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Meanwhile, opioid manufacturers and distributors contend with multiple DEA penalties
If the position of the Commission on Combating Drug Addiction and the Opioid Crisis is to be believed, the US is in the midst of a national public health emergency on par with a natural disaster or terrorist attack, and immediate action is called for. Yet, this interim report was prepared in the midst of the rancorous debate over repealing Obamacare—regarded by its opponents as an unnecessary intrusion of the federal government into healthcare—and so the result is an odd combination of a call to action combined with “listening sessions” and public hearings, and a goal of issuing a final report Oct. 1. (The Commission missed the original deadline for submitting an interim report, as specified by President Trump’s March 29 executive order, by a month already). Not exactly an immediate response to an emergency that is killing 142 Americans daily, as the report noted.
Some of the delay might be the cognitive dissonance between the actions at the federal level called for while Congress has been debating many ways to reduce federal healthcare support. Among other items, the Commission calls for:
All of these call for increased federal funding and agency involvement in healthcare industry practices; some of them could be implemented immediately, raising the question of what is the holdoff?
Suspicious order monitoring
The Drug Enforcement Administration (DEA) shows up in the interim report as the enforcer of additional education verification for prescribers, and as one of the agencies to combat the illegal importation of fentanyl, heroin and other opioid-based drugs. In the past year, besides the every-day interdiction that DEA (and other agencies) perform, DEA and the Dept. of Justice have been levying heavy fines against both drug distributors (each of the Big three has been hit, most notably McKesson’s record $150-million settlement in January) and manufacturers. The manufacturer targeting is a new development: now, manufacturers are being called on to maintain “suspicious order monitoring” (SOM) systems, just like distributors. In early July, Mallinckrodt settled with DoJ on a $35-million civil fine; Mallinckrodt is one of the largest manufacturers of generic oxycodone. The DoJ statement noted that:
[T]the government learned that manufacturers of pharmaceuticals offer discounts, known as ‘chargebacks,’ based on sales to certain downstream customers. Distributors provide information on the downstream customer purchases to obtain the discount. The groundbreaking nature of the settlement involves requiring a manufacturer to utilize chargeback and similar data to monitor and report to DEA suspicious sales of its oxycodone at the next level in the supply chain, typically sales from distributors to independent and small chain pharmacy and pain clinic customers.
It has not been the case, historically, that manufacturer chargeback management is a resource for preventing drug abuse; that might now be changing.