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Monday, May 03, 2021

AG辦公室: SUBOXONE不實行銷 付款665萬元和解

AG HEALEY SECURES $6.65 MILLION FROM DRUG COMPANY FOR FALSELY AND AGGRESSIVELY MARKETING SUBOXONE

Payment Part of $300 Million Global Settlement with Indivior over Improper Promotion of Suboxone for Opioid Use Disorder Treatment 

BOSTON – Attorney General Maura Healey has secured $6.65 million for Massachusetts from Indivior plc and Indivior Inc. (Indivior) to settle allegations that they falsely and aggressively marketed and promoted the drug Suboxone, resulting in improper expenditures of state Medicaid funds. When treatment is properly administered by a licensed professional, Suboxone and other formulations of buprenorphine can be effective treatments for opioid use disorder by suppressing withdrawal and cravings for opioids.

“We allege this drug company recklessly and illegally pushed doctors to prescribe Suboxone to patients suffering from opioid use disorder, including for uses that were unsafe and not medically necessary,” said AG Healey. “This office remains steadfast in our commitment to go after any company that helps fuel the ongoing deadly opioid epidemic that continues to ravage our communities.”

Under the terms of the global settlement, Indivior will pay $300 million to resolve various civil fraud allegations impacting Medicaid and other government healthcare programs, of which approximately $204 million will go to Medicaid—$91 million of the Medicaid recovery will go to the 50 states, D.C., and Puerto Rico, with the remaining $113 million going to the federal government.

The global settlement resolves the claims against Indivior brought in six qui tam lawsuits pending in federal courts in the Western District of Virginia and the District of New Jersey. A National Association of Medicaid Fraud Control Units (NAMFCU) team worked in conjunction with the U.S. Department of Justice to reach this settlement. In addition to entering into this settlement, Indivior executed a five-year Corporate Integrity Agreement with the U.S. Department of Health and Human Services-Office of Inspector General, requiring Indivior to implement numerous accountability and auditing provisions.

            The settlement agreement with AG Healey’s Office resolves allegations that, from 2010 through 2015, Indivior, directly or through its subsidiaries, promoted the sale and use of Suboxone to physicians resulting in prescriptions that lacked a legitimate medical purpose, were issued without any counseling or psychosocial support, were for uses that were unsafe, ineffective, and medically unnecessary, and that were often diverted.

The AG’s Office also alleges that Indivior knowingly promoted the sale or use of Suboxone Sublingual Film based on false and misleading claims that the film was less subject to diversion and abuse than other buprenorphine products and that it was less susceptible to accidental pediatric exposure than Suboxone Sublingual Tablets.

Indivior also allegedly submitted a petition to the Food and Drug Administration in September 2012, fraudulently claiming that Suboxone Tablet had been discontinued “due to safety concerns” about the tablet formulation of the drug. The company took other steps to fraudulently delay the entry of generic competition for various forms of Suboxone to improperly control pricing of Suboxone, including pricing to the states’ Medicaid programs.

            This settlement is the latest action that AG Healey has taken to combat the opioid epidemic and hold accountable those who are responsible for creating and fueling the crisis. Since taking office, AG Healey has prioritized combating the opioid epidemic through a multi-disciplinary approach that includes enforcement, policy, prevention, and education efforts. Learn more about AG Healey’s work to combat the opioid epidemic here.

In the Massachusetts AG’s Office, this settlement was handled by Assistant Attorney General Stephany Collamore of the AG’s Medicaid Fraud Division.

The Medicaid Fraud Division receives 75 percent of its funding from the U.S. Department of Health and Human Services under a grant award. The remaining 25 percent is funded by the Commonwealth of Massachusetts.

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