Pharmacies and Pharmacists in the Crosshairs: DOJ’s $408 Million Settlement with Rite Aid

Article

Last week, the Department of Justice (DOJ) announced that Rite Aid, ten subsidiaries, and affiliate pharmacies agreed to settle allegations that Rite Aid violated the Controlled Substances Act (CSA) and the False Claims Act (FCA) by filling “unnecessary prescriptions for powerful and addictive opioids.”

The Rite Aid Settlement

Rite Aid agreed to pay $7.5 million in civil fines and allowed an unsubordinated, general unsecured claim of $401.8 million in Rite Aid’s Chapter 11 bankruptcy case currently pending in the District of New Jersey.

The Rite Aid settlement comes on the heels of OptumRX’s agreement to pay $20 million to resolve allegations that it improperly filled opioid prescriptions in conjunction with benzodiazepines and stimulants (commonly called the “trinity” or “holy trinity” of prescription drug cocktails) from 2013 through 2015.

DOJ’s CSA and FCA action against Rite Aid (and Optum Rx) reinforces the government’s clear commitment to holding pharmacies and pharmacists to their mandatory corresponding responsibilities under the CSA to ensure “[a] prescription for a controlled substance … be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”

Increased Enforcement Actions

The DOJ has been prolific in pursuing physicians (despite the Supreme Court’s ruling in Ruan v. United States in 2022) and big pharma companies that manufacture, market, and sell opioids and opioid use disorder (OUD) drugs. With the DEA, the DOJ has ramped up enforcement actions targeted at pharmacists and pharmacies in recent years using predictive data analytics and information from state prescription drug monitoring programs.

In Virginia alone, DOJ has announced the following CSA cases in recent years:

DOJ and its 93 U.S. Attorney’s Offices across the country have made it clear that pharmacists and pharmacies are squarely in the crosshairs of government enforcement action. DEA offices across the country also are working closely with their criminal and civil prosecutors to aggressively investigate possible CSA violations and seek civil penalties.

What This Means for Pharmacies

Pharmacies and pharmacists are increasingly and consistently being held accountable for their corresponding duties to ensure every prescription filled is valid and issued for a legitimate medical purpose. The DEA, as the sole agency responsible for registering pharmacies and pharmacists to dispense controlled substances, holds virtually all the cards in the high stakes game of CSA enforcement.

Our Government & Special Investigations team have deep knowledge and experience advising clients on the Controlled Substances Act and understand how the government approaches CSA investigations. Please contact a member of the team if you have any questions.

Team

Jump to Page