387 



Tlie administration bill, H.K. 11581, introduced May 3, was de- 

 scribed by its sponsor, as follows : 



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 re- 

 quire a showing that new drugs and biologicals are effective for their in- 

 tended 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 re- 

 actions 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 bar- 

 biturates and amphetamines ; and, eighth, to institute more effective factory in- 

 spection for all projects subject to the act. 



It would also authorize the Federal Trade Commission to require the disclosure 

 of ingredients of prescription drugs, their efiicacy and their adverse effects in 

 advertisements directed to physicians.*^ 



Tlie President's reference at his news conference to the search for 

 administrative measures to make safer the investigation of new drugs 

 may have had reference to new regulations under study by FDA. On 

 August 10, FDA amiounced a set of proposed regulations, which 

 would require drug firms to indicate in advance their plans for the 

 investigation of a new drug, to monitor closely the execution of the 

 plans, and to report immediately any adverse findings; such investi- 

 gations were not to be used for promotional or market development 

 purposes.^® 



T^rhen, at length, the drug reform bill was signed by the President, 

 October 10, he paid tribute to its sponsors, and to the bill which, he 

 said, """is designed to provide safer and more effective drugs to the 

 American consumer." He also took note of the role of the thalidomide 

 episode in bringing about this result : 



[Said the President:] The Congress is to be congratulated in moving so 

 quickly. Fortunately, prior to the revelation of the dangers posed by drugs like 

 thalidomide, the foundation for legislative action on drugs had been laid down 

 in exhaustive hearings conducted by Senator Kefauver and others who intro- 

 duced the present bill in its first version and in a legislative proposal on drugs 

 and factory inspection introduced in the House by Congressman Harris.'' 



The spate of drug testimony available to Congress 



A crushing weight of testimony had been accumulated, and continued 

 to grow, in the committees of Congress concerning drug problems and 

 legislative remedies. There had been the 8,669 pages of the first Kefau- 

 ver investigation and the 4,217 pages of the second; Representative 

 Celler's committee had accumulated a further 908 pages of evidence 

 (4 days of hearings, 40 witnesses) ; another 709 pages of evidence (8 



*s U.S. Congress. House. Committee on Interstate and Foreign Commerce. Drug Industry 

 Act of 1962. Hearings before the * * * on H.R. 115S1. 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 stimulation drugs, and clarify and strengthen existing inspection 

 authority with respect to any articles subject to the act ; and to amend related laws • 

 and H.R. 11.582, A bill to protect the public health by amending the Federal Food, Drug' 

 and Cosmetic Act to require a premarketing showing of the safety of cosmetics ; assure 

 the safety, efficacy, and reliability of therapeutic, diagnostic, and prosthetic devices ; and 

 amend the act with respect to cautionary labeling ; and for other purposes. June 19 ''0 

 21, 22; Aug. 20, 21, 22, 23, 1962. (Washington, U.S. Government Printing Office, 1962)' 

 p. 1. 



6u rpjjg PDA proposed regulations are reproduced in ibid., p. 219, sq. 



*' U.S. President (John F. Kennedy). Remarks upon signing the drug reform bill October 

 10, 1962. In Public Papers of the Presidents, John F. Kennedy. 1962, op. cit sec 443 



