Commercial Speech & Prescription Drug Promotion: Where Have We Been & Are We Going Anywhere?

Abstract

Recent decisions have caused the FDA to question whether its regulations of prescription drug promotion comply with the First Amendment. This paper argues that those recent decisions do not compel the FDA to change its prescription drug promotion regulations and that they cannot be considered in isolation from the historical development of the commercial speech doctrine. When this historical development is considered, two competing interests emerge from commercial speech cases. On one hand, an interest in protecting the public welfare suggests that speech restrictions are permissible. On the other, an interest in promotion of free markets limits speech restrictions. The application of the Central Hudson test, or any other method the Court might adopt for determining prescription drug promotion cases, hinges on the balance between these interests. As a result of the uniquely significant public welfare interests at issue in the prescription drug promotion context, the FDA’s current regulations do not violate the First Amendment. In reaching this conclusion, the paper begins by summarizing the current FDA regulations of prescription drug promotion. It then reviews the historical development of the commercial speech doctrine to illustrate the emergence of the competing interests. After pausing to highlight the problems of prior restraints and compelled speech, the paper addresses the effects that recent cases involving FDA regulations have had on the commercial speech doctrine. The final section illustrates how the competing interests that emerge from the historical evolution of the commercial speech doctrine will probably be balanced when applied to the FDA’s regulations of prescription drug promotion and then comments on the use of empirical evidence and the growth of the Internet; two issues that may alter the balance between free market and public welfare interests.