DOJ announces regulatory measures to address opioid crisis News
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DOJ announces regulatory measures to address opioid crisis

The Department of Justice (DOJ) [official website] on Wednesday announced [press release] an amendment [text, PDF] to the Federal Register that will provide the Drug Enforcement Administration (DEA) [official website] with more control in the diversion of opioids.

The final rule was recommended in response to the opioid crisis. Under the rule the DEA will consider the extent to which an opioid is being diverted for abuse when setting its annual opioid production limits. The rule also requires the DEA to produce proposed aggregate production quotas and final aggregate production quota orders to state attorneys general. If a state objects to the production limits set by the DEA, the final rule permits hearings to balance public medical needs with public safety.

Additionally, the rule will open lines of communication with each state’s attorney general, the Department of Health and Human Services, the Food and Drug Administration, the Center for Disease Control, and the Centers for Medicare and Medicaid Services. In making its determination to further limit opioid production, under the rule, the DEA is permitted to consider relevant information from these government agencies and states.

Attorney General Jeff Sessions, in support of the final rule, said [press release]:

The opioid epidemic that we are facing today is the worst drug crisis in American history. 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. [T]his rule brings us one step closer to finally ending this unprecedented crisis.

Other supporters of the rule say it 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.”

An estimated 64,000 lives [press release] were reportedly lost to overdoses in  the US in 2016, with more than 42,0000 deaths [JURIST op-ed] related to opioids, and, according to the Centers for Disease Control and Prevention [official website], nearly 150 Americans [JURIST op-ed] die per day from opiate addiction.

In October President Donald Trump formally declared the opioid crisis a public health emergency.

Numerous lawsuits [JURIST news archive] have been filed against opioid manufacturers and distributors alleging that they have engaged in deceitful practices.

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