Drugs

Revise Dietary Supplement Listing Bill: Researchers

Harvard Medical School researchers say proposed legislation to require dietary supplement manufacturers to provide FDA with some basic information should be revised significantly to make it a true reform and oversight bill. Writing in a New England Journal of Medicine opinion piece, the researchers say the Dietary Supplement Listing Act of 2022 as introduced by Sens. Dick Durbin (D-IL) and Mike Braun (R-IN) would end up institutionalizing misinformation through the FDA Web site.

The bill would require supplement manufacturers to provide FDA with a product’s name, ingredients, and health claims. It also would require FDA to create and maintain a publicly searchable database of the estimated 80,000 supplement products available for sale in the U.S.

“FDA has sought enhanced capabilities for promoting supplement safety, suggesting that certain steps, including the establishment of a registry, would permit the agency to ‘take appropriate action to protect consumers’ from dangerous supplements,” the article says. “There is little chance, however, that the proposed law would meet these important clinical and public health goals; rather, it would create the impression of reform while leaving the current lax regulatory framework largely untouched.”

The researchers say the bill should be extensively revised to introduce basic safeguards. “Congress could give FDA the authority to read a supplement’s label before registering the product and not register the product if the label lists unlawful ingredients or claims,” they write. “The bill could also be revised to permit FDA to swiftly remove products from the registry if the agency determines that they are hazardous…. The legislation could require manufacturers to submit a certificate of analysis to ensure that labels are adequate representations of products’ ingredients. In addition, to avoid misleading consumers, health claims submitted to FDA shouldn’t be posted publicly on its Web site unless the agency confirms that they are supported by high-quality clinical trials.”

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