FDA scrutiny spurs drugmakers to tone down ads

Instead of middle-aged bikers singing "Viva Viagra," as seen in a 2007 commercial, the latest Viagra ad shows a gray-haired man meeting with a doctor. After Pfizer's quit-smoking treatment Chantix was tied to suicides in 2008, the New York-based drugmaker added more than a minute of safety warnings into advertising that earlier had just 14 seconds.

Pfizer isn't alone in bringing a more serious tone to its ads as drugmakers react to added U.S. scrutiny of promotional campaigns for medicines.

New York-based Bristol-Myers Squibb Co. now devotes half of a 60-second Plavix spot to side effects, twice the time in a 2005 ad for the blood thinner. The changes, tied to tighter enforcement of U.S. regulatory guidelines, are "increasingly noticeable" industrywide, said Maura Musciacco, an analyst with Datamonitor Plc. While the changes benefit consumers, they may hurt business, she said.

"Ads are becoming more subtle, and being subjected to much more scrutiny," said Musciacco, whose research company is based in London. "There has been a major change in the last few years. If we continue down this route, it may become counterproductive to advertise to consumers.

"The ads become less memorable and catchy and, at the end of the day, there may be a disincentive" for consumers to try a new product, she said.

Advertisements for prescription medicine have flooded the air waves since 1997 when the U.S. Food and Drug Administration decided to allow drugmakers to shorten the time devoted to risks in their commercials, as long as they directed consumers to another source for more detailed information.

Over the last five years, the agency has increased the number of people monitoring ads by 50 percent to 60 in an effort to keep up, according to Thomas Abrams, director of the Division of Drug Marketing, Advertising, and Communications.

In 2008, drug advertising was put under the spotlight by Congressmen John Dingell and Bart Stupak, two Democrats from Michigan who publicly questioned whether drug advertising properly presented product benefits and risks. When Margaret Hamburg was confirmed FDA commissioner in May, she said the agency would more aggressively enforce existing guidelines.

As a result, the agency issued 41 warning letters to drugmakers, or almost double the number in 2008, according to the agency's warning letter database.

The agency can assess fines, require that a company stop running an ad, force a correction, or even seize the product, according to the FDA.

"Our standards haven't changed, but we are trying to do a better job at reaching the industry," according to Abrams, who said his staff reviewed more than 70,000 pieces of promotional material in 2009.

One result of added enforcement may be fewer ads, said John Busbice, a principal in commercial effectiveness at IMS Health Inc., a Norwalk, Conn.-based market research company.

Pharmaceutical industry spending on consumer ads fell 4.7 percent to $3.25 billion in the first nine month of 2009, compared with the same period a year earlier, and 7.3 percent from 2007, according to The Nielsen Company, based in New York.