DOJ files suit against pharma wholesaler over opioid epidemic

Health

(NewsNation) — The Department of Justice (DOJ) filed a nationwide lawsuit Thursday alleging that one of the nation’s largest wholesale pharmaceutical distributors violated federal law, contributing to the opioid epidemic.

In a civil complaint filed in the U.S. District Court for the Eastern District of Pennsylvania, the DOJ alleges AmerisourceBergen Corporation and two of its subsidiaries, AmerisourceBergen Drug Corporation and Integrated Commercialization Solutions, LLC, violated the Controlled Substances Act (CSA) by failing to report at least hundreds of thousands of suspicious orders to the DEA as required by law.

According to a DOJ release, pharmaceutical distributors that sell controlled substances have a longstanding legal obligation to monitor the orders that they receive from pharmacies and other customers and must inform the DEA each and every time they receive a suspicious order.

“Our complaint alleges that AmerisourceBergen — which sold billions of units of prescription opioids over the past decade — repeatedly failed to comply with that requirement,” Gupta said.

The complaint, which is the result of a multi-year investigation, alleges that the violations took place over the course of nearly a decade, from 2014 through the present.

“The Department of Justice is committed to holding accountable those who fueled the opioid crisis
by flouting the law,” said Associate Attorney General Vanita Gupta.

The government’s complaint specifies several pharmacies for which AmerisourceBergen allegedly
was aware of significant “red flags” suggesting the existence of diversion of prescription drugs to
illicit markets. The complaint asserts that AmerisourceBergen nevertheless continued to distribute
drugs to the pharmacies for years and reported few suspicious orders to the DEA.

AmerisourceBergen said the complaint “cherry picked” five pharmacies it shipped drugs to out of the tens of thousands it works with, and that it ended its relationships with four of them before the DEA took any enforcement action.

Opioids, including prescription painkillers and illegal narcotics, have contributed to more than 564,000 overdose deaths from 1999 to 2020, including more than 68,000 in 2020 alone, according to U.S. government data.

The DOJ is now seeking civil penalties. If AmerisourceBergen is found liable, it could face a fine between $10,000 and $16,864 for each reporting violation — potentially totaling billions of dollars
in penalties.

“For years, AmerisourceBergen put its profits from opioid sales over the safety of Americans,” said
U.S. Attorney Philip R. Sellinger for the District of New Jersey. “According to the complaint, this
was part of a brazen, blatant, and systemic failure by one of the largest companies in America to
comply with its obligations to report suspicious opioid orders, contributing to the epidemic of opioid
abuse throughout this country.”

CVS and Walgreens announced in November that they’ve agreed to pay $5 billion each to settle thousands of lawsuits over their roles in the opioid epidemic

The Food and Drug Administration (FDA) is also now fast-tracking the review for a new opioid overdose reversal drug that would be available over the counter. 

The nonprofit pharmaceutical company Harm Reduction Therapeutics said in a release the FDA had granted it priority review for a new drug application for RiVive, a naloxone nasal spray for emergency overdose treatment.  

Reuters contributed to this report.

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