FDA Policy/General

FDA Abandons Controversial Media Embargo Policy

FDA says it is abandoning a controversial embargo policy directed at reporters that came to light last year by New York University journalism professor Charles Seife. In a lengthy analysis for Scientific American, Seife said that by holding embargoed briefings for select reporters on major issues conditional that the reporters not seek comment from anyone else before the embargo is lifted was actually turning journalist watchdogs into lapdogs, and making reporters into stenographers. He painted a grim picture of FDA and many other scientific agencies and organizations holding out the promise of information to hand-picked reporters in return for the reporters’ agreement to not seek independent comment or verification (see earlier story).

In a 1/19 letter to the Association of Health Care Journalists, outgoing FDA acting assistant commissioner for media affairs Jason Young said the agency’s embargo policy “was not adequately followed,” and that the use of a “close-hold embargo” is not to be used under any circumstance. “This approach, though, runs counter to our policy, and therefore is now included as a special point of emphasis in our staff training,” Young said.

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