Industry hopes Supreme Court will save the AER day

By Shane Starling

- Last updated on GMT

Related tags Supreme court of the united states

Industry groups say mandatory reporting of non-serious Adverse Event Reports (AERs) will lead to, “an avalanche of trivial information” that may jeopardise public safety and confuse and overwhelm financial markets.

The groups say that the Ninth Circuit Court of Appeals verdict in Matrixx Initiatives Inc. v. Siracusano that even statistically non-significant AERs should be reported to financial markets and the FDA is unnecessary and unnecessarily distorting.

They have filed documents to the US Supreme Court which will hear the appeal in the fall.

“The Ninth Circuit‘s rejection of a statistical significance standard is detrimental to investors and consumers,”​ wrote the Council for Responsible Nutrition (CRN) and the Consumer Healthcare Products Association (CHPA) in their amicus curiae, ​a provision that allows interested parties to submit supporting information to the court process.

The Natural Products Association (NPA) submitted an amicus curiae ​of its own.

CRN and CHPA continued: “Under the Ninth Circuit‘s standard, companies have an incentive to disclose all adverse event reports without regard to whether there is any evidence of a causal connection between the adverse event and the product. As a result, the Ninth Circuit‘s approach is likely to bury investorsin an avalanche of trivial information – a result that is hardly conducive to informed decision making.”

“Undifferentiated disclosure of adverse events may also be harmful to consumers. As a result of such disclosures, consumers might stop taking beneficial medications based on concerns about adverse events that are unrelated to the medications.”

Wrong signals

CRN president and CEO Steve Mister told the Ninth Circuit Court of Appeals decision bucked case law (such as Carter-Wallace I and II)​ that found only statistically significant AERs need be mandatorily reported.

“If companies are forced to report every AER it has the potential to send the wrong signals because one-off AERs could be caused by a range of factors,” ​he said. “You need to be able to see the trends.So to report everything could have a greater distorting effect than any kind of non-reporting.”

Mister added that provisions define serious and non-serious adverse events, and that companies are obliged to declare all serious AERs, as determined by the FDA. Even non-serious AERs are required to be archived by companies for six years.

The CRN/CHPA amicus curiae ​highlighted potential causes of AERs that may not be product-related. “For example, an adverse event could be a manifestation of a patient‘s underlying health condition or a side effect of another medication that a consumer is taking.”

The amicus curiae​ can be found here.

Clear implications

“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 Ninth Circuit’s action is not good for manufacturers, not good for consumers, and just is not good law. We hope the Supreme Court will agree.”

The NPA’s counsel, Scott Bass, of Sidley Austin, ​added: “Companies cannot possibly guess in advance what will be deemed adequate disclosure years later in collateral litigation.”

In AER guidance issued last year, the FDA noted AERs are considered “safety reports” ​and were by no means an admission that causality existed between the product and the AER.

AER regulations came into effect in December 2007, requiring all manufacturers, packers, distributors or marketers of dietary supplements to notify FDA of any serious adverse event reports received in connection with their products.

Related topics Regulation GMPs, QA & QC

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