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  1. The United States Supreme Court has recognized that off-label prescribing is an accepted and necessary corollary of the FDAs mission to regulate. Evidence shows that doctors are susceptible to these marketing techniques and that their prescribing habits are impacted. See Notice of Availability, Revised Draft Guidance for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses Recommended Practices, 79 Fed. For purposes of resolving the question at hand, we need to take as given the commercial speech doctrine as presently configured, particularly as set forth in Thompson v. See Lars Noah, Whats Wrong with Constitutionalizing Food and Drug Law? Successful recent prosecutions seemingly belie such practical concerns, but, even if they have some force, ease of enforcement alone would never justify an overbroad restriction on commercial speech. Lastly, the FDAs increasingly popular practice of issuing technically nonbinding guidance documents while counting on its power to cajolea cagey if not always successful effort to shield its dubious policies from judicial scrutiny and avoid other forms of accountabilityseems to represent the least defensible method of all when First Amendment rights hang in the balance. The Agencys rules barring any and all direct claims about off-label uses of pharmaceutical products unmistakably operate to keep truthful information from doctors in ways that the Supreme Court no longer allows. The hearings also amassed abundant evidence to support the conclusion that alternatives, such as disclaimers disclosing the state of the evidence supporting a claim, and postmarket enforcement actions, were inadequate to stop deceptive and dangerous products. Disclaimers are a poor method of controlling off-label promotion because evidence shows that they have a limited impact on physicians and that consumers frequently misinterpret or ignore them. Kesselheim, Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech, 37 225, 250-51 (2011) [hereinafter Kesselheim, Off-Label Drug Use and Promotion].