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 that is scheduled to begin in Cleveland later this month.
For their part, DEA officials have said their production estimates are based on data provided by the companies and federal requirements, and the real problem was the failure of some of those companies to prevent diversion of the pills, as required by laws 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.
The report offers the most comprehensive examination yet of the government agency responsible for preventing opioid painkillers intended for legitimate pain patients from spilling onto the black market. It reviews some of the critiques the drug industry and others have offered as lawyers and the public have sought to assign blame for the addiction and death of the opioid epidemic.
“We found that DEA was slow to respond to the significant increase in the use and diversion of opioids since 2000,” Horowitz wrote. “We also found that DEA did not use its available resources, including its data systems and strongest administrative enforcement tools, to detect and regulate diversion effectively.”
Horowitz determined, for example, 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. He said the DEA did not conduct pre-licensing investigations of doctors, pharmacists, dentists and other individuals who handled narcotics, instead relying on them to voluntarily disclose relevant information, including past criminal activity.
The report criticized the DEA for cutting back on the use of its 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 investigators to instantly halt shipments of pain pills from distributors — 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 moving slowly to approve the orders. In the report, Horowitz confirmed the poor working relationship between the two DEA units, which one official called “toxic.” He said the agency has recently taken steps to improve cooperation.
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. Horowitz said there is not enough data to assess the law’s impact, noting that the decline in immediate suspension orders mainly occurred before the legislation was passed.
In a written response to the report, the DEA said Tuesday 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 A. Brandenberger said.
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 30 percent from January 2017 to August 2019.
Part of that reduction came when the DEA eliminated an emergency cushion built into the production quota. A sharp downturn in prescribing of opioids over the past seven years has also prompted declines in production.
The Healthcare Distribution Alliance, which represents drug distributors, said in a statement that it “welcomes the actions taken by current DEA leadership to curtail annual opioid production quotas and improve communication with registrants. We also are pleased that Congress enacted the SUPPORT Act, which among other things, strengthens DEA’s hand in managing the opioid epidemic and improves coordination, information gathering and communication.”
The organization urged the DEA to finish updating guidance on reporting of suspicious drug orders.
Derek Maltz, who headed DEA’s special operations division from 2005 to 2014, said the agency’s Office of Diversion Control recognized the dangers of the opioid crisis many years before parts of the government that are only now responding to the death toll.
“It’s very sad that the big Beltway machine now wants to use a DEA executive who worked to save lives as a scapegoat,” he said, referring to Joseph T. Rannazzisi, who headed the Diversion Control office for nearly a decade before he was forced out in 2015.
There is no indication in the report that it was requested by a public official. The inspector general sometimes initiates such examinations on his own.
The DEA began cracking down on opioid distributors in 2006, bringing civil and administrative cases against more than a dozen companies over a decade under Ranazzisi. In the past six months, federal prosecutors in three parts of the U.S. have filed the first criminal charges against those wholesalers and a few of their executives.
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. Suspicious orders generally include ordering drugs from wholesale distributors in unusual amounts, frequencies or patterns.
The DEA also discontinued use of a medical examiners database in 2007, and the Department of Health and Human Services stopped using a drug-abuse early-warning network in 2011 — two data sets that might have helped illuminate the emerging crisis, the inspector general wrote.
Even when it was collecting data, it was hobbled by inefficiency, the report said. 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.