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Executive Summary

THOMPSON MEDICAL ASPERCREME PETITION FOR WRIT OF CERTIORARI to the Supreme Court challenges the Federal Trade Commission's 1984 two well-controlled clinical study ruling. Thompson Medical argues that FTC had previously "limited the two well-controlled clinical test requirement to advertising claims that efficacy was medically proven or scientifically established." Citing FTC decisions in cases involving Sterling, Pfizer and Bristol Myers, Thompson Medical maintains that FTC departed from previous conclusions "by equating establishment claims and non-establishment claims" in the Aspercreme case. The company notes that "the court of appeals admitted that the FTC never before required two well-controlled clinical studies to support the simple kind of efficacy claims made by Thompson for Aspercreme. However, rather than reviewing the record relied upon by the FTC for its determination that the facts of this case warranted a departure from all prior precedent, the court merely commended the FTC for applying the proper factors." Thompson Medical's Nov. 24 petition requests a writ of certiorari on the grounds that the court of appeals failed to review the record behind FTC's decision or the record relating to Thompson's efficacy claims for Aspercreme. The Court of Appeals for the District of Columbia issued its judgment affirming FTC's order on May 26, 1986. The petition declares that "the court of appeals abdicated its well-established judicial responsibility to undertake a "through, probing, in-depth review" of agency action to ensure that adjudicative findings are supported by substantial evidence on the whole record, a responsibility that has been placed, by Congress, "in the keeping of the Courts of Appeals." Thompson Medical also argues that FTC's ruling is vague and overbroad and "would prohibit even truthful, non-deceptive advertisement of Aspercreme's purpose and of consumer satisfaction." The petition says FTC's order "will inhibit, and can be read to prohibit totally, absent a very limited type of scientific proof, any statement, even if it makes no express or implied representation that scientific data support the statement." FTC stated in its 1984 decision that a two-study requirement to support efficacy claims is consistent with FDA's requirement for product labeling. The active ingredient in Aspercreme, triethanolamine, was placed in Category III(END ITALICS) in the tentative final monograph for topical analgesics.

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