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Off-Label and Unapproved Use

This archive displays posts tagged as relevant to off-label marketing and prescribing of pharmaceuticals and medical devices. You may also be interested in our pages:

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June 5, 2019

Opioid manufacturer Insys Therapeutics will pay $225 million to resolve federal criminal and civil claims against it regarding the unlawful marketing of its drug Subsys, including the payment of kickbacks to providers through sham "speaker programs" that rewarded practitioners who increased their Subsys prescribing, as well as jobs for prescribers' relatives and friends, and lavish meals and entertainment.  $195 million of the settlement will be paid to resolve False Claim Act allegations in five separate whistleblower lawsuits in which the government intervened in 2018; the whistleblower reward shares have not yet been determined.  To resolve the criminal claims, Insys will pay $2 million and forfeit $28 million; its operating subsidiary will plead guilty to wire fraud and related charges.  In addition, Insys entered into a five-year Corporate Integrity Agreement and a five-year deferred prosecution agreement. Previously, five former Insys executives were convicted of racketeering in connection with Subsys marketing.  DOJ; USAO Mass

Question of the Week — Should the CEO Be Held Accountable?: Lessons from the Insys verdict.

Posted  05/10/19
By Jessica T. Moore
Handcuffed business-leader walking through jail.
In a shocking first, a federal jury has convicted an opioid-company CEO and other top executives of a criminal racketeering conspiracy. Insys founder and chairman John Kapoor and four other executives bribed doctors to overprescribe a highly addictive fentanyl painkiller, and ran a phony call-center to defraud insurance companies into paying for the expensive drug. Although the company itself had already paid over...

May 2, 2019

Insys Therapeutics executives were convicted for their part in a racketeering conspiracy where they defrauded Medicare and private insurance carriers. From May 2012 to December 2015, the defendants bribed medical practitioners to prescribe Subsys, an extremely addictive sublingual fentayl spray intended for use by cancer patients. In furtherance of these efforts, the defendants provided kickbacks to practitioners who increased their Subsys prescriptions. The defendants also defrauded health insurance providers who were hesitant to approve payment for the drug when it was prescribed for non-cancer patients. DOJ

April 4, 2019

Pharmaceutical company Lundbeck LLC will pay $52.6 million to resolve allegations that the company violated the False Claims Act by providing funds to a purportedly independent patient assistance program for its drug Xenazine, approved for Huntington's Disease, in a form that created an improper kickback. Lundbeck was the sole donor to a fund at a foundation that claimed to provide financial support for patients with Huntington’s Disease. However, Lundbeck also referred Xenazine patients with many other conditions to this foundation, which then paid the Xenazine copays for these off-label uses.  When the foundation determined to stop using its Huntington's fund for non-Huntington's patient, Lundbeck redirected its payments to a different general-purpose fund, with the understanding that fund would use the redirected funds to pay Xenazine copays for these same patients.  Lundbeck is alleged to have denied needy Medicare and ChampVA Xenazine patients access to its free drug program, instead referring them to the patient assistance program, permitting Lundbeck to submit claims to federal healthcare programs.   DOJ

February 6, 2019

Abbott Labs has agreed to pay a total of $25 million to settle allegations of paying kickbacks to healthcare professionals in exchange for promotion of its drug, and inappropriately marketing its drug, TriCor, for cardiovascular events not approved by the FDA. The case was initiated by the State of North Carolina and joined by California, Illinois, Nevada, Maryland, Michigan, and Texas, as well as the federal government. NC AG

December 4, 2018

In connection with fraud involving two medical devices, Covidien and ev3 Inc. have agreed to pay a total of $31 million to resolve allegations of violating the False Claims Act. According to whistleblower and former employee of Covidien, Jeffrey Faatz, sister company ev3 Inc.'s Onyx Liquid Embolic System was only FDA approved for use within the brain, but was allegedly being marketed to surgeons for use outside the brain. Furthermore, ev3 reportedly incentivized its sales representatives to sell the device for unapproved purposes by setting up sales quotas and bonuses, and did so even as FDA officials expressed safety concerns to the company's executives. Separately, Covidien was accused of paying kickbacks to hospitals to induce use of its Solitaire mechanical thrombectomy device, causing false claims to be submitted to Medicare and Medicaid. For blowing the whistle on this case, Faatz will receive a relator's share of $2 million. DOJ; USAO CDCA; USAO SDFL; USAO MA

October 26, 2018

Abbott Laboratories and AbbVie, Inc. have agreed to pay $25 million to settle a case initiated by a whistleblower alleging that the pharma companies paid unlawful kickbacks and engaged in unlawful off-label marketing for the drug TriCor.  The kickbacks took the form of gifts and payments for consulting and speaking engagements that were meant to induce or reward physicians for prescribing TriCor.  The off-label marketing consisted of Abbott's advertising the drug for conditions for which it was not FDA-approved.  The whistleblower, Amy Bergman, a former Abbott sales representative, will receive $6.5 million of the settlement.  USAO E.D.Pa.

October 1, 2018

Pharmaceutical distributor AmerisourceBergen Corporation will pay $625 million to the federal government and 43 states to settle claims that between 2001 and 2014 a pre-filled syringe program at one of its subsidiaries, Medical Initiatives, Inc., violated federal law.  Despite lacking the proper licensing and registration, MII opened FDA-approved sterile vials of oncology drugs, and in a non-sterile environment, pooled the medicine and transfered it into non-FDA approved pre-filled syringes which were then sold to oncology practices and physicians.  This practice allowed Amerisource to capture the "overfill" in the original FDA-approved sterile vials and produce a larger number of pre-filled syringes.  AmerisourceBergen also resolved claims that it provided unlawful kickbacks to physicians to induce them to purchase pre-filled syringes rather than vials.  The settlement resolved three qui tam actions initiated by whistleblowers Michael Mullen, Daniel Sypula, Kelly Hodge, and Omni Healthcare, Inc.; a payment of over $93 million will be made to relators. Previously, in September, 2017, AmerisourceBergen Specialty Group pleaded guilty to illegally distributing misbranded drugs and agreed to pay $260 million in criminal fines and forfeitures. USAO E.D.N.Y.NY

AstraZeneca Settles Seroquel False Claims Action -- Again

Posted  08/9/18
AstraZeneca
On August 8, 2018, AstraZeneca agreed to pay $110 million to the state of Texas to settle allegations that it promoted two of its drugs without FDA approval resulting in health risks to children, adolescents, and other state hospital patients. This case was brought by two whistleblowers under the qui tam provisions of Texas’s Medicaid Fraud Prevention Act. The whistleblowers, two former AstraZeneca employees, among...

August 7, 2018

AstraZeneca, the multinational pharmaceutical giant, has agreed to pay Texas $110 million to settle allegations that the company misleadingly marketed two of its drugs, Crestor and Seroquel, in violation of the Texas Medicaid Fraud Prevention Act. The allegations focused on the company’s off-label marketing in 2010, when it was under a corporate integrity agreement. Former employees of AstraZeneca initiated the case under the whistleblower provisions of the Texas Medicaid Fraud Prevention Act. Texas AG
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