Prescription drug advertising will get more scrutiny, FDA promises

• The landscape of prescription drug advertising to consumers will definitely change in the wake of recent government hearings on the popular painkillers Celebrex, Vioxx and Bextra.
• His words were echoed strongly last week by an FDA official who reviews drug ads for accuracy.
• "We are very concerned about the direction consumer advertising seems to be taking."
• But an FDA advisory panel's suggested ban on direct-to-consumer (DTC) advertising for the well-known painkillers known as cox-2 inhibitors is not about to happen.
• Even if the FDA accepts the rest of the panel's recommendations -- that Celebrex, Bextra and Vioxx stay on the market but with warning labels and better consumer information on their cardiovascular risks -- the agency does not have the power to implement an outright ban on advertising.
• Because of the First Amendment, the FDA "does not have the authority to ban direct-to-consumer prescription drug advertising," an FDA spokesperson said.
• In 2005, a recent Kaiser Family Foundation survey found, 90 percent of adults had seen or heard ads for prescription drugs, up from 76 percent in 2000.
• Pharmaceutical companies can advertise approved drugs if the ads are "truthful and not misleading," according to the FDA spokesperson.
• Amgen discontinued the ad as a result, and reportedly has no plans to reissue it.
• The agency can also request that a company stop advertising altogether, an action it has taken twice.
• Cindy Callaghan, director of brand communications at AstraZeneca, described the company's new "unbranded educational ad," which "seeks to educate consumers about potentially serious NSAID treatment-related complications.
• Levinson, however, thinks that advertising directly to consumers "would be a waste of money" from here on out for cox-2 painkillers in particular.
• And even if consumers head to doctors with information from an ad, doctors will probably be reluctant to prescribe the cox-2s, he said.