WASHINGTON (AP) — The maker of epilepsy treatment Keppra
agreed Thursday to pay more than $34 million for marketing the medication to
treat migraine headaches in violation of U.S. drug laws.
subsidiary of Belgian manufacturer UCB pleaded guilty in federal court in Washington to a
misdemeanor in connection with the misbranding.
The government had approved Keppra to treat seizures in
adults and children with epilepsy. A manufacturer may not market or promote a
drug for any use not specified in its approved product label. But prosecutors
said UCB claimed studies showed Keppra was safe and effective for treating
migraines, without disclosing that UCB sponsored the studies or that the
company’s own clinical trial failed to demonstrate such effectiveness.
UCB, which has its U.S.
headquarters in Smyrna, Ga., will pay a $7.55 million criminal fine,
forfeit $1 million in assets and pay $25.7 million to resolve civil claims that
it promoted off-label uses including migraine, pain, bipolar, mood disorders
The federal government will get $15.8 million of the civil
settlement and nearly $10 million will go to state Medicaid programs. The
settlement resolves two lawsuits brought by whistleblowers, who will together
receive payments of more than $2.8 million from the federal share.
The plea is part of an ongoing Obama administration
initiative against health care fraud, including the promotion of drugs for uses
the Food and Drug Administration has not approved as safe and effective. The
Justice Department said it has recovered more than $5.7 billion in Medicare and
Medicaid fraud cases since January 2009.
“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.”