Direct-to-consumer advertising

Template:Tone 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. 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.

Nations permitting DTC

To date only two nations permit DTC (Nation, year of legalization, link to legislation permitting DTC)

• New Zealand (1981)
• United States (1997)

DTC and threats to national sovereignty

• Canada: US terrestrial broadcasters and some US cable broadcasters that have access to the Canadian market via Canadian Radio-television and Telecommunications Commission (CRTC) regulation have effectively overridden Canada's laws that forbid DTC with respect to the transmission of these ads into the Canadian market via these broadcasters. The CRTC has not evicted these broadcasters from access to the Canadian market.
• Mexico: there is a similar case of national sovereignty to Canada with respect to some US terrestrial broadcasters running ads in Spanish on the Univision network—where reception of these broadcasts is possible in Mexico (only the states of Sonora and Baja California are affected).
• With the coming of DTV conversion of the US in 2009, Canada and Mexico may be less affected by US terrestrial broadcasters and the issue of DTC.
• US cable broadcasters on Canadian cable TV systems will continue to be in violation after 2009.

Pharmaceutical industry controversy

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.

DATELINE IN THE 1980s:

The first direct-to-consumer print ad was for Merck's Pneumovax, (pneumonia vaccine) which appeared in Reader's Digest in 1981.

In 1982, the FDA prompted Lilly to retract a press kit for its NSAID (Non Steroidal Anti-inflammatory Drug)Oraflex, citing the “false and misleading” provision of risk information. DTC advertising was only legalized in the US after a 1985 United States 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 TV ads in 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 info.(brief summary). The company also placed a full page ad in the Wall Street Journal, and in the print ad, the full package insert (prescribing information) was included. Under pressure from doctors and the American Medical Association, FDA implemented a moratorium on all advertising in directed to patients. “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,” said Liz Moench, who was then head of marketing at Boots USA and is now president and CEO of MediciGlobal. A moratorium on consumer advertising followed.

During this time, FDA United States 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 requiring advertising directed to consumers to include significant risk information about the prescription drug being advertised. These long consumer warnings often required multiple pages (or infomercial length ads) to fully fulfill the requirement.

DATELINE IN THE 1990s:

In 1997 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, but as shown it began over a decade earlier.

As a result of FDA's draft guidance, spending on DTC advertising increased from $220 million in 1997 to over $2.8 billion in 2002.

1995: Claritin, was approved in 1993 and DTC advertising was launched in 1995. Schering-Plough ran print ads and unbranded broadcast reminder ads at first, but 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 committed to a massive, broadcast-heavy multi-channel consumer campaign aimed at establishing universal brand awareness. Claritin 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 2002 OTC switch.

1997: FDA approves broadcast DTC draft guidance, Aug. 8, effectively enabling broadcast DTC by eliminating requirement that ads present the entire brief summary.

1999: FDA clarifies risk information requirements for broadcast DTC, Aug. 9, allowing for the presentation of a “major statement” of serious risks in lieu of full risk information. Schering-Plough spends $124 million on consumer advertising for Claritin.

DATELINE IN THE 2000s:

2004: Merck withdraws heavily advertised Vioxx on safety concerns, Sept. 30, providing a touchpoint for public ire over drug prices and throwing a shadow over consumer promotion

2005: Sepracor launches Lunesta, April 4, spends $215 million on consumer advertising over the next eight months. Sanofi-Aventis plunks down a cool $88 million defending Ambien's category leadership

2005: Pharmaceutical Research and Manufacturers of America releases its Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines, Aug. 2, heading off Congressional action with industry self-regulation.[1]

• 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.
• This, and many other aspects of DTC advertising, has made it extremely controversial among public health officials and physicians.

Financial services

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.

Digital and the evolution of direct-to-consumer advertising

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.[2]

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.

External links

• Educating the Consumer about Advertising: Some Issues - from the Education Resources Information Center Clearinghouse on Reading and Communication Skills, Bloomington, Indiana.
• Direct to Consumer Advertising in the United States SourceWatch: A Project of the Center for Media and Democracy
• [3] 40 years of DTC by Matthew Arnold/Medicial Marketing and Media]
• [4] Catch the New Pharmaceutical Marketing Wave: Trends & Strategies for Reaching Today's Healthcare Consumer