Devices

Former FDA Commissioner Frank Young Dies at 88

Former FDA commissioner Frank Young died 11/24 at age 88. Young served as commissioner from 1984 to 1989. During his time in office, Young led the agency over several major events, including the Hatch-Waxman Drug Price Competition and Patent Term Restoration Act (1984), and passage of the Prescription Drug Marketing Act (1987). Also during his tenure, FDA approved in 1987 the first drug to combat AIDS (zidovudine), and he presided over the generic drug crisis in 1989, which led to his departure to HHS as assistant secretary for Health, Science, and the Environment under secretary Louis Sullivan.

Despite leaving office 30 years ago, Young remained interested in FDA and its need for independence. Earlier this year, he joined six other former commissioners who called for the agency to be taken away from HHS and reconfigured into an independent federal agency. The seven spent 18 months examining FDA’s position within the federal government, its reporting relationships and required layers of executive branch review, the economic and health consequences of delayed decision making, the growing responsibilities that have been placed on FDA, and the structure of other federal agencies. Describing their proposal in a Health Affairs commentary, the seven said that the “national interest would best be served by a strategy that would enable FDA to act without the delays inherent in multiple levels of clearance, protect its integrity, promote reliance on consistent science-based regulation, and ensure that the American public has access to the best that science and industry can offer.”

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