Affirming the need for a new model for the regulation of drug promotion: a rebuttal to Krause and Zettler.

At the outset, we wish to thank Joan H. Krause1 and Patricia J. Zettler2 for their thoughtful commentaries on our article, ‘Back to First Principles: A New Model for the Regulation of Drug Promotion’. Our New Model is intended as an ‘initial’ proposal for a modern, sustainable regulatory framework that comprehensively addresses drug promotion while protecting the public health, aligning FDA’s policies with the First Amendment, establishing clear and understandable rules, andmaintaining the integrity of the FDA approval process, so we appreciate the feedback and constructive criticism provided by the commenters. However, we contend that both commenters downplayed the impact of the First Amendment in establishing the urgent need for an overhaul of FDA’s oversight of drug promotion. Recent case law, including the Second Circuit’s decision in United States v. Caronia,3 has recognized that the First Amendment does not permit the government to prosecute truthful and non-misleading speech by drug manufacturers. Judicial developments since the publication of our article have continued to recognize the legality of such speech by drug manufacturers.