Direct-to-consumer advertising (DTC advertising) usually refers to the marketing of pharmaceutical products but can apply in other areas as well. This form of advertising is directed toward patients, rather than healthcare professionals. The Food and Drug Administration holds responsibility of regulating DTC advertising. The FDA’s latest version of guidelines, though still in draft form, for pharmaceutical drug advertising was updated in 2009.[1] Forms of DTC advertising include TV, print, radio and other mass and social media. There are ethical and regulatory concerns regarding DTC advertising, specifically the extent to which these ads may unduly influence the prescribing of the prescription medicines based on consumer demands when, in some cases, they may not be medically necessary.
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To date only two nations permit DTC (Nation, year of legalization, link to legislation permitting DTC)
All western nations, with the exception of New Zealand and the United States, have historically (since the 1940s for Australasia, North America, and Europe) banned direct advertising of pharmaceuticals to consumers.
The first direct-to-consumer print ad was for Merck & Co.'s Pneumovax, a pneumonia vaccine, which appeared in Reader's Digest in 1981.
In 1982, the FDA prompted Eli Lilly and Company to retract a press kit for its NSAID, Oraflex The FDA cited the "false and misleading" provision of risk information. DTC advertising was legalized in the US only after a 1985 Food and Drug Administration (FDA) ruling, but the agency required the adverts to include a great amount of information on the risks of the drugs. Rufen, manufactured by Boots, was the first drug to be advertised on US television in 1983.
On May 13, 1983, Boots Pharmaceuticals (the US arm of a major British pharmaceutical company and pharmacy chain) launched the first TV ads for a prescription medicine in a test market; Tampa, Florida for the prescription brand of Ibuprofen called Rufen. The ads, featured CEO John D. Bryer, who delivered the message that Rufen was cheaper than Motrin. It was a price ad and made no efficacy claims and as such it did not include Package Insert information. The company also placed a full-page ad in the Wall Street Journal, and in the print ad, the full package insert, the prescribing information, was included.
Under pressure from doctors and the American Medical Association, the FDA implemented a moratorium on all advertising in directed to patients. Liz Moench, who was then head of marketing at Boots USA and is now president and CEO of MediciGlobal, said: "We thought that way we could navigate this quagmire of FDA indecisiveness, but they were really grappling with how to address labeling and issues of communication."[2] A moratorium on consumer advertising followed.
During this time, the FDA Food and Drug Administration conducted consumer exchange meetings to gauge public reaction to direct-to-consumer advertising of prescription drugs. In 1985, the FDA issued a ruling that required advertising directed to consumers to include significant risk information about the prescription drug being advertised. Those long consumer warnings often required multiple pages (or infomercial-length ads) to fully fulfill the requirement.
Claritin was approved in 1993, and DTC advertising was launched in 1995. At first, Schering-Plough ran print ads and unbranded broadcast reminder ads, but it switched over to branded ads with its Blue Skies campaign. With older competitors like Seldane and Hismanal out of the way and newer drugs Zyrtec and Allegra still in development, Claritin had the market for antihistamines all to itself. Schering-Plough spent $124 million on consumer advertising for Claritin.
Schering committed itself to a massive, broadcast-heavy multi-channel consumer campaign aimed at establishing universal brand awareness. Claritin's DTC spending peaked in 1998, at $142 million in measured media, according to TNS Media Intelligence data but remained strong over the course of five line extensions and a switch to over-thecounter in 2002.
On August 8, 1997, the FDA released its draft guidance that effectively enabled the use of broadcast ads for DTC. This allowed advertisers to forgo the requirement that they scroll or read the entire brief summary, provided they met an "adequate provision" standard for risk information as shown it began over a decade earlier.
As a result of the FDA's draft guidance, spending on DTC advertising increased from $220 million in 1997 to over $2.8 billion in 2002.
In 2002, the Secretary of Health and Human Services began requiring all draft FDA regulatory letters, including letters related to advertising violations, to be reviewed and approved by the FDA's Office of Chief Counsel before they are issued.[3]
In 2004, Merck withdrew heavily-advertised Vioxx on safety concerns on September 30, provided a touchpoint for public ire over drug prices and threw a shadow over consumer promotion.
In 2005: Sepracor launched Lunesta on April 4 and spendt $215 million on consumer advertising over the next eight months. Sanofi-Aventis spent $88 million defending Zolpidem's category leadership.
On 2 August 2005, Pharmaceutical Research and Manufacturers of America released its Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines, with the intent to stop congressional action to end industry self-regulation.[4]
This great amount of advertising has been successful in raising the prescription rate of DTC drugs by 34.2%, compared to only a 5.1% increase in other prescriptions.[5]
That and many other aspects of DTC advertising made it very controversial among public health officials and physicians.[6]
Consumer vulnerability to deceptive advertising is also particularly acute in the area of financial services. Individuals often have little knowledge of the workings of credit, leases, and security agreements. It is sometimes difficult to obtain information on such subjects that would be meaningful to the average consumer, so it is especially important that consumers be on guard against misleading or fraudulent advertisement. Because of the great inequality of bargaining power in this area, the government often backs up the consumer with protective laws.[7][8]
Emerging media channels are causing the consumer channel mix to become increasingly fragmented. Individuals are no longer limited to just the television or newspaper to obtain their entertainment, news, and information, but can access content via websites, online video, social networks, mobile devices, and a variety of other ways. Consumers are especially shifting to new media sources for health and pharmaceutical information – over 145 million U.S. adults looked up health information online in 2008.[1]
The pharmaceutical industry as a whole has not been as quick as other sectors to jump on the digital marketing bandwagon, in part due to unclear guidelines from the FDA. Nonetheless, many direct-to-consumer (DTC) marketers are beginning to recognize the opportunities that new media offers for reaching consumers. Though the vast majority of DTC budgets are still allocated to traditional offline media such as television, newspaper, magazine and radio, marketers are beginning to shift some of their spending to digital activities such as product websites, online display advertising, search engine marketing, social media campaigns, and mobile advertising. Regardless of the advertising channel, pharmaceutical drug advertisers are continuing to increase the amount of money spent on DTC advertising with an increase of 330% from 1996 to 2005.[9]