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PFIZER's PROCARDIA XL BRANDNAME CONSUMER PRINT AD

Executive Summary

PFIZER's PROCARDIA XL BRANDNAME CONSUMER PRINT AD will run through April. The ad is currently appearing in Newsweek, U.S. News and World Report, Reader's Digest, Good Housekeeping, Prevention magazine, and some daily papers, including The New York Times, Pfizer said. The direct-to-consumer ad states: "If you're taking Procardia Capsules . . . Now you can really take it easy." The ad continues: "Now there's a new way to take Procardia that really lets you take it easier. It's new Procardia XL (nifedipine). It's basically the same Procardia you've been taking, but the XL makes it different and it may save you money." Pfizer has been marketing Procardia XL at an 18% discount to the immediate release product on an AWP and patient cost-per-day basis ("The Pink Sheet" Oct. 9, T&G-7). The Procardia XL ad is not Pfizer's first brand-specific prescription drug promotion to consumers. Pfizer indirectly promoted its prescription hypoglycemic agent Glucotrol through a recipe contest for diabetics called the Glucotrol Meal Challenge. The ad appeared in the March 1987 issue of a Florida senior citizens magazine Golden Years. For several years the company has been running its "HealthCare" series of non product-specific consumer ads that describe disease conditions and encourage physician visits. Recently, Pfizer aired institutional television ads for its anti-arthritic agent Feldene. Those ads discussed arthritis symptoms and advised consumers experiencing the symptoms to see a doctor. The Procardia XL ad places Pfizer among the growing number of companies attempting direct-to-consumer prescription drug ads since FDA lifted its moratorium in late 1985. Recent noteworthy consumer ads include Lexis Pharmaceuticals' brand-specific consumer print and TV ad campaign for its generic oral contraceptive N.E.E. 1/35 ("The Pink Sheet" Feb. 13, T&G-3). The ads state that the Lexis product can provide a 50% cost savings over brandname products. Fisons and Sandoz ran consumer print ads in newspapers for their respective allergy medications, Nasalcrom and Tavist-1. Both ads included a brief summary of prescribing information. FDA originally pre-cleared the Tavist-1 ad, but the agency later asked Sandoz to cancel the ad because the "low drowsiness" claim was "false and misleading." The Procardia XL ad was precleared with FDA, Pfizer said. According to the agency, the product-specific ad is not required to disclose prescribing information because it does not disclose what the drug is indicated for and does not discuss a specific dose improvement. The ad also meets FDA criteria because it falls under FDA's definition of a "reminder ad" -- an ad directed at a specific audience that introduces something new, such as a different dose or a lower cost. FDA also considers Lexis' oral contraceptive promotions to be reminder ads. The National Association of Pharmaceutical Manufacturers wrote FDA on Nov. 13 to object to the Procardia XL ad. "We believe that prescription drug advertising of this nature, i.e. directed at the consumer instead of the physician, is improper and an example of 'game playing' by a major pharmaceutical company," the association said. NAPM's letter goes on to say that "the basic claim made in the advertisement is that Pfizer has a new superior product. At a minimum, this should trigger the requirement for full disclosure." The association requested that "appropriate action be taken with respect to the offending advertising." Pfizer is currently in litigation with four generic companies over alleged infringement of its nifedipine process patent, which expires in 1991.

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