Drug Industry Ad Guidelines Draw Criticism, Response

Joyce Frieden

Voluntary guidelines for direct-to-consumer prescription drug advertising released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians, consumer groups, and at least one company, who say they don't go far enough.

"While I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC [direct-to-consumer] advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure," Senate Majority Leader Bill Frist, M.D. (R-Tenn.), said in a statement. Sidney Wolfe, M.D., director of the Public Citizen Health Research Group, called the PhRMA announcement "a meaningless attempt to fool people into believing the guidelines are stronger than they really are."

The guidelines were released in Dallas in early August at a meeting of the American Legislative Exchange Council.

"The centerpiece is the notion that the companies are committing an appropriate amount of time to educate health care professionals about new medications and new indications ... to make sure physicians and other providers know about the medicines and benefits before," direct-to-consumer advertising campaigns are undertaken, Billy Tauzin, CEO of PhRMA and a former congressman from Louisiana, said at a press conference sponsored by PhRMA.

Dr. Frist

Other provisions of the voluntary guidelines, which 23 companies have signed onto, include:

PIDTC ads should be balanced, and discuss both the benefits and risks of the medication. The information should be presented in "clear, understandable language, without distraction from the content."

PIAds should be targeted to avoid audiences that are not age-appropriate. For example, Karen Katen, president of Pfizer Human Health, said that her company would not run a television advertisement for Viagra (sildenafil) during the Super Bowl, when young children may be watching.

PICompanies should submit new DTC print and television advertisements to the FDA before releasing them. "The intent is to make sure that FDA has been able to comment on any programs prior to advertising," said PhRMA board chair Bill Weldon, who is also chairman and CEO of Johnson & Johnson.

PIAds that identify a product by name should include the product's indications as well as its risks and benefits. This means no more ads that just give the name of the medication and tell what it's for, Mr. Tauzin said.

PhRMA also will convene an independent board in about a year to get outside opinion on whether the companies are following the guidelines. The panel will include experts in health care, broadcasting, and other relevant disciplines. The panel's report "will be made public, and also made available to the FDA," Mr. Tauzin said.

Going beyond the PhRMA guidelines, in October, Astra Zeneca proposed a mandatory requirement for pharmaceutical companies to submit all direct-to-consumer advertising to the FDA for review prior to release. The proposal was submitted to the FDA's pubic hearing on direct-to-consumer advertising of regulated medical products. The company stated that it already was following the PhRMA guidelines voluntarily, but felt that the FDA should require a mandatory review.

In recent testimony in Congress on the value of direct-to-consumer advertising, Paul Antony, M.D., Chief Medical Officer at PhRMA, discussed some major fears regarding direct-to-consumer advertising.

"According to a General Accounting Office report, of the 61.1 million people (33% of adults) who had discussions with their physician as a result of a DTC advertisement in 2001, only 8.5 million (5% of adults) actually received a prescription for the product, a small percentage of the total volume of prescriptions dispensed," he said. "Indeed, an FDA survey of physicians revealed that the vast majority of physicians do not feel pressure to prescribe."

A link to the guidelines and Dr. Antony's testimony are available at http://www.phrma.org/mediaroom/press/releases/29.09.2005.1291.cfm.

I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC advertising.

Dr. Frist