XVIII. ANIMAL DRUG AMENDMENTS OF 1968 In 1968, legislation was passed to consolidate provisions of the Federal Food, Drug, and Cosmetic Act with respect to the regulation of new animal drugs. 32 Both the House and the Senate reports on the Amendment pointed out that, in many cases, the requirements for clearance of new drugs for administration to animals were more complicated than the clearance procedures for drugs for human beings. The reports expressed a need for simplification of the clearance procedures because the existing procedures had led to long delays in the clearance of new animal drugs. Prior to the Amendment, a drug which was intended for use in animal feeds was regulated both as a new drug under the new drug requirements of the Act and as a food additive. This meant that the drug must be cleared under the procedures of both sections of the law. Where the product was a combination of drugs containing a certifiable antibiotic, the product was also regulated under the antibiotic section of the Federal Food, Drug, and Cosmetic Act. The Amendment added a new section to the Act, "new animal drugs", to consolidate into one place the various parts of the Act which related to drugs for administration to animals and to animal feeds containing new drugs (including antibiotics). A definition for "new animal drug" and "animal drug" was also added by the Amendment. During the Congressional consideration of the proposed legislation, an attempt was made by the House Committee on Interstate and Foreign Commerce to change the existing provisions of the Act regarding the export of animal drugs and feeds. The bill, as reported from that Committee, contained a provision to exempt those new animal drugs and feeds intended for export from the requirements of the Act. New, more lenient requirements were proposed for those products. The requirements were that the animal drug or feed must (1) comply with the law of that foreign country; (2) comply with the specifications of the foreign purchaser; and (3) be labeled for export. The Senate Committee on Labor and Public Welfare was opposed to this amendment and it was omitted in Conference. Any new animal drug intended for export must comply fully with the requirements of the Federal Food, Drug, and Cosmetic Act. XIX. THE DRUG LISTING ACT OF 1972 As of 1972, the Food and Drug Administration had no ready means of determining what drugs were actually being manufactured and commercially distributed by establishments registered under the Food, Drug, and Cosmetic Act except by periodic inspection of the establishments. In an effort to increase the FDA's regulatory tools in this area, legislation was introduced in the 92nd Congress to provide for a current listing of each drug manufactured, prepared, propagated, compounded, or processed by a registrant under the Act. During the hearings on the proposed legislation, the Commissioner of the 32 82 Stat. 342, 90th Cong., 2d sess.; July 13, 1968. FDA stated that availability of a current inventory of drugs would substantially assist in the enforcement of Federal laws requiring that drugs be pure, safe, effective, and properly labeled. The legislation under consideration was passed and signed into public law on August 16, 1972.32a The Drug Listing Act required manufacturers and processors of drugs to submit to the Secretary a list of all drugs manufactured or processed for commercial distribution. Any drug contained in the list which is subject to the requirements of the Act for new drugs, insulin, antibiotics, or animal drugs must be accompanied by a reference to the authority for marketing and a copy of all labeling for the drug. Those prescription drugs not subject to these specific requirements must be accompanied by a copy of the current labeling, and a representative sampling of advertisements for the product. Over-the-counter drugs not subject to requirements for new drugs, insulin, antibiotics, or animal drugs must be accompanied by the label and package insert and a representative sampling of any other labeling for the drug. In the case of those drugs (prescription or over-the-counter) not subject to the special requirements of the Act, a quantitative listing of all active ingredients is to be submitted. The submission of a quantitative listing of all ingredients (including inactive ingredients) of a particular drug may be required if deemed necessary to carry out the purposes of the Act. The manufacturer or processor may also be required to state why he has determined a particular product is not subject to the requirements for new drugs, insulin, antibiotics or new animal drugs. Supplemental filings are required every six months if there has been a material change in any information previously submitted, if a drug is introduced for commercial distribution after the previous filing, if a drug has been discontinued, or if a previously discontinued drug is reintroduced. The Act also contains a number of other provisions designed to increase the efficiency of the FDA in regulating drugs. XX. HEALTH RESEARCH AND HEALTH SERVICES AMENDMENTS OF 1976, TITLE V-FEDERAL FOOD, DRUG, AND COSMETIC ACT AMENDMENTS (VITAMINS AND MINERALS) In 1976, legislation was passed which had the effect of curtailing proposed regulations of the Food and Drug Administration dealing with the sale of vitamins and minerals.33 For more than ten years, FDA had tried to amend the regulation dealing with special dietary foods and food supplements such as vitamins. A controversy erupted with considerable intensity following the publication of the FDA's tentative orders in the Federal Register of January 19, 1973. The proposed potency limits, labeling restrictions, and other matters brought on a reaction from the health food industry and thousands of users of vitamins for supplements. 32 86 Stat. 559, 92nd Cong., 2d sess.; Aug. 16, 1972. 33 90 Stat. 410, 94th Congress, 2d Session; April 22, 1976. There was so much controversy on the proposed FDA action that an estimated one million pieces of mail flooded congressional offices. 34 Newsweek said the proposed regulations engendered as much mail as the impeachment proceedings. 35 Objectively viewed, there were fundamental issues on both sides. FDA contended that research over a long period of time revealed that vitamins in "excess" could produce harmful effects. Notable examples were Vitamins A and D. Furthermore, FDA contended false therapeutic or radical claims were being made for some products. The other side claimed the consumer was well able to choose those items in their diet he/she required and no "diet dictation" was necessary. Civil libertarians, both right and left, professed fear of governmental "Big Brotherism." Representative Craig Hosmer introduced legislation by the end of the 1st Session of the 93d Congress to overturn the regulations; 218 Representatives—a simple majority-also introduced legislation to overturn the regulations. A similar bill was introduced by Senator William Proxmire and was cosponsored by ten Senators representing a broad range of political philosophies. The amendments passed both the House and Senate. Certain restrictions were now placed on the Secretary of Health, Education, and Welfare. The Secretary may not (a) establish maximum limits on the potency of any synthetic or natural vitamin or mineral within an applicable supplement; (b) classify any natural or synthetic vitamin or mineral as a drug solely because it exceeds the level of potency which is nutritionally rational and useful; (c) require the presence in dietary supplements of nutritionally essential vitamins and minerals; and (d) prohibit in dietary supplements questionable additional supplements of no nutritional value. A large number of other responsibilities remain unchanged. XXI. MEDICAL DEVICE AMENDMENT OF 1976 Medical devices such as orthopedic devices or pacemakers and instrumentation are used to treat a wide variety of diseases and illnesses. Prior to the passage of the Medical Device Amendment, the Food and Drug Administration was forced to develop extensive evidence of harm before a medical device could be removed from the market. Although the devices brought great benefits, they also brought great hazards. It has been estimated that 1,500 firms produce more than 12,000 different medical devices. However, along with this production, there had been approximately 600 deaths and more than 20,000 injuries as a result of the devices in the ten year period, 1961-1971. As expected there was some resistance to the proposed regulations. Different pieces of legislation were proposed for 8 years prior to the amendment. Throughout this period, many manufacturers felt the regulations were not necessary and would depress the development of new devices. However, the great fear of the industry was the concept of pre-market clearance. 34 Congressional Quarterly Weekly Report, Vol. 32, p. 63-67, Jan. 12, 1974. 35 Newsweek, p. 48, Sept. 2, 1974. Nevertheless, with apparently little fanfare, the amendment was passed in an election year, 1976.36 The law defines three classes of devices: Class I. (General) Those devices which already had controls and which were on the market at the time of enactment. They do not require pre-market clearance because their safety and effectiveness was already established. Class II. (Performance Standards) Those devices for which existing controls were insufficient but for which there is sufficient information to establish performance standards to assure safety and effectiveness. Class III. (Pre-Market Approval) Those devices which require premarket approval in the absence of sufficient information to establish performance standards or to assure their safety and effectiveness. Devices in Class III are used to sustain human life, are of substantial importance in preventing impairment of human health, or present a potentially unreasonable risk of illness or injury. The new law will be used to determine the safety and effectiveness of many future medical devices including nuclear powered hearts and artificial organs. It also provides additional protection for consumers who are not knowledgeable about medical device technology. XXII. THE SACCHARIN STUDY AND LABELING ACT There are approximately 1,100 food additives and 40 color additives regulated for direct addition to food under requirements of the 1958 Food Additive Amendment to the Food, Drug, and Cosmetic Act. Because of safety and anti-cancer clauses in the Act, FDA is required to ban from commerce any food additives found to be carcinogenic in animals or humans or otherwise harmful to health. Under the general regulations, a number of additives and colors were banned. On Mar. 9, 1977, the FDA announced that saccharin, the only available artificial sweetener, was found to cause cancer in experimental animals. Under the "Delaney" anti-cancer clause of the Food, Drug, and Cosmetic Act, the FDA moved to ban its use in the marketplace. Public support for the FDA initiative, however, was far from overwhelming, since saccharin and saccharin-containing products are used by millions of persons. During the 95th Congress, several congressional hearings were held to evaluate the medical, social, and financial consequences of a ban on saccharin, as well as to examine whether a total prohibition of saccharin or other food additives found to induce cancer in animals is in the best public interest. Over 100 bills were introduced in the 95th Congress regarding the saccharin issue including the Food, Drug, and Cosmetic Act to give the FDA greater latitude in the control of food additives, to revise the standards for regulating food additives found to induce cancer in man or animals, and to permit the continued use of saccharin while appropriate tests are undertaken to evaluate its risks and benefits. 36 90 Stat. 539, 94th Congress, 2d Session, May 28, 1976. On Nov. 23, 1977, President Carter signed the Saccharin Study and Labeling Act-P.L. 95-203 (S. 1750). The law requires that within 90 days of enactment, all packages of saccharin and food containing saccharin must carry labels warning that the product could cause cancer; the Food and Drug Administration cannot implement their proposed ban for 18 months; and provides for a study period concerning the toxicity and carcinogenicity of saccharin and its impurities, the health benefits, if any, from the use of non-nutritive sweeteners, and the evaluation of Federal regulatory policy. As required under P.L. 95-203, the National Academy of Sciences released its first study assessing the risks of saccharin in November 1978. The Academy's panel of experts concluded that saccharin is indeed a carcinogen, although one of low potency, as compared with other cancer-causing agents. The panel also stated that additional laboratory tests to establish the carcinogenicity of saccharin are not needed. With this report in mind, the 96th Congress must decide what action, if any, it will take when the present moratorium expires on May 23, 1979. CAPSULE LEGISLATIVE HISTORY OF THE FEDERAL FOOD, DRug, and COSMETIC ACT I. The Food and Drug Act of 1906 (S. 88) P.L. 59-384; June 30, 1906. Senate Report No. 59-8 (Com. on Manufacturers). House Report No. 59-2118 (Comm. on Interstate and Foreign Commerce). Conference Report No. 59-5056. Feb. 21: considered and passed Senate. June 23: considered and passed House, amended. June 29: Senate agreed to conference report. II. The Sherley Amendment of 1912 (H.R. 11877) Aug. 19: considered and passed House. III. The Federal Food, Drug, and Cosmetic Act of 1938 (S. 5) P.L. 75-717; June 25, 1938. Senate Report No. 75-91 (Comm. on Commerce). Senate Report No. 75-152 (amended report). House Report No. 75-2139; supplemental report, pt. II (Comm. on Interstate and Foreign Commerce). Conference Report No. 75-2716. Mar. 9: considered and passed Senate. June 1: considered and passed House, amended. IV. Insulin and Antibiotic Certification Amendments |