On March 4, 2015, the Government Accountability Office (GAO) released a report titled, Drug Shortages: Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved. GAO’s report examined, (1) the trends in such shortages, (2) the effect on patients and providers, (3) DEA’s administration of the quota process, and (4) coordination between DEA and FDA to prevent and mitigate shortages.
- DEA has not effectively administered the quota process that limits the amount of controlled substances available for use in the United States;
- DEA has failed to meet statutory and regulatory deadlines for setting quota for more than the last decade (something we have discussed on this blog);
- DEA’s weak internal controls jeopardize the agency’s ability to effectively manage the quota process;
- more
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