Drugs

House Committee Questions FDA Drug Shortage Actions

The chairs of the House Energy and Commerce Committee and its subcommittees on health and oversight and investigations are asking FDA commissioner Robert Califf for detailed information on drug shortages. In a 3/27 letter, the committee leaders said, “FDA states that it monitors ongoing drug shortages and works closely with manufacturers and others in the supply chain to understand, mitigate, and prevent or reduce any related impacts. FDA has also requested additional legal authority from Congress to gain additional access to medical supply chain information. However, it is not clear to the committee that FDA is effectively using its existing authorities.”

The letter says the Coronavirus Aid, Relief, and Economic Security Act requires, for the first time, companies to report annually amounts of each listed drug manufactured, prepared, or processed for commercial distribution and information on where active pharmaceutical ingredients and finished dosage forms were made. “It is not clear to the committee what FDA has done with the new data,” the letter says. “To date, FDA has not publicly released any summary of these reports in an aggregated way that may inform policymakers and provide the data Congress and others need as we examine ways to make sure the supply chain for drugs Americans need is secure.”

The letter poses a series of detailed questions specific to shortages of albuterol, Pluvicto, cisplatin, fluorouracil, methotrexate, bacillus calmette-guerin, amoxicillin, acetaminophen, and ibuprofen.

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