Drugs

FDA Looking at Opioid Packaging Changes: Gottlieb

FDA commissioner Scott Gottlieb says the agency is talking with drug companies about possible changes to opioid packaging to reduce access to the drugs. He told CNN that companies might find the agency’s action “disruptive” and “uncomfortable.” In addition to packaging changes, he said FDA could promote ways to treat patients with alternative medications that don’t produce a high.

Gottlieb said the idea of packaging a limited number of opioid pills in a blister pack is gaining traction within the agency and will be the subject of an upcoming workshop. He said it would also be possible to put additional requirements on doctors who want to prescribe a 30-day supply of the drugs, such as requiring additional provider education.

“We’re at a point in this crisis that we’re going to have to think of ideas and taking actions that are going to be more disruptive and are going to be uncomfortable to some parties,” the commissioner told CNN. “But we have to take more vigorous action to get ahead of this. Something like this could move potentially quickly. We’re invested in taking a hard look at this and seeing what the opportunities are.”

Gottlieb said there currently are three approved alternative treatments and “they all work well. We’re going to be putting out new guidance to manufacturers, to product developers trying to lay out new pathways, that they can develop alternatives to some of the treatments that are available.”

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