Drugs

Lawmakers Want FDA Jurisdiction on Execution Drugs

Senators Cory Booker (D-NJ) and Elizabeth Warren (D-MA) are calling on the Department of Justice (DoJ) to rescind its Office of Legal Counsel’s 2019 opinion on FDA jurisdiction over execution drugs and allow the agency to regulate the products. “The DoJ under the current Administration has reversed previous OLC opinions that were legally unsound and should do so here,” the lawmakers contend in a 5/21 letter to DoJ.

Booker and Warren argue in their letter that the opinion is “misguided” and “inconsistent with the principles of fairness and justice, undermines drug safety, and facilitates legally dubious state execution methods. It blocks the FDA from intervening when states obtain unmarked vials from underground suppliers, inject their citizens with contaminated solutions, and cause needlessly painful deaths.”

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