Drugs

HHS, Purdue Differ on Buprenorphine

In a sweeping HHS announcement of the Biden administration’s strategy for curbing drug overdoses, secretary Xavier Becerra said one element in the plan is to expand the number of doctors who can prescribe buprenorphine to treat addiction, bypassing rules requiring hours of training for the physicians. The Washington Post reports the plan also calls for reducing the stigma associated with substance use disorder that can keep people from seeking treatment.

The article quotes Stanford University psychiatry professor Keith Humphreys, who was a drug policy expert in the Obama administration, that the plan “does the three things you have to do to reverse an addiction epidemic: prevent people from developing the disorder, treat those who have it, and keep those you can’t treat alive.”

A bit of a dissent was voiced by RTI International senior public health scientist Jon Zibbell, who studies street drug use. “Everything in there is kind of stuff we’re already doing,” he told the Post. “I see nothing in there that’s really evolving to the nature of the crisis.

As if to show its reformed character under reorganization meanwhile, Purdue Pharma, which was a focus of the eight-part Hulu series “Dopesick,” reviewed by FDA Webview editor and publisher Jim Dickinson, tells healthcare professionals in information on its Butrans (buprenorphine) transdermal system CIII that the drug “exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Butrans and monitor all patients regularly for the development of these behaviors and conditions.” The product information also references the opioid analgesic REMS that FDA has in place.

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