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FDA Warns Pfizer, Pharmacia Celebrex Ads Are Misleading
By CHRIS ADAMS
WASHINGTON -- For the third time in a little over a year, the Food and Drug Administration has warned that the marketing of the hot-selling arthritis drug Celebrex is false or misleading. As a result, the drug's co-marketers, Pfizer Inc. and Pharmacia Corp., were told to cut a widely run TV commercial titled "City Park." In that ad, vocalists sing "Celebrate, celebrate -- do what you like to do," while arthritis sufferers play in the park. "Bill" with "arthritic knees" zips down a path on a scooter, for example.
In a Nov. 14 letter, the FDA's Division of Drug Marketing, Advertising and Communications called the ad "misleading because the totality of the images, the music, and the audio statements ... overstate the efficacy for Celebrex." The FDA said the activities and statements in the ad "collectively suggest that Celebrex is more effective than has been demonstrated by substantial evidence." A Pharmacia spokeswoman said the ad was pulled and retailored in light of the FDA criticisms. The revised ad returned Nov. 23 and continues to run. Celebrex is hugely important to Pfizer, of New York, and Pharmacia, of Peapack, N.J. Celebrex had one of the most successful drug launches ever; sales for the first three quarters of this year exceeded $1.8 billion. But the drug competes with Merck & Co.'s Vioxx, and the fight for the arthritis market is especially intense. Both drugs were introduced in 1999. "They are in a battle royal with Merck -- it's an extremely important drug," said Hemant Shah, a drug-industry analyst with HKS & Co. Twice before, in October 1999 and April 2000, the FDA warned that the marketing material for Celebrex was false or misleading. At issue in both cases was what the FDA referred to as "homemade" promotional pieces used by sales representatives who try to persuade doctors to prescribe a particular drug. In the 1999 letter, the FDA cited one homemade promotional piece that asked, "Why should I use Celebrex over Vioxx?" The answer: "the proven efficacy and benefit of superior safety of Celebrex." The FDA objected to the suggestion of a "superior safety" profile "compared to Vioxx, when such has not been demonstrated by substantial evidence," the agency wrote. In the April 2000 letter, the companies also were cited for "several unsubstantiated comparative claims comparing Celebrex to Vioxx." The FDA further criticized the continued use of homemade promotional pieces, even after the companies had dismissed them as isolated occurrences. The FDA said it was concerned such activities "demonstrate a continuing pattern and practice of violative behaviors that evince widespread corporate involvement and acquiescence with your employees' activities." Write to Chris Adams at chris.adams@wsj.com2
Updated December 12, 2000
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