Amgen is paying up to resolve claims that it broke the rules while marketing anemia drug Aranesp and anti-inflammatory blockbuster Enbrel. The company has settled with 48 states for $71 million, marking the latest state-level crackdown on alleged marketing violations in the pharma industry.
Amgen has already paid $762 million to wrap up off-label marketing claims with the feds. Now, 48 states have won another promise to pay from the California-based drugmaker. This time, it's $71 million to resolve allegations that it broke the rules when marketing its anemia drug Aranesp and anti-inflammatory blockbuster Enbrel, two of its best-selling meds.
On Friday, Amarin won what was being called a First Amendment free speech victory for drugmakers. It got a federal court to say the FDA cannot bar Amarin from discussing off-label use of its fish-oil drug Vascepa for a wider group of patients than it is approved for.
Inspire Pharmaceuticals' AzaSite is approved to treat bacterial conjunctivitis, more commonly known as pink eye. But that's not all the company hawked it for when it was part of Merck & Co., the U.S. Justice Department says.
Pfizer got a federal judge to toss an investor lawsuit last year tied its now-withdrawn pain drug Bextra. But it wasn't the only investor suit raising similar issues, namely that the board had not been forthright about issues with the drugs. Another was just days away from trial, that is until the drugmaker agreed to settle it for $400 million.
The pharma industry's free speech stand in a whistleblower lawsuit against Millennium Pharmaceuticals? Not so fast, says the Department of Justice. The First Amendment doesn't protect speech that spawns illegal conduct, federal prosecutors say in their own brief in the case.
Since a U.S. circuit court decided the First Amendment protected a pharma sales rep from off-label marketing charges, the free-speech arguments have multiplied in cases across the country, testing that Second Circuit decision in other regions.
PhRMA has jumped into a California False Claims Act case, with a friend-of-the-court brief defending Millennium Pharmaceuticals, Schering-Plough and Merck's right to talk up unapproved uses of the clot-fighting drug Integrilin.
While it was fighting a hostile takeover by Valeant Pharmaceuticals, Allergan found time to claim its free-speech rights in a dispute over eye-drug promotions. The U.S.-based drugmaker used a similar tactic back in 2009, in a lawsuit over its Botox marketing.
Studies have shown that cutting down on face time between pharmaceutical reps and healthcare providers can cut down on expensive brand prescribing. But now, new data suggest that scaling back rep visits can also lower off-label prescribing.