Prescription-drug makers updated their voluntary standards for direct-to-consumer advertising to make the ads more informative, but the measures stop short of changes sought by government and industry critics.
The companies said they will halt advertising that includes promoting prescription drugs for uses that the Food and Drug Administration hasn't approved or using actors as physicians without saying so. The guidelines say celebrity endorsers shouldn't say they use a drug unless they actually do.
Billy Tauzin, president of Pharmaceutical Research and Manufacturers of America, the industry trade group that issued the standards Wednesday, said the aim was to address the concerns of doctors, Congress and other critics while continuing to keep patients informed about valuable treatments.
"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," Mr. Tauzin said.
Drug makers began advertising directly to consumers after the FDA relaxed its ad policies in 1997. The industry now spends more than $5 billion a year on direct-to-consumer ads that include print, radio and television.
Studies show the ads spur patients to take needed medicines, but research also shows that the promotions encourage use of often-expensive drugs, driving up health-care spending. Some opponents also say ads to consumers can be misleading by not giving enough information about the risks presented by a drug.
Criticism intensified when Pfizer Inc. ran ads for the cholesterol-lowering drug Lipitor that featured Robert Jarvik, inventor of an artificial heart. In a hearing in May, Rep. Bart Stupak, a Michigan Democrat, said the ads were misleading because Dr. Jarvik wasn't a practicing physician.
While the new standards are intended to address those practices, Mr. Stupak said he planned to continue looking into the accuracy of ads. Though he described the industry's move as positive, he said its practical effect would be minor. "It's an opportunity to pull the wool over the eyes of consumers while they sell more drugs," he said in an interview.
Pfizer pulled the Jarvik ads in February, after Congress began investigating. A Pfizer spokesman said the company "fully supports" the new ad standards.
Mr. Stupak and other critics said the changes announced Wednesday don't go as far as those advocated by a panel on drug safety for the Institute of Medicine, part of the National Academy of Sciences. The panel recommended that companies wait two years before advertising a prescription drug directly to consumers so that its effects can be better understood. The new standards, by contrast, don't stipulate a time period.
Mr. Tauzin said drug makers didn't want to specify a two-year delay because some drugs, like the cervical cancer vaccine Gardasil, are so beneficial that their use should be promoted right away. He said that decision is better left to the individual company assessing a specific drug.
Critics also said that television ads should include the phone number at the FDA for patients to call to report a side effect. Under the voluntary standards, only print ads would include the number. "I think the changes are really trivial," said Peter Lurie, deputy director of the health research group at Public Citizen, a pharmaceutical-industry watchdog group.
Arthur Higgins, chief executive of Bayer AG's Bayer HealthCare unit and a member of the PhRMA executive board, said the new measures were designed to answer criticisms of the industry. He added that if critics aren't satisfied by the self-regulation efforts in one or two years, the industry would be willing to sit down and try to address any remaining concerns.
Jonathan D. Rockoff and Shirley S. Wang, The Wall Street Journal. December 11, 2008
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