GAO Gives FDA Recommendations for AER Regulation

GAO report

Written By:
WholeFoods Magazine Staff
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Washington, D.C.—In mid-March, the U.S. Government Accountability Office (GAO) released a report regarding the U.S. Food and Drug Administration’s (FDA) regulation of adverse event reports (AERs) when it comes to dietary supplements. This report was developed at the request of Representative Henry Waxman (D-CA) and Senator Richard Durbin (D-IL). At their prodding, GAO examined the number and source of AERs FDA received since 2008; any actions FDA took to make sure companies complied with AER requirements; and what FDA has done to follow up on GAO’s 2009 recommendations for enhancing its oversight of dietary supplements.

GAO found that the agency received 6,307 AERs from 2008 to 2011, mostly from industry and mostly from combination products and those not classified elsewhere. In addition, FDA increased its inspections of firms (from 120 in 2008 to 410 from Jan. 1 to Sept. 30, 2012) to ensure compliance with AER requirements and took regulatory action 19 times for AERs noncompliance. Since some consumers are reporting problems to places like poison control centers, GAO expressed concern that FDA isn’t receiving all possible AERs.

While the agency has used AERs for some consumer protection acts, GAO believes FDA is missing some opportunities. GAO gave FDA several recommendations, including collecting information from poison centers; creating a process for logging information on how it is using AERs; establishing a system to inform consumers of protective actions they could take; making AER collection more efficient by allowing mandatory AERs to be collected electronically; letting the FDA Commissioner decide what information should be uploaded to FDA’s Web site regarding protective measures for dietary supplements; and establishing a timeline for issuing a final guidance on NDI notification and a draft guidance on liquid products.

Several organizations weighed in on the report, including the National Products Association. “The Natural Products Association and our industry supporters advocated for the law that established Adverse Event Reporting,” said Dr. Cara Welch, senior vice president of scientific and regulatory affairs for the Natural Products Association, “and we’re pleased to see that the GAO report confirms the importance of this law in the industry. In fact, it shows that 71 percent of adverse events reported to the FDA came from the supplement industry per the requirements of SAER law.” She also found that the agency taking action for AER violation encouraging.

The president and CEO of Council for Responsible Nutrition (CRN), Steve Misters, also lauded the report.:“We believe that the recommendations from the GAO report are reasonable and open the door for further dialogue with FDA as to how industry and government can continue to work together to help ensure consumers are making wise decisions about incorporating dietary supplements into their health regimens.”  But, Mister also said that while CRN supports transparency about AERs, there should be consumer education about the fact that just because he/she experienced a reaction while taking a product, it does not proof a causal relationship between the two.

Meanwhile, the American Herbal Products Association weighed in on the recommendations. It felt additional documentation of how FDA uses AERs is redundant because this process already exists, and it supports electronic submission of AERs. All groups are looking forward to the additional guidance suggested by GAO.

GAO is currently in the process of evaluating FDA’s response to their recommendations and will post information on its Web site when it is made available. The full report, Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products, is available here: www.gao.gov/products/GAO-13-244.

 

Published in WholeFoods Magazine, May 2013 (online 3/21/13)