Drugs

House Wants FDA Briefing on Fake Ozempic

The bipartisan leadership of the House Energy and Commerce Committee is asking FDA for a staff briefing about the presence of counterfeit copies of Novo Nordisk’s Ozempic (semaglutide) injection 1 mg in the U.S. drug supply chain (see earlier story).

A 10/8 letter to FDA commissioner Robert Califf notes the agency alerted the public 12/2023 about counterfeit Ozempic injection products in the legitimate drug supply, and a subsequent investigative article “found that thousands of counterfeit Ozempic pens had arrived in a warehouse in Elmira, New York, as early as the fall of 2023. The fact that counterfeits made it so far into the legitimate supply chain raises concern about potential gaps in our supply chain security infrastructure. This threat continues to grow.”

The letter also raises concerns with counterfeit Ozempic entering through illegal channels. For example, it references a 5/1 Department of Justice press release that reported FDA’s Office of Criminal Investigations was involved in the arrest of an individual for selling misbranded and adulterated weight loss drugs on TikTok. “The committee fully supports these continued investigations of unlawful sales,” it says.

The letter acknowledges the “sensitivities” of an ongoing investigation, but the committee requests “additional, updated information about the agency’s response. There is a compelling public interest in understanding how these incidents have occurred and what actions can be taken to maintain public confidence in the safety of drug products in the legitimate supply chain. We expect the FDA to provide important information about this counterfeit drug security breach of the legitimate supply chain in a restricted setting to account for the sensitivities of ongoing investigations.”

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

Read more

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