Last week, the Department of Justice (DOJ) announced that it had finalized new rules to prevent the diversion of prescription opioids in a move designed to curb the national opioid crisis.  The rules, initially proposed in April 2018, received over 1600 comments during a 30-day comment period.

A DOJ summary of the new rules notes that the current regulations, initially issued in 1971, needed to be updated “to reflect changes in the manufacture of controlled substances, changing patterns of substance abuse and markets in illicit drugs, and the challenges presented by the current national crisis of controlled substance abuse.”

The new rules strengthen Drug Enforcement Agency (DEA) controls over diversion, allowing DEA to take into consideration the extent that a drug is diverted for abuse when it sets annual opioid production limits. Information regarding diversion can be obtained from opioid manufacturers, who may now be required to provide information that “may be helpful in detecting or preventing diversion, including customer identities and amounts of the controlled substance sold to each customer.” In addition, the final rule allows DEA to consider relevant information from a number of other federal agencies, including 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. The new rules also allow for a greater role for state attorneys general, requiring DEA to share information with them and to provide for hearings when states object to proposed quotas.

“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.”

“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 new rules are effective 30 days after their publication in the Federal Register.

The FisherBroyles Pharmacy and Health Care Law team is pleased to keep you updated on events of interest to those in the healthcare and pharmaceutical industries. Questions regarding the subject matter of this alert may be directed to any of the following attorneys:

Brian Dickerson, FisherBroyles Partner
Brian E. Dickerson

Anthony Calamunci, FisherBroyles Partner
Anthony Calamunci

Nicole Waid, FisherBroyles Partner
Nicole Hughes Waid

Amy Butler, FisherBroyles Partner
Amy Butler