Dietary supplements: FDA may have opportunities to expand its use

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One potential measure of underreporting is the number of dietary supplement-related health problems managed as poison exposure cases by poison centers. According to annual reports by the American Association of Poison Control Centers (AAPCC), poison centers received 145,775 calls from consumers or others related to dietary supplements from 2008 through 2010. 34 These include cases in which the consumer took more than the directed amount of a product, accidentally ingested the product, or used the product as directed but experienced an adverse event. 35 According to AAPCC reports, there were 4,863 cases of adverse events from 2008 to 2010, over 1,000 more than the 3,827 AERs FDA received during the same period. 36 We could not estimate how much overlap, if any, occurred between cases reported to FDA and the poison centers or determine whether some of the cases managed by poison centers were serious and might have also been reported to firms. However, the greater number of calls received by poison centers suggests that consumers, health care practitioners, and others may have contacted poison centers without reporting the adverse event to FDA. FDA officials said that they are interested in reviewing the poison center data related to dietary supplements and have held discussions with AAPCC representatives. Specifically, CFSAN officials said that they want to review the raw poison center data on dietary supplements to understand what it includes and whether it would be useful for their analysis. However, these officials said that they were unable to review the raw dietary supplement data without purchasing it and said that FDA should have access to the data at no additional cost given the current 34 Poison centers do not define dietary supplements according to the Federal Food, Drug, and Cosmetic Act. Therefore, we worked with AAPCC representatives and FDA officials to make the appropriate adjustments to the data to make them comparable to FDA’s AERs. For more information on our scope and methodology, see appendix I. 35 Based on discussions with FDA officials, we focused our analysis on adverse events under use as directed, since these types of cases were most similar in nature to the types of AERs FDA received. 36 Because FDA officials told us that AERs are primarily associated with product use as directed, we adjusted the poison center data to include only those cases where an individual experienced an adverse reaction when using the product as directed and excluded reports resulting from misuse, abuse, or accidental ingestion. Page 21 GAO-13-244 Dietary Supplements
level of federal support for poison centers. 37 For example, a 2012 study commissioned by the AAPCC, federal funding accounted for an estimated 13 percent (about $17 million) of poison centers’ annual operating budget in 2011. 38 An FDA official noted that, in a 2004 report, the Institute of Medicine recommended that poison center data become available to all appropriate local, state, and federal public health units on a real-time basis and at no additional cost. 39 In this report, the Institute of Medicine also recommended that poison centers receive sufficient federal funding to cover core activities, which at the time were estimated to cost approximately $100 million annually. 40 According to AAPCC representatives, AAPCC does not receive federal appropriations to cover cost of collecting, maintaining, and sharing poison center data at the national level and generally charges federal agencies to access the data. 41 AAPCC representatives also said that they were willing to work with FDA on reduced pricing. Specifically, based on a May 2012 quote, accessing 4 years’ worth of AAPCC data of about 5,400 product codes would have 37 AAPCC representatives said that they had offered to provide FDA with a smaller, targeted analysis of the dietary supplement data at no charge to temporarily meet FDA’s needs while a longer-term agreement was negotiated, but CFSAN officials told us that they needed to see the raw data for such an analysis to be informative and prior to agreeing to a longer-term arrangement. AAPCC representatives told us that since they do not own the poison center data—only the national database where it is stored—they cannot release it without the 57 poison centers’ permission. 38 The Lewin Group, Final Report on the Value of the Poison Center System, (Falls Church, VA: The Lewin Group: 2012) http://production-aapcc.dotcloud.com/about/lewingroup-report/ (accessed January 7, 2013). The report notes that its findings do not include recent reductions in federal funding to poison centers. Additionally, according to AAPCC representatives, AAPCC funding and data management costs were not included in this report. 39 National Academy of Sciences, Institute of Medicine, Forging a Poison Prevention and Control System (Washington, D.C.: 2004). 40 According to the 2012 Lewin Group Report, total expenditures to maintain the poison center services nationwide were an estimated $136 million in 2011. 41 According to AAPCC representatives, AAPCC does not own the data collected by poison centers, but owns and operates the national database where the data are stored. These representatives said that there are large costs for collecting, maintaining, analyzing, organizing and reporting on the national data which are borne by AAPCC and its members, and that the sales of the national data support these costs. As of February, 2013, the annual operating budget for the national database was approximately $3 million, according to an AAPCC representative. Page 22 GAO-13-244 Dietary Supplements
Page 1 and 2: GAO United States Government Accoun
Page 3 and 4: Contents Letter 1 Background 7 FDA
Page 5 and 6: Abbreviations AAPCC American Associ
Page 7 and 8: supplement labels include a list of
Page 9 and 10: mild and moderate adverse events to
Page 11 and 12: from other FDA consumer protection
Page 13 and 14: • FDA’s Center for Drug Evaluat
Page 15 and 16: Figure 1: Process for Reporting a H
Page 17 and 18: pass the AER or cluster of AERs to
Page 19 and 20: Table 2: Examples of FDA Consumer P
Page 21 and 22: to provide information on AERs FDA
Page 23 and 24: other outcomes in the AERs was avai
Page 25: Consumers and Others May Not Be Vol
Page 29 and 30: detection of potentially harmful pr
Page 31 and 32: Figure 5: Number of Foreign and Dom
Page 33 and 34: Figure 6: Proportion of Dietary Sup
Page 35 and 36: Table 3: Identified Advisory and Re
Page 37 and 38: egistered with FDA as required. 53
Page 39 and 40: Because FDA has the burden of proof
Page 41 and 42: products. We also identified 11 reg
Page 43 and 44: submit these AERs in hard copy by m
Page 45 and 46: (accelerated heart rate). 68 FDA of
Page 47 and 48: c According to FDA data, as of July
Page 49 and 50: potential safety concerns from AERs
Page 51 and 52: We are sending copies of this repor
Page 53 and 54: Appendix I: Objectives, Scope, and
Page 55 and 56: Appendix I: Objectives, Scope, and
Page 57 and 58: Appendix II: Data on Consumer Appen
Page 59 and 60: Appendix II: Data on FDA’s Consum
Page 65 and 66: Appendix III: Comments from the Dep
Page 67 and 68: Appendix III: Comments from the Dep
Page 69: GAO’s Mission Obtaining Copies of

Dietary supplements: FDA may have opportunities to expand its use

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