Drugs

Senators Urge FDA: Do More to Resolve Drug Shortages

A bipartisan letter from four senators is urging FDA commissioner Robert Califf and HHS secretary Xavier Becerra to step up efforts to help resolve amoxicillin and other drug shortages. “The record high levels of respiratory illnesses have spiked demand for amoxicillin and other essential medicines, and patients and providers continue to experience disruptive shortages, which have led to delays in care and compromised health outcomes,” the letter says. “We urge the Department of Health and Human Services and the Food and Drug Administration (FDA) to convene the Drug Shortage Task Force and work with stakeholders, including providers, on identifying factors and potential solutions to mitigating the amoxicillin shortage. Further, we request an update on FDA initiatives to prevent and mitigate drug shortages.” The letter was signed by Sens. Amy Klobuchar (D-MN), Sherrod Brown (D-OH), Ed Markey (D-MA) and Bill Cassidy (R-LA).

Addressing the amoxicillin shortage has been a priority for FDA. Last month, the agency issued an immediately in effect guidance on the preparation of beta-lactam oral antibiotic suspension products compounded by pharmacists. The agency said it has received requests for clarification about preparation of compounded versions of the products from FDA-approved tablets and capsules. “The guidance describes steps to reduce the risk of cross-contamination between these and other products,” the agency said. “Amoxicillin is a beta-lactam drug, and compounding this drug in an environment without appropriate safety measures could lead to cross-contamination of other drug products. Beta-lactam drugs can cause life-threatening allergic reactions in some patients.”

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