The Drug Enforcement Administration has faced criticism for its role as a gatekeeper in the opioid addiction epidemic, with Acting Administrator Chuck Rosenberg lamenting during a congressional hearing this year that “we are part of the problem.”
But the DEA is taking a step this week that will reduce the amount of opioid medications manufactured in the U.S. next year. Production quotas for several highly addictive and potentially fatal drugs — including oxycodone, fentanyl, morphine and hydrocodone — will be reduced in 2017 by up to 34 percent over the amounts allowed this year, according to a final order to be published Wednesday in the Federal Register.
The DEA controls the amount of drugs produced annually in order to meet research and medical needs. In a statement issued Tuesday, the agency indicated the reduction results from a decrease in demand for opioids via prescriptions and the elimination of an artificially-high production requirement to avoid drug shortages.
Officials said a large part of the reduction was made through the elimination of a 25-percent production buffer put in place in 2013 in response to concern over a possible shortage of painkillers.
“The buffer proved unnecessary, because past quotas for these drugs proved adequate,” said DEA spokeswoman Barbara Carreno. “We believe the additional reductions in the quota for specific painkillers, such as hydrocodone and oxymorphone, are a result of practitioners listening to us and to other agencies, such as the CDC, about the intensity of the opioid epidemic we all face and reducing their prescribing of these drugs.”
With the rate of opioid overdose deaths from prescription drugs and heroin hitting record levels in 2014 — killing nearly 30,000 people — lawmakers lobbied the DEA to roll back the 25 percent buffer, arguing that doing so was necessary to stem the tide of addictive painkillers that have flooded the United States.
“Fourteen billion opioid pills are now dispensed annually in the United States — enough for every adult American to have a bottle of pills,” a coalition of Democratic senators, led by Dick Durbin of Illinois, wrote in a letter sent to the DEA this summer. “Certainly, the pharmaceutical industry is at fault for decades of misleading information about their products and the medical community bears responsibility for its role in overprescribing these dangerous and addictive drugs, but we remain deeply troubled by the sheer volume of opioids available — volumes that are approved by DEA.”
Asked about the production levels during an Senate Judiciary Committee hearing in June, Mr. Rosenberg agreed that there were too many opioid pills produced but said the DEA was trying to meet legitimate industry needs and requests when determining what amounts of controlled substances should be produced each year.
“Are we failing in some way? Yeah, I think so,” he said.
Regulations to crack down on “pill mill” doctors in recent years have made opioids more difficult to come by.
But the efforts have led to a new epidemic — people whose painkiller prescriptions have dried up increasingly are turning to heroin as an easier and cheaper way to feed their addictions. A Gallup poll in June found that more than four-in-10 Americans see prescription painkillers and heroin as a “crisis” or “very serious problem” in their communities.
Production quota figures provided by the DEA show that manufacturing of many opioids — which increased significantly since OxyContin hit the market in 1996 — have begun to wane in recent years. But several of the reductions adopted for 2017 represent the largest production quota declines in the last decade.
The approved production of oxycodone meant for sale increased from 56,000 kilograms in 2006 to a peak of 153,750 kilograms in 2013. The amount approved for production in 2017 — 108,510 kilograms — is a 22 percent decrease over production levels approved in 2016.
Meanwhile, production of hydrocodone will be capped at 58,410 kilograms in 2017, a 34 percent decrease from the 88,500 kilograms allowed in 2016. Morphine production quotas will decrease 34 percent from 62,500 kilograms to 41,000 kilograms, and fentanyl will decrease 24 percent from 2,300 kilograms to 1,750 kilograms.
“We hope the attention of practitioners who are still overprescribing opioid painkillers will be caught by these reductions, and they will give consideration to modifying their own prescribing practices,” Ms. Carreno said.
The DEA determines how much of the controlled substances should be produced each year by evaluating the prior years’ quotas, sales, current inventories as well as export requirements and new applications for use.
The reductions for 2017 were not just limited to opioids.
Despite the DEA’s decision this year to loosen restrictions on facilities that can grow marijuana for research purposes — the University of Mississippi has held a near half-century monopoly on growing pot for research — the production levels for marijuana will decline by 28 percent. In 2017, 472 kilograms of marijuana can be produced.
Ms. Carreno said the production of marijuana was limited in 2017 because the University of Mississippi “has a large amount on hand and doesn’t need to grow much this coming year.”
She notes that much of the marijuana to be grown in 2017 will be for research into cannabidiol and other cannabinoids.