How the FDA Regulates Drug Promotion and Medical Education before Drug Approval

Abstract

In recent years, medical symposia and seminars have become increasingly popular as means by which pharmaceutical companies can disseminate information about new drugs or new indications before approval by the Food and Drug Administration. The once bright line between drug advertising and medical education has blurred, and the FDA is attempting to regulate new forms of promotion without interfering with scientific discourse. At the same time, the Supreme Court has extended the constitutional protections for free speech to advertising, further complicating the FDA's regulatory tasks. This article examines the constitutional limits on the FDA's powers, describes how the FDA is regulating in these new areas, and identifies six factors that influence the FDA's decisions to prohibit or permit preapproval activities sponsored by drug firms.