Drugs

FDA’s Political Turn Risks Its Core Mission: Expert

FDA’s vast responsibilities — regulating and monitoring everything from drug and device safety to the food supply and cosmetics — make it one of the most important federal agencies. Yet former Alliance for a Stronger FDA executive director and now regulatory expert and author of the blog FDA Matters (www.fdamatters.com) Steven Grossman is warning that the agency’s current trajectory risks undermining its effectiveness by prioritizing political expediency over rigorous inquiry and public input.

Grossman, who has spent 20 years briefing lawmakers and stakeholders on FDA’s role, offered a characteristically understated critique of the agency’s political domination. “I am troubled by how many FDA initiatives start with labor-saving conclusions rather than labor-expanding questions,” he writes on his blog. “In the past, FDA has always seen the wisdom of public input, especially consultation with outside experts through advisory committees chosen for balance and breadth of view. We need that back ASAP.”

The critique is striking given Grossman’s history as a consistent defender of FDA. He has long argued that the agency’s reach — regulating nearly $4 trillion in goods globally and overseeing about 20% of U.S. consumer spending — is indispensable to public health and economic stability. He frequently cites the agency’s complexity, with hundreds of unique regulatory activities, and its global scope, with oversight of nearly 300,000 facilities worldwide.

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