Drugs

FDA Can’t Regulate Execution Drugs: DoJ Opinion

The Justice Department says FDA “lacks jurisdiction” to regulate articles, including drugs, intended for use in lawful executions. An opinion from the department’s Office of Legal Counsel says the agency has not historically exercised jurisdiction over articles intended to carry out a lawful sentence of capital punishment.

Federal court cases have addressed when the agency may lawfully decline to enforce the Federal Food, Drug, and Cosmetic Act (FFDCA) against articles intended for use in capital punishment but “have not squarely addressed whether FDA has administrative jurisdiction in the first place,” the opinion says. “Congress has repeatedly authorized the death penalty on the assumption that there are lawful means to carry it out, but the regulation of such articles under the FDCA would effectively require their prohibition because they could hardly be found ‘safe and effective’ for such an intended use.”

The opinion says that consistent with the agency’s practice for several decades before 2017, the Office of Legal Counsel concludes that when an article’s intended use is to effectuate capital punishment by a state or the federal government, it is not subject to regulation under the FFDCA.

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