The U.S. Drug Enforcement Administration is moving to curb the national opioid epidemic by slashing the production of a number of popular prescription painkillers.
In a notice published Wednesday in the federal register, the DEA finalized a previous order on 2017 production quotas for a variety of Schedule I and II drugs, including addictive narcotics like oxycodone, hydromorphone, codeine and fentanyl. The agency has the authority to set limits on manufacturing under the Controlled Substances Act.
In a release, the DEA said it is reducing “the amount of almost every Schedule II opiate and opioid medication” by at least 25 percent. Some, like hydrocodone, commonly known by brand names like Vicodin or Lortab, will be cut by one-third.
Citing falling sales and declining demand from doctors for the drugs, the DEA says the new numbers will “meet the estimated medical, scientific, research, industrial, and export needs for the year and for the maintenance of reserve stocks.”
For the past four years, the agency has implemented a 25 percent buffer on quotas for prescription opioids, designed to protect against potential shortages. The DEA says it never had to tap into the surplus, however, and is now eliminating it, which will account for a large portion of the change.
The DEA’s announcement comes as the nation grapples with a raging opioid epidemic claiming tens of thousands of lives each year. Fatal overdoses from opioids hit record levels in 2014, with prescription painkillers causing the deaths of 18,893 people and heroin killing 10,574.
In 2013, doctors wrote nearly 207 million prescriptions for narcotic painkillers, up from around 76 million in 1991, according to the National Institute on Drug Abuse. Much of this was due to the pharmaceutical industry’s lobbying and PR campaign, led by Purdue Pharmaceutical, to boost the use of narcotics. (Purdue would ultimately plead guilty to misleading the public about the addiction risk posed by the painkiller OxyContin, which contains oxycodone, and pay a $634.5 million fine.)
DEA quotas also played a role in empowering pharmaceutical companies to flood the market with pills. In 1993, three years before Purdue released OxyContin, the agency capped oxycodone manufacturing at just 3,520 kilograms, journalist John Temple writes in his book American Pain. But by 2007, this number had shot up to 70,000 kilograms, an almost twentyfold increase. Production peaked in 2013, with pharma companies churning out more than 150,000 kilograms of oxycodone. Next year, with the revised quotas in place, they’ll produce more than 108,000 kilograms.
The Centers for Disease Control and Prevention released new guidelines for prescribers earlier this year in hopes of targeting abuse. The new rules encouraged doctors to utilize non-opioid therapies over narcotics and to prescribe the lowest possible dose of opioids in order to minimize risk.
Congress has also been vocal about encouraging doctors to prescribe fewer opioids in the midst of the crisis. Over the summer, a group of senators called on the DEA to direct pharmaceutical companies to do their part by stemming the supply of painkillers.
“We urge DEA to utilize its existing quota setting authority, to the fullest extent possible, to combat this epidemic,” read a letter written by Sen. Dick Durbin (D-Ill.) and co-signed by a handful of his colleagues.
“Fourteen billion opioid pills are now dispensed annually in the United States – enough for every adult American to have a bottle of pills,” the letter said. “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 over-prescribing these dangerous and addictive drugs, but we remain deeply troubled by the sheer volume of opioids available – volumes that are approved by DEA.”
We remain deeply troubled by the sheer volume of opioids available – volumes that are approved by DEA. Senators' letter to the DEA
But moves to address addiction and abuse by cutting the supply of a drug can have unintended consequences. In fact, the surge in heroin deaths over the past decade has been widely linked to aggressive efforts by the federal government to crack down on prescription pills. And the potential hazards of this approach have long been known to drug policy officials.
“We always were concerned about heroin,” Kevin Sabet, a former senior drug policy official in President Barack Obama’s administration, told The Huffington Post during an investigation into the heroin epidemic in Kentucky. “We were always cognizant of the push-down, pop-up problem. But we weren’t about to let these pill mills flourish in the name of worrying about something that hadn’t happened yet. … When crooks are putting on white coats and handing out pills like candy, how could we expect a responsible administration not to act?”
Others have expressed concern that choking off the supply of legal opioid medications could simply lead users to shift their habits, turning instead to increasingly deadly street drugs. Drug policy reform advocates have regularly called for the federal government to divert additional resources into treatment for addiction and alternative medications for pain management.
Officials could do this by further expanding access to maintenance drugs like methadone or buprenorphine, or by loosening rigid restrictions on less conventional medicine. The Obama administration has shown a greater commitment to treatment in recent years, but critics say it could do more.
Meanwhile, the DEA has refused to reschedule marijuana, even as a handful of studies suggest that increased access to medical cannabis has led to reductions in opioid overdose deaths and decreased dependence on narcotic painkillers more broadly. The agency is also trying to implement a ban on kratom, an herbal supplement that some scientists believe could aid in the development of safer, less addictive pain medications. And the DEA’s latest quota numbers show an extremely negligible interest in ibogaine, a naturally occurring psychoactive substance ― now in Schedule I ― that has shown promise as a treatment for heroin addiction.
The DEA is likely aware of the controversial nature of its decision. The agency gave interested parties a chance to weigh in when it initially signaled its intent to scale back opioid production in July. It received a number of comments, and only one expressed support for slashing quotas.
This story has been updated with additional information about DEA quotas and oxycodone production.
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