Supreme Court Makes Ruling Affecting FDA Regulation -- Wide-ranging Implications

Normally, we would not post anything this wonky, but the Supreme Court has quietly made a ruling that will forever alter one of the basic mechanisms by which the FDA does its job of safeguarding the American public from fraudulent claims by drug makers.  Whether this is a good thing or a bad thing depends entirely on the specifics of each situation.  For a better understanding of why this is so, you may want to refer to our blog post, Thought-provoking Legal News, Part I.

FDA Cannot Prohibit Truthful Marketing About Off-Label Uses, Court Says.  from Dermatology Daily 8/10/15
The Wall Street Journal (8/8, B1, Burton, Subscription Publication) reported that a Federal court held that the Food and Drug Administration cannot prevent Amarin Pharma Inc. from marketing its fish-oil product for an off-label use, so long as its claims are truthful.

        According to the New York Times (8/8, B1, Pollack, Subscription Publication), the decision “could inhibit the ability of the F.D.A. to regulate one aspect of pharmaceutical marketing.” Judge Paul Engelmeyer wrote that the agency “may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment.”

        The Washington Post (8/7, Johnson) reported that “the judge’s decision does require that the off-label promotion of a drug not be misleading,” adding that the decision “also opens up the question of who adjudicates whether unapproved uses of a drug are truthful.”

        The AP (8/8, Perrone) reported that according to some lawyers, “other companies could follow a similar path by filing lawsuits in the second circuit.”

        A column by Forbes (8/7) contributor John Osborn argued that “it’s hard to find any ambiguity in today’s order” and concluded “the long restrained, tightly controlled communication of scientific and medical information...has been loosened.”

        A column by Forbes (8/9) contributor Paul Hsieeh contends that the decision was an “important legal victory” and calls patients, physicians, and “pharmaceutical companies creating innovative new products” the “winners” in this case.

        Also reporting are Bloomberg News (8/8, Edney), Reuters (8/7, Pierson), and TIME (8/7, Zorthian).