PhRMA Releases Outline of Voluntary Prescription Drug Advertising Guidelines

The Pharmaceutical Research and Manufacturers of America on Thursday released an outline of voluntary guidelines on how drug manufacturers should advertise prescription products to consumers, the Boston Globe reports (Henderson, Boston Globe, 7/22). Few details were available on Thursday, but a PhRMA spokesperson said the code of conduct will go beyond FDA regulations (Sander, New York Post, 7/22). The guidelines recommend that drug makers:

Discuss new drugs with physicians before launching consumer advertising campaigns;

Target ads to appropriate age groups and audiences;

Include information about drugs' risks and benefits;

Make claims about drugs only when there is substantial evidence to support the claims (Appleby/Schmidt, USA Today, 7/22);

Promote disease awareness; and

Inform uninsured patients about programs that provide no-cost or reduced-cost drugs (Boston Globe, 7/22).

The guidelines, which were adopted unanimously by PhRMA's board of directors, do not set a time period between a drug's release and when it will be advertised, "as had been called for by industry critics who say doctors need time to understand drugs" before patients begin requesting them, the New York Times reports.

In addition, PhRMA is still working on plans to address consumer complaints, according to PhRMA Senior Vice President Ken Johnson. Johnson said details of the guidelines will be disclosed at a news conference next month (Saul, New York Times, 7/22).

Frist Comments

In a statement on Thursday, Senate Majority Leader Bill Frist (R-Tenn.) commended the industry for drafting "greater restrictions on out-of-control direct-to-consumer advertising," adding, "I look forward to reviewing the industry's complete and final recommendations and examining areas where improvements may be needed." However, the group "deflected a plea by [Frist] to voluntarily limit direct-to-consumer advertising for two years after launching a new drug," according to the Philadelphia Inquirer.

Frist had proposed the voluntary moratorium on July 1, saying many drug commercials are "misleading" and often "oversell hope." Johnson said in a telephone interview, "We have a great deal of respect for Sen. Frist. We can and will do a better job of advertising. But we also believe that patients have a right to know about new drugs" (Ginsberg, Philadelphia Inquirer, 7/22).

Additional Reaction

Sidney Wolfe of the consumer advocacy group Public Citizen said more stringent enforcement of drug advertising by FDA would be more effective than voluntary guidelines from the industry. "The FDA should go back to the 157 times they stopped illegal ads in 1998 from the 24 times they did last year," Wolfe said, adding, "PhRMA can claim it will urge members not to take out misleading ads, but, if they do, the FDA is not going to stop them and neither is PhRMA."

PhRMA CEO Billy Tauzin said, "By approving these principles, the industry is demonstrating its commitment to direct-to-consumer advertising as a way to encourage doctor-patient discussions and provide patients and consumers with accurate, accessible and timely health information" (USA Today, 7/22).

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