DEA Allowed Increase of Opioid Production as Overdose Deaths Surged, IG Says

October 1, 2019 by Dan McCue
Members of P.A.I.N. (Prescription Addiction Intervention Now) and Truth Pharm staged a protest on Sept. 12, 2019 outside Purdue Pharma headquarters in Stamford, over their recent controversial opioid settlement. (Erik McGregor/Zuma Press/TNS)

WASHINGTON – The Drug Enforcement Agency allowed drug manufacturers to increase production of opioids, despite the fact that overdose deaths were becoming a national health crisis, a government watchdog said in a report released Tuesday.

The Justice Department’s inspector general review of the agency’s regulatory activities and enforcement efforts related to opioids covers the period of 2010 to 2017.

It found that even as the number of opioid-related deaths skyrocketed between 2013 and 2017, the DEA failed to use “its data systems and strongest administrative enforcement tools” to combat the illegal diversion of prescription painkillers.

At the same time, it authorized manufacturers to produce “substantially larger amounts of opioids,” the report said.

“We 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,” the inspector general’s investigators said.

“Yet, from 2003 through 2013 DEA was authorizing manufacturers to produce substantially larger amounts of opioids,” they continued.  “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 report said.

The Inspector General’s office also found that DEA policies and regulations did not adequately hold registrants accountable or prevent the diversion of pharmaceutical opioids.

For instance, the DEA’s preregistration process did not adequately vet all new applicants before DEA registration was granted.

Second, the Inspector General found the DEA has regulations that fail to assess the suitability of potential new registrants, which may prevent the agency from identifying registrants whose applications merit heightened scrutiny.

And while electronic prescriptions can prevent prescription fraud in many instances, DEA has not taken steps to revise its regulations and require all prescribers to submit prescriptions electronically.

Finally, beginning in 2013, DEA rarely used its strongest enforcement tool, the Immediate Suspension Order, to stop registrants from diverting prescription drugs and the DEA continues to experience challenges in rendering timely final decisions in administrative actions against registrants for diversion and other alleged violations, the report said.

While the Justice Department and DEA have recently taken steps to address the crisis, “more work is needed,” the inspector general said.

Toward that end, the inspector general offered nine recommendations:

1. Develop a national prescription opioid enforcement strategy that encompasses the work of all DEA field divisions tasked with combating the diversion of controlled substances, and establish performance metrics to measure the strategy’s progress;

2. Require criminal background investigations of all new registrant applicants;

3. Implement electronic prescribing for all controlled substance prescriptions;

4. Require that all suspicious orders reports be sent to DEA headquarters;

5. Take steps to ensure that DEA diversion control personnel responsible for adjudicating registrant reapplications are fully informed of the issues that results in the revoking of the prior registration;

6. Revise field division work plan requirements to allow the flexibility to target registrants for investigation;

7. Revive a drug abuse warning network to identify emerging drug abuse trends and new drug analogues and respond to these threats in a timely manner;

8. Make efforts to enlist state and local partners to provide DEA with consistent access to state-run Prescription Drug Monitoring Programs;

9. Consider expanding the Opioid Fraud and Abuse Detection Unit pilot to additional U.S. Attorney’s Offices and increasing the number of federal prosecutors dedicated to prosecuting opioid-related cases.

West Virginia Attorney General Patrick Morrisey, who sued the DEA over the amount of opioids it allowed to be manufactured each year, called Tuesday’s report a “bombshell.”

“For years, the DEA was grossly negligent in its mismanagement of the national drug quota system,” Morrisey said. “Unfortunately, this mismanagement contributed to the senseless death of many Americans. Fortunately, we are now working with the Trump Administration to reverse the awful trends we saw for many, many years.

“We first sent a Freedom of Information Act request to the DEA back in 2015, when we suspected that the DEA was ignoring its statutory mandate to allocate supply on the basis of medical need,” the attorney general said. “We then followed up with a lawsuit against the DEA in 2017 and worked closely with the Trump Administration to ensure that the national drug quota rules focused on medical need, not industry want.

“Now, the regulations and the national drug supply takes into account diversion and suspicious orders and increase the number of checks in the system to prevent past mistakes from occurring in the future. I applaud President Trump for his willingness to rein in an out-of-control bureaucracy that was one of the root causes of the opioid epidemic,” he said.

According to the Centers for Disease Control and Prevention, as of 2017 in the United States more than 130 people die every day from opioid overdose.

Since 2000, more than 300,000 Americans have lost their lives to an opioid overdose, the DCD said.

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