Opinion ID: 312813
Heading Depth: 1
Heading Rank: 1

Heading: statutory history and scheme

Text: 3 The statutory history and regulatory scheme are discussed and considered in Weinberger v. Hynson, etc., supra (hereinafter referred to as Hynson). Therefore, another full recitation of the applicable statutes and regulations is unnecessary. We will, however, discuss the pertinent provisions of the legislation in our consideration of the issues which petitioner continues to urge upon us. 4 By way of background, petitioner has for approximately 25 years distributed and sold in interstate commerce products for animal feeding purposes containing iodinated casein, also known as Protamone. For some years subsequent to 1945, animal applications of iodinated casein were the subject of new animal drug applications, specifically, NADAs Nos. 5-633V and 5-987V. The applications had been approved by the United States Food and Drug Administration. 5 In 1962, Congress amended the Food, Drug and Cosmetic Act to expand jurisdiction of the Commissioner of the Food and Drug Administration to allow review of new drugs for substantial evidence of both safety and effectiveness. Pub.L. 87-781, 76 Stat. 780. The provision applied equally to human and animal drugs until the amendments in 1968, Pub.L. 90-399, 82 Stat. 342, separated and recompiled the provisions relating to animal drugs. S.Rep.No.1308, 90th Cong., 2d Sess.; 1968 U.S.Code, Cong. and Adm.News, p. 2607 et seq. These separate provisions are, insofar as applicable here, nearly identical. 6 To effect the provisions of the 1962 amendment, particularly 21 U.S.C. Sec. 355(e), the FDA by notice in 31 Fed. Reg. 9426 on July 9, 1966, announced that the National Academy of Sciences-National Research Council (NAS-NRC) had agreed to assist the FDA in its review of claims of effectiveness for drugs that had been approved from 1938 until October, 1962. All holders of NDAs were directed to submit data to NAS-NRC in order to facilitate the determination whether there was ground for invoking Sec. 505(e) of the Act, and to provide each holder of an approved newdrug application an opportunity to present for the consideration of NAS-NRC the best data available to support the claims. 7 Petitioner responded to the notice by submitting data for each iodinated casein product on a Drug Efficacy Study-Form Letter A. According to the data submitted on the forms, Protamone: 8 (1) Improves growth and feathering in turkeys, chickens, or ducks. 9 (2) Improves egg production and eggshell texture in laying hens and breeders. 10 (3) Diminishes carcass fat on ducks. 11 (4) Increases milk and butterfat production in goats, sheep, beef cattle, and dairy cattle. 12 (5) Increases rate of growth, fertility and libido in goats, sheep, swine, beef cattle and dairy cattle. 13 (6) Increases milk flow and weaning weights and decreases baby mortality in swine. 14 In support of these claims petitioner submitted with these Forms A various citations to and reprints of studies allegedly evidencing the claims of effectiveness. The NRC then reviewed these data, and revealed its detailed reasoning on Forms B-1, which appear as a part of the official record filed in the office of the clerk of this court, but not in the Appendix. Apparently, petitioner never received the Forms B-1, but only the Forms B-2, which contain only the NRC's ultimate findings, and the FDA Notice of Hearing, 36 Fed.Reg. 17367, infra, which summarized these findings. We shall review seriatim the supporting data and NRC B-2 conclusions which were given to petitioner. 15 To support its claim that Protamone improves growth and feathering in turkeys, petitioner submitted only an article cited at 27 Poultry Sci. 670 (1948) entitled The effect of iodinated casein on moulting turkeys. The conclusion of the NRC as to this claim was not effective. Under explanatory statements it said: Induces moulting; no data on growth and feathering. (Emphasis supplied.) 16 To support its claims that Protamone improves egg production and texture, and growth and feathering in chickens, petitioner cited 33 articles. The Form B-2 from the NRC said not effective. No data to substantiate claims. 17 To support its claims that Protamone improves growth and feathering and decreases carcass fat in ducks, petitioner cited four articles. The B-2 form from the NRC said effective, but said the label's [c]laims should state 'increases daily gain' instead of 'improving growth and feathering.' 18 To support its claim that Protamone increases milk and butterfat production, growth, fertility and libido in goats and sheep, petitioner cited 14 published articles, attached two unpublished articles and a letter of endorsement from a corporate farm as to goats; as to sheep it cited 24 published articles and attached two unpublished articles. The Forms B-2 from the NRC evaluated iodinated casein as to both goats and sheep as follows: 19 a. Milk production-probably effective 20 b. Rate of growth-probably not effective (more information needed) 21 c. Fertility and libido-probably not effective (more information needed). 22 According to the NRC, Categories b and c above must have more information before further consideration can be given. 23 To support the claims Protamone increases milk flow and weaning weights, reduces baby mortality and improves growth, market finish, fertility and libido in swine, petitioner cited 28 articles and attached two articles. The NRC said on the Form B-2, not effective. Claims on milk flow: not adequately substantiated. Rate of growth or breeding performance: no adequate evidence. 24 Supporting its claims that Protamone increases milk and butterfat production, growth, fertility and libido in beef and dairly cattle, petitioner cited nine articles as to beef cattle and as to dairy cattle apparently cited 81 articles, plus attaching nine articles and various letters, advertisements and news items. As to both beef and dairy cattle, the NRC reported on the B-2 forms the following evaluation: 25 a. Rate of gain-probably not effective 26 -more information needed 27 b. Libido and fertility-probably effective 28 -for bulls only 29 -more information needed 30 c. Milk production-Probably effective 31 Qualification on label-'effective for limited periods of time' 32 -'effect limited to declining phase of lactation' 33 -'must be accompanied with increased feed intake' 34 -'may increase heat sensitivity of animal.' 35 Following this NRC evaluation of the data submitted by petitioner, the Commissioner published on October 8, 1970, at 35 Fed.Reg. 15859 his findings based upon the NRC evaluation. They were: 36 1. Iodinated casein is effective for increasing daily gain in growing ducks and increasing milk production in dairy cows. 37 2. Information provided does not contain substantial evidence of effectiveness of iodinated casein for improving fertility in bulls; increasing milk production in goats, beef cows, and sheep; in improving fertility in boars, goats, and sheep; and for improving rate of gain in dairy cattle, sheep and goats. 38 3. Iodinated casein is not effective for improving growth and feathering in turkeys and chickens; increasing milk flow in nursing sows; or improving egg production and eggshell texture in chickens. 39 As to the uses found effective, the NRC and FDA found the label should qualify the claims by informing the user as follows: 40 1. The claim for increased milk production in dairy cows should be qualified as follows: (a) Effective for limited periods of time, (b) effectiveness is limited to the declining phase of lactation, (c) administration must be accompanied with increased feed intake, and (d) may increase heat sensitivity of the animal. 41 2. The claim for improving growth and feathering in growing ducks should state 'increases daily gain'. 42 This order gave petitioner six months in which to alter its labeling to conform to these findings or submit additional evidence of efficacy. Petitioner did neither. Instead, its technical counsel wrote the FDA on March 22 and April 13, 1971, requesting the Forms B-1 of the NRC studies. 43 Upon expiration of the six months, the Commissioner entered a Notice in the Federal Register, 36 Fed.Reg. 17367 (Aug. 28, 1971), proposing to withdraw petitioner's NADAs for iodinated casein pursuant to Sec. 512 of the Act, 21 U.S.C. Sec. 360b(e), on the grounds that there was a lack of substantial evidence of its effectiveness for its labeled purposes. This notice, after referring to the prior announcement in 35 Fed.Reg. 15859, stated: 44 Therefore, notice is given to AgriTech, Inc., . . . and to any interested person who may be adversely affected that the Commissioner of Food and Drugs proposes to issue an order under the provisions of section 512(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(e)) withdrawing approval of NADA No. 5-633V, NADA No. 5-987V, . . . and all amendments and supplements thereto. This action is proposed on the grounds that there is a lack of substantial evidence that the drugs have the effect they purport or are represented to have under the conditions of use prescribed, recommended, or suggested in their labeling. 45 In accordance with the provisions of section 512 of the act (21 U.S.C. 360b), the Commissioner will give the applicant and any other interested person who would be adversely affected by an order withdrawing such approval an opportunity for a hearing at which time such persons may produce evidence and arguments to show why approval of said new animal drug applications should not be withdrawn.