Yet another drugmaker has joined the off-label marketing club. UCB agreed to pay $34 million to resolve claims it marketed its epilepsy drug Keppra to treat headaches and pain, uses not approved by the FDA. The deal with the Justice Department also requires UCB to plead guilty to a misdemeanor.
As the New York Times reports, Keppra was approved in 1999 to treat seizures, but five years later, UCB handed out posters touting research showing the drug could prevent migraines. What the posters didn't say was that UCB had sponsored the studies. They also didn't say UCB's internal research failed to prove that Keppra could prevent the headaches.
So, UCB didn't have the data to seek FDA approval for a migraine-prevention indication. But the company believed Keppra had more profit potential as a migraine treatment--and a remedy for other off-label uses--than as an epilepsy drug, court documents said. UCB put its pursuit of profits ahead of its obligations to patients," U.S. Attorney Ronald Machen Jr. said in a statement. "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."
A $34 million settlement is chump change compared with the off-label settlements that have been coming out of the Justice Department, including Pfizer's record-setting $2.3 billion deal related to marketing of Bextra and several other drugs. Even the sub-billion-dollar settlements, such as AstraZeneca's $520 million Seroquel deal, dwarf this one. Still, it shows that government prosecutors--and whistleblowers--are on the job.