Bausch & Lomb Subsidiary Busted for Bribes, Off-Label Marketing
A small drug company that was bought last year by Bausch & Lomb has pleaded guilty to bribing doctors to prescribe eye pain drug Xibrom for unapproved uses and will pay $33.5 million in fines to settle both a criminal and civil case against it.
Golf & Wine
B&L subsidiary ISTA Pharmaceuticals on May 21 agreed to pay the fines to the Department of Justice and a whistleblower who helped the government nail ISTA for violating the federal Anti-Kickback Statute, according to the DOJ.
Prior to being bought by B&L, ISTA was allegedly enticing doctors to prescribe Xibrom, an ophthalmic, nonsteroidal, anti-inflammatory drug to treat and prevent cystoid macular edema following Lasik and glaucoma surgeries. However, the drug has only been approved by the FDA to treat pain and inflammation following cataract surgery. Such off-label uses violate the federal Food, Drug and Cosmetic Act.
The government also alleged that ISTA was paying (or offering to pay) doctors to prescribe Xibrom. ISTA was providing doctors with other free products and setting up golf outings, wine-tastings, and other events in order to induce them to prescribe Xibrom, according to the DOJ.
In addition to the fine, ISTA will be excluded from federal programs like Medicare – a rather toothless punishment, seeing as how the company is being wound down by Bausch & Lomb anyway. B&L agreed to implement a compliance and ethics program as part of the plea deal.
B&L reportedly bought ISTA in June 2012, but the conduct at issue happened between 2006 and 2011.
“What happened here was that ISTA was desperate to grow revenues in order to become an attractive merger target,” a lawyer who is familiar with the case tells Lawyers.com. “The easiest way to do that was to push its drug for unapproved uses.”
It worked – for a while. ISTA was successful in selling itself to B&L, but ultimately the ploy failed. “It’s not just large pharma companies that need to be alert to the rules and comply with them,” says the lawyer. “Smaller companies will be subject to the same scrutiny.”
The uses for which Xibrom was being prescribed may not seem to very different from its approved use at first glance, the lawyer says the problem was that ISTA was pushing docs to prescribe it for longer and in higher doses, and that can be very dangerous.
He uses Tylenol as an analogy: “If you take it for the dosage and length of time it’s been approved for, it’s harmless, but if you take 10 Tylenol a day for a year, it’s going to cause damage to your body,” he says.
In fact, ISTA’s case serves as an important warning to consumers. “FDA labels are important; they matter,” says the lawyer. “As patients you should pay attention to labels.” If your doctor prescribes a drug to you for a purpose other than what it’s approved to do, you should question him or her about it.
“Patients need to be their own advocates, and likewise, pharma companies need to take these rules seriously because the DOJ takes them seriously,” the lawyer says.