It was inevitable. When a U.S. circuit court decided the First Amendment protected a pharma sales rep from off-label marketing charges, the free-speech arguments had to multiply. And they have, in cases across the country, testing that Second Circuit decision in other regions.
The latest: PhRMA jumped into a California False Claims Act (FCA) 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.
It's a wisely chosen target: The case, filed by former Millennium sales rep Frank Solis, hinges on journal articles that the company allegedly distributed to doctors, along with letters summarizing the studies. Schering-Plough copromoted Integrilin with Millennium, and Merck ($MRK) bought Schering in 2009.
The articles were published in "reputable journals," PhRMA notes in its brief, including Cardiology and American Heart Journal, and the letters "accurately" summarized the published trial results. The company "accurately disclosed" that the off-label uses discussed weren't approved by the FDA.
So, this isn't a case in which a pharma company is accused of paying a doctor to call its antidepressant a "skinny, horny, happy pill," or promoting a drug for patients not only excluded from the FDA's official approval list but actually warned away from it.
Of course, PhRMA's brief includes a lot of preamble about doctors needing accurate and current information about unapproved uses for drugs. The brief also pokes holes in the Food, Drug and Cosmetics Act's (FDCA's) justification--or lack thereof--for off-label marketing prosecution under the FCA. And, by extension, Solis's argument in this particular case.
The upshot, according to PhRMA? The court should toss out the case.
But the argument PhRMA is making goes way beyond this particular legal fight. The group's dismissal argument comes down to this request. The court should interpret the FDCA in a way that avoids the "constitutional problem" of infringing pharma's free speech rights. The court could decide that the law prohibits "at most, only false speech." That theoretically would give drug reps free rein to talk about off-label uses, as long as they speak the truth.
Or that FDCA violations don't automatically make a healthcare claim for off-label drug use "false"--and therefore a violation of the FCA. That could decouple off-label marketing and FCA violations, washing away the foundation for many whistleblower lawsuits.
Meanwhile, the FDA says it's in thinking mode about off-label marketing. Agency officials said at a recent legal conference that they're evaluating their policies "in light of court decisions on First Amendment issues." The FDA should get a move on. Obviously, PhRMA has done plenty of thinking of its own.
- see the Law360 article (reg. req.)