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FDA Warns Makers of Arthritis Drug For Making False Marketing Claims

By CHRIS ADAMS and JILL CARROLL
Staff Reporters of THE WALL STREET JOURNAL
 

WASHINGTON -- The Food and Drug Administration said the marketing of hot-selling arthritis drug Celebrex was "false, lacking in fair balance, or otherwise misleading," marking the fourth time in 16 months that the drug has been cited for improper marketing.

In a "warning letter" dated Feb. 1, the FDA cited "repeated promotional activities that minimize the potentially serious risk of using Celebrex" together with a common blood-thinning medication.

Previously the FDA had been assured that such marketing problems wouldn't recur regarding the drug, which is co-marketed by Pfizer Inc. and Pharmacia Corp.

"Despite your assurances, however, your violative promotion of Celebrex has continued," the letter said.

Separately, an FDA advisory panel Wednesday refused to endorse a claim that Celebrex is gentler on the stomach than other painkillers that are also nonsteroidal anti-inflammatories. Pharmacia had hoped to show a clear safety advantage in order to persuade the FDA to relax warnings on the drug's label.

Thursday, that same panel will hear a similar argument from Celebrex's main competitor, Merck & Co.'s Vioxx. Combined, the drugs sold more than $4 billion last year, and analysts see room for continued growth in the arthritis market.

While the agency regularly monitors drug marketing and routinely tells companies to cut offending material, it only sends four or five warning letters a year.

Although the drug is co-promoted by the two companies, the letter was addressed to Pharmacia, whose precursor company discovered the drug. It told Pharmacia to cut the offending material, and to send letters to doctors or other health-care providers who were given the errant presentations.

A Pharmacia official said the company has already taken action to stop the presentations the FDA criticized. "We are working diligently with the FDA" to make sure presentations are fair and accurate, said Pharmacia spokesman Craig Buchholz.

The previous two letters sent on the same issue were not classified as "warning letters." They concerned what the FDA referred to as "homemade" promotional pieces used by sales representatives who try to persuade doctors to prescribe a particular drug.

The most recent letter concerned audio conferences in which a doctor, trained by the drug maker, calls groups of doctors to discuss the drug and its effectiveness over a speaker phone. During the conferences cited by the FDA, the doctor made "several unsubstantiated comparative claims" regarding Celebrex, the FDA said.

Celebrex also has been cited once for a television ad containing images the FDA said overstated the drug's effectiveness.

Write to Chris Adams at chris.adams@wsj.com⁶ and Jill Carroll at jill.carroll@wsj.com⁷

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