Pharma Company Fights Back on Off-Label Drug Use Prosecutions
We’ve written on this blog several times about successful prosecutions connected to so-called “off label” drug use, including the use of antipsychotics for agitation in dementia patients. See here and here, for example. Now, courtesy of a New York Times article, there is news of a pharmaceutical company’s lawsuit to preempt such prosecutions, raising First Amendment free speech rights as grounds for off-label advocacy:
On Thursday, Amarin Pharma took the unusual step of suing the Food and Drug Administration, arguing that it has a constitutional right to share certain information about its product with doctors, even though the agency did not permit the company to do so. Lawyers for the company said that they believed their case was the first time a manufacturer had pre-emptively sued the agency over the free-speech issue, before it had been accused of any wrongdoing. Other companies have sued the agency only after they have gotten into trouble….
Lawyers for Amarin say the company is not proposing to market Vascepa to a wider population of patients, merely to share with doctors the results of a 2011 company-sponsored clinical trial that showed the drug lowered triglycerides in patients with “persistently high” levels….
More details about the suit available here.