Drugs

Clarify Memory Supplement Oversight Roles: GAO

The Government Accountability Office (GAO) says FDA and the Federal Trade Commission (FTC) should give consumers additional guidance to clarify the agencies’ differing roles in their shared oversight of memory supplement and other dietary supplement marketing on the Internet. A GAO report examines (1) how memory supplements are marketed and the extent to which the marketing targets older adults and may violate federal requirements; (2) related enforcement and outreach actions taken by FDA and FTC; and (3) challenges to agency oversight.

According to GAO, oversight of memory supplements falls under FDA’s general authority to regulate dietary supplements and their labeling, while FTC exercises general authority to enforce prohibitions against deceptive advertising.

“Between 2006 and 2015, FDA and FTC have taken similar types of enforcement actions for memory supplements as for other dietary supplements — with most FDA actions being Warning Letters and FTC actions being a mix of administrative and federal court actions,” the report says. “Nineteen of 551 enforcement actions involved memory supplements. The agencies coordinate enforcement actions in the same way for all dietary supplements. FDA and FTC have done some outreach to industry and consumers on dietary supplement use by older adults as well as some specific outreach related to memory supplement enforcement actions. In prioritizing enforcement and outreach efforts, the agencies focus on safety, egregiousness of deception, and impact of marketing.”

GAO reports that FDA faces challenges related to limited information about the dietary supplement market, including memory supplements, to inform its oversight efforts. It says FDA officials said they are exploring ways to obtain additional market information to improve the agency’s oversight.

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