Drugs

Naloxone Availability Advisory Committee Meeting

The FDA Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will meet 12/17-18 to consider various options for increasing access to naloxone. FDA commissioner Scott Gottlieb says the advisors “will help us weigh logistical, economic, and harm reduction aspects of different strategies. And we will consider whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death.”

Gottlieb’s statement says there is the potential for significant costs and burdens that may be associated with naloxone co-prescribing, including the direct economic costs to consumers and health systems. They also include practical considerations such as the need for manufacturing volume growth for naloxone, and the risk of drug shortages of the product that could come from a sudden spike in prescribing.

“The committee will be asked to evaluate these and other considerations, as part of our effort to consider any potential challenges to wider co-prescribing of naloxone for all or some prescription opioid patients,” Gottlieb says.

The notice says the agency is making progress in efforts to advance development of an over-the-counter naloxone product as a way to promote wider access to the drug. In a new approach, he says, FDA has created a model drug facts label and simple pictogram and is conducting label comprehension testing. Using that information, naloxone manufacturers could focus their efforts on final label comprehension testing of how well consumers understand product-specific information that hasn’t been already tested in the more general facts label.

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