DOJ Announces Regulatory Steps to Address Opioid Epidemic

The Department of Justice today announced the finalization of an April proposal to improve the Drug Enforcement Administration's ability to combat the national opioid crisis.

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The Department of Justice today announced the finalization of an April proposal to improve the Drug Enforcement Administration's ability to combat the national opioid crisis.

If DEA believes that that a particular opioid or a particular company's opioids are being diverted for misuse, the new rule being sent for publication in the Federal Register "allows DEA to reduce the amount that can be produced in a given year," according to a DOJ press release.

"These revised limits will encourage vigilance on the part of opioid manufacturers, help DEA respond to the changing drug threat environment, and protect the American people from potentially addictive drugs while ensuring that the country has enough opioids for genuine medical, scientific, research and industrial needs," according to the DOJ.

"The opioid epidemic that we are facing today is the worst drug crisis in American history," Attorney General Sessions said in a written statement. "To help end it, DEA must make sure that we prevent diversion and abuse of prescription opioids. Today's new rule, by taking diversion of these opioids into account, will allow to DEA to be more responsive to the facts on the ground. More importantly, it will help us stop and even prevent diversion from taking place. The American people can be confident that we are now better equipped to protect them from dangerous drugs and that this rule brings us one step closer to finally ending this unprecedented crisis."

The final rule enhances the roles for the state attorneys general. It requires DEA to share notices of proposed aggregate production quotas, and final aggregate production quota orders, to the state attorneys general. It also allows for a hearing if necessary to resolve an issue of material fact raised by a state’s objection to a proposed aggregate production quota as excessive in relation to legitimate U.S. need.

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