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BLOCK DRUG MAY MARKET PROMISE, SENSODYNE-F PENDING APPEAL

Executive Summary

BLOCK DRUG MAY MARKET PROMISE, SENSODYNE-F PENDING APPEAL of a December 1985 court ruling that barred marketing of the toothpastes. Illinois Northern District Court Judge Susan Getzendanner ordered in an April 25 ruling that Block may continue marketing the two products on the condition that labeling include a warning statement alerting consumers to consult a dentist if pain or hypersensitivity persists. Getzendanner's ruling in December upheld FDA's 1983 contention that the Promise and Sensodyne-F combination of potassium nitrate/sodium monofluorophosphate (MFP) made the products unapproved new drugs. Getzendanner explained that while the court believes its ruling will be affirmed on appeal, Block has "made a sufficient showing of likelihood of success on appeal to warrant the grant of a stay." The showing of likelihood of success is based on the fact that although the court found the evidence presented to it "insufficient to satisfy the statutory standards [of safety and efficacy], the evidence was sufficient to support a common-sense conclusion that the product is safe and effective for its intended uses, and to support a finding of general recognition in fact as to safety and effectiveness," Getzendanner stated. Getzendanner also noted that there had been no precedented situation of two safe and effective ingredients combined to form a new product in which: "there is some scholarly recognition of the combined product's safety and effectiveness, no evidence that the combined product is actually unsafe, and no theoretical basis for assuming that the two active ingredients will interact." In her ruling, Getzendanner commented that Block's "failure to obtain the required FDA approval was not a flagrant violation of the statute." She said that "according to defendants' experts, there was no chemical, physical, or physiological basis, as substantiated by human clinical studies, for concluding that the two ingredients will interact to affect the safety or efficacy of either active ingredient." Thus, Getzendanner stated, the generally available scientific literature on the two different ingredients could rationally be extrapolated to form a basis for concluding that the combination found in Promise is also safe and effective." "While the government's experts disputed this assertion," Getzendanner continued, "the court found significant that those experts had no theoretical basis for assuming that the two ingredients would interact with each other." Addressing FDA concerns that the grant of a stay "might encourage other companies to bypass FDA's procedures," Getzendanner stated that "the ruling in this case is a narrow one, limited to the unique situation of the case presented. In the usual case, I will continue to give great weight to the government's interest in maintaining its authority and enforcing compliance with regulatory standards."

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