Advertising is everywhere.
That should come as no surprise to anyone who has lived in modern America. It is impossible to turn on the television, ride the subway, or even sort through the daily mail without coming across an ad for a new car, a soft drink, or the latest digital toy. These advertisements have only one goal: to entice you to buy their products. This is harmless enough when these ads refer to shoes, peanut butter, or shampoo. But what about drugs, especially prescription medications?
Pharmaceutical companies and their hired advertising firms are increasingly marketing their wares directly to consumers and bypassing healthcare providers. Are drug companies really doing the public a service by disseminating this type of information? Can the motive to increase prescription volume (and profits) be reconciled with this goal of consumer education? Is this form of advertising really in the public’s best interest?
To better explore direct-to-consumer (DTC) advertising, we must first examine the roots of commercial advertising of drugs, the role of the FDA in regulating advertising, and the legal protections surrounding commercial free speech. With that historical and legal context, we will then look at the economics and effects of DTC advertising. Finally, we will conclude with perceptions (both patient and physician) about DTC advertising and propose a possible solution to the controversy.
Historical trends in direct-to-consumer advertising
The stunning imagery of “the purple pill”, the bumblebee encouraging us to ask our doctors about Nasonex, or the “Viva Viagra” commercials, are relative newcomers to the public sphere. Not until 1997 did the FDA permit broadcast advertisements for prescription drugs.
Currently, only two countries in the world, the United States and New Zealand, allow this type of advertising. Early print advertisements dating back to the 18th century were only for over-the-counter medications. These ads made inflated claims that their products could cure everything from alcoholism and obesity to dyspepsia. Unfortunately, before the early 1900s, there was little governmental oversight over drug safety or efficacy. By the turn of the 20th century, a glut of new products flooded the American pharmaceutical market, many with dubious claims of effectiveness.
Congress, wanting to ensure that drugs on the market were safe for consumer use, passed the Food, Drug, and Cosmetic Act in 1938 which gave the FDA the authority to mandate that drug companies prove their products safe before marketing them. Congress later amended the original law in 1962 to grant the FDA additional authority to regulate advertisements of prescription drugs and to further require that pharmaceutical companies prove that their products were not only just safe, but also efficacious.
During this time, pharmaceutical companies, while complying with federal regulations, advertised their products only to healthcare professionals. OTC medications were still advertised to the public, but advertising prescription medications over the heads of physicians was thought socially unconscionable. This changed in 1981 when Merck published the first DTC ad for a prescription medication, Pneumovax, in Reader’s Digest. Following Merck’s lead, several other companies began to print consumer-directed ads. Then in 1983 the first televised DTC ad, for Boots Pharmaceutical’s Rufen (prescription strength ibuprofen), aired.
Given concerns about the possible negative—but unproven—effects of DTC advertising of prescription medications, the FDA imposed a moratorium on advertisements later that year to further study the issue. After two years, the FDA suspended the moratorium in 1985. Although the agency felt that “direct to the public prescription advertising was not in the public interest”, it lifted the moratorium due to concerns over commercial free speech; it also believed that current guidelines regulating advertising were sufficient enough to protect consumers. Furthermore, the agency explicitly warned that these DTC ads “should be held to the same standards as those directed to physicians.”
For the next twelve years, advertisements were primarily focused in print media. This was because of the “brief summary” requirement. The FDA required all prescription drug ads to disclose a brief summary which included all the warnings, precautions, contraindications, and adverse events of a particular drug. This was difficult to accomplish in a one-minute television or radio ad, essentially barring broadcast advertisements. Under pressure from the pharmaceutical lobby, the FDA conducted a series of public hearings in 1995 to reconsider its restrictions on DTC advertising. Then in August 1997 the FDA released a new set of guidelines entitled “Guidance for Industry: Consumer-Directed Broadcast Advertisements.”
This statement, publicized more as a reinterpretation of current regulations, drastically changed the way that pharmaceutical companies were allowed to advertise. To make broadcast advertising easier, the new statement no longer mandated the lengthy brief summary and replaced it with the “adequate provision” clause. Adequate provision meant that since advertisements no longer had to present all the risks and precautions, they must provide consumers with alternative means of acquiring this information by referring them to a toll-free telephone number, a website address, a concurrently running print advertisement, or referral to a healthcare provider. Also, broadcast advertisements had to comply with a new “major statement” clause which required that only the major risks and most common adverse effects be disclosed. With these new rules, pharmaceutical companies could easily saturate the airwaves with ads, as long as the ads counseled patients to “talk to your doctor.”
There are three types of DTC advertisements, only one of which is subject to regulation. The first are the so-called “help-seeking” advertisements. These advertisements describe a disease or condition, but they do not discuss specific treatments. Instead, they encourage the consumer to discuss the condition with their doctor. The second type are “reminder” advertisements. In these ads, the drugmaker can mention a particular medication, but cannot give information on the drug’s indication or make claims about efficacy. These first two types of ads are not required to disclose any risk information because they do not discuss benefits.
The third type, the one from which the controversy stems, are the “product-claim” ads. These discuss both the drug and the condition for which is supposed to be used. The FDA requires drugmakers to include a “fair balance” of risks and benefits, and that the ads contain both the major statement and adequate provision according to the 1997 guidelines.
Since the relaxation of advertising rules in 1997, there has been tremendous growth in the amount of money spent on DTC ads, both print and broadcast. In 1996, pharmaceutical companies spent $11.4 billion on all promotional spending (most of which was spent on advertising to healthcare professionals and free samples). Of this, 14.2%, or $985 million, was spent on DTC ads. By 2005, total promotional spending had nearly tripled to $29.9 billion, while the amount spent on DTC ads quadrupled to $4.2 billion. Indeed, by the year 2000, Merck was spending more money advertising its soon-to-be defunct painkiller, Vioxx ($160 million), than Budweiser ($146 million), Pepsi ($125 million), or Nike ($78 million). Those ads paid off; drug sales for Vioxx topped $1.5 billion that year.
Role of the FDA
Although Congress has afforded regulatory power to the FDA, the agency has faced serious challenges to its ability to ensure that DTC advertisements are accurate and reasonable. One hurdle that hampers the FDA is the lack of manpower . For example, the number of promotional pieces submitted to the FDA for review has ballooned from 32,000 in 1999 to nearly 53,000 in 2004. Despite this growth in the volume of consumer ads, staffing at the FDA’s Division of Drug Marketing, Advertising and Communications has been relatively stagnant.
In 2002 when drug companies spent $2.9 billion on advertising, there were only three staff members to review these ads. By 2004 there were four staff members, even though spending on ads had increased to $4.5 billion. Furthermore, with the ever-increasing number of ads produced, the FDA has not been able to keep up with pre-market review. The percentage of broadcast advertisements that underwent FDA review before airing fell from 64% in 1999 to 32% by 2004.
This review process greatly increased the amount of time it took for warning letters to reach offending advertisers, so much so that by the time the letters were released, the ads were already off the air.Also, in this decade, there has been a change in the culture of the FDA. Under the conservative leadership of Secretary Tommy Thompson in 2002, the Department of Health and Human Services began requiring that all regulatory letters to industry about advertising violations first be approved by the FDA’s Office of Chief Counsel.
Coupled with the declining real power of the FDA, is a general misconception by the public of the FDA’s role in regulation. According to one study, 50% of consumers thought that DTC ads had to be pre-approved by the government; 43% believed that only drugs that were completely safe could be advertised; and 21% thought that only extremely effective drugs could be advertised to the public. These misguided beliefs and the diminishing ability of the agency to wield regulatory authority over the pharmaceutical industry can create a false sense of security in the objectivity and truthfulness of drug advertisements.
Commercial free speech and First Amendment rights
Legislatures, both state and federal, have also weighed in on the legality of direct-to-consumer advertising of prescription drugs. Two high-profile cases in the 1970s brought the idea of “commercial free speech” into the judicial vernacular. In the 1976 case of Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, the Supreme Court ruled that state laws could not block pharmacies from advertising prescription drug prices. When Justice Harry Blackmun, writing for the majority, declared that “the free flow of commercial information is indispensable,” he extended First Amendment protection to commercial advertising. The decision was not unanimous, though. Then- Associate Justice William Rehnquist, the lone dissenter, protested the notion that advertising was worthy of the same free speech protections afforded to political and social rhetoric. In his dissenting opinion, he wrote that “there are sufficient dangers attending [the] widespread use [of pharmaceuticals] that they simply may not be promoted in the same manner as hair creams, deodorants, and toothpaste.”
To determine whether limits on commercial free speech are acceptable, the Supreme Court established the “Central Hudson Test.” These guidelines were based on the 1980 case, Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, wherein the state of New York wanted to prevent utility companies from broadcasting ads encouraging consumers to use more electricity. The Central Hudson Test has three main criteria for determining whether a restriction on commercial free speech is permissible: is the speech misleading (if so, then the speech can be banned); does banning the speech advance a government interest (if not, then the government has no role in attempting to regulate the speech); and can that interest be advanced through less restrictive means (if so, then the less restrictive means should be undertaken).
One could argue that a ban on prescription drug advertising may indeed serve a government interest, that of protecting consumers from potentially misleading ads, but neither industry nor consumer groups have brought forth a case, for fear of losing an incredibly murky constitutional battle. This did not stop U.S. Representative Henry Waxman (D-Calif.), however, from trying to attach a rider to a drug safety bill in 2007 that would have banned DTC ads for drugs that had been on the market for less than three years.The bill passed without his amendment.
Insights from the medical profession
The American Medical Association issued its own statement on DTC advertising in 1999. The AMA currently asks physicians to remain vigilant for advertisements that promise unfounded benefits and for those that do not comply with FDA standards. Furthermore, the AMA cautions physicians not to be biased against advertised drugs and to not feel pressured to prescribe these drugs against their better judgment. Instead, it urges doctors to foster a relationship with the patient that encourages an open dialogue about effective, individualized medical treatment.
Direct-to-consumer prescription drug advertising has grown tremendously in the last decade. Furthermore, with the help of the Supreme Court, DTC advertising is protected under the doctrine of commercial free speech. The FDA, with its limited staff and resources, faces the enormous challenge of trying to police these advertisements to make sure that misleading information does not reach the public. If current trends continue, the growth in DTC advertising will only increase. What effects, if any, does advertising have on drugs costs and physician prescribing behavior?
[Editor's note: Stay tuned for parts 2 and 3 of this series, coming soon.]
Ishmael Bradley is a resident physician and Section Editor of Clinical Correlations, where this post originally appeared.
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