Drugs

Senators Want Opioid Label Changes

Sens. Maggie Hassan (D-NH) and Mike Braun (R-IN) are calling on FDA commissioner Robert Califf to “update FDA’s opioid labeling practices to reflect current public health and safety knowledge.” In a 4/28 letter, the two cite 2021 opioid death statistics from their states and assert that many people who die from an overdose first become addicted through a legal prescription for OxyContin or other FDA-approved drugs. “Despite this harm, FDA continues to permit doctors to prescribe these drugs to be sold under misleading and inaccurate labels,” they write.

They suggest these reforms:

revise the labeling for long-term use of opioids by removing “unsupported” claims about their long-term efficacy;
replace abuse-deterrent language and identify evidence-based language that more accurately conveys the intended meaning; and
evaluate the efficacy of enriched enrollment randomized controlled trials.

“Physicians and other prescribers rely on the FDA label to guide and inform clinical decisions,” Hassan and Braun conclude. “The label should be based on the best available science, in order for medications to provide the most benefit to patients with the least harm.”

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