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. GAO’s report concluded, among other things the following:
- 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;
- DEA lacks critical management information because it does not have performance measures related to setting quotas, nor does it monitor data to assess its performance;
- DEA does not have reasonable assurance that the quotas it sets are in accordance with its requirements and cannot ensure continuity of its operations, as it does not have protocols, policies, training materials, or other documentation to manage the quota process; and
- DEA and FDA have not established a sufficiently collaborative relationship to deal with drug shortages.
In response to this report, DEA asserts that there is no causal relationship between its quota process and drug shortages. The agency also took exception to the methodology and data analysis in GAO’s review. With that said, DEA acknowledged its repeated failure to issue quota in a timely manner, attributing its lack of compliance to its own regulations to inadequate staffing. Upon issuance of the GAO report, Senators Grassley and Feinstein scheduled a hearing before the Caucus on International Narcotics Control, to discuss the findings of GAO’s report. The hearing is planned for April 14, 2015.