* Illegal drug promotion occurred in 2004 in U.S.
* UCB to pay $25.8 mln to settle parallel civil case
(Adds plea in court, U.S. attorney, executive comments)
WASHINGTON, June 9 The American unit of Belgian
pharmaceutical company UCB SA (UCB.BR) pleaded guilty on
Thursday and will pay $34.4 million to settle criminal and
civil charges that it illegally promoted a drug for migraines.
The company pleaded guilty to one count of promoting the
epilepsy treatment drug, Keppra, in the United States in 2004
for migraine treatment without the necessary approval from the
Food and Drug Administration, the U.S. Department of Justice
The drug was only approved by the FDA to help treat those
who have seizures from epilepsy.
"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," said U.S. Attorney Ronald Machen.
The case is the latest settlement by a major pharmaceutical
company over touting drugs in the United States for uses that
have not been approved by the FDA, known as off-label
UCB will pay about $8.6 million in criminal fines and
forfeiture and another $25.8 million to settle parallel civil
allegations involving false claims submitted to U.S. federal
healthcare programs, according to the plea agreement.
The company was accused of promoting Keppra with posters
that claimed it was safe and effective for migraines and cited
studies that it also claimed were independent -- but in fact
were sponsored by UCB, according to the Justice Department.
In those posters, UCB failed to disclose that its own
trials had failed to demonstrate the drug was effective for
migraines or that it had backed the studies, the agency said.
As part of the settlement, the company agreed to implement
procedures and reviews to avoid and detect any future similar
conduct. As a result, UCB will not face probation, according to
the plea agreement filed in court.
The head of the company's North American operations said in
a statement that UCB has worked to improve its compliance
program and takes the matter "very seriously."
"We are pleased to have resolved this matter and look
forward to continuing to work with the many organizations with
whom we partner to advance our mission of transforming the
lives of people living with severe diseases," said Greg Duncan,
UCB's president for North American Operations.
The case is USA v. UCB Inc., No. 11-mj-375 in U.S. District
Court for the District of Columbia.
(Reporting by Jeremy Pelofsky with additional reporting by
Lisa Richwine, editing by Lisa Von Ahn and Gerald E.