Drugs

Sclerotic’ FDA ‘Shuns Innovation’: Column

Taxpayers Protection Alliance executive director Ross Marchand uses a Baltimore Sun op-ed column to complain that FDA “has lost its way and shuns innovation.” He writes that as a result, “frustrated Americans are increasingly rebelling against the sclerotic agency by turning to gray and black markets for unproven ‘Chinese peptides’ and other drugs.”

While FDA commissioner Marty Makary’s list of 2025 accomplishments touted reducing decision times, hitting drug target date goals, accelerating cures, cutting red tape, and ushering in a new era of innovation, Marchand writes, Makary can only succeed in accelerating cures by boosting agency approvals and greenlighting lifesaving new medications, which he says can be done without compromising safety.

The op-ed contains several examples of the FDA approach to drugs that Marchand says show how bad the agency’s risk aversion has become.

He concludes that “FDA can save and improve countless lives by truly ‘accelerating cures’ and ‘cutting red tape.’ The current approach just isn’t working for millions of Americans suffering from treatable diseases.”

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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