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 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
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,
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. ▪