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10.1177/1527476404270605 Television&NewMedia /August2006  Jaramillo /Pills GoneWild Pills Gone Wild Medium Specificity and the Regulation of Prescription Drug Advertising on Television Deborah L. Jaramillo University of Texas, Austin  In 1997, the Food and Drug Administration (FDA) significantly altered the landscape of commercial media. Because of a clarification of rules regarding advertising, various media  would now be able to exploit the vast market potential of pharmaceuticals (or pharmaceuti- cal companies would now be able to exploit the vast marketplace of commercial media). Since 1997, cutting-edge medications have shared the stage with beer, cars, and fast food. The problem is the treatment of prescription drugs as just another line of products between television programs—a trend that is only escalating. This article questions the place of pharmace uticals on televis ion by explori ng the privileged position of comme rcial speech, the industrial circumstances behind the integration of pharmaceuticals into advertising, the implicat ions of the advertisements, and the role of the FDA in regulat ing them. By delving into the dangers of mixing drugs and television, the author hopes to make a strong case for tighte r , media-c enter ed regulation of direct -to-co nsume r prescription drug advertise ments. Keywords: advertising; branding; direct-to-consumer ads; prescription drugs; regulation The Food and Drug Administration’s 1997 decision to relax regulations prohibiting certain types of prescription drug advertisements has resulted inaba rra ge of telev ision commer cials aes theticizingdisease s, pills, and the side effects that accompany them (Food and Drug Administration, 2001). The relaxed regulations have broader implications beyond the superficial opening up of airtime markets to comprehensive prescription drug ads. Direct-to-consumer (DTC) ads—as the FDA refers to them—are by no means a new development. Though they have existed for yea rs in a highl y restricted form, only recently have they been able to blossom into full- fledged commercial messages. T wo asp ect s of DTC ads are especi all y sig ni fi cant and uniqu e. Fir st , they are for prescription—not over-the-counter (OTC)—medicines. Unlike the simple process of buying Tylenol or Metamucil, accessing this particular 261 TELEVISION & NEW MEDIA V ol. 7 No. 3, August 2006 261–281 DOI: 10.1 177/1527476404270605 © 2006 Sage Publications

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10.1177/1527476404270605Television&NewMedia /August2006 Jaramillo /Pills GoneWild

Pills Gone WildMedium Specificity and the Regulation ofPrescription Drug Advertising on Television

Deborah L. JaramilloUniversity of Texas, Austin 

In 1997, the Food and Drug Administration (FDA) significantly altered the landscape of commercial media. Because of a clarification of rules regarding advertising, various media would now be able to exploit the vast market potential of pharmaceuticals (or pharmaceuti-cal companies would now be able to exploit the vast marketplace of commercial media).Since 1997, cutting-edge medications have shared the stage with beer, cars, and fast food.The problem is the treatment of prescription drugs as just another line of products betweentelevision programs—a trend that is only escalating. This article questions the place of pharmaceuticals on television by exploring the privileged position of commercial speech,the industrial circumstances behind the integration of pharmaceuticals into advertising, theimplications of the advertisements, and the role of the FDA in regulating them. By delving

into the dangers of mixing drugs and television, the author hopes to make a strong case fortighter, media-centered regulation of direct-to-consumer prescription drug advertisements.

Keywords:  advertising; branding; direct-to-consumer ads; prescription drugs; regulation

The Food and Drug Administration’s 1997 decision to relax regulationsprohibiting certain types of prescription drug advertisements has resultedin a barrage of television commercials aestheticizing diseases, pills, and theside effects that accompany them (Food and Drug Administration, 2001).

The relaxed regulations have broader implications beyond the superficialopening up of airtime markets to comprehensive prescription drug ads.Direct-to-consumer (DTC) ads—as the FDA refers to them—are by nomeans a new development. Though they have existed for years in a highlyrestricted form, only recently have they been able to blossom into full-fledged commercial messages.

Two aspects of DTC ads are especially significant and unique. First, theyare for prescription—not over-the-counter (OTC)—medicines. Unlike thesimple process of buying Tylenol or Metamucil, accessing this particular

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product legally involves overcoming significant barriers. Second, DTC adson television underscore the issue of medium specificity—that is, the idea

that there are qualities found on one medium that are not present onanother. DTC ads, therefore, carry a singular burden that print advertise-ments do not. Issues like time constraints, saturation, mass audience, andaesthetics have everything to do with the role of medium specificity indetermining the efficacy and specialized danger of the ads.

The first aspect is undoubtedly under the jurisdiction of the FDA, thegovernment agency that dictates the normative health of the United States.The second aspect does not, however, fall under the rubric of that agency.Traditionally, the Federal Trade Commission regulates the general

umbrella of advertising. TheFDAcontrolsonly those aspects of advertisingthat relate to prescription drugs. The Federal Communications Commis-sion has its own regulatory control over advertising in broadcasting, but ithas not comenear the DTC debate. Thiserror inturf allotment appears tobea tremendous oversight, especially considering that the principal player inDTC expenditures is the television industry.

The main concern of this article, then, is the intersection of three impor-tant issues: a highly specialized, nontraditional commercial product; theinstitution of advertising; and the medium of television. With this intersec-

tion driving my research, I will argue that the aestheticization of illness andcontrolled substances necessitates a deeper consideration of medium spec-ificity than has been given by the FDA. DTC ads on television implicitlycarry a degree of import that must be acknowledged through the propercombination of regulatory agencies. Since the overarching issue here is theprotection and regulation of commercial speech, I will begin by outliningthe trajectory of advertising from an unprivileged form of speech to a pro-tected right. I will accompany that with a review of literature on commer-cial speech. The purpose of this first section is threefold: (1) to highlight

the privileged position of advertising in the United States, (2) to empha-size thatcommercial speech is not fullyprotected,and (3) tostress that if theSupreme Court has seen fit to grant commercial speech a haven under theFirst Amendment, the necessary regulatory steps must be taken to ensurethat these advertisements do not have free reign on any media. Followingthat will be an examination of advertising regulation. For the prescriptiondrug advertising case study, I will provide a concise history of prescriptiondrug ads, the FDA’s 1997 decision, the heated discourse surrounding DTCads, and the implications for a medium specific approach to regulation.

Though I will address DTC ads in print media, I will focus on broadcastmedia in a more concerted fashion.Along these lines, I muststress that I amconfronting the issue of DTC ads from a media studies and political econ-omy of communications standpoint. I emphasize this to differentiate thiswork from many other investigations of DTC ads that originate from the

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health sciences. A media-centric project may highlight issues overlooked by a health sciences approach. I will start, then, with a review of the cases

pertinent to the First Amendment protection of commercial speech and theliterature written about this protection.

Safe Speech

Protected speech under the First Amendment is not explicitly cordonedoff to include only political or civic-minded speech. The men who draftedthe Bill of Rights section of the Constitution merely stated, “Congress shallmake nolaw?abridging the freedom of speech, or of the press” (U.S. Consti-tution, First Amendment). What has come to be defined as protectedspeech since then has been at the center of great debate and consternation.First Amendment protection is a difficult enough terrain to wander intowith strictly social or political speech. The vagueness of the amendmentleaves itwide open for interpretation, whichraises the ire of those leftout orsummarily restricted by the Supreme Court’s interpretations. Questionsabout what the framers did or did not mean by the statement aside, there isno dispute that the “right” is stated in a negative fashion. The explicitappeal to be left alone by the government raises interesting issues about thegovernment’s intervention in speech that some feel should be protected.This is where we encounter the complicated area of commercial speech andits equally difficult trek from no protection to protection with limits.

The first case before the Supreme Court to deal with the question of pro-tection for commercial speech was Valentine v. Chrestensen (316 U.S. 52) in1942. In it, Chrestensen was challenging an ordinance that prohibited himfrom distributing handbills with an advertisement printed on one side ofthem and a protest against the city on the other side. The court held thatcommercial speech was not on the framers’ minds when they drafted theamendment, so the ordinance was not unconstitutional. It is interesting tonote that four notable handbill distribution cases showed up in 1939 beforeValentine. In Schneider v. State of New Jersey, Town of Irvington (308 U.S. 147[1939]), Young v. California, City of Los Angeles (308 U.S. 147 [1939]), Snyder v. Milwaukee (308 U.S. 147), and Nichols v. Massachusetts, City of Worcester (308U.S. 147 [1939]), the court struck down anti-handbilling laws because thesecompanion cases dealt specifically with the distribution of religious and/or political speech. In the Schneider case, the court specifically noted thathandbilling ordinances were not out of order if they prohibit “commercialsoliciting and canvassing (308 U.S. 165).” The stage had been set, then, todeal explicitly with a commercial handbill case with apparent ease.

The doctrine against freedom of commercial speech was held up in 1951in Breard v. City ofAlexandria (341 U.S. 622), whenthe prohibitionof door-to-door canvassing was found not to violate First Amendment rights. A city

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commissioner sued the New York Times for libel over a paid advertisementthat suggested he ordered police officers to unduly hamper civil rights pro-

tests. In 1964, the Supreme Court reversed his wins in circuit court and Ala- bama’s Supreme Court in the case New York Times v. Sullivan (376 U.S. 254).What makes this case significant is its insistence on First Amendment pro-tection of the newspaper in spite of the fact that money exchanged hands inthe placement of the ad. The court felt the commercial natureof the transac-tion had no bearing on content—the ad in question was termed an “edito-rial advertisement” (376 U.S. 266) and considered to be well withinConstitutional protection.

Another significant case dealing with advertisements in newspapers

was Pittsburgh Press Co. v. Pittsburgh Commission on Human Relations (413U.S. 376 [1973]). At issue was a collection of gendered help-wanted ads thatviolated the Pittsburgh Commission on Human Relation’s sex-free ordi-nance. The advertisements were found to be “classic examples of commer-cial speech” in that they posited no political stances or gendered prefer-ences (ibid.). For this reason, the court did not recognize anyunconstitutionality in the commission’s ordinance. A newspaper adver-tisement in Virginia publicizing abortion services in New York led toBigelow v. Commonwealth of Virginia (421 U.S. 809) in 1975. The ad violated a

Virginia statute prohibiting publications from supporting the practice ofabortion, and the Virginia Supreme Court upheld the newspaper editor’sconviction. The Supreme Court did not concur, and the smallest amount ofprotection was lent to commercial speech because the ad held informationthat was valuable to a certain audience. The court found an interesting bal-ance between what constitutes commercial speech and what qualifies asprivileged space in the realm of ideas. What they did not do was defineright then and there the degree to which the First Amendment could covercommercial speech. In any case, it was a small but important victory for

commerce.The case to which commercial speech advocates point as being the one

that sealed the deal was Virginia State Board of Pharmacy v. Virginia CitizensConsumer Council (425 U.S. 748) in 1976. Just as relevant is the fact that thiscase involves prescription drug advertising, an issue already dealt with inthe California Supreme Court case Shirley Terry v. California State Board of Pharmacy (96S.Ct. 2617) also in1976. InbothShirley Terreyand Virginia StateBoard, the advertising of drug prices was a point of contention. And in bothcases, this type of advertising was held to be of social value because infor-

mation of this type was vital for consumers’ sakes. The prohibition of priceadvertising was therefore found to be unconstitutional. The specializednature of the pharmacist’s product was an extenuating circumstance,according to the court, and the judgment was not intended to extend to allother professions.

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The development of commercial speech protection has, according tosome theorists, been the result of a dialectical opposition between two pri-

mary ideas (Rome and Roberts 1985). The first is the idea that commercialspeech is so radically and inherently different that it does not merit thesame degree of protection (if any protection at all) as individual speech(ibid.). The second is the belief that the First Amendment protects every-one—speaker, listener, speech—and that to exclude the speech of corpora-tions is to impair the proper functioning of the market (ibid.). The free flowof information from seller to potential buyer is key to this second argumentand, indeed, tomuch of the literature deriding the absenceof full protectionfor commercial speech (Coase 1977; Johnson 1977; Rome and Roberts 1985;

Beales and Muris 1993; Johnstone 1993; Kaplar 1993; Walsh and DeVore1997). At their roots, these supporters of protected commercial speechappeal to one of the most basic tenets of Western liberal thought—that themarketplace is the best determinant of value. In addition to citing John Mil-ton and J. S. Mill, Coase (1977) appeals to the works of Adam Smith andAaron Director to prove that the markets of goods and ideas should notcompete for primacy but should, instead, be considered equally importantto the proper functioning of everyday life (p. 2). Smith, of course, natural-ized the exchange of goods and claimed it was the outgrowth of man’s

innatedesire toexchange ideas (Napoleoni 1975, 33). This typeof reasoningis at the heart of the procommercial speech protection literature.

In addition to the privileging of the marketplace, a second fundamentaltenet of liberalism that informs proprotection literature is the mistrust of agovernment that is too involved in regulation. Kaplar (1993) writes thatagency regulation of commercial speech is nothing short of a massive“exception to the Constitution” that proves the failure of checks and bal-ances (p. 44). In his two-part test to determine whether speech should beregulated—a social cost-benefit analysis and a determination if the govern-

ment “has a strong incentive to repress”—he maintains that the fragility ofcommercial speech and the tendency of regulators to “play favorites” aretwo essential reasons why commercial speech should deserve the sameamount of protection as political and religious speech (ibid., 75). Classicalliberalism undergirds all of the rhetoric behind the support for commercialspeech protection, and regulation is seen as almost as big an affront todemocracy as the total exemption of commercial speech from the cover ofthe First Amendment.

Alexander Meikeljohn’s distinction between “public” and “private”

speech provides a framework for the opposition.For Meikeljohn, only pub-lic speech should beprotected,as it is the typeof speech that relates to“self-government” (Barron and Dienes 1979, 158). Also countering theproprotection camp is literature that takes the position that democracy isneither served nor advanced by the inclusion of commercial speech in First

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Amendment protection (McChesney 1998, 1999). Indeed, the protection ofthe wealthy and the protection of the manyappear tobe mutually exclusive

(McChesney 1999, 11).Thoughproponents of protectedcommercialspeechcite the canonical liberal thinkers, McChesney (1998) reminds us that theFirst Amendment and J. S. Mill’s On Liberty originated at a time and a place“where speech was not regarded as a commercial enterprise” (p. 5). News-papers were commercial media at this time, but they operated within a sys-tem of competition before the onslaught of monopoly capitalism and anoligopolistic industrial organization (ibid.). When the change did come,and media were enveloped in a more corporate mode of operation, it became harder to maintain a “strict line” between types of speech

(McChesney 1999, 268). This, for McChesney, is the root of the problemthathas resulted in the diminished capacity to separate and distinguish thenoncommercial from the commercial (ibid.). Not to idealize the good olddays with undue (and problematic) nostalgia, but his argument that theconflation of commercial and political speech is damaging to a democraticway of life is well taken. The market-guided approach to life is likewisederided as a myth that has radically altered First Amendment interpreta-tion, pulling it in the direction of increasing corporate domination of sociallife (ibid., 256–57).

C. Edwin Baker’s (1989) liberty theory stands opposed to the market-place of ideas theory that serves as the basis for the commercial speech pro-tection advocates (p. 3). Liberty theory advances two central argumentsagainst First Amendment protection of commercial speech. The first statesthat commercial speech is market driven and, as such, that it operatesunder the rules of the market. It is therefore not beholden to “substantivevalues” or “individual liberty”—concepts that form the basis of the FirstAmendment—and should not be protected (ibid., 196). The second argu-ment emphasizes the differences between expression and market

exchange. The power hierarchy that exists in market exchanges is not con-nected to individual liberty and should be regulated. Because commercialspeechisapartofthoseexchanges,itshouldberegulated,too(ibid.,197).

What we have, then, are two opposing views of what constitutes ahealthy democracy. On one side is the idea that (U.S.) democracy is andshould be driven by whatever is conducive to a properly functioning mar-ket. On the other side is the firm belief that the first position onlydepoliticizes the public and conflates the right to live freely with the right tobuy freely. The protection of commercial speech is an essentially anti-

democratic result of misguided faith in a commercial way of life. I will usethe latter position, and especially the ideas behind Baker’s liberty theory, both to oppose the FDA’s reversal of DTC ad regulations and to supporttighter, more media-literate regulation against DTC ads. First, I will move

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on to a brief examination of the process of regulating one major area ofcommercial speech—advertising.

Ad Agencies (Regulatory, that is)

One would presume that the degree of protection afforded to commer-cial speech might quell the cries of injustice from the corporate sector, butthe responsibility of regulation is spread out over so many federal agenciesthat the unrest is only exacerbated. The FTC; FDA; FCC; U.S. Postal Service;U.S Bureau of Alcohol, Tobacco, and Firearms; and Securities ExchangeCommission all have jurisdiction over advertising practices (Wood 1996,169). Advertising can even contend with a group at the state level: theNational Association of Attorneys General (Wood 1996). The defaultagency thatdeals with unfair ordeceptiveadvertising in general is the FTC.Among its responsibilities are reviewing scripts and storyboards for com-mercials, substantiating efficacy claims, investigating demonstrations, andrequesting “corrective advertising” to reverse false claims (Barnouw 1978,89). At the heart of the FTC’s mission is the “smooth operation of the mar-ketplace,” a commitment that necessarily involves keeping a watchful eyeon howadvertisements contributeto or impede “consumers’opportunitiesto exercise informed choice” (Federal Trade Commission1999a). The FTC’smission appearstocoincide with the proponentsof commercial speech pro-tection; everyone seems to have the consumer’s best interests in mind. Thedifference is that the FTC and other agencies position themselves as barriers between advertisers and consumers, allegedly allowing onlyhonest ads to pass.

On occasion, various agencies join forces to combat dishonest or unfairadvertising. One example of interagency cooperation is the collaboration between the FTC and the FDA in matters concerning dietary supplements.The responsibilities are split between the two agencies, with the FDA over-seeing labeling, inserts, and point-of-sale promotional materials and theFTC dealing with advertising and direct marketing (Federal Trade Com-mission 1999b). Though the FTC deals with accuracy in ads and lawenforcement, the FDA dictates the nation’s health standards and deter-mines the safety of health-related products (Beales and Muris 1993, 144). Inissues concerning health, then, both agencies have general jurisdiction, and both agencies can look over each other’s regulatory shoulder (ibid., 143–44). But the overt cooperationends with prescription drugs. In this area, theFDA has jurisdiction over both labeling and advertising. The FTC still hasthe power to step in, but nominally, the FDA is in control. Prescriptiondrugs are a step above OTC medicines and dietary supplements; these arepotent substances that presumably require the oversight of one “expert”agency. But this raises the important issue of specialized areas. As the

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agency is constructed, the FDA seems the logical choice to have exclusivedomain over the area of prescription drugs—what gets approved, what

gets rejected, and so forth. But once the FDA moves into the terrain ofadvertising in broadcast media, it is no longer an “expert” and should bedemoted accordingly. If interagency cooperation exists between the FDAand FTC, surely the FCC can provide the same service.

There is no truly compelling reason why the FCC has not stepped in.With the exception of Fairness Doctrine implications for political cam-paigns (until the death of the Fairness Doctrine), the FCC has removeditself from issues of advertising since the early 1970s. In 1967, the FCCissued a statement that mandated free-of-charge counter-ads to accom-

pany cigarette commercials. Congress was convinced by the counter-ads,so they banned cigarette ads in 1970 (Barnouw 1978, 87). A debacle fol-lowed, with environmentalists demanding commercial time under theFairness Doctrine to answer ads from car and oil companies, which in turnprompted fear from the networks that had no desire to lose money on freeairtime handed over to “issue advertising” (ibid., 87–88). The networksthen invoked their policy of not selling commercial time to “issues,” butMobil Oil officially declared that its First Amendment rights were beingviolated (ibid., 88). Mobil felt that its omnipresence on news programs and

the like was just entertainment—not hard-hitting, focused time like com-mercials selling the beauty of Big Oil. For environmentalists, the timedevoted to them on programs was insufficient, and commercial time wasalready devoted to industries representing issues like nuclear power. Thisis where the FCC backed out. It issued a statement in 1971 that cigaretteswere “unique” and the ban should not be extended to general productadvertisements. After that, it deferred advertising issues to the FTC and tothe television industry’s code of standards and practices (ibid., 89).

Not only is the FCC’s presence crucial at this time, but the special nature

of broadcast media necessitates the agency’s intervention. In Bates v. StateBar of Arizona (433 U.S. 350 [1977]), the court emphasized that the “specialproblems of advertisingon the electronic broadcastmedia” wouldcall for aspecial degree of attention. That alone should make it plain that the FDA isout of its element on television and that the addition of prescription drugsto the televisual landscape combines two issues with very unique circum-stances. To begin to understand those unique circumstances, let us nowturn to the case study on DTC ads and the pharmaceutical industry.

Television: The New Pushe rTo initiate the case study, I will provide a history of prescription drug

advertisements and the role of the FDAin regulating them. Food and drugsfell under FTC regulation in 1938 with the Wheeler-Lea Act, and by 1948

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the FDAhad food and drug labeling well under its control (Johnstone 1993,3). The 1962 passage of the Kefauver-Harris Drug Amendments com-

menced the FDA’s exclusive regulation of prescription drug advertising,thereby removing that task from the FTC’s designated set of responsibili-ties under the Wheeler-Lea Act (ibid., 5). Under the amendments, “full dis-closure” of side effects was mandatory, but this was softened to a “briefsummary” (ibid., 3, 5). In 1969, updated regulations took the time con-straints of broadcast media into account with the provision that ads onradio or television needed only a disclosure of “major” side effects ratherthan a brief summary (ibid., 10). In the early 1980s, DTC ads began toappear in print. Propelled by its desire for consumer advertising, the Ciba

Geigy pharmaceutical company proposed a commercial that then-FDACommissioner Hayes felt trivialized “the importance and dangerousnature of [prescription] drugs” (Feather 1997, 40). In 1983, Hayes—frus-trated by the ads and under pressure from Congress, the AmericanMedicalAssociation, and, interestingly, major pharmaceutical companies—calledfor a moratoriumonDTC ads until the FDAcould assess if theyshould con-tinue and if they should be regulated. Exempt from the moratorium were“reminder ads,” which relay only the drug’s name but not its function, and“health messages,” which only discuss the benefits of getting examined by

a doctor for certain ailments without specifically naming a drug (Johnstone1993, 11). The FDA proceeded to conduct some interesting social scienceresearch on audience reception. According to Kenneth Feather, former reg-ulatoryreviewofficer of the Center for DrugEvaluation and Researchat theFDA, the research involved investigating “various aspects of brief summa-ries, and how they’re read, and how best to deal with some of this informa-tion” (Feather 1997, 41). At the conclusion, the FDA determined that audi-ence members exposed to fictitious drug ads in a theatre setting did, in fact,understand the drug warnings. In 1984, after the FDA reprimanded Boots

Pharmaceuticals for false advertising, pharmaceutical companies held aconference on televised DTC ads. The majority of representatives in atten-dance derided DTC ads for “undermining the doctor-patient relationship,heightening product liability exposure, and unduly increasing marketingexpense” (Johnstone 1993, 12). The opposition from pharmaceutical com-panies, coupled with constant congressional pressure, brought any furtherdiscussion to a halt. The FDA ended the moratorium, convinced that theregulatory status quo was sufficient. The result of sticking with the statusquo was a systematic prevention of broadcast DTC ads, considering that

the “brief summary” that was possible in print media was simply too longto include in a 30-second broadcast commercial (ibid., 13.).

Inevitably, the limitations on broadcast DTC ads were dealt with ininventive ways on cable television. On deciding to launch the Cable HealthNetwork (which later became the Lifetime Network), Dr. Art Ulene

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approached the FDAtodeterminea legal way of airing industry-supportedprogramming geared toward doctors (Feather 1997, 23). The proposed

solution was to scroll the brief summary at the end of their health program-ming, and the FDA approved it. American Medical Television directed adsto physicians without a brief summary but with a phone number. Othersmade a practice of combining reminder ads and health messages in onecommercial break so that viewers could essentially do the work that thepharmaceutical companies could not (ibid., 14). That very same practice became a point of contention after the FDA revised the regulations it wasdetermined to keep fourteen years earlier.

The FDA revised its DTC drug advertising regulations in 1997 and

issued itsfinal draft guidance in 1999.The FDAdecided torevisit itsregula-tions because of “consumer demand for information” about drugs and because of “changes in consumers’ ability to get additional product infor-mation” (Woodcock 2003, 3).Basically, theFDAfelt that broadcast commer-cials “could be constructed to ensure access to product labeling informa-tion” (ibid., 3). The most substantial changes to the regulations involved amore broadcast-friendly list of requirements for DTC ads. As for the finaldraft guidance of 1999, DTC ads for prescription drugs on broadcastmediamusthavethe following: an informationhotline,a recommendation toseek

supplemental information in print form, a recommendation to seek out aphysician to inquire about the drug, a web site, and a “major statement” ofside effects communicated in a “consumer-friendly” manner (Food andDrug Administration 1999a). Key to this regulation reform is the “majorstatement” that replaces the prohibitive “brief summary” of side effectsand contraindications.

Even that basic provision has been argued against and sidestepped alto-gether. Writing in favor of DTC ads, scholar John E. Calfee argued that theFDA’s insistence that DTC ads “balance information about risks and bene-

fits” wentagainst the heart and soul of advertising as a “dynamic medium”(Marshall 2004, 56). In 2000, Roche Laboratories Inc. defied the guidelineoutright by combining a reminder ad and a health-seeking ad for itsantiobesity drug, Xenical, in one commercial breakto avoidany unappetiz-ing discussions of “oilystools and gas”—twoof Xenical’s majorside effects(Scussa 2001). Both ads used the same music and images to reinforce theconnection between the product name in the reminder ad and the promptto inquire about obesity in the ad shortly following the reminder ad. TheFDA could do nothing about these ads since each one, on its own, was per-

fectly legal. Schering-Plough tried the same tactic in a magazine, but theirmistake was putting the reminder ad and help-seeking ad back to back,with nothing separating them. The FDA declared that ad misleading because there were no side effects listed (Scussa 2001). In addition to theinteresting implications that these two incidents raise for medium

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specificity, the story points to the rate at which pharmaceutical companieshave plunged headfirst into DTC advertising and saturating ad space and

time.In 1998, one year after the FDA relaxed its DTC rules, pharmaceuticaladvertising was already ranked “13th among 360 advertised product cate-gories” (Return to Spender 1998). Since 1994, DTC ad spending has risensubstantially each year. Though estimates of total amounts spent on DTCads vary from source to source, they are consistently not far off from eachother. Combining the numbers from the Kaiser Family Foundation,Sonderegger Research Center, and the National Institute for Health CareManagement Research and Educational Foundation, theaverage spending

in 1999 was $1.824 billion to promote 92 pharmaceutical brands. In 2000,$2.483 billion was spent to promote 103 brands (Brown 2002; Scussa 2001).This increased to$2.7 billion in 2001 (Young 2003, 122 ). Compare this to the$266 million spent in 1994, and the dramatic increase is evident (Brown2002). So while “spending on [DTC ads] increased by 145%” from 1997 to2001, “researchanddevelopment spending increased by59%” (Young 122).

According to Fortune, the industry’s profits rose from $28 billion in 2000to $37.3 billion in 2001 (Public Citizen 2002, 33). These truly astronomicalnumbers may mean on the surface that this is a game solely about profits.

But growing budgets have made pharmaceutical companies heavilydependent on the abilityof theirblockbuster drugs to pay off (Brown 2002).It is argued that one problem with this dependence may end up being arerouting of resources away from development of new medicines andtoward winning patent extensions of blockbuster drugs (ibid.). Anotherequally pertinent problem is how a drug goes from being a health improve-ment strategy to a brand-building strategy.

Branding is a subset of marketing that simply means “the developmentand maintenance of sets of product attributes and values which are coher-

ent, appropriate, distinctive, protectable, and appealing to consumers”(Murphy 1987, 3). The “attributes and values” are embodied in the brand,“a mixture of tangible and intangible values symbolized in a trademarkwhich, if properly managed, creates value and ensures influence on a mar-ket over time” (Blackett and Russell 1999, 1). The key issues here are theconstruction of values, the passive yet vital role of consumers, and theinfluenceon—notcoexistence with—themarket.As production hasshiftedto overseas factories, large U.S. companies have focused their energies noton manufacturing products but on manufacturing brands (Klein 2000, 3).

So the strategies that have defined such corporations as Nike and Disneyhave now been co-opted by the pharmaceutical industry. The actual pill isperipheral to the lifestyle that is being builtand promised to consumers, notpatients.

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The criteria for selecting the coveted Brand of the Year award consist ofthe following: “Must be pharmaceutical product, must be among the 100

 best-selling drugs by worldwide sales, must have potential for strongfuture growth, must be strong against rivals, must have a significant mar-keting budget, must be widely prescribed” (Brown 2001). Sales, growth,andmarketing aretheoverwhelming yardsticksby which pharmaceuticalsare measured. No mention is made of efficacy. This batch of criteria onlyserves to construct prescription drugs as no different than tennis shoes orsoft drinks. Likewise, the FDA, pharmaceutical companies, and pharma-ceutical trade magazines rarely refer to the sick people who may need to bemedicated as patients. The viewers watching DTC ads are not constructed

as ill but rather as very special shoppers. Research and development sec-tions of pharmaceutical companies are consequently pushing for remediesin a “wider variety of ailments[,] . . . jockey[ing] for pole positions in vari-ous drug categories” (Buss 1998). Vioxx, winner of Brand of the Year in2001, was on top not because it necessarily helped anyone but because ofsales, product launch success, and clinical trials to “expand indications andmarket reach” (Brown 2001, italics added).

The values being pushed in this rush to brand—“one of the most inten-sive efforts by a single industry to turn products and companies into a new

category of household names”—all boil down to better living throughchemistry (Buss 1998). For instance, Joan Lunden hawking Claritin on TV brings the reassuring Good Morning America brand to the allergy medica-tion. The allegedly virile masculinity of Major League Baseball players andNASCAR drivers lend credibility and gender security to Viagra (Alm2002). Former Chicago BearscoachMike Ditka put a face to another erectiledysfunction drug during the 2004 Super Bowl. This strategy is not new.Even an aging Mickey Mantle shilled for Voltaren, an arthritis drug(Feather 1997, 28). Brands are also established through pill shape and color.

The erectile dysfunction pill Viagra is not pink for a reason. Psychologistswork with marketing consultants to develop pills and distinctive namesthat will not only differentiate the product but will also give the pill a branded identity (Wen 2001).

Branding also places the pills into very specific spotlights. Cross-platformmarketing has even been used to take advantage of other brands. ScheringLaboratories spread Clarinex overall of TimeWarner’s branded media out-lets, including America Online, CNN, and Time magazine. The cross-mar-keting is incredibly intrusive, resulting in blatant agenda setting especially

on CNN Headline News, where Schering sponsored a health update, andon TBS, where the company sponsored a “Defining Moment” segment toair during Major League Baseball games(Howard 2002). Partnerships withretailers also constitute another marketing strategy that merges drug brands with trusted store brands. This type of alliance then yields

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comarketed communications in which pharmaceutical companies use aretailer’s database to get into the direct-mail business (Buss 1998). These

“guerilla campaigns” are an almost desperate attempt to lure sufferers/consumers to drugs and make nonsufferers aware that in case they do getill, the brand will be around (ibid.).

The reason for the branding surge lies in the very traditional goal ofsecuring market share. Prior to two major developments—a quicker drugreview process and a marked increase in new drugs available—pharma-ceutical companies had a lock on the market and did not have to beparticu-larly aggressive with their ads (Feather 1997, 24). But with the availabilityof generic drugs and the fact that many blockbuster drugs will be losing

their patents and/or going OTC very soon, these companies need to createa sense of loyalty to brands that will be competing with many others drugsthat can use the same active ingredients. By “increasing comfort levelswithmedication and with some of the risks,” DTC ads eliminateone of the obsta-cles to getting specific drugs prescribed (ibid.). And though pharmaceuti-cal companies have not stopped advertising in physicians’ journals, DTCads allow the companies to reach patients without going through thetraditional gatekeeper.

Doctors have responded to the ads with mixed feelings. Some doctors

complain that the bonds patients establish with the on-screen pills make itdifficult for them to recommend alternatives since they spend most of theoffice visitexplaining why thatpill may not be the best solution (Wen 2001).The FDA’s 2002 Survey of Physicians found that “about 75 percent” of doc-tors surveyed “believed that DTC ads cause the patients to think the drugworks better than it did, and many physicians felt some pressure to pre-scribe something when patients mentioned DTC ads” (Woodcock 2003 7).In the final analysis, there is no way to avoid the fact that any patient needsa doctor to prescribe the drugs, but companies perceive DTC ads as allow-

ing the patient to enter the office armed with information. The problem isthat the information is vague, at best. The form of the commercials commu-nicates general concepts associated with quality of life rather than thedetails that are actually relevant to the disease and health care. This is whythe merging of the brand and the advertisement is especially pernicious. Ifthe free flow of information is the foundation for First Amendment protec-tion of commercial speech, then the branded commercial contributes noth-ing substantial to social discourse other than images of happiness andallergy-free mornings.

The Commercials

Before the FDA’s 1983 moratorium on DTC ads, Commissioner Hayeswas shown a commercial for a Ciba Geigy antihypertension drug. Kenneth

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Feather (1997) recalled the commercial in an interview conducted by FDAhistorians:

So they had this commercial with two obviously middle-aged kinds ofguys. . . . The one gentleman was speakingtothe other about this drugthat hewasjustputon,howwonderfulitwas,andhowhecouldremainactive,anditdidn’t interfere with his lifestyle, et cetera, et cetera, and, of course, up to himwalks this very lovely young lady dressed in a bathing suit or tennis outfit,something that madeher obvious charms noticeable,and it was his new wife.So the hidden message, of course, was the fact that it didn’t make him impo-tent. Well . . . Dr. Hayes just hit the ceiling when he saw that, because thefear . . . the fear among many people in the agency is advertising on TV will

tend to trivialize the importance and the dangerous nature of prescriptiondrugs. (P. 40)

The same advertising tactics thatpromptedsuch fear in the 1980s remainfully operational today. Woodcock (2003) notes twoprimary concerns withDTC ads: “overstatement of the product’s efficacy and inadequate convey-anceofrisk information”(p. 7). To this I would add that these two problemsareaidedtoagreatdegreebythe method of overstatementor conveyance. Inaddition to appealing to basic emotions with heartbreaking stories of che-

motherapy patients who do not have enough energy to spend time withtheir grandchildren, DTC ads on television employ catchall symbols thatsuggest concepts rather than articulate information. An ad for the antide-pressant drug Zoloft features a black-outlined bouncing ball with a face toillustrate the stages of depression. Not only does this imagery infantilizethe patient, but he or she has also been reduced to a caricature of a mentalillness. Images of flowing wheat fields in commercials for the allergy drugAllegra confront allergy sufferers with ideas about freedom to breathe. Ashot of a woman playing with dogs illustrates freedom from pet-related al-

lergies. And perhaps the most puzzling is the surreal image of purple pillsfalling from the sky over an almost postapocalyptic rocky terrain in aNexiumad. Herethe pills are linked tosomething as organic and natural asrain, but the commercial’s mise en scene—large black rocks, ominous sky, bizarre people dressedin black, invadingpurple pills—does little to denoterelief from acid reflux.

Equally problematic are the visuals that interfere with the so-calledinformative voice-over. In a regulatory letter demanding that Alza Corp.pull its ad for Ditropan XL, an FDAemployeecited the “clutter and distrac-

tion” of the visuals as detrimental to the imparting of information (FreeRein 2003, 33). This issue was explored in a Consumer Reports “computer-assisted analysis” of 564 letters sent by the FDAto pharmaceutical compa-nies from 1997 to 2002 (ibid., 35). Its study found that the FDAcited variouscompanies 363 times for downgrading the risks associated with the

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advertised drugs (ibid.). Though the commercials technically followed theguidelines—statement of risks, toll-free number, and so forth—the FDA

characterized the visuals as “obfuscatory” (ibid.).Aesthetics point to the difference between television and print ads. Inprint, there is no motion and decidedly less emotion. Print ads can run anexcessively long list of indications, contraindications, and side effects (albeitin ocular-damaging small print). However, the expense of a 30-second tele-vision commercial leaves little time for the famous “major statement” ofside effects, usually delivered in a soothing, almost happy, tone of voice, sothat diarrhea, headache, and nausea sound almost pleasant and evenworthwhile. DTC ads in print also have the advantage of reaching a highly

targeted audience. A drug for premenstrual dysphoria can be sure to reachthe appropriate niche if it is placed in magazines like Cosmopolitan orWoman’s Day. The same can certainly besaid for television to the extent thatthe same drug can be placed heavily throughout a TV program with strongfemale demographics—Oprah, for instance—or on an entire branded chan-nel like Oxygen (targeting women) or Spike TV (targeting men). The differ-ence lies in the structures of both media. A magazine is self-contained. Aspecific channel may also be self-contained (like Time Warner’s CartoonNetwork or Scripps’ Food Network), but ad spaces are not cordoned off to

specific viewers. Anyone can watch anything at just about any time. This isnot to say that only certain people should have access to these ads in thesame way that some groups argue children should not have access to SexandtheCityor Buffy theVampire Slayer. This is not about subjective notions ofviewer responsibility. My point is that the pervasiveness and style of theseads on television attempt to rein prescription drugs into a standard com-mercial discourse.There is nodoubt that prescription drugs are and alwayshave been commodities. But their placement alongside commercials forrel-atively benign products in addition to the outright fetishization in these

commercials attempt to erase their highly specialized nature.The potentially lax attitude toward prescription drugs is reinforced, of

course, by the marketing itself. One advertising executive remarked thatthe move to TV has raised the bar for DTC ads since any “high-impact, branded TV campaign” must necessarily compete against “a standard likeCoca-Cola” (Krajnak 1997). What the pharmaceutical companies are argu-ing is informative and necessary to the health of the nation is interpreted byadvertising agencies as “great consumer TV” (ibid.). I am not arguing thatgood intentions are getting lost in the translation. Rather, the impulse for

these ads to be televisual involves so many factors—demographics, aes-thetics, symbols, time constraints—that there should be a distinction made between what constitutes good consumer TV and a truly informativeadvertisement. This is where the FCC should reenter the arena it sogracelessly left many years ago.

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Public Medication, Public Interest, andPrescriptions for Regulating DTC Ads

The “major statement” of side effects was an “alternative mechanism”worked into regulations specifically for broadcast media because the FDArecognized “broadcast’s inherent limitations” (Food and Drug Adminis-tration 1999b). If the FDA acknowledges the special circumstances of broadcast media, it mustalso beable toacknowledge that it cannot possiblyundertake the management of broadcastads on itsown. Barron and Dienes(1979) recognizes that the “importance of broadcasting as a vehicle for dis-seminating information” coupled withthe importance of truthful advertis-ing necessitates a higher degree of government regulation (p. 187). Both ofthose factors involve a substantial public interest, and for that reason, theFCC must be involved. A study on consumer awareness of DTC ads foundthat the “major statement” of side effects deterred 61 percent of viewerssurveyed from taking the drug in 1999 but only 38 percent in 2000. Thestudy also found that half of the respondents seek more information aboutthe drug, and 73 percent successfully recalled information in the commer-cials (Study finds 2000). People are being informed by these barely infor-mative spots, and there is no more compelling reason for specializedregulation than this.

In Virginia State Board of Pharmacy, consumers—not pharmacists—chal-lenged the statute. This relates directly to the consumer’s right to knowposited byCoase(1977) and others. But this is not the case with prescriptiondrugs because of their special status. Certainly, patients have every right toexplore theirmedication options. However, DTC ads target an uninformedcitizenry thatwill not receive any substantial information fromthe ads. Thepatient must still go through the middleman, the physician. It is thus neces-sary to privilege the expert in this case not because people are inherentlyand hopelessly ignorant but because prescription drugs are unattainable(legally) without a physician’s approval.DTC ads only providea televisualdescription of an idealized way of life with the medication. Free flow ofinformation might be an argument in favor of DTC ads if only there wereanything informative actually being communicated. Instead, we getimages of walks on the beach, allergy-free women playing with dogs, andlittle purple pills falling from the sky. This is manipulative advertising that,notwithstanding actual audience reception, seeks to alter the doctor-patient relationship with respect to medication. In all of this, I do not pur-port to privilege or romanticize the top-down, hierarchical doctor-patientrelationship, but again, prescription drugs carry certain inescapable baggage with them.

There is no doubt that health is of the utmost public interest. There is,however, a doubt that DTC ads and the surrounding atmosphere of medi-

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cation saturation contribute in any way to the public health. JusticeBlackmun, in Virginia State Board of Pharmacy, stated that commercial

speech is essential to the “formation of intelligent opinions as to how [thefree enterprise system] ought to be regulated or altered” (425 U.S. 765). Anatmosphere conducive to forming those intelligent opinions is preciselywhat is lacking in DTC ads. Barron and Dienes (1979) concedes the publicinterest point, but he rightly points out that just becausecommercial speechmay include some public interest does not mean that commercial speechand public speech are the exact same thing (p. 171). In the case of DTC ads,these commercials absolutely include some public interest, but they are notserving the public interest. The strategies used to communicate the mes-

sage—slick production values, soothing voices, the branding imperative—render important information secondary to the primary commercialmessage.

When prescription drugs met modern television advertising, the profitmotive instantlytraveled to its logical and televisual extreme at the expenseof medicinal truthsand the peoplewho rely on them. Obfuscatory commer-cials that use smoke and mirrors to sell health to ill people is the best exam-ple of a lie on a commercial medium that trades in half-truths and outrightdeceptions. This is not speech that betters society or even questions or

opposes it in any meaningful way. It does not contribute to discourse. Itdoes, however, make a gargantuan industry even larger. Sales of the fiftymost advertised drugs resulted in almost 50 percent of the $20 billionincrease in spending on drugs from 1999 to 2000 (Public Citizen 2002, 28).Meanwhile, the costs of prescription drugs continue to rise, and pharma-ceutical companies have their sights set on extending the patent lives oftheir biggest sellers. As a result, less money is spent on development ofnewer and better drugs, and more is focused on marketing and patentextension. Under liberty theory, then, this wholly profit-driven “speech”

deserves no more protection than everyday exchange. Strict regulation isnecessary.

Present regulation involves the following. Pharmaceutical companiesare not required to submit their promotional materials to the FDA. A Con-sumer Reports article cited a University of California at Los Angeles studythat found that almost half of 329 Sacramento residents thought that “drugads are preapproved by the FDA” (Free Rein 2003, 33). This is not the case,as the review process can take longer than even the commercial’s run ontelevision. The already lengthy review process was exacerbated in 2002

when the Bush administration began requiring legal counsel to review theletters sent by the FDA to the offending pharmaceutical companies (D.Y.122 ). The result is that the commercials air while the review process is tak-ing place. The Center for Drug Evaluation and Research (CDER) has a spe-cial branch to review drug promotional materials, the Division of Drug

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Marketing, Advertising, and Communications (DDMAC). In 2001, theyreceived 36,700 pieces of promotion material; 486 of these were broadcast

advertisements (Woodcock 2003, 4).Accordingto Janet Woodcock, directorof the CDER, not all materials are thoroughly reviewed, though TV andradio ads, in particular, are “flagged for expedited review” (p. 4). Ads thatmisrepresent the drugs in any way are eventually handled in a number ofways. Offenders are generally sent “untitled letters,” which are essentiallycease and desist notices (ibid., 5). Companies whose ads may threaten thewell-being of the public are sent “warning letters” (ibid.). Because they arereviewed by legal counsel, warning letters are strong indications that legalaction, if taken, will have a “relatively high likelihood of succeeding in

court” (ibid.). In moreseverecases, the DDMAC can issue “injunctions andconsent decrees,” “referrals for criminal investigation or prosecution,” orembark on “seizures” (ibid.). But again, submission of materials is entirelyvoluntary. And if a misleading commercial is not submitted, the DDMACmight issue a letter after the commercial has completed its run ontelevision.

This is what can be done. Banning prescription drug advertisementsfrom the air is the best solution but impossible. Commercial speech is pro-tected, and the Bush administration does not have a history of cutting back

the rightsof corporations.For its part, the DDMAC has instituted programsto educate the pharmaceutical industry, law firms, and advertising agen-cies about FDA regulations concerning DTC ads (ibid. Woodcock 2003, 5).The effort is noble but not necessarily effective. I propose that the FDAmake the review process mandatory, as it is currently optional. The FCCshould be added to the review process, as should activists and scholarswho have experience with the complexities of media, aesthetics, and pro-paganda. To address the issue of problematic aesthetics and imagery, theFDA should include in its general guidelines a standardized form of pre-

scription drug advertisement that cannot benefit from the minds of adver-tising executives. And to fix the problem of saturation advertising, whichnormalizes certain prescription drugs and downgrades their potentialharm, the FCC should impose a limit on the number of DTC ads aired perday. Image and frequency limitations can then make it easier to devote per-tinent commercial time to actually informing people about the medicationrather than simply selling them ethereal ideas about happiness throughless sneezing, less social anxiety, and more erections. If this type of speechmust be protected, it has to be regulated. I readily admit that I feel uncom-

fortable prescribing limitations on any type of speech, but we need toremind ourselves that commercial speech cannot be on the same level asspeech against war or speech in favor of gender equality. If the two types ofspeech have the same degree of protection, the one with more funding andmore politicians on its side will most definitely drown out the other and

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only further entrench society in a corporatized vision of the world and, inthis case, of health.

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Deborah L. Jaramillo is a doctoral candidate in the Department of Radio-Television-Film at the University of Texas at Austin.

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