Drugs

CDER’s Ellis Unger Retiring After 24 Years at Agency

After 24 years at FDA, CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger has decided to retire to spend more time with family. Joining FDA in 1997 as a medical officer at CBER, in 2003, he transitioned to CDER when regulatory authority for therapeutic biologics was transferred there and he began serving as Division of Cardiovascular and Renal Products deputy director. In 2009, Unger moved to the Office of Drug Evaluation-I in 2009, and became its director in 2012. And last year, as part of CDER’s reorganization, Unger moved to his current position.

Unger may best be remembered for being embroiled (see story) in the review and approval of Sarepta’s controversial Duchenne drug Exondys 51 (eteplirsen). At the time, he found himself in contentious dispute with then-CDER director Janet Woodcock that saw her overriding his decision to reject the drug’s approval (see earlier story). In response to a memo from FDA commissioner Robert Califf that ruled in Woodcock’s favor to approve eteplirsen, Unger complained that proper procedures were not followed because Woodcock failed to review all evidence and analyses before she rendered her decision, and that the decision would set a general precedent — where accelerated approval could be provided for a rare disease based solely on the medical and scientific judgment/opinion of the Center director.

Unger was also particularly troubled that the approval could lower the standard for all rare disease drugs. He questioned whether any increase in a surrogate endpoint could be used to support approval for other drugs. “Perhaps granting accelerated approval to drugs that show a mere scintilla of an effect on a surrogate endpoint represents a stroke of brilliance — one that will stimulate investment in the development of drugs for these disorders,” he told Califf. “But in my opinion, this approach should receive broader public (and FDA) input before being implemented. Your decision seems to say that the ‘reasonably likely’ standard for accelerated approval need have no quantitative component at all.

This foreboding concern about accelerated approval appears to have again been raised in FDA’s recent controversial approval for Biogen's Alzheimer’s therapy Aduhelm (aducanumab).

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