As One Hundred Thousand People Overdosed, DEA Allowed for 400 Percent Increase in Production of Oxycodone: Report
The Drug Enforcement Agency (DEA) allowed drug makers to ramp up the production of opioids over the same period of time that 141,298 people died from overdoses in the U.S., according to a report conducted by the U.S. Department of Justice and data compiled by the Centers for Disease Control and Prevention (CDC).
The mission of the DEA is to enforce laws and regulations related to "controlled substances," which include illegal drugs such as heroin and legal but closely monitored drugs such as prescription opioids.
But during some of the most critical years of the opioid epidemic, the agency seems to have supported opioid manufacturing. In a scathing 77-page report, the Office of the Inspector General (OIG) said the DEA was "slow to respond" to the crisis in a number of ways, failing to develop a comprehensive strategy to cull the epidemic and to cut production quotas for manufacturers profiting off their drugs' widespread abuse.
"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 report said. "Yet, from 2003 through 2013 DEA was authorizing manufacturers to produce substantially larger amounts of opioids," citing a 400 percent increase in oxycodone's Aggregate Production Quota (APQ), which the DEA establishes annually, between 2002 and 2013.
In the same time period, deaths involving prescription opioids rose nearly every year, according to data pulled from the CDC, from 6,483 in 2002 to 14,145 in 2013. The total death count reached 141,298 before the DEA stopped permitting increases in oxycodone production, finally cutting the APQ for the drug in 2017 by 25 percent. In 2018, the DEA further reduced the APQ for oxycodone by 6 percent, according to the report.
Since the cuts, there has been a precipitous decline in the number of these opioid prescriptions, down more than 30 percent from January 2017 to August 2019, according to a DEA spokesperson.
Still, there's no evidence described in the report that suggests the DEA had a coherent, national plan that used the full force of its regulatory powers to slow the distribution of the drugs. Isolated projects, like the DEA's "360 Strategy" launched in November 2015, educated communities about the dangers of opioids, but they didn't tackle the big picture, failing to measurably cut the diversion of legally manufactured pharmaceutical drugs into illegal markets.
Most concerning when it comes to inter-agency collaboration, the DEA also failed to capture shareable data about the pipelines of illegally trafficked opioids, the OIG pointed out. On top of that, their systems that monitor ordering patterns from registrants, who are supposed to obtain and distribute narcotics legally, couldn't and still can't detect many of the most dangerous opioids.
West Virginia Attorney General Patrick Morrisey, who began a lawsuit against the DEA in 2017 for mismanaging its drug quota system in favor of drugmakers, responded to the OIG's bombshell report in a statement.
"For years, the DEA was grossly negligent in its mismanagement of the national drug quota system. 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," he said.
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, according to reporting by the Washington Post. Cutting back the overall supply also risked denying legitimate pain patients the drugs.
A DEA spokesperson told Newsweek they removed about 900 bad actors from their registrar in the past 8 years, and, in partnership with the United States Attorneys' Offices across the country, the DEA has secured more than $245 million in civil penalties from some of the nation's largest drug distributors.
"DEA appreciates the OIG'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 spokesperson said. "While only a minute fraction of the more than 1.8 million manufactures, distributors, pharmacies and prescribers registered with DEA are involved in unlawful activity, DEA continuously works to identify and root out the bad actors."
Earlier this summer, Johnson & Johnson was ordered to pay $572 million to Oklahoma for deceptively marketing painkillers. Purdue Pharma, creator of the blockbuster painkiller OxyContin, filed for bankruptcy as part of an ongoing settlement with the thousands of cities and counties suing the company for its role in the crisis. Drug companies accused of complacency while these pills illegally flooded communities have argued they only produced as many as the DEA allowed.
The DEA wasn't the only governing body with a delayed response to the opioid epidemic. Congress didn't pass legislation specifically targeting opioid abuse until well after 2015.
Read the full report here:
