FDA Policy/General

FDA Slowness Helped e-Cig Epidemic: Rep. Pallone

House Energy and Commerce chair Frank Pallone (D-NJ) says the current youth vaping epidemic could have been averted if FDA in 2017 had not delayed reviewing e-cigarettes that are on the market. In exercising its enforcement discretion, FDA has given e-cigarette makers until 5/2020 to submit data on their products for review. “While I am pleased by the Administration’s announcement that it plans to pull all flavored e-cigarette products from the market until they undergo full FDA review, I believe that ban should occur immediately,” Pallone said during opening remarks at a hearing on e-cigarettes 9/25.

During the hearing, FDA acting commissioner Ned Sharpless agreed that the agency “should have acted sooner.” Sharpless, who became acting commissioner in May after Scott Gottlieb resigned, added that the agency is “going to catch up.” He said data the agency has seen show a continued rise in the “disturbing rates of youth e-cigarette use, especially through the use of non-tobacco flavors. In particular, these data show that more than a quarter of high school students were current e-cigarette users in 2019 and youth e-cigarette users cited fruit and menthol/mint flavors as being the most popular.”

In the coming weeks, Sharpless said a compliance policy related to e-cigarettes will be issued. “FDA intends to prioritize enforcement action such that flavored e-cigarette products will be expected to exit the market unless and until manufacturers of these products provide scientific evidence demonstrating that marketing their products is appropriate for the protection of the public health,” he said. Once the policy is in place, Sharpless said FDA will use its enforcement tools to remove the illegal products from the market.

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