Opinion ID: 442774
Heading Depth: 2
Heading Rank: 2

Heading: The Current Status of WANS.

Text: 58 Because the 1962 grandfather clause does not apply to WANS as a matter of law, WANS must meet the requirements of the Act as currently in force. Alcon contends that even under the current Act, WANS is exempt from FDA approval because it is now generally recognized among experts ... as safe and effective. 21 U.S.C. Sec. 321(p). It is true that the jury found affirmatively for Alcon on those issues. But, again, the record requires the conclusion that the factual questions of general recognition should not have been submitted to the jury in the first place, because Alcon failed to introduce the type of substantial evidence of effectiveness required by the Act as a matter of law. 59 Under the Hynson decision, supra, the evidentiary standards for effectiveness required for a new drug application under 21 U.S.C. Sec. 355(d) must also be applied to any drug for which general recognition of effectiveness among experts is claimed under Sec. 321(p). Section 355(d)(5) requires that an application be rejected if the FDA finds a lack of substantial evidence that the drug will have the effect it purports or is represented to have. Substantial evidence is defined in the same subsection as evidence consisting of adequate and well-controlled investigations, including clinical investigations, [conducted] by experts.... (emphasis supplied). WANS's claimed effectiveness must be supported with evidence of this kind for it to obtain exemption from new drug approval requirements today. 60 Alcon concedes that no investigations of any kind have ever been conducted to test WAN's efficacy. But at trial it successfully introduced three studies conducted in 1968 and 1969 using a drug called Emeserts. 19 Emeserts is an antiemetic like WANS which contains the same amounts of the same active ingredients found in WANS. There is no evidence in the record concerning the inactive ingredients in either drug. See note 3, supra. Alcon's theory is that WANS and Emeserts are, in effect, the same drug, and that the Emeserts studies were adequate and well-controlled investigations within the meaning of Sec. 355(d). Thus Alcon argues that the Emeserts studies may be considered as evidence that demonstrates WANS's effectiveness. 61 The testimony of one of Alcon's experts, Dr. Kalman, was directed largely to this issue. Dr. Kalman had never personally examined WANS or Emeserts by chemical or other scientific means; he based his testimony simply on his reading of the drug products' labels (including their lists of ingredients) and some other, unspecified information furnished to [him] by Alcon. He then offered his theoretical opinion that the clinical effects of Emeserts and WANS would be identical or nearly so, although the drugs may not be identical in terms of their inactive ingredients. 62 There are a number of reasons why this testimony is insufficient as a matter of law to support application of the Emeserts test results to an evaluation of WANS. First, there is precedent for rejecting an expert's theoretical evaluation of a drug. United States v. 7 Cartons, More or Less (Ferro-lac), 293 F.Supp. 660, 666 (S.D.Ill.1968), aff'd in part and vacated in part, 424 F.2d 1364 (7th Cir.1970). We doubt that a review of a drug product's label and unrevealed information supplied by the interested drug company is sufficient foundation on which to base an expert opinion as to the clinical effects of two drugs. This is especially true where, as here, the WANS label does not even reveal the chemical makeup of the wax base of the drug. See note 3, supra. Second, Dr. Kalman did not testify that Emeserts and WANS are bioequivalent; he qualified his testimony by stating that the drugs were identical or nearly so. It is well recognized that so-called inactive ingredients may affect the rate at which the active ingredient is delivered. United States v. Generix Drug Corp., 460 U.S. 453, 455, 103 S.Ct. 1298, 1300, 75 L.Ed.2d 198 (1983). Indeed, there was unrebutted trial testimony in this case to the effect that WANS's wax base may contribute to the erratic absorption of its active ingredients, which in turn can result in health dangers due to an oversupply of the active ingredients in the bloodstream. In the absence of any expert testimony specifically addressing the inactive ingredients in the two drugs, bioequivalence of Emeserts and WANS was, as a matter of law, not demonstrated. 20 63 The deciding factor on this issue, however, is that even if the Emeserts studies could be substituted as evidence of WANS's effectiveness, the testimony of Alcon's own expert leads to the unavoidable conclusion that those studies were not the sort of adequate and well-controlled investigations required by Sec. 355(d). Alcon's witness Dr. Brown, who was qualified by the district court as an expert in statistics and clinical trials, testified that the Emeserts studies were comparable to other papers [published] during that era [i.e., the late 1960s], but that they did, for the most part, fail to use some of the methods that most recently ... have come to be regarded as more important in the [design] of clinical [investigations]. 21 Because Alcon has chosen not to submit a new drug application for WANS in the past, however, it is subject to the effectiveness standards employed by experts today, not 15 years ago. In light of the testimony of Alcon's own expert that the Emeserts studies did not meet present-day standards for adequate and well-controlled investigations, and considering all the other evidence on this issue in the record, it is clear as a matter of law that Alcon failed to produce the types of studies required to demonstrate substantial evidence of effectiveness. 64 For all these reasons, the Emeserts studies could not and should not have been applied to WANS in this case. As a matter of law, therefore, Alcon failed to meet the substantial evidence requirement of Sec. 355(d). Thus it was premature and unnecessary to submit to the jury any question of WANS's general recognition among experts for effectiveness; Alcon's preliminary evidence required by the statute on this issue was legally insufficient to create an issue for the jury. Consequently, the FDA's motion for a directed verdict on the question of current recognition of effectiveness should also have been granted. 65