Senate OKs AER Bill

WASHINGTON--The U.S. Senate passed, by unanimous consent, the Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3546) legislation that would require mandatory submission of serious adverse event reports (AERs). Introduced this summer by longtime Senate rivals Orrin Hatch (R-Utah) and Richard Durbin (D-Ill.), the AER bill seeks to require manufacturers, packers or distributors of OTC drugs or dietary supplements in the United States to notify the Food and Drug Administration (FDA) within 15 business days of any reports of any serious AERs associated with their products. Serious events include death, a life-threatening experience, inpatient hospitalization, disability or incapacity, birth defect, or medical/surgical intervention to prevent one of these outcomes.

"This is a good bill that helps the Food and Drug Administration immediately respond to serious problems," Hatch said, after the bill left committee for the Senate floor.

The bipartisan bill had broad backing, including support from groups such as the American Herbal Products Association (AHPA), the Center for Science in the Public Interest (CSPI), the Consumer Healthcare Products Association, the Natural Products Association (NPA, formerly National Nutritional Foods Association), the Consumer’s Union, the United Natural Products Alliance and the Council for Responsible Nutrition (CRN). A companion bill, H.R. 6168, was introduced by Rep. Chris Cannon (R-Utah) in September; it is currently pending in the House Energy and Commerce Committee’s Subcommittee on Health.

Steve Mister, president and chief executive officer (CEO) of CRN, relayed the group's praise for the Senate's passing this important piece of legislation, stating the mandatory AERs will benefit both consumers and the supplement industry. "More than 150 million Americans use dietary supplement products, and those consumers deserve to know that if they report a serious adverse event they believe may be associated with a supplement product, that the regulatory body that oversees the supplement industry will be made aware of that report," Mister said. "We believe that, ultimately, such a system will highlight the strong safety record of dietary supplements. CRN strongly encourages the House of Representatives to consider the Senate-passed bill and quickly enact this legislation."

Linda A. Suydam, D.P.A., president of CHPA, echoed the appreciation for the Senate's approval of this bill, noting CHPA has long been an advocate of mandatory AERs for all OTC medicines and nutritional supplements. "Manufacturers of many OTC drugs are already required to report serious adverse events to [FDA]," she said. "This legislation would codify this procedure for all drugs and extend the practice to dietary supplements. 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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