U.S. drug agency proposes rules to rein in opioid manufacturing

WASHINGTON (Reuters) - The U.S. government on Tuesday proposed tightening rules governing the amount of prescription opioid painkillers that drugmakers can manufacture in a given year, in hopes of reining in the deadly opioid epidemic.

FILE PHOTO: Attorney General Jeff Sessions speaks during a civil rights initiative announcement at the Fair Housing Act 50th Anniversary at the Justice Department in Washington, U.S., April 12, 2018. REUTERS/Yuri Gripas

The Drug Enforcement Administration’s proposed changes to its regulations over addictive drug manufacturing quotas were announced by Attorney General Jeff Sessions. The plan could sharply reduce the annual production of painkillers.

“Under this proposed new rule, if DEA believes that a company’s opioids are being diverted for misuse, then they will reduce the amount of opioids that company can make,” Sessions said in prepared remarks.

The plan could affect opioid makers such as Purdue Pharma LP, Johnson & Johnson, Teva Pharmaceutical Industries Ltd and Mallinckrodt, as well as companies that distribute the drugs.

Hours before the announcement, federal, state and local law enforcement officials in West Virginia announced a crackdown on an opioid trafficking ring in Huntington, known as “ground zero” for the epidemic.

West Virginia sued the DEA in December over drug quota rules, arguing the agency’s policy wrongfully sets manufacturing quotas based on amounts of pills drugmakers expect to sell, not legitimate medical needs.

That approach, the state argued, has contributed to the growing addiction problem and the illegal diversion of pain medication.

“We must end senseless death in West Virginia,” said the state’s Attorney General Patrick Morrisey. West Virginia is among the states that have suffered most from the crisis.

The Trump administration has made combating the opioid epidemic a top priority.

Last year, Trump declared it a national emergency, in a move to shore up more resources to expand access to treatment and give the government more flexibility in waiving rules and restrictions to expedite action.

Sessions has created an opioid task force and deployed prosecutors to hard-hit areas of the country with a mandate to bring more cases against traffickers.

While some enforcement efforts have focused on illicit traders and doctors who over-prescribe, the government has also increasingly been taking aim at the drug companies themselves.

Recently, it sought permission from a federal court to participate in settlement negotiations aimed at resolving lawsuits by state and local governments against opioid manufacturers and distributors.

The DEA proposal calls for quotas to be set after considering the potential for diversion of the drugs into illicit channels, and weighing input from states and other federal agencies such as the Food and Drug Administration, the Centers for Disease Control and the Centers for Medicare and Medicaid Services.

Sessions said the DEA has also entered into a prescription drug information-sharing arrangement with 48 state attorneys general to help them sniff out criminals peddling dangerous painkillers.

According to the Centers for Disease Control and Prevention, 42,000 people died nationwide from opioid overdoses in 2016, the last year with publicly available data.

Reporting by Sarah N. Lynch; Editing by G Crosse, Bill Trott and David Gregorio