The Dietary Supplement and Nonprescription Drug Consumer Protection Act, also known as the “AER law,” requires dietary supplement and over-the-counter (OTC) product manufacturers to submit serious adverse event reports (AERs) to the Food and Drug Administration (FDA) starting December 2007.
Twelve years after the Dietary Supplement Health and Education Act (DSHEA) was signed into law, the “AER bill” was passed unanimously by the Senate and approved by a two-third majority in the House in December 2006. The bill was signed into law[i] by President George W. Bush on December 22, 2006 (Law No. 109-462). The “AER bill” was originally sponsored by Senators Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), Dick Durbin (D-Illinois), Michael Enzi (R-Wyoming), and Edward Kennedy (D-Massachusetts), and was introduced in the U.S. Senate in June 2006 and the U.S. House of Representatives in September 2006.
Effective December 2007, the new amendment to the Federal Food, Drug and Cosmetic Act (FFDCA) will require supplement labels to include a telephone number for the reporting of serious adverse events, and submission of the reports by supplement companies to FDA within 15 days. By law, FDA is required to consolidate multiple reports of the same incident. Individual states would be precluded from establishing their own AER systems. Records related to each adverse event report have to be maintained by the responsible party for six years. Under the AER law, the reporting of serious adverse events would be a legal requirement, as opposed to the current voluntary Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS).
An adverse event is defined in the Act as any “health-related event associated with the use of a nonprescription drug that is adverse, including an event occurring from an overdose of the drug, whether accidental or intentional; an event occurring from abuse of the drug; an event occurring from withdrawal from the drug; and any failure of expected pharmacological action of the drug.” A serious adverse event is defined as any “health-related events resulting in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability, congenital abnormality or birth defect, or any medical or surgical intervention to prevent the above outcomes.”
If a complaint is received on a branded product, the manufacturer of the product will have the legal responsibility of reporting serious adverse events in connection with these products. For private label products, the retailer has the choice to either assign the reporting responsibility to the manufacturer of their private label products or to report serious adverse events themselves.
The Act includes language to make it clear that reporting an AER to the FDA “shall not be construed as an admission that the dietary supplement involved caused or contributed to the adverse event.” The privacy of individuals reporting adverse events will also be protected. Additionally, it would be illegal to file a false AER report. While the Act became effective December 22, 2007, FDA has until August (270 days from the date of enactment of this Act) to issue guidance on the minimum data elements that should be included in a serious adverse event report.
Faced with these time constraints, and prior to the release of the FDA guidance, manufacturers have already started to develop their plans for label revisions, call-in centers, the collection and review of reports and appropriate submission of the reports to the FDA. Although the dietary supplement industry does not anticipate many AERs, each manufacturer needs to develop an appropriate plan for handling this complex process and demonstrate compliance with the law in the event of an audit.
[i] Dietary Supplement and Nonprescription Drug Consumer Protection Act http://www.govtrack.us/congress/billtext.xpd?bill=s109-3546