Adverse Event Reporting bill introduced

June 26, 2006

A new bill, S. 3546-the Dietary Supplement & Non-Prescription Drug Consumer Protection Act-has been introduced. If passed, the bill will amend the Food, Drug & Cosmetic Act to require the reporting of "serious" adverse events by manufacturers for both OTCs and dietary supplements to the FDA.

Adverse Event Reporting bill introduced

A new bill, S. 3546-the Dietary Supplement & Non-Prescription Drug Consumer Protection Act-has been introduced. If passed, the bill will amend the Food, Drug & Cosmetic Act to require the reporting of "serious" adverse events by manufacturers for both OTCs and dietary supplements to the FDA. The bill includes the following provisions about the reporting. It should: be limited to serious adverse events and not require reporting of just any complaint; not require retailers, even those who sell products under their own label, to report adverse events from customers to the FDA; be limited to products sold in the U.S.; allow third parties to report or evaluate claims; and allow for a state preemption provision. The National Nutritional Foods Association (NNFA) and the Consumer Healthcare Products Association (CHPA) both issued statements supporting the bill. NNFA said, "The bill represents a fair and meaningful collaboration among the supplement industry, our bipartisan champions in the Senate, and legislators who would like to see more stringent oversight of dietary supplements." CHPA stated, "CHPA commends Senators Hatch (R, Utah), Harkin (D, Iowa), Durbin (D, Ill.), Enzi (R, Wyo.), and Kennedy (D, Mass.) on developing and introducing S. 3546. This legislation, if passed, will ensure FDA has the tools it needs to fulfill its public health mission to more aggressively monitor the medicines and nutritional supplements it regulates. "

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