The Department of Justice today announced the finalization of an April proposal to improve the Drug Enforcement Administration’s ability to control the diversion of dangerous drugs in the midst of the national opioid crisis. Announced in April by Attorney General Jeff Sessions, the final rule sent for publication today in the Federal Register establishes that DEA will take into consideration the extent that a drug is diverted for abuse when it sets its annual opioid production limits.
If DEA believes that that a particular opioid or a particular company’s opioids are being diverted for misuse, this allows DEA to reduce the amount that can be produced in a given year. 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.
“The opioid epidemic that we are facing today is the worst drug crisis in American history,” Attorney General Sessions said. “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 the 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.”
“These common-sense actions directly respond to the national opioid epidemic by allowing DEA to use drug diversion as a basis to evaluate whether a drug’s production should be reduced,” said DEA Acting Administrator Uttam Dhillon. “This also opens the door for increased communication and better information sharing between DEA and individual states, as we work together to address the opioid problem plaguing our country.”
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.
DEA also announced that the final rule allows DEA to consider relevant information from the Department of Health and Human Services, Food and Drug Administration, the Centers for Disease Control, and the Centers for Medicare and Medicaid Services, as well as relevant information from the states.
Following April’s announcement of the proposed rule changes, DEA received more than 1,600 public comments in response.
NOTE: To view the advance text of the final rule as approved by the Acting Administrator and submitted for publication in the Federal Register click here.
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Author: July 11, 2018