PhRMA Announces Updated Voluntary Restrictions on Direct-to-Consumer Advertising
The Pharmaceutical Research and Manufacturers of America on Wednesday announced an updated set of voluntary guidelines on direct-to-consumer drug advertising, but some lawmakers and critics said the new standards do not go far enough to address their concerns, the Wall Street Journal reports. Billy Tauzin, president of PhRMA, said the new advertising restrictions are intended to address concerns from lawmakers, physicians and others who have called for measures to ensure that advertisements provide patients with adequate information about them (Rockoff/Wang, Wall Street Journal, 12/11).
The new voluntary guidelines call for:
- DTC drug ads to explicitly indicate to viewers if an actor is portraying the role of a physician;
- Print and television ads that feature celebrity endorsers to state that the opinions or experiences expressed in the ads are solely those of the endorsers;
- Print and television ads to include a contact number to FDA that allows consumers to report any side effects; and
- Broadcast ads that market products and include information meant for adults not to be aired during programs that target children (Johnson, CQ HealthBeat, 12/10).
PhRMA also announced that it will stop advertising products that are being marketed for uses that have not been approved by FDA.
Tauzin said, "Our goal is to constantly look at (the ads) and see if we can improve them, so they are more informative, more educational and less promotional" (Wall Street Journal, 12/10). In a statement, Tauzin added, "Through these strengthened principles, we renew our commitment to work with [FDA] and health care professionals to further enhance the value of balanced DTC education for consumers and patients."
Reaction
House Energy and Commerce Committee Chair John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) praised the trade group's move for the new standards but said that they do not address a recommendation for a waiting period before companies launch ads for newly approved drugs (CQ HealthBeat, 12/10). A drug safety advisory for the Institute of Medicine under the National Academy of Sciences recommended a two-year wait before pharmaceutical companies begin marketing a drug directly to consumers so that any problems and side effects can be better understood (Wall Street Journal, 12/11). In May, the lawmakers sent letters to the CEOs of four pharmaceutical companies and PhRMA calling for an end to the use of "deceptive" DTC drug advertising (CQ HealthBeat, 12/10).
At a congressional hearing in May, Stupak criticized an ad for Pfizer's cholesterol drug Lipitor that featured Robert Jarvik, creator of an artificial heart. Stupak said the ad was misleading because Jarvik is not a practicing physician. Pfizer pulled the ad in February (Wall Street Journal, 12/11).
In a statement, Stupak said, "On one hand, PhRMA has taken our committee's concerns seriously by revising parts of their DTC code," but "on the other hand, some of these changes are merely a rewording of prior policy that does nothing to increase consumer protection" (CQ HealthBeat, 12/10). Stupak said he would continue to examine the accuracy of DTC drug ads.
Tauzin said that the new standards did not specify the two-year delay because some companies said that some treatments offer significant benefits that should be promoted immediately to consumers, adding that the decision on marketing timelines should be made by the individual pharmaceutical companies (Wall Street Journal, 12/11).
