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# FDA Chief Counsel on Upcoming First Amendment Work
- URL: https://www.fdaweb.com/fda-chief-counsel-on-upcoming-first-amendment-work/
- Published: 2018-05-08T12:00:00.000Z
- Updated: 2026-09-15T00:03:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141390

FDA has hinted that it is working on a guidance on manufacturer communications about their products under the First Amendment. In her annual address to the Food and Drug Law Institute, FDA chief counsel **Rebecca Wood** noted that there has been great interest in the parameters of a firm’s communications about health care economic information with payors, formulary committees, and similar entities. She said industry is interested in obtaining more input about how firms should communicate with certain professionals “particularly in light of the sophistication and built-in skepticism of that audience. We anticipate having more to say on this important matter.”

Wood’s address affirmed the importance of the First Amendment based on numerous court decisions and the significant role it plays in the agency’s regulatory work. “Indeed, it is difficult to have a discussion in this area today without due consideration for the role of constitutionally protected speech,” she said. “And the First Amendment recognizes a critical role for the robust discussion of truthful and non-misleading scientific and medical information, and a measure of breathing room for such discussions. The extent to which the First Amendment requires a safe harbor for such information — even in the absence of FDA approval — presents important questions that the agency and the courts continue to wrestle with.”

Woods said the agency’s internal First Amendment Working Group continues to evaluate issues that arise at the agency. She said that among these are: “Is there more that the agency should do to refresh its regulations to reflect the courts’ modern approach to the First Amendment and to bring additional certainty to its work? Can the agency do more through guidances published pursuant to the agency’s Good Guidance Practices to enhance transparency on these issues? Can the agency improve training to equip those charged with carrying out its public health mission to identify and consider First Amendment issues with lasting and flexible tools to identify and address these important considerations? These are key questions that we continue to study closely.”

Additionally, Wood said that a final rule on “intended use” that saw its effective date delayed in March is still alive and well ([see earlier story](https://www.fdaweb.com/indefinite-delay-for-intended-use-rule/)). The delay gives the agency more time for it to “consider the feedback received, to make sure that our approach is guided by our public health mandate, and to ensure the clarity of our rules on the subject,” she said.  

In concluding her address, Wood pledged to continue to “work with the FDA bar as we unpack these important and challenging questions.”