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Media Release Update: 10/12/07 |
The Dietary Supplement and Non-Prescription Drug Consumer Protection Act, S.3546
The Institute for Health Research, Inc. is a nonprofit, exempt organization. Its web site is at: www.inhere.org.
In 2006 Congress adopted the Dietary Supplement and Non-Prescription Drug Consumer Protection Act. Known as the “AER” law (for “Adverse Event Reporting”) the new law requires manufacturers and distributors to report all “serious” adverse events to the FDA. The bill was introduced June 21, 2006, adopted on December 9, 2006 and signed into law on December 22, 2006, effective December 22, 2007.
The Institute notes that the law specifically authorizes nutrient companies to hire “third parties” to evaluate and report the adverse events. In our view, this offers professionals in the field new opportunities to provide services to consumers and purveyors, while collecting safety information of research interest to the Institute.
Therefore the Institute has resolved to support the creation of a new community outreach, Adverse Event Reporting Consultants (AERC). We have obtained an appropriate web address: www.aer-consultants.com for the Project. The idea here is to create a collaborative structure, under the general sponsorship of the Institute for Health Research, in cooperation with healthcare professionals and advocacy groups, that can act in good faith, as a neutral third party, to evaluate adverse reaction claims, on behalf of consumers and purveyors alike.
AERC will not be expected to determine responsibility or corrective action and will be limited to a standard of reasonable care in determining if the allegations meet the “serious” requirement for reporting to the FDA.
We have access to experts in Biochemistry, Health, Law, Event Reporting and the like. We propose to teach marketers how to keep proper Quality Control (QC) records and provide us the information we will need to professionally determine if the “event” is “serious” enough to report.
If so, AERC will report the event to the FDA on behalf of the marketer. The Institute will use the information (with personal and company identifications removed) for its research purposes, to help prove the overall safety of Dietary Supplements. Costs and consultant fees will be recompensed by the purveyors, within the context of a nonprofit, cooperative program. While this service will be available to any purveyor of products covered by the bill, it might be most valuable to smaller vitamin purveyors who could find the availability of high quality expert review of possible adverse events cost-effective and supportive of their reputations.
Dietary Supplement Purveyors will be invited to become Associate Members of IHR (though this is not required for companies to participate in the AER screening and reporting system).
The consultancy will offer a wide variety of experts an opportunity to bring their talents and knowledge to bear on Adverse Event Reporting, to the benefit of both consumer and vitamin industry, in the context of a cooperative, independent, third-party, nonprofit setting.
Some of the law’s proponents say it will offer the industry a chance to prove what many know is true science: Dietary Supplements are safe. This expected outcome will reinforce the public's understanding that Dietary Supplements are Foods and should be treated as such. An additional approach to protecting Health Freedom is Dr. Ron Paul (R-TX)'s H.R. 2117, The health Freedom Protection Act - http://www.house.gov/paul/ While the IHR does not support specific legislation, such laws should also be considered by policy makers.
We invite experts and professionals in all appropriate fields, as well as formulators, manufacturers and distributors of Dietary Supplements and other nutritional or natural products to contact us regarding their suggestions and ideas to make this Institute Project a success. Please contact us for further information, with AERC in the subject line.
This is the revised beta version of this web page. Please check back here often as this web page will change as this project develops. Initially we were concerned with the final wording of statutory requirements; now we are concerned with regulatory requirements and private alternatives. Developments will be reported in the History section of this site, as they happen. As the law's reporting requirements become effective, our emphasis will shift to educating the industry and helping companies set up appropriate QC reporting systems in conjunction with the IHR Third Party Evaluation and Reporting System.
Ralph Fucetola JD
Trustee, IHR