Drugs

FDA Aims to Ban Flavored e-Cigarettes

After a 9/11 White House meeting between FDA acting commissioner Ned Sharpless, HHS secretary Alex Azar and President Donald Trump, the agency is moving forward to ban non-tobacco-flavored e-cigarettes, including mint and menthol. FDA is preparing an enforcement and compliance guidance in the coming weeks to spell out its plans, Azar said after the meeting. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth,” Azar said.

The full court press against e-cigarettes comes as preliminary numbers from the National Youth Tobacco Survey show a continued rise in the “disturbing rates of youth e-cigarette use, especially through the use of non-tobacco flavors that appeal to kids,” an agency release said. “In particular, the preliminary data show that more than a quarter of high school students were current (past 30 day) e-cigarette users in 2019 and the overwhelming majority of youth e-cigarette users cited the use of popular fruit and menthol or mint flavors.”

FDA said that going forward all electronic nicotine delivery system products will need to file premarket tobacco product applications with the agency in order to be legally marketed.

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