The House Energy and Commerce Committee earlier this month wrote Lipitor marketer Pfizer seeking an explanation for Mr. Jarvik's appearance in the commercial. Yesterday, the committee asked the FDA turn over records that led to the ad's approval.
Mr. Jarvik invented the Jarvik artificial heart, but his qualification to recommend Lipitor has drawn questions. In the Lipitor ad, Mr. Jarvik says, "I'm glad I take Lipitor," but he said in an ABC News interview last week that he wasn't a user when the ads started.
"We are aware of advertisements for Pfizer's Lipitor with Dr. Robert Jarvik, who appears to state in the advertisement that he takes Lipitor," committee Chairman John Dingell and Rep. Bart Stupak (both D-Mich.), chairman of the panel's Oversight and Investigations subcommittee, wrote FDA Commissioner Andrew von Eschenbach.
"We are concerned that consumers may misinterpret the health claims of a prescription drug promoted in a direct-to-consumer advertisement utilizing a celebrity physician. In addition, we are concerned that Dr. Jarvik's qualifications may be misinterpreted given that he may not be a practicing physician with a valid license in any state."
The letter asks the FDA to explain not only how it approved the ad, but whether it continued to monitor the advertising after approval.
Pfizer in a statement defended the use of Mr. Jarvik in the Lipitor ads, from Publicis Groupe's Kaplan Thaler Group, New York. "Pfizer takes its responsibility with regard to DTC advertising very seriously," the company said in a statement. "Our foremost concern is that the tone and content are appropriate for the intended audiences, and that it will ultimately result in encouraging valuable patient/physician dialogue that can lead to appropriate treatment.
Adonis Hoffman, senior VP-general counsel for the American Association of Advertising Agencies, also defended the move. "I'm confident that the manufacturers of prescription medications are as concerned about public safety as our policymakers. ... The drug industry has a new voluntary self-regulatory system in place and is more attuned to how it communicates with consumers than ever before."