Summary
Makers of prescription drugs can expect more scrutiny of their ads, Food and Drug Administration officials say. In the wake of highly publicized problems with arthritis drugs like Vioxx, officials say they will be making changes in how they review ads aimed directly at consumers. "Consider this a heads up," one official told an audience at a recent drug marketing convention. "We are very concerned about the direction consumer advertising seems to be taking."
Original source:
http://www.ajc.com/health/content/shared-auto/healthnews/safp/524307.html
Details
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.
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