Drugs

Lawmakers Urge FDA to Block Super Bowl Drug Ad

Senators Dick Durbin (D-IL) and Roger Marshall (R-KS) are urging FDA to take enforcement action against a planned direct-to-consumer (DTC) commercial that will run during the Super Bowl 2/9 which omits safety or side effect information. The commercial promotes Hims & Hers’ compounded version of the GLP-1 weight loss drug semaglutide.

In a 2/7 letter to FDA, the lawmakers contend that the advertisement appears to be “exploiting a perceived loophole in federal law regarding promotions of compounded drugs by telehealth companies.” However, the letter argues, the ad does fall under the agency’s jurisdiction, and the lawmakers note that legislation is forthcoming to close any gaps regarding prescription drug advertising.

“We recognize the important roles that pharmaceutical compounding and telehealth play in the health care delivery system, helping to ensure access to FDA-approved products and filling a need for more customized treatments,” the letter says. “However, we believe there should be no disparity in pharmaceutical advertising requirements between regulated entities.” Despite any loophole that the company may believe allows it to omit safety information, the letter reminds FDA that it “may already have the authority to take enforcement action against marketing that may mislead patients about this company’s products.”

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