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 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.
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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)
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