77TH CONGRESS HOUSE OF REPRESENTATIVES { REPORT No. 1542 AMENDING THE FEDERAL FOOD, DRUG, AND COSMETIC ACT DECEMBER 17, 1941.-Committed to the Committee of the Whole House on the state of the Union and ordered to be printed Mr. LEA, from the Committee on Interstate and Foreign Commerce, submitted the following REPORT [To accompany H. R. 6251] The Committee on Interstate and Foreign Commerce, to whom was referred the bill (H. R. 6251) to amend the Federal Food, Drug, and Cosmetic Act, as amended, by providing for the certification of batches of drugs composed wholly or partly of insulin, and for other purposes, having considered the same, report favorably thereon with amendment and recommend that the bill, as amended, do pass. GENERAL STATEMENT This bill is designed to meet a situation which requires prompt legislative action to protect more than a million of our people who use the drug insulin for diabetes mellitus. If this drug is not accurately standardized, the lives of these people are immediately endangered. The rigid control of the drug now prevailing under existing patents on insulin will shortly be lost through the expiration of the patents. Insulin now on the market in the United States is controlled by the Insulin Committee of the University of Toronto, Canada, which holds the patent on the product and its process of manufacture. Through its licensing arrangements with manufacturers of insulin in the United States, the committee requires that the manufacturer first assay and standardize each batch and then submit a sample to the committee's laboratory at Toronto, which also assays the product. The commit'tee refuses to release the batch for distribution unless and until it is accurately standardized. This protection ceases December 24, 1941, through the expiration of the patent. The life expectancy of users of insulin would be short if the drug were not available. With it, most of these sufferers can live a normal span. Each user of insulin must learn through his physician the 2 AMEND FEDERAL FOOD, DRUG, AND COSMETIC ACT quantity and frequency of dosage necessary for him. Most diabetics subsequently buy their insulin direct from drug stores and administer it to themselves with only occasional checkups by physicians. If the drug is too strong, insulin convulsions may follow and even death. If it is too weak, coma may result from which the patient may not recover. Such results are particularly likely if he is relying upon himself alone for the administration of the drug. With no other drug are the consequences of failure of accurate standardization so dramatic and so immediate. The board of trustees of the United States Pharmacopoeia issued the following statement: Because of the special nature of insulin which makes it a matter of life or death, that the product be fully efficient in the dosage prescribed by the physician, and never of less or of greater strength than the standard prescribed, it is proposed that the two-assay control which now prevails under the insulin patents be continued, and that the Food and Drug Administration do not release for general sale or distribution, any product until it is assured that the product meets the standards and assay which the United States Pharmacopoeia specifies. A similar statement by the American Medical Association has been published in its journal. INADEQUACY OF EXISTING LAW The approach to the problem suggested in the statement issued by the board of trustees of the United States Pharmacopoeia cannot be adopted without new legislation, since the Federal Food, Drug, and Cosmetic Act contains no authority to prevent the sale of batches of insulin pending check assay to guarantee its proper standardization. The only action that can be taken under the present terms of the law is to proceed after samples are collected from interstate shipments and assay has shown the strength, quality, or purity of the drug to deviate from the standard required by the Pharmacopoeia or from the standard set up in the labeling of the product. Even when a sample is collected promptly after the shipment reaches its destination considerable time for distribution occurs because the assay is timeconsuming; the gravity of the consequences that might ensue from the distribution of improperly standardized products before the sanctions of the law could be invoked can easily be imagined. SCOPE OF AMENDMENTS The provisions of the bill would meet this problem by requiring that, before distribution in interstate commerce, batches of drugs composed wholly or partly of insulin, be certified as safe and efficacious, in accordance with regulations promulgated by the Federal Security Administrator. Any such drug which is from a batch not so certified or which after certification fails to meet the conditions of certification, would be deemed to be misbranded under the Federal Food, Drug, and Cosmetic Act and subject to the civil and criminal provisions of that act. To avoid possibility of a shortage of insulin pending formulation of certification regulations, provision is also made for the release, prior to promulgation of such regulations, of batches of insulin which, in the judgment of the Administrator, may be released without risk as to safety and efficacy of use. This provision would permit prompt release of batches of insulin which have AMEND FEDERAL FOOD, DRUG, AND COSMETIC ACT 3 already been passed by the Insulin Committee of Toronto University as being of the required strength, quality, and purity. A precedent for this type of control in a field where the menace to public health is not as serious as inadequately controlled insulin is found in those provisions of the Federal Food, Drug, and Cosmetic Act prohibiting the use of coal-tar colors in foods, drugs, and cosmetics unless such colors are from batches previously certified by the Administrator as harmless and suitable for such use. These provisions of the act have worked satisfactorily to the Government, the industry and the public. The provisions of the bill are made more specific than was deemed necessary for the provisions relating to certification of coal-tar colors, which were regarded as a legislative validation giving force and effect of law to a preexisting administrative practice. EXPLANATION OF THE BILL The basic provisions for certification of insulin are contained in section 3 of the bill. Sections 1 and 2 implement the certification provisions so that compliance with such provisions can be enforced under the civil and criminal provisions of the act. Section 1 so amends the act that its prohibition against forging, counterfeiting, simulating, or falsely representing, or using identifica tion devices without proper authority, would apply in the case of such identification devices as may be required or authorized for insulin under section 3 of the bill. Section 2 would include, among drugs which under the act are deemed misbranded, any drug which is composed of, or contains insulin which is not from a batch certified or released under section 3 of the bill. Also any such drug, though from a certified or released batch, would be deemed misbranded after the effective period of the certificate or release expired, or on failure of the particular drug and its package to comply with the terms of the certification or release. Section 3 directs the Federal Security Administrator to establish, pursuant to regulations, standards of identity, strength, quality, and purity for drugs composed wholly or partly of insulin and tests and methods of assay to determine whether batches of such drugs, or packages therefrom, meet the standards prescribed by such reguIations for such drugs. Your committee have amended this section to provide that, if such a standard of identity, strength, quality, or purity for any drug is set forth in an official compendium, no differing standard for such drug may be prescribed under this section. It also requires the Administrator to establish testing and certifying facilities and procedure, and to issue certificates for batches meeting these requirements. Inasmuch as over-age or improperly packaged or labeled insulin is unsafe, such certificates are to be effective only for periods prescribed in the regulations, and the certified batches and drugs therefrom are to be protected by such certificate only for the prescribed period, or for such part thereof as such drug meets the labeling and other requirements prescribed in such regulations for the protection of the public. The section also provides that the Administrator shall determine, and set out in the regulations, schedules of fees which will cover the cost to the Government of equipping and maintaining the facilities, 4 AMEND FEDERAL FOOD, DRUG, AND COSMETIC ACT and compensating the personnel, required for making the tests and assays and following the other procedures necessary in certifying insulin. Subsection (b) guards against any arbitrary establishment of tests and methods of assay differing from the test or method set forth for the drug in an official compendium. Following the pattern in other provisions of the act, subsection (c) provides for the application of the hearing and judicial review procedures of section 701 of the act, to the regulations insofar as they prescribe tests or methods of assay to determine strength, quality and purity for a particular drug, which are different from any test or method set forth for such drug in an official compendium. The term "official compendium" is already defined in section 201 (j) of the act to include the United States Pharmacopoeia. Provision for release prior to the promulgation of regulations, of insulin which, in the Administrator's judgment, may be released without risk as to safety and efficacy, is also made in this section. This provision is necessary to prevent shipment in interstate commerce, pending the formulation of the contemplated regulations, of insulin which is not of the proper strength, quality, or purity to protect users. It would, however, permit prompt release of batches of insulin which have already been passed by the Insulin Committee of Toronto University as being of the necessary strength, quality, and purity, thus avoiding risk of a shortage. Section 4 is designed to expedite issuance of initial regulations under section 506. It directs the promulgation of these regulations within 45 days. CHANGES IN EXISTING LAW In compliance with paragraph 2a of rule XIII of the Rules of the House of Representatives, changes in the Federal Food, Drug, and Cosmetic Act of June 25, 1938, as amended, made by the bill as introduced are shown as follows (new matter is printed in italics; existing law in which no change is proposed is shown in roman. No provision of existing law is proposed to be omitted): SEC. 301. The following acts and the causing thereof are hereby prohibited (i) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by regulations promulgated under the provisions of section 404, 406 (b), 504, 506, or 604. SEC. 502. A drug or device shall be deemed to be misbranded (k) If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to section 506, and (2) such certificate or release is in effect with respect to such drug. CERTIFICATIONS OF DRUGS CONTAINING INSULIN Sec. 506. (a) The Federal Security Administrator, pursuant to regulations premulgated by him, shall provide for the certification of batches of drugs composed wholly or partly of insulin. A batch of any such drug shall be certified if such drug has such characteristics of identity and such batch has such characteristics of strengik, quality and purity, as the Administrator prescribes in such regulations as necessary to ade quately insure safety and efficacy of use, but shall not otherwise be certified. Prier to the effective date of such regulations the Administrator, in lieu of certification, shall issue a release for any batch which, in his judgment, may be released without risk to the safety and efficacy of its use. Such release shall prescribe the date of its expiretion and other conditions under which it shall cease to be effective as to such batch and as to portions thereof. AMEND FEDERAL FOOD, DRUG, AND COSMETIC ACT 5 (b) Regulations providing for such certification shall contain such provisions as are necessary to carry out the purposes of this section, including provisions prescrib ing (1) standards of identity and of strength, quality, and purity, (2) tests and methods of assay to determine compliance with such standards, (3) effective periods for certifi cales, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof, (4) administration and procedure, and (5) such fees, specified in such regulations, as are necessary to provide, equip, and maintain an adequate certification service. (c) Such regulations, insofar as they prescribe tests or methods of assay to determine strength, quality, or purity of any drug, different from the tests or methods of assay set forth for such drug in an official compendium, shall be prescribed after notice and opportunity for revision of such compendium, in the manner provided in the second sentence of section 501 (b). The provisions of subsections (e), (), and (g) of section 701 shall be applicable to such portion of any regulation as prescribes any such different test or method, but shall not be applicable to any other portion of any such regulation. |