The voluntary guidelines are available at www.phrma.org/publications/policy//admin/2005-08-02.1194.pdf
New voluntary guidelines for direct-to-consumer prescription drug advertising released by the Pharmaceutical Research and Manufacturers of America have drawn criticism from politicians and consumer groups 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.
Among other things, the guidelines call for pharmaceutical manufacturers to educate physicians and other health care providers about new drugs before advertising them to consumers.
“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.
The length of time the companies will take to educate physicians will depend on several factors, including whether the drug is a life-saving one and how complex the risk-benefit profile is, Mr. Tauzin said. “We are also committed to continuing to educate health care professionals as additional info about a medication is obtained from all sources, even after medication has begun being marketed.”
Other provisions of the voluntary guidelines, which 23 companies have signed onto, include:
▸ DTC 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.”
▸ Ads 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.
▸ Companies should submit new DTC print and television advertisements to the FDA before releasing them. PhRMA board chair Bill Weldon said this does not mean that companies would submit an ad to the FDA on Tuesday and then run it on Wednesday.
“The intent is to make sure that FDA has been able to comment on any programs prior to advertising,” said Mr. Weldon, who is also chairman and CEO of Johnson & Johnson.
▸ Ads 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.