FDA Reprimands 4 Drug Makers for Misleading Promotions

AstraZeneca, Pharmacia Corp., Abbott Laboratories and ICN Pharmaceuticals Inc. were reprimanded by the Food and Drug Administration for misleading consumers and doctors in promoting their drugs.

The agency said the promotions downplayed risks and lacked balance.

For example, AstraZeneca’s advertising for its Nolvadex breast cancer treatment implied “greater efficacy than demonstrated by substantial evidence,” the FDA said.

The FDA has been trying to enforce boundaries set under a 1997 law that lifted some restrictions on drug advertising and let drug makers pitch products in television commercials.

The agency is polling doctors and consumers to see how the ads influence behavior. Critics say the ads spur consumers to demand drugs they don’t need.

AstraZeneca’s advertisements for Nolvadex fail to point out that the drug may increase a patient’s risk of developing uterine cancer, the FDA said in a letter to the company. Nolvadex is the brand name for tamoxifen, a 25-year-old breast cancer drug.

ICN’s journal advertisements for Efudex, which treats precancerous lesions, are unbalanced because they downplay risks spelled out in the cream’s label, such as the potential for miscarriage when applied during pregnancy, the FDA said.

Pharmacia’s claims for Genotropin to treat stunted growth confuse readers because they don’t clearly note caveats including the drug’s approval for children only up to age 2, the FDA said.

A spokeswoman for Pharmacia, which made the claim in a mailing to doctors, said “the company takes these things very seriously.”

The FDA warning occurred because Pharmacia thought that if it didn’t mention the drug’s name, the mailing would be considered educational and the company could advertise without mentioning risks, Pharmacia spokeswoman Caroline Bullock said.

The FDA cited Abbott’s Knoll division for promotional materials distributed in the Detroit area that included “before” and “after” pictures of individuals said to have lost weight using Knoll’s Meridia obesity drug.

Officials at AstraZeneca, ICN and Abbott didn’t return calls.

The FDA also recently found fault with Eli Lilly & Co. and Icos Corp. for promotions of their experimental impotence treatment, Cialis, and with Cephalon Inc. for promotion of its Provigil narcolepsy drug.