDER Director

FDA has named physician–epidemiologist Tracy Beth Høeg as CDER acting director, replacing director Richard Pazdur, who submitted his retirement paperwork earlier this week. Høeg, who previously served as senior advisor for clinical sciences in both the Office of the Commissioner and CBER, was selected by FDA commissioner Marty Makary to accelerate CDER’s modernization efforts and strengthen scientific coordination across the agency, according to a news release.

“Dr. Høeg is the right scientist to fully modernize CDER and finish the job of establishing a culture of cross-center coordination there,” Makary said. He highlighted her work at CBER on advancing scientific rigor and contributing to the FDA’s roadmap for reducing and replacing animal testing.

Høeg’s selection has raised concern with public health experts because of her past criticism of Covid-19 policies and vaccines. She previously questioned aspects of U.S. Covid-19 policy, including certain childhood vaccination mandates and mask or mitigation strategies for children.

Høeg, a medical doctor with a Ph.D. in public health and epidemiology, trained at the Medical College of Wisconsin, the University of Copenhagen, and the University of California, Davis. Before joining the FDA, she worked in physical and interventional spine and sports medicine and was a visiting scholar at MIT’s Sloan School of Management.

In a statement, Høeg said she intends to prioritize scientific rigor and transparency during her tenure. “CDER plays a crucial role in ensuring the medicines we rely on are both safe and effective,” she said. “I am committed to transparency, honesty, and decisions based on rigorous science and ensuring important changes happen efficiently.”

As part of the same announcement, FDA appointed Karen Murry as director of the Office of Nonprescription Drugs (ONPD), which oversees regulatory decisions for over-the-counter products. Murry previously served as ONPD deputy director.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome