Vanda comments on FDA’s recently announced guidance on communication

Vanda Pharmaceuticals announced that it submitted a comment letter on January 5, regarding the FDA’s recently announced policy – by way of a draft guidance document – that substantially restricts drug manufacturers’ ability to communicate truthful, non-misleading information about FDA-approved drugs. Vanda’s comment argues that there are four problems with the FDA’s approach: The FDA’s guidance imposes content-based burdens on drugmakers’ protected commercial speech in violation of the First Amendment; The FDA’s standards are too vague to satisfy the minimum requirements of due process; The Federal Food, Drug and Cosmetic Act does not give the FDA the authority to regulate marketing of approved drugs for off-label use; The FDA’s guidance in fact sets binding standards, even though the FDA describes the guidance as a “nonbinding statement of policy.”