FDA CITES PFIZER FOR FALSE, MISLEADING ADS

The controversy surrounding Pfizer's Cox-2 inhibitors, Celebrex and Bextra, took a new turn when the company was cited by the FDA for making false and misleading statements in advertisements for the painkillers.

In an untitled letter published on the FDA's website, the agency's Division of Drug Marketing, Advertising, and Communications (DDMAC) took Pfizer to task for five ads promoting Celebrex (celecoxib) and Bextra (valdecoxib). The agency ordered Pfizer to halt the ads immediately, and asked the company to provide written confirmation acknowledging that it understands the need to discontinue them.

DDMAC said the promotional pieces run afoul of numerous agency principles, including omission of material facts, statement of misleading safety claims and unsubstantiated declarations of superiority.

DDMAC asked Pfizer to submit a response by Jan. 26 detailing its actions to halt the promotions. Pfizer did not return multiple calls seeking comment on the untitled letter.

To view a copy of the letter, go to http://www.fda.gov/cder/warn/2005/12560-letter.pdf (http://www.fda.gov/cder/warn/2005/12560-letter.pdf).