1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction?
While commercial speech may or may not be a protected form of speech under the first amendment, it is counter to the FDA's role in protecting the public from fraudulent claims or misleading advertising. The question of who gains by this decision should be weighed carefully. As it stands, the very consumers the FDA is mandated to protect will be at the mercy of those truly benefit from the rule.