American Journal of Law & Medicine

You can't say that on television: constitutional analysis of a direct-to-consumer pharmaceutical advertising ban.


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)1 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 Commission (3) 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.


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 Kefauver- Harris 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. (12) 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. (14)

In 2004, the FDA published another guidance to address print DTCA. (15) The FDA was concerned that the highly technical and scientific language often used in print advertisements was confusing to readers, and therefore that the advertisements failed to adequately communicate important risk information. (16) To correct this issue, the FDA issued a draft guidance recommending that pharmaceutical companies use clear and easily understandable language to present all risk information in their print DTCA. (17) To that end, the guidance recommended that all print DTCA were to include the contraindications, warnings, major precautions, and three to five common, non-serious adverse side effects of the advertised product. (18)

In 2007, the Food and Drug Administration Amendments Act (FDAAA) introduced several new programs and requirements for DTCA. (19) First, the FDAAA granted the FDA authority to require pre-market review of DTCA. (20) The FDAAA also instituted an advisory review program that encouraged pharmaceutical companies to voluntarily submit their television advertisements to the FDA before releasing them to the public so that their content could be reviewed for accuracy and conformity with the relevant guidelines. (21) To engage in the program, pharmaceutical companies were required to pay a fee that would ultimately cover the costs of reviewing their advertisement. (22) If a pharmaceutical company put its television advertisement through the advisory review program and integrated the FDA's suggestions, it would be immune from civil penalties if the advertisement was later found to be violative of the regulations. (23)

One of the stipulations of this program was that it needed to draw in $11.25 million in fees by a certain date in order to continue. (24) In January 2008, the FDA announced that it would not go forward with the fee-for-review program because the program was not allotted the requisite user fees in the Consolidated Appropriations Act of 2008, and the program has since ceased to exist. (25)

Another FDAAA provision outlines a scheme of hefty penalties to be levied against pharmaceutical companies that disseminate false or misleading advertisements. First-time offenders face a maximum $250,000 fine. (26) Every subsequent violation in the following three-year term draws a maximum $500,000 fine. (27) Accordingly, the United States Attorney General may collect unpaid fines plus interest if they become past due. (28)

The trend in DTCA regulation suggests that the FDA is trying to maintain some control over the information disseminated to the public, but the wave of DTCA in recent years may be too much for the FDA to handle. Since the FDA operates DTCA regulation on a post-market review system, and employs only about eight individual reviewers (29) to examine approximately 21,000 advertisements each year, (30) misleading or ultimately false advertisements may remain in the media and influence consumers for a significant period of time.

Considering the limited resources of the FDA, in conjunction with the magnitude of some pharmaceutical campaigns, the danger of misleading advertisements to the public is immense. Even so, pharmaceutical companies still stand to benefit from their advertising campaigns: in 2008, they made an average nine-dollar return for every single dollar they spent on all advertising. (31) If the Government were to seize even a maximum fine of $250,000, or a total of $750,000 after one subsequent violation, an incredible sum of money would remain. Ultimately, these fines carry little to no deterrent effect because of the rarity of their issue, and the significant monetary return pharmaceutical companies receive from their investments in DTCA. (32)

This gap in enforcement, along with the increase in healthcare costs that results from constant episodes of unnecessary care, is part of the reason why the concept of banning DTCA has gained popularity in recent years. The fact that Congress granted the FDA authority to require pre-market review signals its intent to rein in some of these outrageous expenditures by more strictly regulating the source of consumer drive in the pharmaceutical industry.

The following Part will review the relevant commercial speech jurisprudence to understand both the potential treatment of commercial speech as a fundamental right under the First Amendment and the level of scrutiny that the Supreme Court has historically applied, and will likely apply in commercial speech cases going forward.



Virginia Pharmacy Board v. Virginia Citizens Consumer Council, a 7-1 decision, was the first case where the Supreme Court recognized First Amendment protection for commercial speech by invalidating a statutory ban on pharmacist drug price information. (33) The majority was careful to point out that it was only speaking to the question of whether a ban on truthful, lawful information where the state can show only "fears" of possible negative consequences developing without such a restrictive statute was constitutional. (34) The Court concluded that such a ban without further proof of its effect is unconstitutional under the First Amendment. (35)

While the Court made clear that a statute banning truthful advertisements without solid evidence of its potential efficacy would not be constitutional, the Court also pointed out that this same threshold would not be applicable to statutes that simply impose a "time, place, [or] manner" restriction on truthful advertising. (36) Such restrictions are constitutional so long as they "are justified without reference to the content of the regulated speech, ... serve a significant governmental interest, and ... leave open ample alternative channels for communication of the information." (37)

The Court in dicta made note of the fact that the truth of much commercial speech is more readily assessed by the disseminators of such information, and not the public it will ultimately reach. (38) The Court reiterated that regulations requiring "additional information, warnings and disclaimers" are certainly warranted where the speech would otherwise be deceptive to the public. (39) Finally, the Court explicitly left open the door to restrictions that merely "insure[] that the stream of commercial information flow[s] cleanly as well as freely," showing that regulations cleansing commercial speech of misleading or deceptive elements before allowing dissemination are permissible. (40)

In a biting dissent, Chief Justice Rehnquist argued that the majority's holding would open the gates to "active promotion of prescription drugs ... and other products the use of which it has previously been thought desirable to discourage." (41) Chief Justice Rehnquist went on to severely criticize the Court's lack of discussion about the real dangers of preventing states from restricting "commercial efforts on the part of those who profit from the sale of prescription drugs to put them in the widest possible circulation" without showing that the advertisements are untruthful or misleading. (42) Finally, Chief Justice Rehnquist closed his dissent with a notion that has carried through in arguments supporting such restrictive legislation: "The societal interest against the promotion of drug use for every ill, real or imaginary, seems to me extremely strong. …

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