Generally, the government believes it must regulate company speech to fulfill the core mission of the FDA. I appreciate their perspective, but no one has ever suggested that the agency should not continue to review clinical data and approve a product at first instance. In the Amarin filing, the Justice Department asserts that eliminating the current limits on company speech would “return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses.” That’s a stretch, as if to say that we are about to return to the days of the old West where traveling medicine men pitched tonics and syrups of unknown origin claiming that they were “good for what ails ya!”
In addition to the First Amendment question at the core of the case, there also is a practical problem in that the Federal government has not seen fit to tell physicians how to practice medicine (an area long regulated by the states), which includes the discretion to prescribe drugs and biologics and to use devices for these very same off label purposes. This has meant, in effect, that nearly everyone in the healthcare system – doctors, patients, medical researchers, payers, providers – is free to discuss the clinical data and the off label utility of products except for the folks who presumably know more than anyone else about the product profile. Companies may not talk openly except under limited circumstances, such as when a doctor inquires of a medical affairs representative.