03.22.13
The Government Accountability Office (GAO) released a report on March 18, which examined the Food and Drug Administration's (FDA) use of adverse event reports (AERs) to identify and respond to safety concerns associated with dietary supplements.
The report, “Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products,” examined the number of supplement-associated AERs FDA has received since 2008, actions FDA has taken to ensure compliance with AER reporting and recordkeeping requirements, how AERs are used to initiate and support consumer protection efforts, and the extent to which FDA has implemented recommendations GAO made in a report issued in 2009.
In response to GAO’s report, various industry organizations are chiming in with their perspective on the report’s findings, as well as offering recommendations to address the issues raised within the assessment.
Dr. Cara Welch, senior vice president of scientific and regulatory affairs of The Natural Products Association (NPA) voiced support for the GAO dietary supplements report, noting that, “The Natural Products Association and our industry supporters advocated for the law that established Adverse Event Reporting and we’re pleased to see that the GAO report confirms the importance of this law within the industry. In fact, it shows that 71% of adverse events reported to the FDA came from the supplement industry per the requirements of SAER law.”
She added, “The GAO report helps demonstrate that consumer safety is the number one priority for supplement manufacturers. NPA echoes the GAO recommendation that FDA expand their information collection by partnering with poison control centers and educating the public.”
Further, she commented, “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. Still, we are concerned any time a violation may be found. NPA offers extensive educational opportunities to help supplement makers comply with government regulations and recently partnered with other industry members to offer widespread education on adverse event reporting.”
President of The American Herbal Products Association (AHPA) Michael McGuffin also issued a series of responses to address the specific GAO recommendations contained in this report. In a press release, Mr. McGruffin commented on the following GAO recommendations:
“Recommendation #1: FDA should continue efforts to explore all possible options to obtain poison center data if the agency determines that the data could inform FDA's ability to identify potential safety concerns from adverse event reports for dietary supplements.
AHPA Response: This recommendation may not be objectionable so long as the minimum elements required for an AER report are within the poison control center information and upon the understanding that AERs, wherever they originate, do not constitute evidence that there is a causal relationship between the reported adverse event and the named dietary supplement.
Recommendation #2: FDA should incorporate a mechanism to collect information on when AERs are used to support and inform consumer protection actions (i.e., surveillance, advisory, and regulatory actions).
AHPA Response: This recommendation is already addressed in that FDA currently uses AERs to develop consumer communications. The agency has a history of doing exactly this, most recently with the issuance in 2008 and 2009 of safety alerts in relation to AERs received in association with Total Body Formula and Hydroxycut products, respectively. If the GAO is asking for a separate mechanism to oversee the safety of dietary supplements, it would be redundant and not necessary.
Recommendation #3: FDA should implement a mechanism for electronic submission of mandatory AERs.
AHPA Response: AHPA is not opposed to this recommendation if it can be executed within the agency's normal reporting structure, if it enhances the AER program, and if it is consistent with other FDA electronic records submissions.
Recommendation #4: FDA should determine what additional information FDA can provide to the public about dietary supplement AERs consistent with existing law and make the information publicly available and readily accessible on its website.
AHPA Response: AHPA is supportive of FDA treating all products under its jurisdiction equally in the matter of AERs, without regard for their regulatory category. Both drug and supplement AERs are currently accessible through requests filed under the Freedom of Information Act. FDA may at some time determine to make AERs more easily accessible to the public, and should provide similar access across product categories.
Recommendation #5: FDA should establish a time frame for issuing final guidance for the draft (1) NDI guidance and (2) guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients.
AHPA Response: AHPA continues to work with FDA on both of these issues, and looks forward to continued dialogue with the agency so that FDA can issue timely, fair, equitable and clear guidance regarding the requirements of the Dietary Supplement Health and Education Act of 1994.”
The report, “Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products,” examined the number of supplement-associated AERs FDA has received since 2008, actions FDA has taken to ensure compliance with AER reporting and recordkeeping requirements, how AERs are used to initiate and support consumer protection efforts, and the extent to which FDA has implemented recommendations GAO made in a report issued in 2009.
In response to GAO’s report, various industry organizations are chiming in with their perspective on the report’s findings, as well as offering recommendations to address the issues raised within the assessment.
Dr. Cara Welch, senior vice president of scientific and regulatory affairs of The Natural Products Association (NPA) voiced support for the GAO dietary supplements report, noting that, “The Natural Products Association and our industry supporters advocated for the law that established Adverse Event Reporting and we’re pleased to see that the GAO report confirms the importance of this law within the industry. In fact, it shows that 71% of adverse events reported to the FDA came from the supplement industry per the requirements of SAER law.”
She added, “The GAO report helps demonstrate that consumer safety is the number one priority for supplement manufacturers. NPA echoes the GAO recommendation that FDA expand their information collection by partnering with poison control centers and educating the public.”
Further, she commented, “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. Still, we are concerned any time a violation may be found. NPA offers extensive educational opportunities to help supplement makers comply with government regulations and recently partnered with other industry members to offer widespread education on adverse event reporting.”
President of The American Herbal Products Association (AHPA) Michael McGuffin also issued a series of responses to address the specific GAO recommendations contained in this report. In a press release, Mr. McGruffin commented on the following GAO recommendations:
“Recommendation #1: FDA should continue efforts to explore all possible options to obtain poison center data if the agency determines that the data could inform FDA's ability to identify potential safety concerns from adverse event reports for dietary supplements.
AHPA Response: This recommendation may not be objectionable so long as the minimum elements required for an AER report are within the poison control center information and upon the understanding that AERs, wherever they originate, do not constitute evidence that there is a causal relationship between the reported adverse event and the named dietary supplement.
Recommendation #2: FDA should incorporate a mechanism to collect information on when AERs are used to support and inform consumer protection actions (i.e., surveillance, advisory, and regulatory actions).
AHPA Response: This recommendation is already addressed in that FDA currently uses AERs to develop consumer communications. The agency has a history of doing exactly this, most recently with the issuance in 2008 and 2009 of safety alerts in relation to AERs received in association with Total Body Formula and Hydroxycut products, respectively. If the GAO is asking for a separate mechanism to oversee the safety of dietary supplements, it would be redundant and not necessary.
Recommendation #3: FDA should implement a mechanism for electronic submission of mandatory AERs.
AHPA Response: AHPA is not opposed to this recommendation if it can be executed within the agency's normal reporting structure, if it enhances the AER program, and if it is consistent with other FDA electronic records submissions.
Recommendation #4: FDA should determine what additional information FDA can provide to the public about dietary supplement AERs consistent with existing law and make the information publicly available and readily accessible on its website.
AHPA Response: AHPA is supportive of FDA treating all products under its jurisdiction equally in the matter of AERs, without regard for their regulatory category. Both drug and supplement AERs are currently accessible through requests filed under the Freedom of Information Act. FDA may at some time determine to make AERs more easily accessible to the public, and should provide similar access across product categories.
Recommendation #5: FDA should establish a time frame for issuing final guidance for the draft (1) NDI guidance and (2) guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients.
AHPA Response: AHPA continues to work with FDA on both of these issues, and looks forward to continued dialogue with the agency so that FDA can issue timely, fair, equitable and clear guidance regarding the requirements of the Dietary Supplement Health and Education Act of 1994.”
