- By: Andrew David Easler, Esq.
- Published: Oct, 7 2021
- Updated: Nov, 4 2023
In a collaboration of 14 state and federal agencies, the United States Department of Justice announced that it has reached a final settlement agreement on criminal and civil investigations of a pharmaceutical manufacturer Insys Therapeutics. The investigation covered activity starting as early as August of 2012, the same year Insys was approved for using its sublingual fentanyl spray, Subsys.
This is settlement marks a major win for the United States, a nation embroiled in an Opioid Crisis with wide-reaching consequences for the nation, its economy, and its future. Fighting the epidemic has been a major initiative for the Trump Administration. President Donald Trump has vowed that, “[t]ogether, we will defeat this epidemic – it’s a true epidemic – as one people, one family, and one magnificent nation under God.” This settlement shows that the Department of Justice is making progress on that front.
What could have been so atrocious as to warrant five mail fraud guilty pleas, $2 million in fines, $28 million in forfeiture, and a $195 million in civil settlement on allegations of violations of the False Claims Act? It boils down to bribes and kickbacks to physicians in exchange for feeding Insys with more and more prescriptions. According to the DOJ report, from 2012 to 2015 Insys would pay physicians to speak at “peer-to-peer” educational lunches and dinners for exorbitant fees in exchange for writing prescriptions in often medically unnecessary scenarios.
You might be wondering, so what? Some doctors prescribed some drugs that were a little over the potency the patient needed, what’s the big deal? This drug isn’t for migraines, Subsys is a spray formulation of fentanyl–a synthetic opioid and is one of the most dangerous drugs available in America. How dangerous? The Center for Disease Control and Prevention indicates that it is up to 100 times more potent than morphine. According to the DEA, by 2016, the nationwide synthetic opioid death toll rose to 19,413 fatalities and that fentanyl “dominates” the synthetic opioid category in number of overdoses and deaths.
Fentanyl is potent, but why should Big Pharma and healthcare providers take all of the heat? It’s true that they are only part of the problem, but they comprise a major part. In 2015 there were approximately 6.5 million fentanyl prescriptions dispensed in the US alone, according to the same DEA report. That is more than the population of Los Angeles and Houston, combined!
How has the Opioid Crisis affected the drug and alcohol testing industry? In 2018 the United States Department of Transportation amended its drug testing panel to include four semi-synthetic opioids including Hydrocodone, Hydromorphone, Oxycodone, and Oxymorphone. In addition, states across the country are also amending their statutes to include expanded opioid panels for employers.
While the Insys settlement doesn’t represent a proverbial albatross around the neck of the Opioid Crisis, it should serve as a cautionary tale to other pharmaceutical companies. It should also be a warning to employers, Designated Employer Representatives (DERs), and Drug and Alcohol Program Managers (DAPMs) who are on the front lines of the crisis to review their drug-free workplace policies and to determine whether the drug testing panels they are authorized to test include synthetic and semi-synthetic opioids—particularly for individuals in safety-sensitive positions.
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