Statements submitted by--Continued Schwartz, Adolph K., on behalf of the Associated Drug & Chemical Page Industries of Missouri, Inc., re H.R. 11581.. 623 618 Newspaper clipping "Advertising Drugs in a Cutback" by Peter Bart from the New York Times, August 18, 1961.. Recommended amendments to sections 121-126 of H.R. 11581_. Statement of principles of ethical drug promotion... Comments on Testimony, H.R. 11581, Food and Drug Administration_ Feeney, Dr. Robert J., suggested modifications, extension of certifica- 570 263 408 545 425 Habberton, B. G., re interest of the dairy industry and its products 456 Examples of new drug applications that have become effective 85 Ribicoff, Hon. Abraham- Letter dated July 2, 1962 re White House letter to Senator 74 Letter dated July 11, 1962, re regulation of drug advertising-- Inspection refusals-Federal Food, Drug, and Cosmetic Act, January 84 Jehle, Philip, State statutes having inspection provision for drugs. 527 229 Larrick, Hon. George P., Commissioner, FDA, "New Drugs for In- 219 647 Scheele, Dr. Leonard A., excerpt from the Federal Register of August 219 "Soviet and the American Pharmaceutical Systems: Some Paradoxical 344 White House letter to Senator James O. Eastland dated April 10, 74 Communications submitted to the committee Continued Adamy, Clarence G., executive vice president, National Association Albanese, Anthony A., the Winifred Masterson Burke Relief Founda- Page 639 653 Allen, John W., president, National Bakery Suppliers Association, 668 Allport, Peter W., Association of National Advertisers, Inc., letter 651 American Medical Association, letter to supplement comments of 604 Anderson, Francis V., letter dated May 31, 1962. 675 Austern, H. Thomas, counsel, National Canners Association, letter 637 Beesley, Eugene N., letter dated August 29, 1962 re expenditures of 186 Bishop, Wendell W., president, Mayonnaise & Salad Dressing Manu- 673 663 National Pecan Shellers & Processors Association, letter dated Pet Food Institute, letter dated May 31, 1962. Calvert, G. K., Trappe Frozen Foods Corp., letter dated June 25, 1952 667 703, 704 Emme, E. L., general manager, Godefroy Manufacturing Co., letter 670 545 690 Epply, N. D., letter dated August 21, 1962- 639 Erickson, Dr. Donald J., president, American Congress of Physical 701 1962. 697 Froikin, Norman M., affidavit submitted in behalf of Glo-Rnz, Inc.- Gibson, Robert L. Jr., Libby, McNeill & Libby, letter dated July 10, Gilman, Alfred, professor and chairman, Albert Einstein College of 654 Goodrich, Walker R., vice president-personnel, Seeman Bros., Inc., 674 Gripaldi, Benedict V., president, National American Cosmetology 689 Habberton, Benjamin G., letter dated August 23, 1962__. Heckman, Jerome H., counsel for the Society of the Plastics Industry, 670 Hitchner, L. S., president, National Agricultural Chemicals Association, 702 Communications submitted to the committee Continued Hull, J. E., Manufacturing Chemists' Association, Inc., letter dated Page 652 Jones, L. Meyer, D.V.M., Ph. D., director of scientific activities, 552 Kennard, William J., M.D., executive vice president, Aerospace 662 Kerr, Francis C., executive director, Frozen Pea Council, letter dated 672 Kinney, H. S., Kinney & Co., Inc., letter dated June 18, 1962 – 667 Additional comments, dated August 30, 1962. 570 109 Levin, I., executive secretary, National Feed Ingredients Association, 669 Martin, William, American Syrup & Preserving Co., letter dated Major, J. M., Jr., president, National Preservers Association, letter 674 671 Mayer, Leo, M.D., chairman, the Physicians Forum, Inc., letter dated 707 Miller, Lloyd C., Ph. D., director of Revision, U.S. Pharmacopeia, 645 Mueller, Gerhard O. W., professor of law, New York University, 665 Nickstadt, A. G., president, Noville Essential Oil Co., Inc., letter 653 Porter, Pliny A., publisher, the Reuben H. Donnelly Corp., letter 661 Rubenstein, Robert M., executive director and counsel, National 647 Schieffelin, William J., III, president, Drug, Chemical & Allied Trades 661 707 672 643 650 Upjohn, Harold L., M.D., the Upjohn Co., letter dated August 17, 705 Versis, A. S., Versis Foods, Inc., letter dated June 21, 1962- 701 669 White House letter to Senator James O. Eastland dated April 10, 74 Winebrenner, Wirt S., vice president, D. E. Winebrenner Co., Inc., 691 Young, C. R., secretary, the R. T. French Co., letter dated June 13, 648 Young, J. Banks, National Cotton Council of America, letter dated 700 Zeger, Paul E., vice president, finance and treasurer, Seeman Bros., 671 DRUG INDUSTRY ACT OF 1962 TUESDAY, JUNE 19, 1962 HOUSE OF REPRESENTATIVES, COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE, Washington, D.C. The committee met, pursuant to notice, at 10:20 a.m., in room 1334, New House Office Building, Hon. Oren Harris (chairman of the committee) presiding. The CHAIRMAN. The committee will come to order. This morning the committee is meeting for hearings on two very important bills, and, two bills of wide interest, judging by the mail and telephone calls I received. H.R. 11581 and H.R. 11582 were introduced by me on May 3, to give effect to a part of the President's message on consumer protection; that is, that portion of the message dealing with strengthening the regulatory authority with respect to food, drugs, cosmetics, and devices. H.R. 11581, referred to as "Drug and Factory Inspection Amendments of 1962," proposes to authorize the Department of Health, Education, and Welfare, first, to issue regulations requiring drug manufacturers to maintain facilities and controls that will assure the reliability of their products; second, to require a showing that new drugs and biologicals are effective for their intended use as well as safe before they may be marketed; third, to withdraw clearances granted on new drugs when there is substantial doubt as to the drug's safety or efficacy; fourth, to require manufacturers to advise the Food and Drug Administration of clinical experience and reports of any adverse reactions to new drugs and antibiotics; fifth, to require the same safety testing and certification procedures for all antibiotics as are now applicable to only a few antibiotics; sixth, to assign generic names to drugs; seventh, to establish an enforceable system of preventing the illicit distribution of habit-forming barbiturates and amphetamines; and, eighth, to institute more effective factory inspection for all products subject to the act. It would also authorize the Federal Trade Commission to require the disclosure of ingredients of prescription drugs, their efficacy and their adverse effects in advertisements directed to physicians. H.R. 11582, cited as the "Cosmetics and Therapeutic Devices Amendments of 1962," would authorize the Department of Health, Education, and Welfare, first, to require a manufacturer of cosmetics to show that the products are safe before they may be marketed; second, to issue regulations requiring manufacturers of devices subject to the act to maintain facilities and controls that will assure the reliability of their products; third, to require the manufacturer of 1 devices to show that products are safe and efficacious before they may be marketed; and, fourth, to require appropriate cautionary labeling of hazardous substances or pressurized containers of articles subject to the act. This bill also provides that the anticancer clause in the food and color additive amendments to the act would not apply to additives used in feed for animals raised for food production where the chemical does not harm the animal and its use does not leave a residue in the edible products from the treated animal. Copies of the bills along with agency reports may appear at this point in the record. (H.R. 11581, H.R. 11582 and various agency reports are as follows:) [H.R. 11581, 87th Cong., 2d sess.] A BILL To protect the public health by amending the Federal Food, Drug, and Cosmetic Act to assure the safety, efficacy, and reliability of drugs, authorize standardization of drug names, establish special controls for barbiturate and stimulant drugs, and clarify and strengthen existing inspection authority with respect to any articles subject to the Act; and to amend related laws Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act, divided into titles and sections according to the following table of contents, may be cited as the "Drug and Factory Inspection Amendments of 1962". TABLE OF CONTENTS TITLE I-Drugs PART A-AMENDMENTS TO ASSURE SAFETY, EFFICACY, AND RELIABILITY Sec. 101. Requirement of adequate controls in manufacture. Sec. 102. Premarketing showing of new drug efficacy. Sec. 103. Records and reports as to experience on new drugs. Sec. 104. Procedural changes as to new drugs, and additional grounds for withdrawal or suspension of approval of new drug applications. Sec. 105. Certification of all antibiotics. Sec. 106. Records and reports as to experience on antibiotics. Sec. 107. Biological drugs. Sec. 108. Effective dates and application of part A. PART B-STANDARDIZATION OF DRUG NAMES Sec. 111. Authority to standardize names. Sec. 112. Name to be used on drug label. PART C-SPECIAL CONTROL FOR BARBITURATE AND STIMULANT DRUGS Sec. 121. Findings and declaration. Sec. 122. Control of barbiturate and stimulant drugs. Sec. 123. Prohibited acts. Sec. 124. Grounds and jurisdiction for judicial seizure and condemnation. Sec. 126. Effective date. PART D-AMENDMENTS AS TO ADVERTISING Sec. 131. Requirement of informative prescription drug advertisements. TITLE II-CLARIFICATION AND STRENGTHENING OF FACTORY INSPECTION AUTHORITY Sec. 201. Factory inspection. Sec. 202. Confidentiality of information obtained by inspection, etc. Sec. 203. Effective date. TITLE I-DRUGS PART A-AMENDMENTS TO ASSURE SAFETY, EFFICIENCY, AND RELIABILITY REQUIREMENT OF ADEQUATE CONTROLS IN MANUFACTURE SEC. 101. (a) Clause (2) of paragraph (a) of section 501 of the Federal Food, Drug, and Cosmetic Act is amended to read as follows: “(2) (A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or personnel or controls used for, its manufacture, processing, packing, or holding were inadequate (as determined in accordance with regulations promulgated by the Secretary on the basis of good manufacturing practice) (i) to insure that its identity and strength do not differ from, and that its purity, quality, and |