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Events in a Delaware federal courtroom last week have made the federal government’s bid to duck accountability for the opioid crisis untenable. 

U.S. District Judge Colm Connolly dismissed much of a Justice Department lawsuit against Walmart related to the opioid crisis, leaving an unlikely path forward for the government’s claims. The decision straightforwardly concludes that certain of the government’s liability theories are manufactured and highly motivated. 

That is the case because the federal government was badly in need of bogeymen to distract from their own policy failures on the opioid crisis. Independent probes, including one from the Justice Department’s own inspector general, establish that the federal government bears culpability for the addiction crisis, certainly far more so than a chain pharmacy. 

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The Obama-era DEA facilitated the opioid crisis through inaction and incompetence, a report concludes. (Screenshot/YouTube)

The DOJ IG report in particular slow-walked a devastating conclusion – the Obama-era DEA facilitated the opioid crisis through inaction and incompetence.

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Start with the annual production quotas (APQs). Federal law requires DEA to set production levels for prescription opioids at a level that reflects "legitimate medical and scientific need." The IG report found that the agency routinely increased APQs by substantial amounts between 2010 and 2016, even as addiction and overdose deaths raced upward. For reference, overdose deaths skyrocketed an average of 71% annually between 2013 and 2017. 

Furthermore, the FDA approved the prescribing of Oxycontin to 11-year-old children in 2015 and the American Medical Association continued to support "pain as the 5th vital sign" until 2016. "Pain as the 5th vital sign" was the federal government’s policy enacted in the 1990s that created the addiction crisis by incentivized the over prescribing of opioids. 

Even as American overdose deaths soared, the IG report found that DEA failed to account for "diversion" when it set APQs. Diversion is a term of art that refers to patients or bad actors "diverting" opioid medicines from their legitimate uses. 

An internal DEA component, the office of diversion control, seemed better aware of the situation and cautioned agency leaders to deny requests from specific pharmaceutical companies for APQ increases, according to the report. 

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Sadly, agency leaders disregarded those warnings. In fact, DEA consistently favored data from industry sources when setting APQs over guidance from the FDA, which advised only modest APQ increases. 

DEA had other regulatory tools beside APQs to protect American patients. They failed to use these tools. 

Physicians and pharmacies must have a DEA registration to prescribe or dispense opioids, per the Controlled Substances Act (CSA). Obtaining a license to dispense was far too easy. 

DEA did not conduct preregistration background checks on applicant doctors, dentists, pharmacists or pharmacies. Investigators were even prohibited from consulting certain federal criminal databases when vetting applicants. 

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Instead, agents relied on applicants to disclose relevant information in good faith, even in cases in which the applicant had previously engaged in criminal activity.

Losing a license to dispense did not even preclude a provider from obtaining one in the future. The IG identified an instance in which a dentist successfully re-registered despite a 25-year history of drug abuse and multiple felony convictions. The dentist had twice surrendered his medical license and CSA registration.

The agency can also rescind a license when necessary and has an emergency tool – the immediate suspension order (ISO) – for doing so. The report found DEA reduced its use of ISOs by 80% between 2010 and 2017. 

In one representative case, investigators discovered a 62-year-old California doctor was dispensing opioids to three female patients in their 20s in exchange for sex. Rather than immediately issue an ISO, the agency deliberated internally for months before referring the case to a federal prosecutor. 

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While the doctor may well be guilty of federal crimes, DEA’s most pressing responsibility was to immediately rescind his ability write opioid prescriptions. 

The report sketched other failures. Anti-diversion teams were poorly staffed and data they collected was sparse. The agency refused to implement electronic rather than paper prescribing for opioids, a powerful anti-fraud tool some states implemented on their own. 

All told, it is clear that DEA flooded the country with addictive opioids and largely failed at its obligation to police problem prescribers. 

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That the government failed to protect its own people has largely escaped notice. Popular accounts of the crisis villainize business – and quite reasonably so, in many cases – without treating regulatory failures. Government lawyers and Obama-era law enforcement officials are happy with this outcome. 

Let us hope Judge Connolly’s decision, and the seemingly inevitable demise of the government’s crusade against Walmart, will force a reassessment of the crisis and its actual causes. 

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