Devices

Ban Skin Shock Devices: 29 Associations

Some 29 advocacy organizations are again calling on FDA to release a proposed ban on using electric skin shock devices to treat a person’s self-injurious or aggressive behavior. In a 1/23 letter circulated by the Autistic Self Advocacy Network, the groups say it has been eight years since FDA released its first proposal to ban the devices and 10 years since a panel of experts recommended that they be banned.

In 2021, the letter says, a federal court overturned the rule on questions about FDA’s authority to issue a ban, but not on questions about the facts and evidence of harms caused by the devices. “Since then,” it says, “Congress has answered that question decisively. In the 2022 Consolidated Appropriations Act, Congress expressly affirmed FDA’s legal authority to ban electric skin shock devices used to treat self-injurious or aggressive behavior. With this congressional clarification of FDA’s authority, the time has come for FDA to act.”

The advocacy groups say that in the years since the issue was first brought to FDA, “many people with disabilities have been subjected, without their consent, to unbearably painful electric shocks for behaviors such as getting out of one’s seat, interrupting, whispering, slouching, swearing, or failing to maintain a neat appearance.”

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