Pharmaceutical conglomerate seals multimillion-dollar opioid agreement
Breaking: Walgreens Settles Opioid Scandal for $300 Million
In the ongoing saga of the U.S. opioid crisis, retail giant Walgreens Boots Alliance has agreed to shell out a whopping $300 million in a civil settlement. The settlement comes in the wake of extensive accusations that the corporation filled "millions of invalid prescriptions for opioids and other controlled substances" for over a decade, violating both the Controlled Substances Act (CSA) and the False Claims Act (FCA).
Yesterday (21 April), the U.S. Department of Justice (DoJ), the Drug Enforcement Administration (DEA), and the Department of Health and Human Services Office of Inspector General (HHS-OIG) announced the agreement. Although it pales in comparison to the nearly $1 billion paid out by consultancy firm McKinsey and Co, it still represents one of the biggest civil penalties ever imposed on a pharmacy under the CSA. Moreover, Walgreens will be on the hook for an additional $50 million should it undergo a sale or merger before the 2032 fiscal year.
Systemic Failure
The federal government's complaint, initially filed on 16 January and amended on 18 April in the US District Court for the Northern District of Illinois, charges Walgreens with knowingly filling "millions of unlawful controlled substance prescriptions" between August 2012 and 1 March 2023. The allegations include prescriptions for dangerously high quantities of opioids, premature refills, and the lethal 'trinity' cocktail - a concoction of opioids, benzodiazepines, and muscle relaxants.
Pharmacists at Walgreens were accused of continuing to dispense these prescriptions despite the lack of a legitimate medical justification. Meanwhile, the company's corporate compliance teams supposedly deprived pharmacists of crucial prescriber information, hindered communication among staff regarding dubious medical professionals, and failed to act upon compelling evidence of systemic misconduct.
Legal Proceedings and Government Response
Following the settlement announcement, the United States has moved to dismiss its lawsuit. Walgreens, in turn, is expected to withdraw a related declaratory judgment action filed in the Eastern District of Texas.
"Pharmacies have a legal obligation to prescribe controlled substances in a safe and professional manner, not dispense dangerous drugs for profit," stated Attorney General Pamela Bondi. Deputy Assistant Attorney General Michael Granston of the DoJ's Civil Division added, "We will continue to hold accountable those entities and individuals whose actions contributed to the opioid crisis, whether through illegal prescribing, marketing, dispensing, or distributing activities."
New Compliance Measures
In addition to the financial restitution, Walgreens has entered into comprehensive compliance agreements with the DEA and HHS-OIG. The company has pledged to implement policies requiring pharmacists to verify the legitimacy of controlled substance prescriptions prior to filling them, conduct annual training for pharmacy staff, and establish systems capable of blocking prescriptions from prescribers identified as issuing illegitimate prescriptions.
"Pharmacies have a responsibility to ensure that every prescription for highly addictive controlled substances is legitimate and issued responsibly in compliance with the Controlled Substances Act," commented DEA Acting Administrator Derek Maltz. "When one of the nation's largest pharmacies fails at this obligation, they jeopardize the health and safety of their customers and place the American public in danger."
The Walgreens case comes as part of a growing list of civil and criminal actions targeting pharmaceutical manufacturers, distributors, and now pharmacies in response to the opioid epidemic. US Attorney John Durham of the Eastern District of New York commented, "This settlement holds Walgreens accountable for failing to comply with its critical responsibility to prevent the diversion of opioids and other controlled substances."
US attorney Kelly Hayes for the District of Maryland noted, "With the power to dispense potentially harmful substances comes the responsibility to ensure that every prescription is legitimate before it is filled. When pharmacies fail that responsibility, we will work with others across the country to hold accountable those who put patients and communities at risk."
- Walgreens Boots Alliance is set to pay a $300 million settlement for its role in the opioid crisis.
- The settlement is a response to accusations of filling millions of invalid prescriptions for opioids and other controlled substances.
- The settlement is one of the biggest civil penalties ever imposed on a pharmacy under the Controlled Substances Act (CSA).
- Despite the settlement, it still falls short of the nearly $1 billion paid by McKinsey and Co.
- Walgreens may have to pay an additional $50 million if it undergoes a sale or merger before the 2032 fiscal year.
- The federal government's complaint accuses Walgreens of knowingly filling millions of unlawful controlled substance prescriptions.
- The allegations include prescriptions for dangerously high quantities of opioids, premature refills, and the lethal 'trinity' cocktail.
- Pharmacists at Walgreens were accused of continuing to dispense these prescriptions without a legitimate medical justification.
- The company's corporate compliance teams were alleged to have deprived pharmacists of crucial prescriber information.
- The teams were also accused of hindering communication among staff regarding dubious medical professionals.
- They were further criticized for failing to act upon compelling evidence of systemic misconduct.
- Following the settlement announcement, the United States has moved to dismiss its lawsuit.
- Walgreens is expected to withdraw a related declaratory judgment action filed in the Eastern District of Texas.
- Attorney General Pamela Bondi stated that pharmacies have a legal obligation to prescribe controlled substances in a safe and professional manner.
- The DEA and HHS-OIG have entered into comprehensive compliance agreements with Walgreens.
- Walgreens has pledged to implement policies requiring pharmacists to verify the legitimacy of controlled substance prescriptions.
- The company has also committed to conducting annual training for pharmacy staff.
- Walgreens has vowed to establish systems capable of blocking prescriptions from prescribers identified as issuing illegitimate prescriptions.
- DEA Acting Administrator Derek Maltz commented that pharmacies have a responsibility to ensure that every prescription for highly addictive controlled substances is legitimate.
- Maltz added that when pharmacies fail at this obligation, they jeopardize the health and safety of their customers.
- The Walgreens case is part of a growing list of actions targeting pharmaceutical manufacturers, distributors, and pharmacies in response to the opioid epidemic.
- US Attorney John Durham of the Eastern District of New York commented that the settlement holds Walgreens accountable for failing to comply with its critical responsibility to prevent the diversion of opioids and other controlled substances.
- US attorney Kelly Hayes for the District of Maryland noted that with the power to dispense potentially harmful substances comes the responsibility to ensure that every prescription is legitimate.
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