FEDERAL SECURITY AGENCY, Họn. RoBERT CROSSER, Chairman, Committee on Interstate and Foreign Commerce, House of Representatives, Washington 25, D. C. DEAR MR. CHAIRMAN: This letter is in reply to your request of March 5, 1949, for a report on H. R. 3151, a bill to amend the Federal Food, Drug, and Cosmetic Act of June 25, 1938, as amended, by providing for the certification of batches of drugs composed wholly or partly of any kind of aureomycin, chloramphenicol. and bacitracin, or any derivative thereof. This bill would amend sections 502 and 507 of the Federal Food, Drug, and Cosmetic Act so as to provide for aureomycin, chloramphenicol, and bacitracin, three new "miracle" drugs, and their derivatives the same certification procedure now required in the case of penicillin, streptomycin, and insulin. The bill is identical with a draft bill which we submitted with our letter of February 21, 1949, to the Speaker of the House of Representatives, a copy of which is enclosed for your convenience. As we As appears from the enclosed letter, the amendment is essential to protect patients against a dangerous departure of new drugs from standards of identity, strength, quality, and purity appropriate to their safe and efficacious use. have indicated, it is recognized by the manufacturers of these drugs that pretesting and certification is necessary not only for the protection of the public health, but for their own protection as well. As a matter of fact, the three large producers of these drugs have requested that steps be taken to establish a certification system for aureomycin, bacitracin, and chloramphenicol similar to that now in effect for penicillin and streptomycin. We therefore urge the enactment of this measure. As stated in the enclosed letter, the Bureau of the Budget has advised that there is no objection to the submission of this legislation to the Congress. Sincerely yours, J. DONALD KINGSLEY, Acting Administrator. The honorable the SPEAKER OF THE HOUSE OF REPRESENTATIVES, Washington 25, D. C. DEAR MR. SPEAKER: As you know, the Federal Food, Drug, and Cosmetic Act contains provisions in section 507 and related sections requiring that penicillin and streptomycin, and all products containing them, be pretested by the Government and certified before interstate distribution. The reasons underlying the requirements for certification of penicillin and streptomycin are that they are highly efficacious in many serious diseases suffered by large numbers of our population, that unusual difficulties are inherent in their manufacture, that the methods for testing finished lots for determining safety and efficacy are not yet entirely satisfactory, and that there exists an unusual likelihood that lots will appear on the market which are not of the appropriate strength, quality, and purity. It requires not only the greatest care on the part of the manufacturer to insure that the product is what it should be, but check testing by a disinterested and competent authority as well. During the past few years a number of new drugs have been developed which have effects on specific diseases similar to those demonstrated for penicillin and streptomycin. The dramatic effects produced by these new antibiotics, shown in the treatment of serious and often fatal diseases, are demonstrated daily. Each of these new antibiotics is effective in certain diseases and not in others. For example, penicillin is very effective in the treatment of pneumococcic infections and streptococcic infections, while streptomycin has been found extremely useful in the treatment of tuberculosis. There has been a constant search for new antibiotics which will broaden the effectiveness of these drugs. The new drugs about which this letter is concerned, aureomycin, chloramphenicol, and bacitracin, have successfully broadened the field to include a number of diseases not heretofore amenable to treatment. For example, aureomycin has been found valuable in the treatment of certain rickettsial diseases, such as Rocky Mountain spotted fever and scrub typhus, and has been found successful in the treatment of primary atypical pneumonia, a disease for which we have never had a satisfactory cure. Similarly, chloramphenicol has been found valuable in the treatment of both rickettsial and virus diseases, but in addition has proved to be extremely valuable in the treatment of typhoid fever. Bacitracin has been utilized against certain diseases which have been found not to react favorably to treatment with penicillin. The last-named drug is used primarily for topical application, because of inherent toxic properties. These drugs, like penicillin and streptomycin, are produced by the growth of microorganisms, and their manufacture and testing are subject to the same kind of unexplained vagaries that characterize the production of all biological products. Because of the toxicity of bacitracin, in some instances at least, the need for predistribution checking is even greater than with penicillin. The certification procedure we are now recommending for aureomycin, chloramphenicol, and bacitracin has precedent in the terms of the Federal Food, Drug, and Cosmetic Act, not only in the penicillin and streptomycin provisions but in the provisions of section 506, which requires certification of insulin, the drug which enables diabetics to live a nearly normal span of life. In common with penicillin, streptomycin, and insulin, aureomycin, chloramphenicol, and bacitracin present problems of a common pattern in the importance of their need for effective control in the interest of public health. They are all highly efficacious for one or more serious diseases; they all present unusual difficulties in the process of manufacture and the methods of testing finished lots, and for this reason are prone to depart from standards of identity, strength, quality, and purity appropriate to insure safety and efficacy of use. The general provisions of the law applicable to other drugs are quite ineffective in meeting the needs of public protection presented by these articles. There is no authority in these general provisions for testing by the Government before distribution even where the manufacturer desires such testing as an insurance against mistakes. Examinations can be made only after the products are shipped or offered for shipment in interstate commerce. With the sanctions of seizure, criminal prosecution, and injunction contained in the act, and the facilities available for enforcement, only a fraction of the output of any drug can ordinarily be given attention and proceeded against effectively when it fails to meet appropriate standards. Seizure of widely dispersed products is possible in only a relatively small proportion of cases. Criminal prosecution and injunction proceedings do not benefit the patients who have received ineffective or toxic drugs contained in the shipments upon which such actions are instituted. It is probable that as improved techniques in manufacture and better methods of testing are developed, the need for pretesting and certification of aureomycin, chloramphenicol, and bacitracin may no longer exist. That probability with respect to penicillin and streptomycin was recognized in section 507 (c), which directs the Administrator to promulgate regulations exempting the drug from certification requirements when that procedure is not necessary to insure safety and efficacy of use. This provision would apply equally to aureomycin, chloramphenicol, and bacitracin if the recommended amendment is adopted. A draft of the amendment is attached. This proposed legislation has been discussed with representatives of members of the industry who produce aureomycin, chloramphenicol, and bacitracin or who may be concerned with its production. There appears to be no significant opposition to the proposal. In fact, the present basic producers of aureomycin, chloramphenicol, and bacitracin have requested that steps be taken to establish a certification service for their products similar to that now being utilized for penicillin and streptomycin. The cost of establishing and maintaining the certification service, as with penicillin and streptomycin, will be borne by the manufacturing industry through payment of appropriate fees. The Bureau of the Budget advises that there is no objection to the submission of this proposed legislation to the Congress for its consideration. Sincerely yours, OSCAR R. EWING, Administrator A BILL To amend the Federal Food, Drug, and Cosmetic Act of June 25, 1938, as amended, by providing for the certification of batches of drugs composed wholly or partly of any kind of aureomycin, chloram phenicol, and bacitracin, or any derivative thereof. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 502 (1) of the Federal Food, Drug, and Cosmetic Act of June 25, 1938, as amended (U. S. C., 1946 edition, title 21. ch. 9), is amended by deleting the word "or" preceding the word "streptomycin" and inserting in lieu thereof a comma and by inserting after the word "streptomycin" the following: ", aureomycin, chloramphenicol, or bacitracin.". SEC. 2. (a) The heading of section 507 of such Act, as amended, is amended by deleting the word "or" preceding the word "streptomycin" and inserting in lieu thereof a comma and by adding at the end of such heading the following: aureomycin, chloramphenicol, or bacitracin". (b) The first sentence of subsection (a) of such section 507 is amended by deleting the word "or" preceding the word "streptomycin" and inserting in lieu thereof a comma and by inserting after the word "streptomycin" the following: ", aureomycin, chloramphenicol, or bacitracin,". Hon. ROBERT CROSSER, THE SECRETARY OF COMMERCE, Chairman, Committee on Interstate and Foreign Commerce, House of Representatives, Washington, D. C. DEAR MR. CHAIRMAN: This letter is in reply to your communication of March 5, 1949, requesting the Department's comments on H. R. 3151, a bill to amend the Federal Food, Drug, and Cosmetic Act of June 25, 1938, as amended, by providing for the certification of batches of drugs composed wholly or partly of any kind of aureomycin, chloramphenicol, and bacitracin, or any derivative thereof. The proposed bill would amend the Federal Food, Drug, and Cosmetic Act of June 25, 1938, by providing for the certification of drugs composed wholly or partly of any kind of aureomycin, chloramphenicol, and bacitracin. I am of the opinon that enactment of this amendment would provide a very desirable broadening of the certification requirements presently set forth in section 502 (1) of the Federal Food, Drug, and Cosmetic Act. I have been advised by the Bureau of the Budget that there is no objection to the submission of this report to the committee for its consideration. Sincerely yours, CHARLES SAWYER, Secretary of Commerce. MARCH 30, 1949. Hon. ROBERT CROSSER, Chairman, Committee on Interstate and Foreign Commerce, House of Representatives, Washington, D. C. MY DEAR MR. CHAIRMAN: This is with further reference to your letter of March 5, 1949, enclosing a copy of H. R. 3151, Eighty-first Congress, first session, entitled "A bill to amend the Federal Food, Drug, and Cosmetic Act of June 25, 1938, as amended, by providing for the certification of batches of drugs composed wholly or partly of any kind of aureomycin, chloramphenicol, and bacitracin, or any derivative thereof," introduced March 2, 1949, by Representative James Percy Priest, of Tennessee, and requesting a prompt report, together with such comment as the Commission may desire to make concerning the proposed legislation. In response thereto, I wish to advise that the bill has been carefully examined and the following comment is submitted by the Commission for the information of your committee: Aureomycin, chloramphenicol, and bacitracin are antibiotic drugs having exceptional value in the treatment of certain diseases of animals and man. It is important that these antibiotic drugs and their derivatives have the potency claimed for them. Since the manufacture of these preparations involves complicated technical procedures, it is in the interest of the public to have each batch of each of these antibiotic drugs and each derivative thereof certified as to identity, strength, quality and purity, in order to insure safety and efficacy of use. Members of the staff of the Federal Trade Commission have followed carefully the discovery and development of these antibiotics and know their usefulness has been established in a number of communicable diseases in which neither penicillin nor streptomycin have curative value. It appears, therefore, that in order to assure uniform potency and to achieve the greatest possible safety and benefit to health in the use of these antibiotics, each manufactured batch of each preparation containing one or more of these drugs or their derivatives should be properly tested and certified before it is distributed in commerce H. R. 3151 makes provision for such testing and certification and its enactment will be in the public interest. By direction of the Commission. Sincerely yours, LOWELL B. MASON, Acting Chairman. APRIL 4, 1949. r. B.-Pursuant to regulations, this report was submitted to the Bureau of the Budget on March 30, and on April 1, 1949, the Commission was informed by telephone that there would be no objection to the presentation of the report to the committee. LOWELL B. MASON, Acting Chairman. CHANGES IN EXISTING LAW In compliance with paragraph 2a of Rule XIII of the Rules of the House of Representatives, changes in existing law made by the bill, as introduced, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italics, existing law in which no change is proposed is shown in roman): FEDERAL FOOD, DRUG, AND COSMETIC ACT SEC. 502. A drug or device shall be deemed to be misbranded (1) If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of [penicillin or streptomycin] penicillin, streptomycin, aureomycin, chloramphenicol, or bacitracin, or any derivative thereof, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to section 507, and (2) such certificate or release is in effect with respect to such drug: Provided, That this paragraph shall not apply to any drug or class of drugs exempted by regulations promulgated under section 507 (c) or (d). * ** * * CERTIFICATION OF DRUGS CONTAINING [PENICILLIN OR STREPTOMYCIN] PENICILLIN, STREPTOMYCIN, AUREOMYCIN, CHLORAMPHENICOL, OR BACITRACIN SEC. 507. (a) The Federal Security Administrator, pursuant to regulations promulgated by him, shall provide for the certification of batches of drugs composed wholly or partly or any kind of [penicillin or streptomycin] penicillin, streptomycin, aureomycin, chloramphenicol, or bacitracin, or any derivative thereof. A batch of any such drug shall be certified if such drug has such characteristics of identity and such batch has such characteristics of strength, quality, and purity, as the Administrator prescribes in such regulations as necessary to adequately insure safety and efficacy of use, but shall not otherwise be certified. Prior 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 as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof. O H. Repts., 81-1, vol. 3– -14 |