OIG Releases Final Report on Supplement AERs 38743

OIG Releases Final Report on Supplement AERs

WASHINGTON--After a month and a half of "draft report" scuttlebutt, the final version of recommendations for handling adverse event reports (AERs) for dietary supplements was released April 20. In Adverse Event Reporting [AER] for Dietary Supplements: An Inadequate Safety Valve, the Office of the Inspector General (OIG) gave its overview and recommendations about how the industry and Food and Drug Administration (FDA) deal with AERs. Murmurings about this report began when a "draft" report was given to FDA, industry organizations and public interest groups in early March in order to add their comments and suggestions to the final version.

OIG's Office of Evaluation and Inspections assembled the report to "protect the integrity of the Department of Health and Human Services programs as well as the health and welfare of beneficiaries served by them." In collecting information for this report, OIG analyzed data from FDA's database; FDA laws, regulations, policies and procedures; several AERs; and relevant literature. OIG also interviewed FDA officials, industry representatives and scientific experts. However, OIG did not evaluate the internal operating procedures of the current AER system, a fact that many in the industry say negate the findings of this report.

"You can't find out if FDA can do its job with its existing authority until it is investigated why it isn't able to do the job," said Tony Young, counsel for the American Herbal Products Association (AHPA), one of the organizations to comment on the report before it was made final. "OIG didn't look at the system to ascertain why it wasn't working, they simply assumed it wasn't working and offered [through these recommendations] a bunch of improvements."

According to the OIG's findings, FDA suffers from limited medical, product, manufacturer, consumer and trend information relating to dietary supplements. This lack of "vital information to adequately assess signals of possible public health concerns generated by the [AER] system" might have led to FDA rarely taking safety actions to protect consumers, according to OIG. For example, between 1994 and 2000, OIG documented 32 safety actions, whereas there were more than 100 million people taking supplements in that time period. And in 1999, Poison Control Centers received 13,000 reports related to dietary supplements compared to FDA's 460.

In response to these findings, OIG recommended "a blueprint for action" for both FDA and dietary supplement manufacturers. Some of the actions for FDA included comparing AER information with Poison Control Centers, informing healthcare providers how to distinguish AERs from dietary supplements and expediting the development and implementation of Good Manufacturing Practices (GMPs). The actions OIG suggested for manufacturers included reporting serious adverse events to FDA and registering the company and its products with FDA.

The dietary supplement industry had mixed reactions to the report. Public interest groups criticized OIG for not asking for more regulatory action. Sidney Wolfe, M.D., director of the Public Citizen Health Research Group, stated that without additional legal authority, FDA is positioned to wait until there are enough deaths or injuries before a recall can begin, as he sees the case has been with ephedra. He went on to state that better regulations need to go into effect in order to combat current-day concerns, including the potential for BSE-contamination in various supplements.

The industry organizations faulted OIG for not evaluating internal operating procedures for AERs and for comparing dietary supplements with drugs. "It is not the failing in the current AER system for dietary supplements that has led to the relatively low number of FDA actions," said R. William Soller, Ph.D., senior vice president and director of science and technology at the Consumer Healthcare Products Association (CHPA), "but rather the generally excellent safety profiles of many dietary supplements." He added that public awareness campaigns would effectively bridge the gaps that are inherent in AER surveillance systems.

However, FDA reported that the findings were a fair assessment of the challenges the agency faces due to lack of funds and manpower. In its response to the draft report, FDA wrote that the agency asked for but didn't receive additional funds for its AER system in fiscal years 2000 and 2001. For fiscal year 2002, FDA submitted to Congress a report on the cost for implementing its Dietary Supplement Strategic Plan that ensures a better AER system, a plan it published last January. FDA is "hopeful" that Congress will give the agency more funding based on this report.

To read the 110-page report, visitwww.hhs.gov/oig/oei/reports/a519.pdf.