US FDA warnings target four drug companies

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WASHINGTON (Reuters) – The U.S. Food and Drug Administration has asked Bayer AG, Amylin Pharmaceuticals, Eli Lilly, and Cephalon to stop using “misleading” promotions for some drugs, according to letters released by the agency on Tuesday.

Health

The FDA cited the companies for exaggerating the benefits or omitting important risk information in direct-to-consumer advertisements and other promotions for Eli Lilly’s depression drug Cymbalta and diabetes drug Byetta, which it shares with Amylin, Bayer’s birth control device Mirena and Cephalon’s lymphoma treatment Treanda.

The FDA called for the companies to immediately stop using the promotional materials in question.

The FDA sends dozens of letters each year about drug marketing violations, but under the Obama administration it has vowed to ramp up oversight and enforcement of the pharmaceutical industry.

The FDA wrote that a print ad for Cymbalta “entirely omits risk information” in the main part of the ad and directs readers to a single-spaced paragraph on another page that included unrelated ads. The disconnect was “not likely to draw readers’ attention,” the FDA wrote in the January 7 letter.

The letter said that Lilly also minimized the risks of Cymbalta in another promotional ad listed in WebMD’s Little Blue Book publication, which lists health resources.

Company spokesman Charles McAtee said the drugmaker was taking immediate steps to stop the promotions and was reviewing all Cymbalta marketing materials.

The FDA wrote in a separate letter to Lilly and Amylin that, at a medical meeting in Washington in June 2009, company representatives had overstated the ability of Byetta to help patients lose weight. It said they also exaggerated how well the drug worked and promoted unapproved uses.

Both companies said in a statement that they took the letter seriously and would “take action as needed.”

The FDA cited Bayer over its program touting Mirena in people’s homes and other private settings.

The FDA wrote that the script suggested that using the intrauterine contraception device could help women “look and feel great,” but it was “not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great.”

Bayer spokeswoman Rose Talarico said the drugmaker discontinued that program in February 2009 and would respond to the FDA.

Another letter cited Cephalon for omitting important risk and other information in a pocket-sized Treanda dosing card aimed at doctors. Company spokeswoman Jenifer Antonacci said it had stopped giving out the cards and was reviewing all promotional items for the product.

The FDA posted links to the letters on its website here

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