GlaxoSmithKline To Pay $3B In Misbranding Case

About two weeks ago, I noted that Johnson & Johnson had agreed to pay $1.5 billion for telling people what its drugs could do without the FDA's permission.

Now, in "the largest health care fraud settlment in U.S. history," GlaxoSmithKline is to pay $3 billion and plead guilty to criminal charges.

One of the charges is that GSK promoted Wellbutrin for uses the FDA hadn't approved. The charging document doesn't allege that the company had any reason to doubt that the drug was safe and effective for those purposes; it merely hadn't made a case to the FDA.

Another charge is that GSK promoted Paxil for young patients despite not only lacking the FDA's permission but also having studies that cast doubt on the drug's efficacy with patients under 18. The prosecution also admits that GSK had a study supporting the drug's use with these patients (though it claims the company gave it too positive a spin), and the document does not assert that it mentions all the relevant studies GSK had. Perhaps under just laws there would be a case involving Paxil, though not Wellbutrin, that the government could make -- a case in which it would have to argue that GSK did not believe, or did not reasonably believe, that Paxil was safe and effective when taken by young patients. But under the current laws, the essence of the case was only that the FDA hadn't been convinced -- the same as the case over Wellbutrin.

So this isn't a case about health care fraud at all. It's a case about making arguments for your products without the government's permission. The government says the drugs involved were "misbranded," but it's the government that misbranded its case.