Four Drugmakers Targeted by the FDA for Violating TV Ad Rules
By Brian Reid
Washington, Dec. 7 (Bloomberg) -- Pfizer Inc., Pharmacia Corp., Eli Lilly & Co. and Bristol-Myers Squibb Co. ran afoul of federal rules governing television advertising for drugs, according to letters sent by U.S. regulators.
The U.S. Food and Drug Administration singled out five ads for four drugs in letters sent to the companies in November and released on the agency's Web site this week. The FDA said the ads violated regulations designed to ensure patients receive accurate product information about risks and benefits.
The FDA cited two ads for Pharmacia's painkiller Celebrex, a $1 billion-a-year best-seller for the company.
One, which depicts a series of active people with arthritis, ``collectively suggests that Celebrex is more effective than has been demonstrated by substantial evidence,'' the agency wrote.
Because so-called reminder ads aren't allowed to suggest how a drug should be used, the agency objected to a second, reminder advertisement that says, ``Celebrate, Celebrate. Do what you like to do.'' The ad, which gives no information about the drug's use, safety or effectiveness, may have made suggestions about the drug's use, according to the FDA.
Pharmacia has stopped both ads and has been broadcasting modified versions since late November, according to a Pharmacia spokeswoman.
'Think It's PMS?'
The FDA took issue with Eli Lilly's ad for its new drug Sarafem, which uses the ingredient found in Prozac to treat a severe form of premenstrual syndrome, called premenstrual dysphoric disorder. The agency said the commercial didn't accurately portray the disorder the drug is approved to treat.
A frustrated women is shown, wrestling with a shopping cart. The ad says, ``Think it's PMS? It could be PMDD.'' That, the agency said, made no clear distinction between PMS and the more severe problems, such as marked depression, characteristic of PMDD.
``The overall message trivializes the seriousness of PMDD,'' the FDA said in its letter to the company. ``For a diagnosis of PMDD, these and other symptoms must markedly interfere with work, school, usual social activities and relationships.''
That ad has also been withdrawn by the company.
``We're in the process of reviewing and responding to that notification,'' said Laura Miller, a spokesman at Eli Lilly.
The FDA also objected to a commercial for Bristol-Myers's Vaniqa, approved for women for removal of facial hair. The agency said the ad should display the company's toll-free phone number or Web site address more prominently and questioned ``ambiguous language'' about use of the product.
Finally, the FDA targeted an ad for Pfizer's Zithromax, an antibiotic widely prescribed for children. In the style of the children's program ``Sesame Street,'' the commercial said, ``Pfizer brings parents the letter 'Z' for Zithromax.''
Because so-called reminder ads aren't allowed to suggest how a drug should be used, the agency objected to the implication that the drug should be given to children.
quote.bloomberg.com
I never saw any of the ads.
Jack |
