Feds seek rule change for drugmakers to battle opioid crisis

Posted at 3:19 AM, Apr 18, 2018
and last updated 2018-04-18 04:19:45-04

CHARLESTON, W.Va. (AP) – Drugmakers would be required to identify a legitimate need for controlled substances to justify their production under a proposed rule change intended to rein in the diversion of drugs for illicit purposes, the Drug Enforcement Administration announced Tuesday.

According to the DEA, current regulations were issued in 1971 but need to be updated to reflect the nation’s opioid abuse crisis and changes in the manufacture of controlled substances.

"It’s a common sense idea: the more a drug is diverted, the more its production should be limited," U.S. Attorney General Jeff Sessions said in a statement. The proposed rule "will give DEA more information to help the agency protect law-abiding Americans from the threat of drugs – and that makes all of us safer."

The proposed rule seeks input from states and federal agencies.

The statement said the DEA will consider the extent that a drug is diverted for abuse when it sets annual production limits, including a decrease if it believes a certain opioid or a particular company’s products are involved.

West Virginia Attorney General Patrick Morrisey sought to limit how many opioid pills can be manufactured each year. Morrisey has said evidence of diversion had been ignored for years. West Virginia by far leads the nation in the rate of fatal drug overdoses.

The new limits will encourage manufacturers to be vigilant and help DEA respond to the changing drug threat environment, the statement said. It added that the changes also will protect U.S. residents from potentially addictive drugs while ensuring enough opioids exist for concrete medical, scientific, research and industrial needs.

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4/17/2018 4:19:09 PM (GMT -5:00)