Opinion ID: 442774
Heading Depth: 2
Heading Rank: 1

Heading: The 1962 Grandfather Clause.

Text: 41 If WANS meets the conditions of the grandfather clause, see supra, pp. 107-108, then it is exempt from the current effectiveness requirements. We therefore consider this issue first. We note at the outset that, as an exemption to a comprehensive regulatory statute concerned with public safety, the grandfather clause is to be strictly construed, and Alcon bears the burden of proof as to each condition. See United States v. Allan Drug Corp., 357 F.2d 713, 718 (10th Cir.), cert. denied, 385 U.S. 899, 87 S.Ct. 203, 17 L.Ed.2d 131 (1966); United States v. An Article of Drug (Bentex Ulcerine), 469 F.2d 875, 878 (5th Cir.1972), cert. denied, 412 U.S. 938, 93 S.Ct. 2772, 37 L.Ed.2d 397 (1973).
42 The grandfather clause provides that a pre-1962 drug will not be exempt from the 1962 amendments unless it is currently intended solely for use under conditions prescribed, recommended, or suggested in labeling of the drug prior to 1962. Labeling is broadly defined in the Act (21 U.S.C. Sec. 321(m)): 43 The term labeling means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. 44 Prior to trial the parties stipulated as to what documents constituted labeling for WANS prior to 1962 and at the time of trial. Thus all the facts material to the labeling issue were undisputed, 14 and the only issue to be resolved was one of law for the court, applying the statutory language intended solely for use under conditions. This issue simply was not one of fact for the jury to decide. 15 45 Pre-1962 labels suggest a number of uses for WANS other than suppression of nausea and vomiting. These other uses were eliminated from WANS labels in 1967 after the FDA took issue with them. The FDA contends that this change alone requires judgment against Alcon on this issue; the FDA's position is that pre-1962 and current labeling must be exactly the same for the grandfather clause to apply. See United States v. 1,048,000 Capsules (Afrodex), 347 F.Supp. 768, 770 (S.D.Tex.1972), aff'd, 494 F.2d 1158 (5th Cir.1974); Allan Drug Corp., supra, 357 F.2d at 719 (labeling must contain[ ] the same representations concerning its use). 46 Alcon, however, cites legislative history of the grandfather clause to the effect that the 1962 amendments were intended to address only new uses of existing drugs. See, e.g. S.Rep. No. 1744, Part 1, 87th Cong., 2d Sess. 17 (July 19, 1962), U.S.Code Cong. & Admin.News 1962, pp. 2884, 2893 (Any such new use would have to be submitted for FDA approval); S.Rep. No. 1744, Part 2, 87th Cong., 2d Sess. 8 (Aug. 21, 1962) (existing claims will be exempt); 108 Cong.Rec. 17,366 (Aug. 23, 1962) (remarks of Sen. Eastland) (same). Since WANS was recommended for the suppression of nausea and vomiting in 1962 and is so recommended today, Alcon asserts that the labeling condition of the grandfather clause is satisfied. 47 Alcon dropped the other suggested uses for WANS in 1967 after the FDA evinced some concern about the safety of those uses. An argument can be made that such voluntary relabeling to eliminate questionable uses of an unapproved drug is to be encouraged, and that the literal language of the grandfather clause does not require that such corrective relabeling operate to transform old drugs into new ones requiring FDA approval. See Allan Drug Corp., supra, 357 F.2d at 721 (Seth, J., dissenting) (It would seem that the purpose of the Act is to encourage label corrections rather than to discourage them.) We need not decide this issue in the present case, however, because it is clear from the stipulated labeling that the conditions for use of WANS suggested specifically in connection with vomiting and nausea have changed significantly since 1962. 48 It must be noted that the operative term in the statutory language appears to be conditions, not use. We read the language to mean that even if particular uses of a drug are the same, a change in the suggested conditions for its use will suffice to remove the drug from the protection of the grandfather clause. Current WANS labeling states that WANS is indicated in the symptomatic treatment of nausea and vomiting, without apparent qualification as to cause. Yet the 1962 WANS labeling listed eleven specific types of, or causes of, nausea and vomiting under indications. Nothing in the record indicates that these eleven causes are the only possible causes of nausea and vomiting, however, and trial testimony revealed that a number of other conditions can cause vomiting. Thus the current WANS labeling suggests that the drug be used for conditions not listed in the 1962 labeling. 49 Furthermore, in 1962 WANS labeling stated that WANS was Preferred by ... Patients of all ages and that Children ... of all ages tolerate [WANS] exceptionally well. In stark contrast, current WANS labeling states, apparently in bold print, Do not use in infants below the age of 6 months. It further indicates that WANS is not recommended for treatment of uncomplicated vomiting in children and ... should be limited to prolonged vomiting of known etiology [i.e., cause]. The labeling goes on to discuss the suspicion of a link between drugs like WANS and Reye's Syndrome, the same concern that led the FDA to bring this action. Thus it appears that the suggested conditions for use of WANS in children have changed dramatically since 1962. We do not view this labeling change as simply a minor correction of possibly erroneous claims. Instead, it indicates that new information about the health effects of WANS has become available since 1962, information that Alcon apparently considers reliable enough to include on its labels. This new information, and WANS's changed labeling, indicate that the existing claims made for WANS with regard to nausea and vomiting in 1962 are no longer accurate. The general purpose of the Act to protect the public's health and safety would be ill-served if such new labeling information had no effect on an unapproved drug's regulatory status. The new conditions now suggested for use of WANS in the treatment of nausea and vomiting are sufficient to take WANS out of the grandfather clause and place it squarely within the requirements of the Act as amended. 50
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