Washington, DCWhen health officials expressed concern over Chantix side effects in 2008, Chantix manufacturer Pfizer started airing new television ads that feature more than a full minute of safety warnings. Previously, the ads contained about 14 seconds of safety content, according to Bloomberg News.
Pfizer is not alone—all drug manufacturers are reacting to tighter policing of advertising regulations by the US Food and Drug Administration (FDA). Since 1997, when the agency began allowing drug manufacturers to devote less air time to risks so long as the ads directed consumers to another source for detailed information, drug advertising has exploded on the airwaves. The FDA more than doubled its number of staff dedicated to monitoring for compliance, just to keep up.
The turning point came when Michigan Reps. John Dingell and Bart Stupak began questioning whether drug advertising properly presented the benefits and risks. In May 2009, under new leadership, the FDA began a new era of enforcement.
"Our standards haven't changed," said Thomas Abrams, director of the Division of Drug Marketing, Advertising, and Communications, in comments published on 1/31/10 in Bloomberg News. "But we are trying to do a better job at reaching the industry. We are trying to reach companies so they can do the right thing."
Last year Abrams' staff reviewed more than 70,000 pieces of promotional material and issued 41 warning letters to drugmakers—double the number from 2008.
In May the FDA released draft guidelines designed to clarify what is appropriate in ads, addressing issues such as raising music volume or using distracting images while discussing safety issues.
"Many drug manufacturers have revised their commercials to more prominently feature the side effects of prescription drugs and disclose key information," said Stupak. "This increased diligence by manufacturers is promising, though there is still much room for improvement."
The new Chantix ads show real people talking about their experience with Chantix. Jim Sage, vice president for US primary care marketing, told Bloomberg News that "the ads are serious and they also strike an emotion. Using patient testimonials is a relatively new technique. It has become a more effective way to speak to consumers."
Sage said Pfizer vets all new ads through the FDA before sending them to air. He indicated that Pfizer did not change its strategy in the face of increased regulatory oversight.
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