DEA needs better management of quota process for controlled substances

The Drug Enforcement Agency (DEA), responsible for setting quotas of controlled substances, has not responded to manufacturers’ applications for these quotas in a timely fashion-and this has contributed to the shortage of controlled substances over the last decade, according to a recent GAO report.

Marcia Grouse, GAO’s director of Health Care, testified last week before the Senate Caucus on International Narcotics Control, explaining that both DEA and FDA are responsible for the prevention of controlled substances shortages and the response to any of these drug shortages.

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“We found significant weaknesses involving DEA’s management of the quota process for controlled substances. We found that DEA had not responded to manufacturers’ annual quota applications of bulk manufacturing and procurement quotas by its regulatory deadline of July 1 for any year from 2001 through 2014,” Grouse told the Senate Caucus.

In 2011, DEA response to manufacturers’ quota applications took an average of 182 days past the July 1 deadline, and in 2012, DEA averaged 178 days past the July date to respond, according to Grouse. In addition, DEA did not propose aggregate production quotas (APQs) by May 1, as it is required by its regulations.

DEA also dragged its feet on responding to supplemental quota applications, which require a 30-day deadline. “It is worth noting that DEA responded to 21 percent of supplemental applications within 30 days during 2011 and 2012, suggesting this requirement could post a challenge during a future shortage,” Grouse said.

Reason for slow response

DEA reported that its slow response to setting quotas of controlled substances within the required time frames was due to inadequate staffing. DEA stated that it had difficulty finding appropriate candidates with the necessary skills and who could pass the background checks for employment. The agency also noted that some qualified candidates who were offered positions turned them down.

DEA also noted that drug manufacturers would revise their applications for quotas of controlled substances and that affected the turnaround time of the applications.

“Ten manufacturers reported to FDA that quota-related issues caused 7 of the 40 shortages of some drugs containing schedule II substances from January 2010 through June 2013,” Grouse testified.

DEA did not agree that quotas can cause specific drug shortages because the agency sets quotas at the class level of a substance. However, GAO said DEA’s actions would affect drug shortages because “[manufacturers’] decisions are made within the confines of the amount and timing of the quota granted by DEA.”

GAO had four suggestions to improve DEA’s quota process. “We recommended that DEA (1) strengthen its internal controls of Year-End Reporting and Quota Management System (YERS/QMS), (2) establish performance measures related to quotas, (3) monitor and analyze YERS/QMS, and (4) develop internal policies for processing quota applications and setting aggregate, annual and supplemental quotas.”

GAO also recommended that DEA create policies and procedures to work with FDA and set a time frame for responding to FDA’s requests to review shortage-related quota applications.