GAO Reports FDA Increased AER Inspections, Enforcement

A March-released U.S. Government Accountability Office (GAO) report to Congress on FDA’s oversight of adverse event reporting (AERs) says the agency not only increased the number of AER inspections it performed in recent years but also increased enforcement efforts against firms guilty of infractions.

The GAO reports that FDA increased its number of AER inspections from 120 in 2008 to 410 during the period spanning January–September 2012. The agency’s enforcement actions included warning letters, injunctions, and import refusals.

“While the FDA increased the number of inspections from 120 in 2008 to more than 400 in 2012, NPA is encouraged that they only had to take 19 actions related to AER violations during this time,” commented the Natural Products Association (NPA; Washington, DC).

The number of AERs reported to FDA is also on the rise. “Specifically, the total number of AERs FDA received annually more than doubled over the period, from 1,119 in 2008 to 2,480 in 2011. This rise in AERs was driven by a large increase in the number of mandatory industry AERs,” the GAO reports.

Mandatory AERs refers to AERs reported by companies to FDA. The GAO report indicates that more companies are filing mandatory AERs and that the number of these mandatory AERs nearly tripled between 2008 and 2011, from 689 in 2008 to 2,040 in 2011.

By contrast, the number of AERs consumers themselves filed remained steady and lower, averaging about 461 annually. The GAO also points out that many consumers may actually report AERs to poison centers instead of FDA. In its report, the GAO encouraged FDA to consider whether reviewing poison center data might provide the agency with a more complete picture of total adverse events.

What types of AERs is FDA getting? Most were linked with dietary supplements, the GAO reports: “Most of these AERs were linked with supplements containing a combination of ingredients, such as vitamins and minerals or were otherwise not classified within FDA’s product categories.”

The GAO also notes that FDA has taken steps to implement many of the recommendations that were part of a GAO report on FDA’s AER system back in January 2009. For instance, recommendations urged the agency to issue guidance for new dietary ingredients, clarify the boundary between dietary supplements and conventional food, and expand partnerships to improve consumer understanding-all of which FDA has done. In this latest report, the GAO further recommends that FDA finalize any remaining guidance related to GAO’s 2009 recommendations.

On the whole, industry members, including trade associations, responded positively to the GAO report. “This GAO report indicated that 71% of serious adverse events reported to FDA came from the industry itself-and CRN will continue to urge the supplement industry to comply and support FDA in taking enforcement action against those companies that do not,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC).

He also urged that AERs not be taken out of context because “just because a consumer may have taken a product at the same time they experience an adverse symptom, it may not translate into a causal relationship between a product and the adverse event itself.”