You Can't Say That on Television: Constitutional Analysis of a Direct-to-Consumer Pharmaceutical Advertising Ban

By Mulligan, Lia | American Journal of Law & Medicine, April 1, 2011 | Go to article overview

You Can't Say That on Television: Constitutional Analysis of a Direct-to-Consumer Pharmaceutical Advertising Ban


Mulligan, Lia, American Journal of Law & Medicine


I. INTRODUCTION

In one year, you will watch roughly sixteen hours of pharmaceutical advertisements.1 Sometime during those sixteen hours, you may recognize in yourself the symptoms portrayed in the advertisements. You may even wonder whether you would benefit from a particular drug. But will you visit your doctor with the fear that you may be suffering from a previously undiagnosed disease? Will you encourage your doctor to prescribe the medication you saw in the advertisements? Will your insurance cover the costs of your medication? More importantly, will you even need the medication at all?

The trend in the pharmaceutical industry to increase yearly spending on direct-to-consumer pharmaceutical advertising (DTCA) seems almost disrespectful considering the magnitude of the healthcare crisis in which the United States is currently embroiled.2 This notion is inflamed when accounting for the fact that (arguably) one of the biggest problems in our healthcare system is the amount of money spent on healthcare each year. DTCA has been a catalyst for controversy ever since it became a viable marketing tool in the 1970s. In light of recent economic developments, the focus of the debate has shifted to the ultimate all-or-nothing question: is it finally time to ban DTCA for good?

This Note will begin by discussing a brief history of DTCA regulation in the United States. The discussion will then move to the constitutional protection afforded to commercial speech by analyzing several relevant Supreme Court decisions. This Part will examine the level of scrutiny the Court has historically utilized when reviewing statutes that restrict commercial speech, and discuss whether the Court is moving towards applying strict scrutiny in this area. Next, this Note will analyze the current legal standard for reviewing statutes restricting commercial speech as it would be applied to a ban on DTCA. This Note will conclude with a brief discussion of the Supreme Court decision in Citizens United v. Federal Election Commission3 and the impact it may have for the constitutionality of a DTCA ban, as well as speculation as to how the current composition of the Supreme Court would affect the review.

II. BRIEF HISTORY OF DTCA REGULATION

DTCA is incredibly rare throughout the world. In fact, the United States and New Zealand are the only countries in the world that allow it.4 In the United States, DTCA was never prohibited,5 but it was not regulated on a federal level until the mid-1900s.6 The 1938 Food, Drug, and Cosmetic Act (FDCA)7 did not mention DTCA because the notion had never been widely discussed or utilized. At that time, the authority to regulate any DTCA technically lay with the Federal Trade Commission.8 In 1962, the KefauverHarris Amendment to the FDCA officially recognized DTCA as a viable tool for pharmaceutical companies, and granted authority to regulate DTCA to the Food and Drug Administration (FDA).9

The FDA issued the first regulations for DTCA content and distribution methods in 1969.10 The 1969 guidance contained four main principles that the advertisements were required to present: (1) truthful information that does not mislead the public in any way; (2) a balance of both the risks and benefits of the advertised product; (3) relevant, material information about the product that relates to its intended uses; and (4) every risk associated with the advertised product's use.11

The fourth requirement made broadcast advertisements particularly difficult to produce because of the time constraints inherent in television commercial slots. Despite this difficulty, a slight upward trend in broadcast DTCA began in the early 1990s and continued until about 1996. ,2 The FDA responded to this trend by releasing draft guidance in 1997- finalized in 1999- specifically addressing broadcast advertisements.13 This guidance replaced the "every risk" element of the initial regulations with a requirement that advertisements only present a statement of the major risks associated with the product's use ("major statement"), and list alternate sources where viewers could access the entirety of the risk information.

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