Dietary supplements: FDA may have opportunities to expand its use
Dietary supplements: FDA may have opportunities to expand its use
Dietary supplements: FDA may have opportunities to expand its use
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products. We also identified 11 regula<strong>to</strong>ry actions for firms also listed in<br />
an AER, representing less than 1 percent of all such actions. The<br />
regula<strong>to</strong>ry actions included 8 import refusals and 3 product recalls, most<br />
of which were for Hydroxycut products. (See app. II for more<br />
information on consumer protection actions.) <strong>FDA</strong> officials <strong>to</strong>ld us they<br />
also <strong>use</strong> AERs <strong>to</strong> moni<strong>to</strong>r the results of these actions. For example, if<br />
<strong>FDA</strong> issued a warning letter <strong>to</strong> a firm based on violations of CGMP<br />
requirements during an inspection, receipt of subsequent AERs <strong>may</strong><br />
indicate that the firm has not rectified <strong>its</strong> practices. Similarly, if <strong>FDA</strong><br />
receives an AER for a product that <strong>FDA</strong> has removed from the market by<br />
a regula<strong>to</strong>ry action such as a recall, <strong>FDA</strong>’s receipt of AERs subsequent <strong>to</strong><br />
the initial action indicates <strong>to</strong> <strong>FDA</strong> that further action <strong>may</strong> be needed.<br />
More Information on How<br />
<strong>FDA</strong> Uses AERs May Help<br />
<strong>FDA</strong> Expand Their Use<br />
<strong>FDA</strong> has limited information on how it <strong>use</strong>s AERs <strong>to</strong> initiate and support<br />
<strong>its</strong> consumer protection actions; such information could improve <strong>FDA</strong>’s<br />
ability <strong>to</strong> assess whether the agency is using AERs <strong>to</strong> their fullest extent<br />
in this capacity and make improvements as needed. For example, prior<br />
work has shown that agencies can <strong>use</strong> data on performance <strong>to</strong> identify<br />
and mitigate problems, allocate resources, and improve effectiveness. 61<br />
Currently, <strong>FDA</strong> <strong>use</strong>s six separate data management systems <strong>to</strong> moni<strong>to</strong>r<br />
the consumer protection actions we reviewed apart from AERs, as<br />
outlined in table 5.<br />
61 GAO, Managing for Results: Enhancing Agency Use of Performance Information for<br />
Management Decision Making, GAO-05-927 (Washing<strong>to</strong>n, D.C.: Sept. 9, 2005). For<br />
information on using performance data <strong>to</strong> improve IT strategic planning and investment<br />
management, see GAO-12-346, Information Technology: <strong>FDA</strong> Needs <strong>to</strong> Fully Implement<br />
Key Management Practices <strong>to</strong> Lessen Modernization Risks (Washing<strong>to</strong>n, D.C.: Mar. 15,<br />
2012).<br />
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GAO-13-244 <strong>Dietary</strong> Supplements