Summary
The FDA sent Pflzer a warning letter stating that its ads for Viagra lack information about the risks and side effects, such as headaches and blurred vision. Impotence is not mentioned in the ad. Viagara's ad, which ran for several months, showed the V part of the drug's logo turning into a pair of glowing devil's horns. The horns were on top of a forty-something man's head. "He's back" was the punch line. FDA warnings take too long to take effect in the pharmaceutical industry.
Original source:
http://www.businessweek.com/bwdaily/dnflash/nov2004/nf20041117_9408_db016.htm
Details
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Pharmaceutical companies love to tout their drug ads as examples of consumer education.
- But that argument hardly stands up in Pfizer's (PFE) latest Viagra pitches.
- The Food & Drug Administration recently sent the outfit a warning letter saying its racy consumer ads for the male impotence drug don't contain enough information about risks and side effects.
- Pfizer agreed on Nov. 15 to pull the ads after the letter was made public.
- The FDA allows drugmakers to advertise their drugs without the side-effects summary if they don't mention the medical condition at all.
- "It's the most blatantly out-of-control ad I've seen," charges Janell Mayo Duncan, legislative and regulatory counsel at Consumers Union, the nonprofit publisher of Consumer Reports.
- Pfizer isn't alone in getting warned, and it's not the first time for the outfit, either.
- In recent years, the FDA has warned the makers of Vioxx and Celebrex, Merck (MRK) and Pfizer, respectively, about advertising their drugs in a too-positive light without explaining possible side effects.
- This latest warning, however, highlights broader problems in the way direct-to-consumer pitches are governed.
- "The agency simply doesn't have enough staff," says Michael Montagne, professor of social pharmacy at the Massachusetts College of Pharmacy and Health Sciences.
- An FDA warning to the world's largest drugmaker for misrepresenting a blockbuster medication (Viagra sales topped $1 billion in 2003) isn't likely to teach the industry any lessons.
- "No publicity is bad publicity in this context," says Gibbons.
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