US Pharma Industry Unveils D-T-C Drug Ad Guidelines

04 August 2005

A voluntary plan to restrict direct-to-consumer drug advertising was launched Tuesday by the Pharmaceutical Research and Manufacturers of America - with the intention of polishing the industry's tarnished public image and heading-off mandatory controls imposed by lawmakers.

PhRMA will also set-up its own advertising accountability unit. This will collate complaints from the public and forward them to the appropriate companies for action.

At the end of a trial period PhRMA will appoint an independent panel to review the process - although it has yet to explain how such a panel can be independent if chosen by the body whose activities it is reviewing.

Such a set-up is unlikely to placate the industry's legion of critics, many of whom argue that self-policing is both inappropriate and inadequate.

Ad industry executives say it is too early as yet to gauge the extent to which the voluntary controls might affect drugmakers' massive d-t-c advertising expenditure.

This is now worth an estimated $4 billion (€3.28bn; £2.26bn) annually, having risen from zero in 1997 when the Food and Drug Administration lifted its ban on d-t-c advertising.

These are the key elements of PhRMA's Guiding Principles:

  • Companies should submit all new direct-to-consumer television advertisements to the FDA before releasing them for broadcast.

  • DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised.

  • DTC television and print advertising should be designed to achieve a balanced presentation of the benefits and risks associated with the advertised prescription medicine. Specifically, risks and safety information in DTC television advertising should be presented in clear, understandable language, without distraction from the content, and in a manner that supports the responsible dialogue between patients and health care professionals.

  • Companies should spend an appropriate amount of time to educate health professionals about new medicines or new therapeutic indications before beginning the first direct-to-consumer advertising campaign. In determining "an appropriate time," companies should consider the importance of informing patients of the new medicine, the complexity of its risk-benefit profile, and health care professionals' knowledge of the condition being treated. Companies should continue to educate health care professionals as additional valid information about a new medicine is obtained from all reliable sources.
Big Pharma's initiative impressed FDA deputy commissioner Dr Scott Gottlieb. "I think the industry itself, issuing principles like it did today, is an important step," he said. "Clearly, they're expressing a willingness to try to police themselves."

But Dr Sidney Wolfe of the Public Citizen's Health Research Group is less easily dazzled: "PhRMA's latest campaign of industry self-regulation via the guidelines announced today is both dangerous and, like previous industry efforts, doomed to failure," he said.

"Selling drugs will always trump obeying the law," Wolfe opined, while calling on the FDA to monitor drug advertising more closely .

Data sourced from New York Times; additional content by WARC staff