When you think of herring fisherman, do you think of the “Chevron Doctrine”? Frankly, you probably don’t think much about either. But, two cases before the Supreme Court—one involving aforementioned herring fishermen—call for at least a significant reel-back, and at most a complete gaffing, of Chevron. The impact of either would be widespread, but one area that could be significantly impacted is the regulation of so-called “off-label” or “inconsistent with label” drug and medical device promotion by the U.S. Food and Drug Administration (FDA. or the Agency).
Bottom line, the FDA’s enforcement policy on off-label promotion may be more susceptible to attack if reviewing courts are no longer guided by the principle of agency deference under the Chevron Doctrine, as the FDA regulates off-label promotion almost entirely through informal, non-legally binding guidance. If the FDA’s guidance-based enforcement policy is limited or overturned, a sea change might be in store for drug and medical device promotion.
