Drugs

Bill to Stockpile Pediatric Cancer Drugs

U.S. Reps. Anna G. Eshoo (D-CA), Diana DeGette (D-CO) and Kim Schrier (D-WA) have introduced the Pediatric Cancer Drug Supply Act of 2024, legislation that is intended to ensure there is a stable supply of essential pediatric cancer drugs in the U.S.

The bill would direct HHS to establish a program to create a reserve supply of essential pediatric cancer drugs by contracting with eligible drug manufacturers to stockpile the medicines. “As part of the contract, drug manufacturers would receive payments from HHS based on the quantity and cost of pediatric cancer drugs held in reserve,” the lawmakers say. “HHS would have authority to order manufacturers to distribute drugs from the buffer stocks into the commercial market to alleviate or prevent drug shortages.”

The bill text is available here.

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