Friday, October 12, 2007

NGO Strives to Help Companies Meet Standard for FDA AER Regulation

Copy of Press Release of 10/13/07 on PR Web:

Nongovernmental Institute Sponsored Framework for Supplement Adverse Event Reporting
More information: http://www.aer-consulting.com/

The Institute for Health Research announces publication of an Internet Guide for companies in the natural products industry using neutral third parties to screen and report possible adverse events resulting from taking dietary supplements or non-prescription medicines, the AER Guide.

Summit, NJ (PRWEB) October 13, 2007 -- The Institute for Health Research announces publication of an Internet Guide for companies in the natural products industry using neutral third parties to screen and report possible adverse events resulting from taking dietary supplements or non-prescription medicines, the IHR AER Guide. The draft guide for vitamin industry companies can be found at the Guide website, AER-Consulting.com. It is intended to meet the standards suggested by the draft AER guidance announced by the FDA yesterday.

The Dietary Supplement and Non-Prescription Drug Consumer Protection Act, known as the Adverse Event Reporting (or AER) Law, goes into effect on December 22, 2007, having been signed into law one year before. To date the FDA has not issued any regulation or guidance enabling the industry to comply with the law. After indications that the agency was going to issue the new regulation in September, to allow the industry sufficient time to react, the lack of action until yesterday has been criticized. 1

Supporting natural products' compliance with the new law, while gathering important research information, the Institute has created a community outreach, Adverse Event Reporting Consultants (AERC) with the web address: aer-consultants.com. It has developed a collaborative structure, under its general sponsorship, in cooperation with credentialed healthcare professionals and advocacy groups, acting as a neutral third party, to evaluate adverse reaction claims, on behalf of consumers and purveyors.

The History of the FDA Bill:

Congress adopted the Dietary Supplement and Non-Prescription Drug Consumer Protection Act. The new AER law requires manufacturers and distributors to report all "serious" adverse events to the FDA. The bill was introduced June 21, 2006 by a group of Senators that included both critics and supporters of the industry. It was supported by major supplement industry groups. Others, including supplement consumer groups and health freedom advocates, vigorously opposed the bill. The bill was adopted on December 9, 2006 and signed into law on December 22, 2006. It becomes effective December 22, 2007 and the FDA had been expected to issue draft Regulations under the statute during September 2007. Issuing them on October 12, 2007 leaves the industry little time to prepare for the new reporting requirement.

With the FDA just specifying how these events are to be recorded and reported, most organizations are concerned how to address these events responsibly. AER Consultants has, as its Counsel Ralph Fucetola JD states, "…stepped up to the plate and developed a framework that in addition to complying with the FDA mandate will allow the collection of data that will be invaluable in the future to determine drug and non-pharmaceutical interactions..." The Institute invites public comment on the implementation of this consumer and industry initiative.

Notes:
1. vitaminlawyerhealthfreedom.blogspot.com/2007/10/fda-faulted-for-failure-to-issue-aer.html

Also, see the FDA comment site for its draft AER guidance:fda.gov/OHRMS/DOCKETS/98fr/07d-0388-gdl0001.pdf

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The Institute for Health Research is a non profit, nongovernmental, exempt organization. P.O. Box 642 Summit, NJ 07901 - Inhere.org . Its trustees are Karen Horbatt, MBA, President of The Green Turtle Bay Vitamin Company, energywave.com, Ralph Fucetola JD, vitaminlawyer.com and Dr. Richard Podell, MD, drpodell.org.
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FOLLOW-UP:

The release has been picked up by Medical News -
http://medical.presslib.com/alternative-medicine/560637.htm

Today, 10/16/07, the release has a top Google position on "AER FDA guide" and the fourth position on "AER FDA."

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