DEA adjusts opioid production quota rules after legal, legislative pressure from state

CHARLESTON — Legal and legislative pressure from West Virginia has led the U.S. Drug Enforcement Administration to modify its opioid distribution quota rules to help curb illegal diversion of the drugs.

State Attorney General Patrick Morrisey just announced that as a direct result of the lawsuit he’d filed, the DEA sent a finalized rule to the Federal Register that includes quota system reforms he and members of the state’s Congressional delegation have pursued.

As Morrisey explained it, the DEA quota system previously relied on the amount of pills pharmaceutical manufacturers expected to sell within a year. “The broken approach did not account for the number of pills diverted for abuse.”

He elaborated, “The DEA’s completely broken system confuses market demand for dangerous narcotics with the amount of legitimate medical need. It relies far too much on just a single piece of dangerously deceptive information: the estimated amount of drugs the industry can sell.”

In comments regarding DEA’s proposed rule, he cited the examples of Kermit, Mingo County, where a single pharmacy received 12 million hydrocodone pills over a six-year period, and Williamson, Logan County, where two pharmacies received over 20 million narcotics over a single decade.

He said, “Manufacturers, wholesalers, and pharmacies had no incentive to report the suspicious orders and prescriptions.”

Following Morrisey’s lawsuit, Morrisey said, a little less than four months ago, U.S. Attorney General Jeff Sessions ordered DEA to review its policy – just hours before a key deadline in the lawsuit. The finalized rule was submitted on Wednesday.

The rule is 27 pages, but Morrisey sums up the key changes in three points:

  • DEA will reduce reliance on market demand estimates by seeking annual input from the U.S. Department of Health and Human Services, Food and Drug Administration, Centers for Disease Control and every state in the nation.
  • DEA will discount market demand estimates by the amount that has been and would be diverted into illicit use. DEA elaborates how it will calculate this in its rule submission.
  • DEA will give states the right to obtain formal administrative hearings to consider concerns and provide evidence of excess opioid supplies.

Responding to DEA’s action, Morrisey said, “The reforms accomplished through this rule and our lawsuit are the first steps toward changing a fundamentally flawed system that for too long placed industry wants over the legitimate medical need and contributed to increased crime, higher medical costs, strained emergency services, greater reliance on foster care and far too many senseless deaths.”

Congressional comments

The quota system has also been on the radar of West Virginia’s Congressional members.

Rep. David McKinley, R-W.Va., told The Dominion Post, “We’re encouraged by this decision to give the DEA greater power over opioid production quotas. Our office has been calling for this action for some time. Back in the seventies when America was facing a major problem with amphetamines, the DEA stepped up and instituted quotas, cutting production by 90 percent, and the problem went away. In the 80s, they did the same thing when Quaaludes became a problem. The DOJ’s action will give them greater leeway to put a halt to overproduction of highly addictive opioid painkillers.”

Sen. Shelley More Capito could not be reached in time for this report.

Sen. Joe Manchin, D-W.Va. (Morrisey is challenging Manchin for his Senate seat), told The Dominion Post, “Since 2016, I have consistently pressured the DEA to fix the quota system and I applaud the DEA and the Department of Justice for implementing these important changes to the quota system.

“I have also pushed the DEA and the DOJ to increase their enforcement efforts against those bad actors who are poisoning our communities,” Manchin continued. “The DEA and DOJ are our first line of defense against the opioid epidemic and I will continue to work with them to reinstate the authority the DEA needs to enforce existing laws in order to keep opioids out of the hands of people who will unlawfully sell them or abuse them.”

Manchin’s press office provided a list of actions Manchin has taken regarding the quota system, starting with a June 2016 floor speech about the problem. A number of letters to and meetings with DEA officials followed.

In December 2017, Manchin sent a letter to Attorney General Jeff Sessions and Acting Administrator Robert Patterson regarding the Ensuring Patient Access and Effective Drug Enforcement Act that was signed into law that significantly stripped the DEA’s authority to stop unlawful distribution of opioids. He requested information on its creation and a list of improvements that Congress could make that would reinstate the DEA’s authority.

Other concerns

Public comments filed regarding the finalized rule point out that curbing the supply of prescription drugs won’t cure the problem. Opioids manufactured in and illegally imported from China and Mexico are accounting for many of the deaths.

Commenters fear that curbing domestic prescription supply will simply deny help to people with real pain.

The DEA responded to those comments saying it believes the misuse of controlled prescription drugs is “inextricably linked with the threat the United States faces from the trafficking of heroin and illicit fentanyl and fentanyl analogs.”

In 2016, it said, nearly 3.4 million people age 12 and up reported misusing prescription pain medicines. About 75 percent of heroin users first misused prescription drugs, often taking them from the medicine cabinets of family and friends before turning to the black market.

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