The Pharmaceutical Research and Manufacturers of America has issued preliminary guidelines on the direct-to-consumer advertising of prescription medicines, at a time when advertising policies are coming under increasing scrutiny, particularly in the wake of Merck & Co’s withdrawal of its blockbuster painkiller, Vioxx (rofecoxib) [[01/10/04a]].

The so-called “guiding principles” recommend that all DTC advertising “should be accurate and not misleading; make claims only when supported by substantial evidence; reflect balance between risks and benefits; and be consistent with [US Food and Drug Administration]-approved labeling.” Companies are urged to hold talks with doctors prior to the launch of a new DTC campaign, and target TV advertisements to the appropriate audiences. In addition, firms are encouraged to promote health and disease awareness as part of their advertising, and include information about assistance programs for the uninsured and low-income.

“Direct-to-consumer advertising can be vitally important to patient education, increasing awareness of diseases and motivating patients to contact their physicians. 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,” said Billy Tauzin, PhRMA’s president and chief executive. The guidelines will now go before each PhRMA member company for its consideration, voluntary adoption and implementation.

Earlier this year, Bristol-Myers Squibb set the ball rolling with the announcement that it would wait at least a year before advertising new drugs directly to consumers [[15/06/05e]]. This triggered calls from US Senate majority leader, Bill Frist, for a ban on DTC ads for the first two years a new drug is on the market [[04/07/05c]]. Although the draft guidelines stop short of this move, Mr Frist welcomed the initiative. “I’m pleased that PhRMA is acting so quickly following my call for greater restrictions on out of control direct to consumer advertising,” he said, adding a cautionary, “I look forward to reviewing the Industry’s complete and final recommendations and examining areas where improvements may be needed.”