Direct-to-consumer advertising in the United States

The United States is one of only two developed countries that allows direct-to-consumer advertising (DTCA) of prescription drugs. (The other country is New Zealand).

A November 2006 report by the U.S. Government Accountability Office report stated that drug companies spent $4.2 billion in 2005 on DTCA. In comparison the drug industry spent $7.2 billion in 2005 promoting drugs to physicians and $31.4 billion on research and development. However, the GAO found that the amount spent on DTCA "increased twice as fast from 1997 through 2005 as spending on promotion to physicians or on research and development." It estimated that spending on DTCA was growing at approximately 20% per year.

In his book, Overdosed America, Dr. John Abramson noted that the "1997 change [in DTCA laws] unleashed an unprecedented onslaught of commercials. By 1999, the average American was exposed to nine prescription drug advertisements on television every day. The number of television ads increased 40-fold between 1994 and 2000."

Spending on DTCA 1997-2005
Table 1: Prescription Drug Promotion and Research and Development, 1997-2005. (Source: U.S. Government Accountability Office, Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising', GAO report Number GAO-07-54, December 14, 2006.

All figures in Billions

Top DTCA Drugs
In 2005 the drugs that were the most heavily promoted were
 * Lunesta - Sepracor spent $227.3 million promoting its prescription sleeping pill
 * Nexium -  AstraZeneca spent $204.9 million promoting its gastrointestinal drug
 * Vytorin - Merck/Schering-Plough spent $161.5 million promoting its cholesterol lowering drug;
 * Crestor - AstraZeneca spent $158.6 million promoting its cholesterol lowering drug;
 * Advair - GlaxoSmithKline spent $138.5 million promoting its asthma product ;
 * Nasonex - Schering-Plough spent $131.8 million marketing its allergies spray
 * Lamisil - Novartis spent $125.9 million promoting its treatment for fungal infections.
 * Plavix - Sanofi-Aventis spent $121.9 million promoting its blood-disorder drug
 * Singulair - Merck spent $121 million asthma and allergic rhinitis drug
 * Wellbutrin XL - GlaxoSmithKline spent $119.9 million promoting its drug for depressive disorder.

DTC under pressure in the US
In the wake of controversy over the safety effects of drugs such as Vioxx and the rapidly escalating expenditure, the drug industry DTC advertising came in for criticism. U.S. Senate Majority Leader Bill Frist called drug ads "fuel to America's skyrocketing drug costs" and asked companies to wait two years before advertising new drugs. In a move to pre-empt any regulatory restrictions on DTC Bristol-Myers Squibb set its own one-year moratorium on new drug ads.

Legislation with bipartisan support would create a new office within the Food and Drug Administration to "evaluate advertisements for new drugs and high-risk drugs and treatments." The American Medical Association is studying whether drug ads lead to "unnecessary prescriptions and higher health costs." All this, the Wall Street Journal reported, has the pharmaceutical industry "scrambling to respond." The lobby group Pharmaceutical Research and Manufacturers of America is "drafting new guidelines." Drug ads should "include a greater discussion of the risks," admitted PhRMA vice-president Ken Johnson. But if restrictions are placed on drug ads, "you'll probably see maybe more public relations" targeted to doctors, predicted Ogilvy & Mather's Michael Guarini. 

In August 2005 Mediaweek reported that new voluntary guidelines issued by the Pharmaceutical Research Manufacturers of America (PhRMA) on Direct-to-consumer advertising "contain few requirements that will add to marketers' ethical and legal burdens in creating drug ads." The guidelines, it reports "do little to go beyond a press release PhRMA issued on July 21, which merely 'encouraged' the industry to better target its audience". Nor do they contain any penalty or enforcement provisions. According to the Wall Street Journal, PhRMA's attempt to pre-empt a review of the ads by the Food and Drug Administration seems doomed to fail. In June former Republican congressmen and now PhRMA president Billy Tauzin told Brandweek that he opposed prohibiting companies from some forms of promotion as "we're in a free speech area…to me that's a human rights abuse" if the rules were to prohibit companies from certain types of communications, he said. 

The Food and Drug Administration will hold a public hearing on direct-to-consumer (DTC) drug advertising, "more than two years after the last public hearing ... failed to produce any guidelines to regulate the $4 billion ad category," notes AdAge. In announcing the November 1 and 2, 2005 meeting in Washington, DC, the FDA said it "believes the agency, the industry and other members of the public now have enough experience with DTC promotion to understand what regulatory issues may need to be addressed." 

Of particular interest are celebrity endorsements, since "such approaches plainly do not reflect a data-oriented approach to promotion." The agency will also ask "whether and how techniques mislead consumers about the risk-benefit tradeoffs" of advertised drugs. 

In August 2005, the Pharmaceutical Research and Manufacturers of America established their own voluntary DTC guidelines. A PhRMA spokesperson said the industry group will speak at the FDA hearing.

In an interview with the New York Times discussing corporate social responsibility, the CEO of Pfizer Hank McKinnell attributed part of the unpopularity of the drug industry to DTC advertising. "One factor was our direct-to consumer advertising. We didn’t do enough to strengthen and reinforce the importance of the doctor-patient relationship. It was a consequence of our success that we created visibility for products and many people in the public said, 'That would be nice, but we can’t afford it'," he said. 

In August 2007, the U.S. Food and Drug Administration announced it will study whether direct-to-consumer drug ads "distract consumers from carefully considering and encoding risk information," reported the Associated Press. The agency will look at "how images used in ads affect consumers" and "how text on the screen can focus or divert attention from audio warnings." The FDA is concerned that "relaxing, upbeat images" and "text directing viewers to company Web sites or magazine advertisements" may distract viewers from "important audio about side effects." 

FDA monitoring of drug ads has drastically decreased, according to an August 2007 study in the New England Journal of Medicine. The agency issued 21 citations in 2006, compared to 142 sent in 1997, according to the study. "During the same period, drug industry spending on such advertising soared 330 percent, to $29.9 billion in 2005," AP noted. 

DTCA Specific Articles

 * Direct-to-consumer advertising in the United States/Drug Companies Pay for Ad Approvals
 * Direct-to-consumer advertising in New Zealand
 * Direct-to-consumer advertising: The Campaign To Overturn Europe's Ban
 * Direct-to-consumer advertising: CanWest's Bid to Overturn Canada's Ban

Other Links

 * Disease awareness campaigns
 * Drug industry
 * Coalition for Healthcare Communication
 * Food and Drug Administration Revitalization Act of 2007
 * Innerstate (Movie)
 * Jim Davidson
 * Pharmaceutical Research and Manufacturers of America
 * Pharmaceutical Safety Institute

U.S. Government Accountability Office Reports on DTCA Advertising

 * U.S. Government Accountability Office, Prescription Drugs: Little Is Known About the Effects of Direct-to-Consumer Advertising, PEMD-91-19, July 9, 1991. (Pdf)
 * U.S. Government Accountability Office, Prescription Drugs: Selected Direct-to-Consumer Advertising Studies Have Methodological Flaws, PEMD-91-20 July 22, 1991.
 * U.S. Government Accountability Office, Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations, Report number GAO-03-177, December 04, 2002. (Text version)
 * U.S. Government Accountability Office, Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising', GAO report Number GAO-07-54, December 14, 2006. (Text version)

U.S. FDA Reports

 * Aikin KJ. "Direct-to-consumer advertising of prescription drugs: physician Survey preliminary results", U.S. Food and Drug Administration, Division of Drug Marketing, Advertising and Communications; 2002.

Academic Papers

 * Steve Woloshin, Linda Schwartz, J. Tremmel, H.G. Welch, "Direct-to-consumer advertisements for prescription drugs: what are Americans being sold?", ''Lancet April 20, 2001.
 * R.A. Bell, M.S. Wilkes, R. L. Kravitz, "The educational value of consumer-targeted prescription drug print advertising", Journal of Family Practice, December 2000.
 * R.A. Bell, R.L. Kravitz, M.S. Wilkes, "Direct-to-consumer prescription drug advertising, 1989-1998: A content analysis of conditions, targets, inducements, and appeals", Journal of Family Practice, April 2000, Volume 49, No. 4.
 * Peter R Mansfield, Barbara Mintzes, Dee Richards, Les Toop, "Direct to consumer advertising", British Medical Journal, January 1, 2005, Volume 330,pp 5-6.
 * Dominick L. Frosch, Patrick M. Krueger, Robert C. Hornik, Peter F. Cronholm and Frances K. Barg, "Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consumer Advertising", Annals of Family Medicine, Number 5, pages 6-13, 2007.
 * Julie M. Donohue, Marisa Cevasco, and Meredith B. Rosenthal, "A Decade of Direct-to-Consumer Advertising of Prescription Drugs", New England Journal of Medicine, Volume 357:673-681, Number 7, August 16, 2007.

Drug Industry Statements, Reports & Guidelines

 * Pharmaceutical Research and Manufacturers of America (PhRMA), "America’s Pharmaceutical Industry Announces Guidelines on Direct-to-Consumer Advertising", Media Release, August 2, 2005.
 * Pharmaceutical Research and Manufacturers of America (PhRMA), "PhRMA Guiding Principles Direct to Consumer Advertisements About Prescription Medicines", August 2, 2005.

General Articles

 * "$2.8B spent for DTC ads", O'Dwyers PR Daily, April 15, 2002. (Sub req'd).
 * Alan Zarembo, "TV Ads for Drugs Help Boost Prescriptions, Researchers Say", Los Angeles Times, April 27, 2005.
 * Beth Herskovits, "Attendees debate DTC advertising at PRSA health academy meeting", PR Week, May 11, 2005. (Sub req'd).
 * "TV ad spend squeeze", PMLive.com, May 24, 2005. (PMLive is the online version of Pharmaceutical Marketing). This artice indicates that several large drug companies are reviewing the amount they spend on DTC television ads in the U.S.
 * Stephanie Saul, "A Self-Imposed Ban on Drug Ads", New York Times, June 15, 2005.
 * Jeanne Lenzer, "American Medical Association rejects proposal to ban consumer adverts for prescription medicines", British Medical Journal, Volume 331 Number 7, July 2, 2005.
 * Jim Edwards, "PhRMA Unveils New Guidelines", MediaWeek, August 02, 2005.
 * Beth Herskovits, "Hefty Merck verdict spurs firms to rethink DTC efforts", PR Week, August 29 2005. (Sub req'd)
 * Rich Thomaselli, "PR Seems To Be the Rx to Get Around DTC Rules: Firms Confirm Pharma Is Seeking Ways To Live with (But Not Skirt) Guidelines," Advertising Age, September 26, 2005, p. 6 (not available online).
 * Rich Thomaselli, "FDA Hearings Could Bring DTC Regulations: Big Pharma Marketers Expect Change After Year of Political Scrutiny," Advertising Age, October 3, 2005, p. 8 (not available online).
 * "200+ Medical School Professors Call for End to DTC Prescription Drug Ads", Commercial Alert, October 27th, 2005.
 * Diedtra Henderson, "Rise of Celebrity Testimonials Spurs FDA Scrutiny", Boston Globe, October 30, 2005.
 * "Celebrity endorsement on the rack", Pharmaceutical Marketing, November 1, 2005.
 * Beth Herskovits, "Both sides of DTC debate rally while FDA holds panels", PR Week, November 3, 2005. (Sub req'd).
 * Jeanne Lenzer, "FDA investigates direct to consumer adverts", British Medical Journal, November 2005. (Sub req'd).
 * Beth Herskovits, "FDA seeking contractor to focus on effectiveness of promotions", January 5, 2006. (Sub req'd).
 * Med Ad News Staff, "DTC Takes a Back Seat", Med Ad News'', May 2006.
 * "CSR and Big Pharma", Chief Executive, June 2006. (This is an interview with Hank McKinnell, chief executive of Pfizer, with the New York Times).
 * Bill Hendrick, "Self diagnosis from TV drug ads can be dangerous", Atlanta Journal-Constitution, January 8, 2007.
 * John Russell, "Rx for drug ads: New Congress could rein in industry's surging direct-to-consumer marketing", Indianapolis Star, January 21, 2007.
 * Alicia Rebensdorf, "How Big Pharma Learned To Seduce You", AlterNet, June 19, 2007.
 * "Drug Trade Group Spent $10.7M Lobbying", Associated Press, August 17, 2007.
 * Matthew Perrone, "FDA to Study Images' Impact in Drug Ads," Associated Press, August 21, 2007.