Pharmaceutical companies yesterday joined hands in committing to a new voluntary code of conduct for direct-to-consumer advertising, that will see it place a balanced emphasis on the risks as well as the benefits of medicines. The Industry has come under increasing criticism for not including risk information in its promotional materials – an issue that has fallen even more under the spotlight following the withdrawal of Merck & Co’s Vioxx [[01/10/04a]]. A class action lawsuit given the go-ahead earlier this week claims the firm’s marketing and advertising of Vioxx was fraudulent and misrepresented the drug's safety and efficacy [[01/08/05a]].

Karen Katen of Pfizer, who chairs the Pharmaceutical Research and Manufacturers of America group, noted: “Through the principles we can improve communications about pharmaceutical risks and benefits, educate the public about prescription medicines and treatment options, enhance health awareness and motivate patients to talk with their healthcare providers about their health.” The organisation will forge an ‘Office of Accountability’ to receive comments from both the public and healthcare professionals on DTC advertising, and will issue periodic reports outlining both the comments and the company response. These reports will be filed with the US Food and Drug Administration and will be reviewed on a yearly basis by an independent panel, which will make recommendations in tandem with the principles.

Specifically, the guidelines state that DTC television advertising for a medicine should be submitted to the FDA prior to release, and include both the health conditions for which it is approved and the major risks associated with the compound. Presentation of risk information also applies to print advertising, and companies should also educate health professionals about new medicines or new labeling prior to launch of the advertising campaign to consumers.

But the move is not without its critics, which say the code is without substance and point out that many of the principles are already required by law. Sidney Wolfe of consumer organization, Public Citizen, noted: “Like many misleading direct-to-consumer ads, the new Pharmaceutical Research and Manufacturers of America guidelines are a meaningless attempt to fool people into believing the guidelines are stronger than they really are. The FDA has had the authority to regulate prescription drug ads for more than 40 years because of failed drug industry self-regulation, but the agency hasn’t done an adequate job. It has too little authority and doesn’t even use the little authority it has.”