FDA failing to provide AER guidance

October 2007

The detailed data required under new adverse event reports (AERs) laws, need to be made transparent sooner rather than later, a major trade group has told the United States Food and Drug Administration.

The Maryland-based American Herbal Products Association (AHPA) has requested what it considers an overdue guidance document to give the supplements industry a clearer idea of what is expected of them when the law kicks in on December 22. FDA guidance was expected on September 19 but has yet to see the light of day.

AHPA is charging the FDA with failing to provide necessary guidance and made its thoughts known in a formal letter to the FDA and its parent agency, the US Department of Health and Human Services (HHS).

The Dietary Supplement and Nonprescription Drug Consumer Protection Act will require serious AERs to be submitted to the FDA. The Act requires the Secretary of Health and Human Services to "issue guidance on the minimum data elements that should be included in a serious adverse event report as described under the amendments made by this Act."

"Congress clearly intended that businesses would have at least 90 days to digest the FDA's guidance and make any necessary changes to their staff or procedures in order be ready to comply with the law when it goes into effect," said AHPA president Michael McGuffin. "The clock is ticking."

AHPA also asked HHS and FDA whether, in the absence of clear guidance, FDA would exercise enforcement discretion if companies do not submit AERs as the agency wishes.

"There's no question that the law goes into effect on December 22," said McGuffin. "Companies are already preparing to submit any serious AERs they receive. However, it's inefficient and confusing to establish a procedure that may change when guidance is finally produced."

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