Bipartisan AER Bill Requires Reporting For All OTC Drugs, Supplements
This article was originally published in The Tan Sheet
Executive Summary
Manufacturers of nonprescription drugs and dietary supplements will have to provide company contact information on product labels in order for consumers to report serious adverse events associated with the products under long-awaited legislation introduced June 21
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Manufacturers of nonprescription drugs and dietary supplements will have to provide company contact information on product labels in order for consumers to report serious adverse events associated with the products under long-awaited legislation introduced June 21. The "Dietary Supplement & Nonprescription Drug Consumer Protection Act" (S 3546) was introduced by Sens. Orrin Hatch (R-Utah), Tom Harkin (D-Iowa) and Richard Durbin (D-Ill.). Senate Health Committee Chairman Michael Enzi (R-Wyo.) and Ranking Member Edward Kennedy (D-Mass.) also are cosponsors. In addition to the new labeling requirement, the bill would require both supplement and OTC manufacturers to report all serious adverse events to FDA within 15 business days of receipt. Firms would have one year from the legislation's adoption date to comply with its requirements. The bill limits adverse event reporting to only serious incidences and defines a serious AE as one that results in "death, a life threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect," or a situation requiring medical or surgical intervention to prevent any of the aforementioned outcomes. Manufacturers also will be required to keep records of all adverse events reported, both serious and non-serious, for six years. The bill mandates that FDA have access to those adverse event records as well. Additionally, the proposed legislation will allow third parties to handle a firm's reporting or evaluation of adverse events. Another provision included in the bill is a preemption measure that would create a federal standard related to adverse event reporting. Several states such as California have tried to pass state legislation in the past that would require dietary supplement adverse event reporting (1 (Also see "Dietary Supplement AER Bill Fails To Pass California Legislature" - Pink Sheet, 6 Sep, 2004.), p. 12). The bill is scheduled for markup by the Senate Health, Education, Labor & Pensions Committee June 28. The AER bill has been several years in the making: Durbin and Hatch reached an agreement to work together on the legislation in June 2004 (2 (Also see "Senators Durbin, Hatch To Work Together On AER Plan" - Pink Sheet, 28 Jun, 2004.), p. 3). Durbin then attempted to attach an AER provision to a defense authorization bill in 2005, noting that attempts to draft the legislation had "achieved nothing" (3 (Also see "Durbin Renews Supplement AER Efforts With Defense Bill Amendment" - Pink Sheet, 1 Aug, 2005.), p. 14). The senators' collaboration on the current legislation "has produced a bill which strikes the right balance between necessary regulation and over-regulation," Hatch stated in a June 21 release. The lawmakers stressed the importance of the bill in promoting public health and identifying signals for potentially harmful OTC drugs and supplements. "I tend to think that if this bill that we've crafted had been in place prior to the whole ephedra thing, we wouldn't have had that problem. We would have had those serious event reports recorded, and we would have nipped that in the bud," Hatch stated during a press conference announcing the bill. Industry trade groups as well as consumer organizations also were pleased with the proposed legislation. The Consumer Healthcare Products Association "has long been an advocate of mandatory reporting of serious adverse events to FDA for all OTC medicines and nutritional supplements," according to President Linda Suydam. Currently serious adverse event reporting is not required for monographed OTCs. "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," Suydam stated in a release. The Council for Responsible Nutrition also supports the measure, stating it is "the right thing for a responsible industry to do." "This bill is another demonstration that the supplement industry is, in fact, regulated and that companies are committed to making regulation work," CRN President and CEO Steve Mister said. The National Nutritional Foods Association "believes the bill will benefit the industry in the long run" by changing critics' perception that the dietary supplement industry is unregulated as well as demonstrating the "exemplary" safety record of dietary supplements. - Jessica Lake |