Drugs

FDA Backs Away From McClellan Contract: Report

FDA reportedly has backed away from awarding a sole source contract to the Duke-Margolis Center for Health Policy headed by former agency commissioner Mark McClellan, for whom now commissioner Scott Gottlieb used to work. Endpoint News says an initial request for proposal said the effort was to “provide supporting research, identify key issues, and convene appropriate subject matter experts to help inform major initiatives for process improvement and regulatory science related to FDA commitments under the 2018 reauthorization of the Prescription Drug User Fee Act (PDUFA 6) and the 21^st Century Cures Act legislation.”

Questions about the sole source contract were raised by Politico and the Washington Post. Harvard Medical School professor Jerry Avorn told the Post it made no sense that the only place that could provide the requested services was a center “run by a drug company advocate. The very fact that they could have thought this was a good idea, even to the point of publishing the request for proposal, is important because of what it reflects about the decision-making process within FDA and the administration.”

Endpoint News says that on 5/16, FDA issued a statement that it had become aware of other groups that could offer a rival bid and thus “decided to change the announcement from a sole source award to an open competitive grant.”

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