While recognizing that both the American Association of Poison Control Centers (AAPCC) and the Food and Drug Administration (FDA) are providing important services under serious budgetary constraints, U.S. Senator Dick Durbin (D-IL) and U.S. Representative Henry A. Waxman (D-CA) today called on the AAPCC to share dietary supplement data with the FDA at no additional cost to taxpayers. While poison control center data may help detect harmful products and identify safety concerns, negotiations over data sharing have stalled due to the high price tag set by AAPCC which received $18.8 million in federal funding in fiscal year 2012 accounting for almost 20% of the organization's budget.
A recent Government Accountability Office (GAO) report, requested by Durbin and Waxman, suggested that there is underreporting of adverse events associated with dietary supplements because consumers and health care practitioners are more likely to call a poison control center than report a problem to the FDA or manufacturer. Between 2008 and 2010, poison control centers received over 1,000 more adverse event reports than the FDA.
"In the GAO report, FDA officials acknowledge that the greatest challenge for identifying potential safety concerns from [adverse event reports] is the small number of [adverse event reports] that FDA receives related to dietary supplements. Officials also recognize that an opportunity to review requested poison control data could potentially improve the agency's ability to detect safety concerns," wrote Durbin and Waxman. "Considering that AAPCC received $18.8 million in federal funding in fiscal year 2012, which accounted for almost 20 percent of the organization's budget, we believe the AAPCC should provide FDA access to the additional data at no cost."
Text of today's letter to the President of the AAPCC follows:
March 27, 2013
Marsha Ford, MD, FACMT
American Association of Poison Control Centers
P.O. Box 32861
Charlotte NC 28232-2861
Dear President Ford:
We write to urge the American Association of Poison Control Centers (AAPCCs) to share data with the U.S. Food and Drug Administration (FDA) related to dietary supplements.
On March 18, 2013, the General Accountability Office (GAO) issued a report, "Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products," assessing FDA's adverse event reporting (AER) system for dietary supplements. FDA's AER system is an important surveillance tool used to help identify and respond to supplements that pose a risk to the public's health.
According to the GAO report, between 2008 to 2010 AAPCCs received over 1,000 more AERs than the FDA. GAO posited that some consumers and health care practitioners may call poison control centers to report a reaction, without reporting an adverse event to the FDA. GAO suggests that FDA's ability to oversee dietary supplements and identify potential safety concerns would be enhanced if AAPCCs provide access to information reported to centers. In the GAO report, FDA officials acknowledge that the greatest challenge for identifying potential safety concerns from AERs is the small number of AERs that FDA receives related to dietary supplements. Officials also recognize that an opportunity to review requested poison control data could potentially improve the agency's ability to detect safety concerns.
While the GAO report acknowledges that the FDA and AAPCCs have attempted to negotiate an agreement through which FDA could review raw poison control center data for their utility, we are disappointed to learn that negotiations stalled due to AAPCC's price tag of $76 million for the data. Even at the discount price of $800,000, the cost is nearly twice the $400,000 budgeted for FDA to process and perform surveillance of dietary supplement adverse events in fiscal year 2011. Further, considering that AAPCCs received $18.8 million in federal funding in fiscal year 2012, which accounted for almost 20 percent of the organization's budget, we believe the AAPCC should provide FDA access to the additional data at no cost.
We recognize that both the FDA and AAPCC are providing important services that protect the public's health, while operating under budgetary constraints. However, we urge the FDA and AAPCCs to continue efforts to establish an agreement that gives the FDA access to poison control center data that could inform FDA's ability to identify potential safety concerns from adverse event reports for supplements.
Thank you for your consideration of this important issue