There is no question that adverse event reporting (AER) has become a prominent issue in the dietary supplement industry and among members of Congress. On the Congressional level, the AER issue was raised on the Senate floor on June 21st between Senators Orrin Hatch (R-UT) and Senator Richard Durbin (D-IL). In this discussion, Senator Durbin agreed to drop his amendment to the Department of Defense funding bill, which would have restricted access to certain dietary supplements on military bases and placed reporting requirements on manufacturers that are stricter than those for over-the-counter (OTC) drugs, if Senators Hatch and Tom Harkin (D-IA) agreed to work together with him on developing legislative language pertaining to an AER system for dietary supplements. Whether or not a workable framework for AERs will be developed this year is still in question. However, several industry experts believe that the focus must remain on developing an AER system that is “appropriate” for the companies involved. Important factors to consider include what constitutes a “serious” adverse event, what the costs to industry will be, who should handle AERs, whether it should be a third party or a system that is implemented within companies themselves, legal liability risks and a host of other issues.

Several of these issues were tackled at a University of Minnesota seminar titled “Adverse Event Reporting and Dietary Supplements: Towards a National System of Surveillance,” which was held at the end of June. The big question is what an AER system for supplements should look like. Douglas Bierer, vice president of scientific and regulatory affairs at the Consumer Healthcare Products Association (CHPA), Washington, D.C., who spoke at the seminar said CHPA’s board of directors was supportive of legislation that would include a mandatory reporting system for serious adverse events for dietary supplements, preemption of state and local AER systems, and nondisclosure of individual records or names. He also highlighted the advantages of a third party reporting service, which relate particularly to smaller companies. While Mr. Bierer noted the merits of a third party system, he also indicated that such a system should be voluntary, and decided upon by each company on a case-by-case basis.

Also speaking at the seminar was Rick Kingston, who comes from the newly created College of Pharmacy Center for Dietary Supplement Safety. He described a third party system in which the center could be useful in developing collection tools specifically tailored for dietary supplements, analyzing and defining the safety profile of dietary supplements, evaluating which AERs are “serious” and need to be reported, and creating a national product database with standardized coding of product categories for tracking products with the same ingredients. He pointed out that the current U.S. Environmental Protection Agency (EPA) rule for insecticides and related products provides a basic framework to consider for dietary supplement AERs.