11/13/2016
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`FBI — U.S. Subsidiary of Belgian Pharmaceutical Manufacturer Pleads Guilty to Off-Label Promotion; Company to Pay More Than $34 Million
`
`Home • Washington • Press Releases • 2011 • U.S. Subsidiary of Belgian Pharmaceutical Manufacturer Pleads Guilty to Off-Label Promotion; Company to Pay More Than...
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`U.S. Subsidiary of Belgian Pharmaceutical
`Manufacturer Pleads Guilty to Off-Label Promotion;
`Company to Pay More Than $34 Million
`UCB Inc. Promoted Anti-Epileptic Drug Keppra for Off-
`Label Uses
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`U.S. Department of Justice
`June 09, 2011
`
`Office of Public Affairs
`(202) 514-2007/ (202) 514-1888
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`WASHINGTON—The U.S. subsidiary of Belgian pharmaceutical manufacturer UCB S.A. pleaded guilty
`today to the off-label promotion of its epilepsy drug Keppra and will pay more than $34 million to
`resolve criminal and civil liability arising out of its illegal conduct, the Justice Department announced
`today.
`
`Under the terms of the plea agreement before the U.S. Court for the District of Columbia, UCB Inc.,
`which has its headquarters in Smyrna, Ga., pleaded guilty to a misdemeanor in connection with the
`company’s misbranding of Keppra, in violation of the Food, Drug and Cosmetic Act. Keppra was
`approved by the Food and Drug Administration (FDA) as an anti-epileptic drug, for the treatment of
`seizures in adults and children suffering from epilepsy. Keppra is not approved for the treatment of
`migraine, headache, psychiatric conditions or pain conditions. Once approved by the FDA, a
`manufacturer may not market or promote a drug for any use not specified in the FDA-approved
`product label. These uses are also known as unapproved or “off-label” uses.
`
`The government alleged that UCB promoted the sale of Keppra for off-label use in the treatment of
`migraine by generating and disseminating posters representing that Keppra was safe and effective for
`treating migraine based on purportedly independent investigator-initiated studies. The posters did not
`disclose UCB’s sponsorship of these studies or that UCB’s own clinical trial had failed to demonstrate
`that Keppra was effective in treating migraine.
`
`UCB will pay a $7.55 million criminal fine for the misbranding of Keppra and an asset forfeiture of
`$1.078 million.
`
`In addition, UCB will pay $25.7 million to resolve civil allegations under the False Claims Act that the
`company illegally promoted Keppra and caused false claims to be submitted to government healthcare
`programs for a variety of off-label uses that were not medically accepted indications and therefore not
`covered by those programs, including headache, migraine, pain, bipolar, mood disorders and anxiety.
`The federal share of the civil settlement is $15,871,208, and the state Medicaid share of the civil
`settlement is $9,893,322.
`
`“UCB put its pursuit of profits ahead of its obligations to patients,” said Ronald C. Machen Jr., U.S.
`Attorney for the District of Columbia. “Today’s guilty plea and UCB’s $34 million payout should remind
`drug companies that try to cleverly design off-label marketing schemes that we will not allow them to
`compromise patient safety.”
`
`“Patients have a right to know that the drugs they are prescribed have been approved by the FDA as
`safe and effective for a particular use,” said Tony West, Assistant Attorney General for the Civil Division
`of the Department of Justice. “Off-label promotion of pharmaceuticals undermines the FDA’s
`important role in protecting the public and is a drain on taxpayer dollars.”
`
`“This settlement demonstrates the ongoing efforts to pursue violations of the False Claims Act and
`recover taxpayer dollars for Medicaid and other federal health care programs,” noted Dwight C. Holton,
`U.S. Attorney for the District of Oregon. “Our office will continue to work with whistleblowers and law
`enforcement to stop health care fraud.”
`
`The civil settlement resolves two whistleblower lawsuits filed under the qui tam, or whistleblower,
`provisions of the False Claims Act that are pending in Washington, D.C., and Oregon: United States ex
`rel. Root v. UCB, Civil Action No. 1:07-cv-1056, and United States ex rel. Maly v. UCB, Inc., Civil Action
`No. 1:08–cv-1161. As part of today’s resolution, the whistleblowers will receive payments totaling more
`than $2.8 million from the federal share of the civil recovery.
`
`Also as part of the resolution accepted by the court, UCB has entered into an expansive corporate
`integrity agreement (CIA) with the Office of Inspector General of the Department of Health and
`ARGENTUM Exhibit 1147
`Human Services. That agreement provides for procedures and reviews to be put in place to avoid and
` Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`promptly detect conduct similar to that which gave rise to this matter.
`IPR2016-00204
`
`“Patients have a right to be prescribed drugs based on sound medical judgment - not on drug company
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`FBI — U.S. Subsidiary of Belgian Pharmaceutical Manufacturer Pleads Guilty to Off-Label Promotion; Company to Pay More Than $34 Million
`11/13/2016
`Patients have a right to be prescribed drugs based on sound medical judgment not on drug company
`payoffs or off-label promotions,” said Daniel R. Levinson, Inspector General of the Department of
`Health & Human Services. “Taxpayers shouldn't have to pay for unlawful conduct.”
`
`“Today’s guilty plea and settlement is evidence of the government’s continued commitment to hold
`pharmaceutical companies accountable when they undermine the drug approval process by promoting
`drugs for uses not approved by the FDA as safe and effective,” said Acting Director Kathleen Martin-
`Weis of FDA’s Office of Criminal Investigations. “We will continue to join forces with the Department
`of Justice and our law enforcement counterparts to seek this kind of criminal resolution when
`pharmaceutical companies put profits ahead of the public health and safety.”
`
`The criminal case was handled by the U.S. Attorney’s Office for the District of Columbia and the Justice
`Department’s Office of Consumer Protection Litigation.
`
`The civil settlement was reached by the U.S. Attorney’s Offices for the District of Columbia and the
`District of Oregon and the Commercial Litigation Branch of the Justice Department’s Civil Division.
`The CIA was negotiated by the Office of Inspector General of the Department of Health and Human
`Services. The investigation was conducted by the Department of Veterans Affairs Office of Inspector
`General, the FBI’s Washington Field Office and FDA Office of Criminal Investigations. Assistance was
`provided by the National Association of Medicaid Fraud Control Units and the offices of various state
`Attorneys General.
`
`This resolution is part of the government’s emphasis on combating health care fraud and another step
`for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was
`announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of
`Health and Human Services in May 2009. The partnership between the two departments has focused
`efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.
`One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has
`used to recover more than $5.7 billion since January 2009 in cases involving fraud against federal
`health care programs. The Justice Department’s total recoveries in False Claims Act cases since
`January 2009 are over $7.3 billion.
`
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