Drugs

CRN Asks FDA to Reconsider Drug Preclusion

The Council for Responsible Nutrition (CRN) petitioned FDA 3/9 to reconsider how it has been invoking the drug preclusion clause of the Dietary Supplement Health and Education Act (DSHEA). CRN says (includes a link to the petition) that the agency has been and will likely continue to be misapplying the clause to dietary supplement ingredients that it has previously acknowledged as lawfully marketed, threatening future innovation in the supplement marketplace.

The association says the drug preclusion clause in DSHEA excludes certain dietary supplement ingredients from the supplement definition where that ingredient is the same as an active drug ingredient and the drug use was first to the market.

“Under FDA’s current interpretation,” CRN writes, “a supplement company has no way of knowing if a drug company has started the process of preclusion because the date that triggers preclusion is confidential…. Meanwhile, the dietary supplement manufacturer could spend millions of dollars researching the effectiveness, confirming the safety, and marketing an ill-fated product to consumers, which is destined to be removed. That outcome is certainly not what Congress intended when it wrote the law.”

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