Drugs

FDA Reorg Could Hurt Supplements: Duncan

Rep. Jeff Duncan (R-SC) says FDA’s proposed Human Foods Program reorganization could adversely affect its regulation of dietary supplements. The agency has proposed creating an Office of Food Chemical Safety, Dietary Supplements, and Innovation, eliminating the current separate Office of Dietary Supplement Programs that now regulates the products.

“I believe that this decision was shortsighted and could lessen the agency’s focus on the dietary supplement industry,” Duncan wrote in an 8/21 letter to FDA commissioner Robert Califf, quoted by Natural Products Insider.

The online newsletter notes that dietary supplement programs were elevated in late 2015 to raise their profile within the agency and enhance the effectiveness of dietary supplement regulation.

The congressman said it is unclear how eliminating the Office of Dietary Supplement Programs benefits consumers or industry stakeholders, a concern that also has been raised by some in the supplement industry.

“I believe eliminating ODSP erodes the prioritization of regulating dietary supplements and undermines the infrastructure that relies on funding specifically for dietary supplements,” Duncan reportedly wrote to Califf. “I believe ODSP should remain freestanding, as was established, that is consistent with the statute” (the Dietary Supplement Health and Education Act of 1994).

Califf has said the dietary supplements program remains an agency priority and there are no plans to reduce the capabilities or resources of ODSP through the reorganization.

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