Drugs

Let Compounders Help with Drug Shortages: Op-Ed

Alliance for Pharmacy Compounding CEO Scott Brunner says Congress should include in any legislation addressing drug shortages provisions that “will equip state-licensed pharmacy compounders to provide urgent-use medications to hospitals and for in-clinic administration, within tight regulatory guardrails, when those drugs are demonstrably in shortage and unavailable from the manufacturer or a licensed outsourcing facility.” Writing in an online Stat op-ed, Brunner notes that in the early days of Covid-19, when essential treatment medications were in short supply, FDA issued temporary guidance to allow traditional compounding pharmacies to prepare 13 Covid drugs from pure ingredients to meet hospitals’ urgent needs. More than 80 pharmacies participated and FDA has said there were no adverse events reported, he says.

“Amid continuing drug supply chain disruptions, pharmacy compounders can play an essential role in alleviating temporary shortages of urgently needed medications if allowed to do so,” Brunner writes. “The Covid example demonstrates that. When patient health is at stake, we need a more nimble system, one that doesn’t require slow-coming special action by FDA to address it. Changes to federal law are required so that when shortage drugs are urgently needed, compounders may assist immediately, without bureaucratic delays and impediments…. We have a choice here: We can decide to live with drug shortages and the patient suffering that results from them, or we can make modest adjustments to federal law that will create a pathway for compounding pharmacies, on a temporary basis and within tight regulations, to fill the gap during drug shortages, alleviate suffering, and even save lives.”

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