DTC Ad Guidelines Tightened, but Congress May Want More

With regulatory changes looming, the future of direct-to-consumer (DTC) advertising in the United States and in Europe seems uncertain.

The Pharmaceutical Research and Manufacturers of America (PhRMA) announced on December 10, 2008, revisions to its voluntary guidelines on how member companies should conduct DTC advertising campaigns for prescription medications. The guidelines made several changes to the previous guidelines that went into effect in January 2006. The new guidelines will become effective in March.

Among the notable changes, pharmaceutical companies must ensure that DTC advertisements that feature paid actors portraying health care professionals should state that actors are used. If actual health care professionals are paid to appear in the advertisement, the ad should acknowledge the compensation for their appearance. In addition, if a celebrity endorses a product in an ad, the company should verify “the basis of any actual or implied endorsement, including whether the endorser is or has been a user of the product.”

The latter recommendation appears to be a response to the controversy surrounding Pfizer's DTC promotional campaign for its cholesterol-lowering drug Lipitor featuring artificial heart inventor Robert Jarvik, M.D. The campaign's ads were criticized as containing a false characterization of Jarvik as a heart specialist. These and other DTC advertisements were investigated by the U.S. House of Representatives Committee on Energy and Commerce in May 2008. The ads were then pulled by Pfizer.

Another revised guideline states that DTC ads “containing content that may be inappropriate for children,” such as medications for treating erectile dysfunction, should be placed in TV programs or publications“ reasonably expected to draw an audience of approximately 90 percent adults.” The previous guideline suggested an 80 percent adult viewership.

The House Committee on Energy and Commerce has been investigating“ misleading and deceptive DTC advertising” since January 2008, according to the committee's Web site. Rep. John Dingell (D-Mich.), the chair of the committee at the time, and Bart Stupak (D-Mich.), chair of the committee's Subcommittee on Oversight and Investigation, sent a letter to PhRMA on May 20, 2008, demanding specific changes in PhRMA DTC guidelines.

In a December 10, 2008, press release, Dingell and Stupak commended PhRMA for incorporating some of their previous demands such as giving more emphasis to black-box warning in the DTC ads. However, they noted that “some of these changes are merely a rewording of prior policy that does nothing to increase consumer protection.” They complained that the revised guidelines did not endorse several of their recommendations, such as imposing a two-year prohibition for DTC advertising after a new medication is approved, which had been advised by the Institute of Medicine. “Our investigation will continue,” said Stupak.

Dingell, meanwhile, was defeated by Rep. Henry Waxman (D-Calif.) in November 2008 in a bid to retain the Committee chair. Dingell officially will hand over the gavel to Waxman when the new Congress convenes in January. Waxman, however, is hardly going to abandon this investigation. On December 8, 2008, Waxman said at a conference sponsored by The Prescription Project, a group critical of industry marketing, that he would pursue legislation to give the Food and Drug Administration the power to ban television commercials for a new drug product for years if the agency deems it necessary.

As regulatory pressure mounts in the United States, related regulations may change in the European Union (EU). On December 10, 2008, the European Commission, the executive branch of the EU, formally proposed uniform regulations on what information about prescription medications can be put on product labeling and the Internet for public access (Psychiatric News, May 16, 2008). Currently, DTC advertising for prescription drugs is banned in the EU, and drug companies are not allowed to provide detailed information about prescription medications on the Internet or in print media. However, specific regulations vary widely across member countries.

The proposed rules stipulate that drug companies may communicate to the public the price, adverse reactions, approved clinical summaries, and environmental impact of their products on packaging, leaflets, and in media channels such as health-related publications and Web sites. The companies are still not allowed to directly promote prescription medications to consumers, however.

European consumer groups and other critics of the proposal fear that the new regulations will be a slippery slope and lead to more open promotion of prescription medications and detrimental consequences for public health.

Other than consumer advocates and regulators, DTC advertising is now getting criticism from some industry insiders as well. At a conference in London on December 2, 2008, William Burns, an executive at the Swiss company Roche said “[DTC] promotion was the single worst decision for the industry,” according to Reuters. He believed that the aggressive DTC promotional model pushed in the U.S. has undermined of the industry's credibility with public.

The United States and New Zealand are the only developed countries where DTC advertising of prescription drugs is legal. ▪