D.E.A. Let Opioid Production Surge as Crisis Grew, Justice Dept. Says

The Drug Enforcement Administration authorized large increases in the production of painkillers even as the number of opioid-related deaths in the United States soared, the Justice Department’s inspector general said in a harsh review on Tuesday.

The watchdog office said that the D.E.A. was “slow to respond” to the opioid crisis, adding that more than 300,000 Americans have died of opioid overdoses since 2000.

“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 review said. “Yet, from 2003 through 2013 D.E.A. was authorizing manufacturers to produce substantially larger amounts of opioids.”

The D.E.A., an arm of the Justice Department, is the federal agency that most directly oversees access to opioids.

“D.E.A. is responsible for regulating opioid production quotas and investigating its illegal diversion,” Michael E. Horowitz, the inspector general, said in a video on Tuesday. “We found that D.E.A. was slow to respond to this growing public health crisis and that its regulatory and enforcement efforts could have been more effective.”

For example, he said, the agency increased production quotas for oxycodone production by about 400 percent from 2002 to 2013, despite evidence that opioids were being overprescribed and misused.

The report said the D.E.A. did not capture enough timely data on opioid abuse or other drug trends. It also noted that the agency had “recently taken steps to address the opioid epidemic, but more work remains.”

A spokeswoman for the D.E.A. said in a statement that the agency “appreciates the O.I.G.’s assessment of the programs involved in the report and the opportunity to discuss improvements made to increase the regulatory and enforcement efforts to control the diversion of opioids.”

“The D.E.A. uses a wide variety of tools — administrative, civil and criminal — to fight the diversion of controlled substances,” she added. “While only a minute fraction of the more than 1.8 million manufacturers, distributors, pharmacies and prescribers registered with D.E.A. are involved in unlawful activity, D.E.A. continuously works to identify and root out the bad actors.”

The report noted that in 2013, there was a sharp decline in the D.E.A.’s issuance of immediate suspension orders, which it called the agency’s “strongest enforcement tool” because the orders can stop companies from distributing drugs.

The agency has attributed that decline to the end of two major operations in 2012, and it said in its statement on Tuesday that it had removed about 900 registrations, which are essentially licenses to handle controlled substances, every year for the past eight years.

Andrew Kolodny, a director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University who also testifies as an expert for government plaintiffs against pharmaceutical companies, said the review did not address the problems at the root of the opioid crisis — such as over-prescription of painkillers — because it was narrowly focused on the D.E.A.

“When you read the report, what you really don’t get out of it is that in almost every way in which the D.E.A. failed — except for the fact that they could have managed their data better — you have pharmaceutical industry and distributor industry influence,” he said.

The inspector general’s review comes at a critical moment in federal opioid litigation: A consolidation of nearly 2,300 cases from cities, counties and tribes nationwide seeking reparations for the epidemic.

The first trial, set to begin in Cleveland this month, pits two hard-hit Ohio counties against an array of drug manufacturers, distributors and retailers, which the plaintiffs blame for the crisis. But in laying substantial blame at the feet of the D.E.A., the inspector general has, in effect, given the drug industry defendants a powerful retort on the eve of trial.

Jan Hoffman contributed reporting.

Source link