Industry Gathers to Analyze, Plan for AER Law

SALT LAKE CITYOn Jan. 11, the United Natural Products Alliance (UNPA) gathered industry stakeholders for a seminar on the chronology, background, requirements, and potential pros and cons of the AER (adverse event report) bill signed by President Bush on Dec. 22, 2006. A roster of Senate staffers, toxicologists, herbalists, naturopathic doctors and other experts detailed the nuances of the AER law and how companies can begin preparations for implementing and managing an AER system.

Kicking things off were Patricia Knight, Hatchs chief of staff, and Peter Reinecke, recently departed chief of staff for Harkin, both of whom were instrumental in getting the bill passed. Knight discussed the legislations journey through 22 drafts to a narrow House victory, providing details on why the three Senators collaborated, and what concerns were brought up in the negotiation of the bills terms. Among the primary issues were the pre-emption clause, which means this law pre-empts any state bills; inclusion of OTC products; permission for the Health and Human Services (HHS) director to modify the MedWatch form used in the federal AER system; allowance for outsourcing of AER management to third-party experts; and limiting AERs to serious, which includes death, hospitalization, life threatening injury or illness, birth defects and any condition that requires medical intervention to prevent serious events. Reinecke added the Food and Drug Administration (FDA) has nine months to issue guidance on its specific data requirements under the new law, but he expects the rules will be similar to the drug model: an identifiable patient, identifiable reporter, a suspected product and an adverse event. He also noted retailers with private label supplements will be permitted to delegate AER responsibility to the actual manufacturer, provided the parties reach an agreement. Further, supplement labels must now include not only the name of the party responsible for AERs, but also an address or phone number for consumers to contact. On labeling, companies will have one year from the date the law is effective to change any labels on product sent out before Dec. 22, 2006.

Other highlights included: Rick Kingston, Ph.D., president, regulatory and scientific affairs for SafetyCall international, who covered the potential roles of third-party providers, the laws protections against false reporting and specific actions companies must take to set up their internal AER management system; Donald Brown, N.D., who explained the challenges and intricacies of the relationship industry companies will have to develop with healthcare professionals, namely practitioners; Francis Brinker, N.D., of the Integrative Medicine program at University of Arizona, who discussed how supplement-herb interactions will affect AERs, especially in the complex realm of concomitant use of herbs and prescription drugs; and Christine Haller, M.D., of the clinical toxicology laboratory at San Francisco General Hospital, who outlined her poison centers FDA sponsored study on adverse events called into the poison center, including details on the prevalence of insufficient data collected in reports and cases involving abuse of products and/or street drugs, especially stimulants.

Capping the seminar, Michael McGuffin, president of the American Herbal Products Association (AHPA), reported on his early efforts to gain industry support for the bill, while responding to concerns raised by industry critics. My job is to worry, he said. I was concerned about all the individual states efforts at their own AER laws, and then ensuing criticism that our industry is not even required to report serious AERs. He expressed disappointment in the clumsy MedWatch form and urged companies to submit suggested modifications.