WASHINGTON - Even as deaths from opioid overdoses grew dramatically, the Drug Enforcement Administration allowed manufacturers to substantially increase the number of painkilling pills they produced each year, the Justice Department's inspector general said Tuesday in a report that offers a harsh critique of the DEA.
Overdose deaths rose by an average of 8 percent from 1999 to 2013 and by a staggering 71 percent from 2013 to 2017. Yet the DEA, which sets annual quotas for narcotic painkillers produced in the United States, authorized a 400 percent increase in oxycodone output between 2002 and 2013, Inspector General Michael Horowitz said, and it did not begin cutting back until 2017.
Drug companies accused of allowing billions of pills to be diverted to the street have long argued that they produced only as many as the DEA allowed each year. The issue is certain to come up at a landmark civil trial of some of those companies that is scheduled to begin in Cleveland this month.
For their part, DEA officials have said their estimates are based on data provided by the companies, and the real problem was the failure of some of those companies to prevent diversion of the pills, as required by federal law and regulations. They also have said cutting back the overall supply risked denying legitimate pain patients the drugs they need if shortages were inadvertently created.
Horowitz also found that when licenses to handle narcotics are stripped from drug manufacturers, distributors and health care practitioners, they can reapply for that authority as soon as one day later.
The report criticized the DEA for cutting back on the use of it most powerful deterrent, immediate suspension orders, between 2013 and 2017, at a time when deaths were skyrocketing. The DEA issued more of the orders - which allow them to instantly halt shipment of pain pills from a distributor - in 2012 than it did from 2013 to 2017.
The Washington Post revealed the sharp decline in immediate suspension orders in 2016, citing conflict between field offices that sought to use that power and the DEA's legal office, which was setting up roadblocks.
The Post reported in 2017 that under heavy lobbying from the drug industry, Congress approved a change in federal law that made use of the orders almost impossible. President Obama signed the law, apparently without the government's drug regulators recognizing what it would mean.
In a written response, the DEA said it has taken away about 900 licenses - known as "registrations"- each year over the past eight years, "preventing further diversion of controlled substances." In concert with federal prosecutors, the agency has brought civil and criminal charges against more companies and practitioners accused of fueling the opioid crisis, spokeswoman Mary Brandenberger said.
The statement said the DEA "secured more than $194 million in civil penalties" in fiscal 2017, "more than the total of the prior seven years combined." Brandenberger said that in the past three years, the DEA has sharply reduced production levels of opioids, while prescriptions for those drugs have declined by more than 36 percent between January 2017 to August 2019.
The inspector general's review described a DEA remarkably deficient in obtaining and using data that would allow it to respond nimbly to an emerging crisis like the opioid epidemic, which has taken more than 400,000 lives over the past 20 years, according to government data.
The DEA's 11-year-old system for recognizing "suspicious" orders of narcotics from dispensers such as drugstores, which provide perhaps the clearest warnings of diversion to the street, captured those orders "from very few registrants," Horowitz noted.
The DEA also discontinued use of a medical examiners database in 2007, and the Health and Human Services department stopped using a drug abuse early warning network in 2011 - two data sets that might have helped illuminate the emerging drug crisis, the inspector general wrote.
Even when it was collecting data, inefficiency hobbled the DEA. Some drug companies reported pill transactions to the DEA's main database monthly, while others did so quarterly. As a result, the DEA was often a year behind in identifying possible bad actors - relying on 2017 annual data in 2018, for example, Horowitz wrote.
In July, The Post reported that database - the Automated Reports and Consolidated Orders System (ARCOS) - showed that 76 billion doses of two opioids, oxycodone and hydrocodone, were delivered across the United States between 2006 and 2012.
Overall, the inspector general concluded “that DEA did not capture (and still does not capture) sufficient data at the manufacturer, distributor, practitioner, and prescriber levels to enable it to detect the diversion of opioids and identify emerging drug abuse trends,” the inspector general concluded.