1. General – Medicinal Products
1.1 What laws and codes of practice govern the advertising of medicinal products in your jurisdiction?
Prescription Drugs
In the U.S., prescription drug advertising is primarily governed by the Federal Food, Drug, and Cosmetic Act (FDCA) and U.S. Food and Drug Administration (FDA) regulations and guidance. In certain circumstances, the U.S. Federal Trade Commission (FTC), as well as individual states, retain jurisdiction over aspects of prescription drug advertising as well (e.g., guarantees, pricing claims, limited-time offers, etc.).
The FDCA sets out broad requirements for prescription drug promotion and authorises the FDA to promulgate related regulations. See, e.g., 21 U.S.C. §352(n). The FDA regulations expand on these requirements in the FDCA, adding details to the statutory framework. See 21 C.F.R. §202.1. The FDA has also developed various non-binding draft and final guidance documents relating to a variety of issues in prescription drug advertising, ranging from direct-to-consumer broadcast advertisements to appropriate risk communication in advertising and social media. The FDA has significant discretion in enforcing the FDCA and its implementing regulations to protect the public health of patients prescribed prescription drug products, although the breadth of the FDA's authority with respect to truthful and non-misleading communications that go beyond approved labelling has been called into question by First Amendment case law.
...
Read Full Story:
https://news.google.com/rss/articles/CBMiVmh0dHBzOi8vd3d3Lm1vbmRhcS5jb20vdW5p...