The Drug Enforcement Administration (DEA) allowed drug makers to increase production of opioids even as overdose deaths were skyrocketing, according to a government watchdog’s scathing report released Tuesday.
While opioid overdose deaths grew by 8 percent per year from 1999 through 2013, and by 71 percent per year between 2013 and 2017, the DEA authorized manufacturers to produce “substantially larger amounts of opioids,” reads the report from the Justice Department’s Office of the Inspector General.
The DEA was “slow” to address the opioid epidemic and did not substantially reduce the number of pills drug makers were permitted to make until 2017, the same year overdose deaths hit a record high, the report says.
“We found that DEA was slow to respond to this growing public health crisis and that its regulatory and enforcement efforts could have been more effective,” Inspector General Michael Horowitz said in a video statement.
The report comes as health officials, states and the federal government look to hold accountable entities that spurned the epidemic, which killed about 400,000 people between 1999 and 2017.
State and local governments have filed hundreds of lawsuits against drug manufacturers and distributors arguing they knowingly caused the epidemic by understating the addictive properties of opioids.
But the report issued Tuesday indicates the federal government also played a role. The DEA, which is charged with keeping controlled substances from being diverted for abuse, had already been criticized by advocates for not using its powers to curb the opioid epidemic.
“Every aspect of the pharmaceutical supply chain bears responsibility for the havoc and senseless death unleashed upon West Virginia – and the DEA is no exception,” said West Virginia Attorney General Patrick Morrisey, who sued the DEA over its quota system.
“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.”
Every year, the DEA sets a quota for how many opioid pills drugmakers are allowed to produce in the U.S.
The DEA permitted drugmakers to increase their production of oxycodone, a highly addictive painkiller, by 400 percent between 2002 and 2013, according to the report.
The DEA didn’t substantially cut the quota until 2017, when opioid overdose deaths reached a peak in the U.S., according to the report.
That year, the DEA cut the quota by 25 percent, and a record-high 48,000 people died from opioid overdoses.
These quotas are set by the DEA with input from the Food and Drug Administration (FDA) and drug manufacturers.
Horowitz also said the DEA isn’t capturing sufficient data from drugmakers, distributors, doctors or prescribers to detect drug trends or suspicious orders, “which may have contributed in its overall slow response to the opioid crisis.”
The report also found that the DEA did not conduct background checks on doctors, dentists and pharmacists applying to handle controlled substances.
The DEA would instead rely on the “good faith of applicants” to disclose that information, even in cases when in which the applicant has previously engaged in criminal activity, according to the report.
The report notes that the DEA doesn’t have a comprehensive national strategy for dealing with the opioid epidemic, although it has had such plans for past drug crises.
In a statement Tuesday, the DEA said it “appreciates” the assessment, and that is has reduced the quota for the seven most frequently diverted opioids for the last three years.
It also said only a “minute fraction” of the more than 1.8 million manufacturers, distributors, pharmacies and prescribers registered with DEA are involved in unlawful activity, and it “continuously works to identify and root out the bad actors.”
The DEA also noted it secured more than $194 million in civil penalties from drug distributors in fiscal year 2017.
Date: October 16, 2019
Source: The Hill
