FDA Commissioner Scott Gottlieb is resigning from his post within a month. His decision has surprised many as he is focused on several key initiatives, including lowering teen vaping rates, fighting the country’s opioid epidemic and speeding up drug approvals. Gottlieb said he was stepping down to spend more time with his wife and three children. A weekly commute from his home in Connecticut to Washington was also said to be a factor. There is no word yet on who might succeed Gottlieb. Posted March 5, 2019. Via FDA.
A new study is throwing water on an argument made for years that the acne drug Accutane (isotretinoin) is linked to an increased risk of depression and mood disorders. Researchers conducted a retrospective study of 38,000 adults, all with an acne condition. About 1,000 were prescribed Accutane, and they took the drug, on average, for five months. An analysis found that 4% of Accutane patients developed depression, compared to 4% of those not taking the drug. Study author Bethanee Schlosser, MD, with Northwestern University Feinberg School of Medicine, told Healthday News that acne itself is associated with increased risk for mood changes, depression and low self-esteem. Posted March 4, 2019. Via HealthDay News.
The FDA has announced new steps it has taken in its effort to combat teen tobacco and vaping use. First, the agency has asked for a meeting with the manager of drugstore chain Walgreen Co. because of repeated violations of selling tobacco products to underage consumers. They found 22% of Walgreens stores that were inspected sold tobacco to underage patrons, the highest rate among drugstores. The FDA has also sent letters to more than 40 companies that may be marketing e-cigarette products illegally. The agency also sent out warning letters to several companies for selling electronic nicotine delivery system products and waterpipe tobacco products that didn’t include a required nicotine warning statement. Posted March 5, 2019. Via FDA.