Drugs

FDA Working on Peptide Accessibility: Politico

HHS secretary Robert F. Kennedy Jr. said last week that FDA will soon make about 14 peptides “more accessible.” Politico reports Kennedy commented on Joe Rogan’s podcast. Politico says the move will please many of Kennedy’s Make America Healthy Again followers who promote the amino acids for a variety of health issues.

“I think within a couple of weeks,” Kennedy said, “we will have announced some kind of new action, and my hope is that they’re going to end up with, they’re still looking at the science, my hope is that they’re going to get moved to a place where people have access from ethical suppliers.”

An HHS spokesperson did not respond to Politico’s questions about what the FDA action might entail. An agency employee who was granted anonymity said there has been no internal communication about what might be coming.

On the podcast, Kennedy blamed the Biden administration for “illegally” reclassifying 19 peptides to a category of substances considered potentially unsafe on the bulks list for compounded drug ingredients. A group of compounding pharmacies sued FDA, claiming the agency used the categorization approach on an interim basis to delay a final rule on what substances may and may not be compounded.

Politico reports that FDA independent advisors supported agency proposals to prohibit the compounding of the substances in late 2024, but the agency never finalized the rules.

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