Opinion ID: 442774
Heading Depth: 3
Heading Rank: 2

Heading: Lack of Scientific Testing.

Text: 51 Even if WANS met the labeling condition of the grandfather clause, the clause would still be inapplicable as a matter of law, because Alcon has produced absolutely no scientific testing evidence of WANS's safety in 1962. We believe it clear as a matter of statutory interpretation that at least some scientific drug testing for safety must have been performed prior to 1962 to fulfill the general recognition requirement of the grandfather clause. 52 Section 505(b) of the 1938 Act required that drug manufacturers submit as part of the [new drug] application (1) full reports of investigations which have been made to show whether or not such drug is safe for use. Pub.L. 75-717, Sec. 505(b) (codified as subsequently amended at 21 U.S.C. Sec. 355(b)) (emphasis supplied). Section 505(d) went on to provide that the new drug application shall be disapproved if the investigations [required by Sec. 505(b) ] ... do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use (emphasis supplied). Explaining Sec. 505(b), the 1938 House Report stated that new drugs [are] to be adequately tested, and referred to laboratory and clinical tests and the manufacturer's tests. H.R.Rep. No. 2139, Part 1, 75th Cong., 3rd Sess. 9 (April 14, 1938). In addition, the contemporary administrative interpretation of the provision reflects the requirement of scientific studies. See Sellers & Grundstein, Administrative Procedure and Practice in the Department of Agriculture under the Food, Drug, and Cosmetic Act of 1938, at 92 (1940), reprinted in H. Toulmin, Jr., The Law of Food, Drugs and Cosmetics Sec. 411 (1st ed. 1942). In this contemporary monograph written by an attorney and a staff member in the Department of Agriculture (the department responsible for the FDA in 1940), the authors state with regard to Sec. 505(b) that [t]he Administration insists upon a certain amount of empirical, clinical testing on humans before it will regard a new drug as safe. Id. at 93. General publication of such studies does not seem to have been required, but the requirement of some valid testing is clear: In rendering a decision that a drug is safe, ... the Administration will accept any valid tests, regardless of source, ... so long as they can be shown to have scientific validity. Id. 16 In addition to the plain language of sections 505(b) and (d) of the 1938 Act, great deference is due the contemporary interpretation given to the Act by those originally charged with its administration. Zenith Radio Corp. v. United States, 437 U.S. 443, 450, 98 S.Ct. 2441, 2445, 57 L.Ed.2d 337 (1978). 53 Alcon argues that the evidentiary standards for new drug applications under Sec. 505 are not applicable in a case where the very claim at issue is that no new drug application is required because WANS in 1962 was not a new drug as defined in Sec. 201(p) of the 1938 Act. This argument is foreclosed, however, by the Supreme Court's reasoning in Weinberger v. Hynson, Wescott & Dunning, Inc., 412 U.S. 609, 628-32, 93 S.Ct. 2469, 2482-84, 37 L.Ed.2d 207 (1973). In Hynson, a drug manufacturer argued that the substantial evidence standard for proof of effectiveness found in Sec. 505 of the Act was not applicable to the requirement for demonstrating the general recognition of effectiveness referred to in the new drug definition of Sec. 201(p). Thus Hynson involved the precise question that at issue here: should the requirements for new drug applications be read into the definitional requirements for new drugs under the Act? The Court rejected the position which Alcon advocates (412 U.S. at 631, 93 S.Ct. at 2484) 17 : 54 [W]e cannot construe Sec. 201(p) to deprive FDA of jurisdiction over a drug which, if subject to FDA regulation, could not be marketed because it had not passed the substantial evidence test. To do so would be to impute to Congress a purpose to paralyze with one hand what it sought to promote with the other. Clark v. Uebersee Finanz-Korp., 332 U.S. 480, 489 [68 S.Ct. 174, 178, 92 L.Ed. 88] [1947]. 55 In a companion case to Hynson, the Court succintly explained its holding: the reach of scientific inquiry [for effectiveness] under both Sec. 505(d) and Sec. 201(p) is precisely the same. Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 653, 93 S.Ct. 2488, 2494, 37 L.Ed.2d 235 (1973). Likewise, the reach of scientific inquiry required for safety under Secs. 505(d) and 201(p) should also be precisely the same, and the safety of a pre-1962 drug must be demonstrated by some sort of contemporaneous, valid scientific tests for the grandfather clause to be fulfilled. 18 It would be anomalous to hold that Alcon could now avoid the full weight of the burden to demonstrate safety that it would have had to satisfy in 1955 (when WANS clearly was a new drug) simply because Alcon marketed WANS for seven years without seeking FDA approval. 56 It is undisputed that there is no evidence of any scientific testing of WANS for safety prior to 1962. Thus, as a matter of law, Alcon's evidence was insufficient to support a finding of general recognition of safety prior to 1962. See United States v. 41 Cases, More or Less, 420 F.2d 1126, 1130 (5th Cir.1970). The FDA's motion for a directed verdict on the grandfather clause questions therefore should have been granted. 57