The Justice Department's inspector general, in a report released Tuesday, said that the Drug Enforcement Administration (DEA) was "slow to respond" as to the increasing use of opioids since 2000.
The DEA was also faulted for rarely using its strongest enforcement tool, the Immediate Suspension Order, to stop registrants from diverting prescription drugs. Weaknesses were also identified in the DEA's registration process, which allowed manufacturers, distributors and health care providers to immediately reapply after their registration was revoked or surrendered.
The report was an examination of the DEA's regulatory and enforcement efforts to control opioids - a class of drugs that includes powerful prescription painkillers such as OxyContin and Vicodin and illegal drugs including heroin and illicitly made fentanyl - since the crisis began to come into focus.
"Unlike past drug crises, in combating the current opioid epidemic DEA failed to develop a comprehensive national strategy that could have focused and directed its regulatory and enforcement efforts," the watchdog report stated.
Opiods have been linked to more than 400,000 deaths in the U.S. since 2000, and as of 2017, more than 130 people die every day in the U.S. from opioid overdoses, according to the Centers for Disease Control and Prevention (CDC).
The report found that “the rate of opioid overdose deaths in the United States grew, on average, by 8 percent per year from 1999 through 2013 and by 71 percent per year from 2013 through 2017. Yet, from 2003 through 2013 DEA was authorizing manufacturers to produce substantially larger amounts of opioids. For example, the Aggregate Production Quota (APQ) of oxycodone in the United States, which DEA establishes annually, increased over 400 percent between 2002 and 2013. It was not until 2017 that DEA significantly reduced the APQ for oxycodone, by 25 percent. In 2018, DEA further reduced the APQ for oxycodone by 6 percent.”
The DEA’s preregistration process did not adequately vet all new applicants before DEA registration was granted, and the organization has regulations that fail to assess the suitability of potential new registrants. This may prevent DEA from identifying registrants whose applications warranted increased scrutiny.
"In combating the current opioid epidemic DEA failed to develop a comprehensive national strategy that could have focused and directed its regulatory and enforcement efforts"
The report found that - as the number of opioid-related deaths drastically increased between 2013 and 2017 - the DEA significantly reduced using one of its key enforcement tools — the ability to suspend manufacturers, distributors and other registrants to keep drugs from being diverted.
The agency issued a peak of 59 of those "immediate suspension orders" in fiscal year 2011. But then the number started dropping, all the way down to five in fiscal 2015. The report said part of the reason for the decline was that so many pill mills had already been shut down, but part of it was actually an icy relationship between different offices in the agency.
In a response included with the report, the DEA said the decline in those suspensions was also due to a decrease in opioid prescriptions and an increase in prescribers, pharmacists and others surrendering their registrations.
The DEA is still experiencing challenges in rendering timely final decisions in administrative actions against registrants, and continuing to raise production quotas even as the number of deaths rose.
The Department of Justice and DEA have recently taken steps to address the opioid epidemic, but that is not nearly enough. The report states that, “in November 2015 DEA implemented its 360 Strategy, which focuses on law enforcement coordination, diversion control and regulatory enforcement efforts, and community outreach. However, we found that the goals of DEA’s 360 Strategy do not specifically address diversion control enforcement efforts and that DEA cannot determine whether the program’s diversion-related activities have improved its field offices’ diversion control enforcement capabilities.”
In a statement, the DEA acknowledged the Inspector General’s assessment of their efforts, while also highlighting the “positive progress that DEA has made in the last several years,” which included that, “in June 2019, two former corporate officers of Miami-Luken, a pharmaceutical distributor, and two pharmacists, were indicted on charges that they conspired to illegally distribute and dispense controlled substances.”
Some of the findings could bolster the argument of drugmakers and distributors, who have said the government should share the blame for the crisis. The first federal trial on the crisis, dealing with claims against the drug industry from two Ohio counties, is scheduled to begin later this month in Cleveland.
The report also found the DEA raised the annual quota of the amount of oxycodone that can be manufactured by nearly 400 percent from 2002 to 2013. In court filings, drugmakers have said that they continued to increase production as the opioid crisis deepened because the DEA said they should.
The report notes the agency had told the U.S. Government Accountability office previously that it is difficult to set a limit that provides for legitimate medical needs and limits abuse and diversion. Since 2014, the oxycodone quota has been reduced, with the biggest cuts — of 25 percent — announced in 2016. The cuts have come as prescriptions have declined and fentanyl and other synthetic street drugs have become the biggest killers among opioids.
The inspector general also called for the federal government to do something some states have done already: Require electronic rather than handwritten prescriptions for all controlled substances, saying that's a way to cut down on fraud. The DEA agreed with that and most of the report's recommendations.