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Abu Dhabi, UAEThursday 21 June 2018

US drug agency proposes rules to rein in opioid manufacturing

New plan comes after the state of West Virginia sued the DEA in December over its drug quota rules

Officials in West Virginia announced a crackdown on an opioid trafficking ring in Huntington, West Virginia, an area known as ‘ground zero’ for the epidemic. AP
Officials in West Virginia announced a crackdown on an opioid trafficking ring in Huntington, West Virginia, an area known as ‘ground zero’ for the epidemic. AP

The United States Drug Enforcement Administration (DEA) on Tuesday unveiled plans to rein in the amount of opioids that can be manufactured by drugmakers in a given year in an effort to combat the deadly epidemic in the United States.

The DEA’s proposed changes to its regulations on addictive-drug manufacturing quotas were formally announced by Attorney General Jeff Sessions in a speech on Tuesday.

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

The new regulatory plan comes after the state of West Virginia sued the DEA in December over its drug quota rules, arguing the agency’s policy wrongfully sets manufacturing quotas based on the amounts of pills that drugmakers expect to sell, not on legitimate medical needs.

That approach, the state argued, has contributed to the growing addiction problem and the illegal diversion of pain medication, while caving to the interests of the drug industry.

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“We must end senseless death in West Virginia,” state attorney general Patrick Morrisey said in a statement. “The reform sought by the DEA proves the impact of our lawsuit is still reverberating in Washington and producing real results capable of ending the oversupply of deadly and addictive painkillers that has killed far too many.”

The new DEA proposal calls for the government to take into account the potential for diversion of the drugs or the illegal distribution into illicit channels.

It also would require the DEA to take into account input from important stakeholders, including states and the components of the US Department of Health and Human Services, such as the Food and Drug Administration, the Centres for Disease Control and Prevention and the Centres for Medicare and Medicaid Services, when setting quotas.

The unveiling of the proposal on Tuesday comes after federal, state and local law enforcement officials in West Virginia announced a crackdown on an opioid trafficking ring in Huntington, an area known as "ground zero" for the epidemic.

West Virginia is among the hardest-hit states in the country’s opioid crisis.

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