Drugs

FDA to Reconsider Mandatory Opioid Prescriber Education

FDA says it is reconsidering the need for mandatory opioid prescriber education through the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). A 10/13-10/14 public workshop will be held in collaboration with the Duke-Margolis Center for Health Policy to allow stakeholders to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS.

An agency notice says FDA will “explore the value of a single source for education on the appropriate use of opioids, risks of opioid abuse and misuse, and treatment of opioid use disorder to address multiple needs and reduce the burden on prescribers.”

Despite a drop in opioid dispensing, the notice says, opioid overdoses and opioid-involved deaths are higher than ever, with opioids often seen in combination with other substances such as cocaine, methamphetamine, and benzodiazepines.

“The rise has been driven primarily by a surge in overdose deaths initially involving heroin and then illicitly manufactured fentanyl and fentanyl analogs,” the notice says. “Although these overdose deaths largely involve illicit substances, many users of illicit opioids are initially exposed to opioids through nonmedical use of prescription opioids.”

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

Read more

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