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Executive Summary

ASPIRIN FREE EXCEDRIN ADS DRAW McNEIL LAWSUIT one week into a media blitz promoting the new Bristol-Myers Squibb acetaminophen/caffeine product. The lawsuit accuses Bristol-Myers Squibb of false claims that Aspirin Free Excedrin is superior to Extra-Strength Tylenol, which contains no caffeine, based on studies allegedly showing caffeine to be an analgesic adjuvant. FDA lists caffeine as Category III in the monograph for analgesic adjuvants. Aspirin free Excedrin began reaching store shelves in June. The suit contends that television commercials for Aspirin Free Excedrin, which began running on Aug. 30, "claim that AF Excedrin relieves headache pain better than Extra-Strength Tylenol." McNeil asserts that "the two products are equivalent pain relievers." In response to the suit, Bristol-Myers Squibb has maintained that its superiority claim "is fully supported by clinical studies" and "will withstand any level of scrutiny." The company points out that the review boards of all three major networks accepted advertising for Aspirin Free Excedrin after a challenge by McNeil. Bristol-Myers Squibb would not provide details of future advertising for the brand, which will include print ads, but the McNeil suit contends that "Bristol plans to spend $9 million in the next four months alone on consumer advertising for AF Excedrin." McNeil asserts that FDA's repeated refusal to grant caffeine Category I status as an analgesic adjuvant comes despite the fact that "Bristol has submitted to FDA more than 40 clinical studies that purport to show caffeine's alleged effect." McNeil also claims that Bristol-Myers Squibb's recently submitted studies are invalid because of "erroneous statistical analysis." Additionally, the suit maintains that the "studies do not establish a clinically significant difference between AF Excedrin and Extra-Strength Tylenol." McNeil's suit alleges that "Bristol-Myers has a history of habitual false advertising and, in particular, making what the Federal Trade Commission (FTC) has called 'now you see it, now you don't' claims for the alleged effectiveness of its pain relievers." McNeil continues: "Bristol Myers is now under a permanent injunction issued by the FTC...[that] prohibits Bristol-Myers from making false advertising claims and requires that it conduct well-controlled clinical trials to support its advertising claims." Sparked by FTC cases against Bristol-Myers and Sterling, the ruling is intended to be observed by all companies. FTC proposed the so-called "two-tiered system" in 1983. Under the system, two or more adequate, well-controlled studies are required to support claims that one product has "established" superior effectiveness over competing products. The ruling did not go into effect until March 1985. The battle over caffeine's effectiveness as an analgesic adjuvant involves a continuing volley of study claims and accusations of invalid study results between those companies that produce caffeine-containing analgesics and those that do not. For example, in November 1989, Bristol Myers submitted clinicals to FDA to show greater efficacy of combination acetaminophen/caffeine; the same week, McNeil submitted four studies claiming "caffeine does not enhance analgesic efficacy of any known analgesic agents" ("The Pink Sheet" December 18, 1989, T&G-6-7). FDA had planned to review caffeine's Category III status at an April 1989 advisory committee meeting. The decision to give Bristol-Myers time to compile data from three studies led to a delay of the review until 1990 ("The Pink Sheet" April 3, 1989, p. 8). No review of caffeine as an analgesic adjuvant is scheduled through the end of the year.



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