DOJ announces regulatory steps to address opioid epidemic

DOJ finalized on Wednesday a proposal to improve DEA's ability to control the diversion of dangerous drugs. Under the rule, submitted for publication in the <i>Federal Register</i>, DEA will consider the extent that a drug is diverted for abuse when it sets its annual opioid production limits.

DOJ finalized on Wednesday a proposal to improve DEA's ability to control the diversion of dangerous drugs. Under the rule, submitted for publication in the <i>Federal Register</i>, DEA will consider the extent that a drug is diverted for abuse when it sets its annual opioid production limits. "If DEA believes 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," DEA said. DEA Acting Administrator Uttam Dhillon noted, "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. 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 mandates that DEA share notices of proposed aggregate production quotas and final aggregate production quota orders to the state attorneys general. In addition, DEA said, the rule allows the agency to consider relevant information from HHS, FDA, CDC, and CMS, as well as relevant data from the states.