Industry has adverse reaction to AER court case

A case involving the Adverse Event Reporting system for over-the-counter products has the dietary supplement industry concerned enough that three associations filed “friends of the court” briefs (amicus curiae) to the U.S. Supreme Court on Friday, Aug. 27.

Amicus curiae educates the court on points of law that are in doubt, or raises awareness about an aspect of the case that the court might otherwise miss. The Washington, D.C.-based Natural Products Association filed its own amicus curiae, and the Washington, D.C.-based Council for Responsible Nutrition and the Washington, D.C.-based Consumer Healthcare Products Association filed jointly, with the aim of educating the courts about the intent of the AER system and how the decision could negatively affect consumers, companies and retailers.

The NPA and other industry trade associations are concerned that a Ninth Circuit Court of Appeals decision (Matrixx Initiatives, Inc. v. Siracusano), which called for the reporting of even non-serious AERs to FDA and the financial markets, will lead to a great deal of irrelevant information that could harm the public and wreak havoc on the financial status of companies. “While the case involves an over-the-counter product, there are clear implications for the supplement industry, especially as the reporting requirements for OTCs and supplements were enacted in the same piece of legislation” said John Gay, executive director and CEO of the NPA.

The decision means that even the most minor of AERs could be released to the public, without any proof of cause, and the company could be held financially liable through a class action suit. “This could easily lead to chasing a lot of windmills that may not be significant,” said Daniel Fabricant, vice president of global government and scientific affairs for NPA.

The case could set a precedent for the dietary supplements industry because it would give the impression that a single AER is causal and consumers could stop taking medications and supplements that are prescribed by their healthcare practitioners when there is no cause to do so. “As one of the principal supporters of the 2006 adverse event reporting law for dietary supplements and OTCs, CRN is concerned that the Court understand that adverse event reports are merely “signals” to FDA of a possible association between an event and a product,” said Steve Mister, president and CEO of CRN. “AERs are not causal, they are not admissions by the manufacturer of a harm, nor do they even signify the company’s agreement with the report. FDA has repeatedly stated that AERS are useful for hypothesis generation, they do not necessarily indicate a connection between the reported harm and the product.” The case will be heard in the fall.