3S6 



Presidential interest in drug efficacy and safety 



The lengthy investigative liearings by Senator Kefauver into the 

 drug industry and the further lengthy hearings on S. 1552, had em- 

 phasized the enforcement of price competition and patent licensing. 

 Similar emphasis had characterized most of the Celler hearing on the 

 companion bill, H.E. 6245. However, President Kennedy had taken 

 the position that the protection of the consumer with respect to drugs 

 was primarily a matter of safety and efficacy, rather than prices. 

 In a special message to the Congress on protecting the consumer in- 

 terest, March 15, the President called for legislation to "strengthen 

 regulatory authority over foods and drugs." New drugs were being 

 placed on the market (9,000 in the last 25 years) with "no require- 

 ment that there be either advance proof that they will be effective in 

 treating the diseases and conditions for which they are recommended 

 or the prompt reporting of adverse reactions." He claimed that more 

 than 20 percent of the new drugs did not live up to the manufac- 

 turer's claims. Accordingly, the President recommended legislation to 

 authorize the Department of Health, Education, and Welfare ( among 

 other things) , to — 



Require a showing that new drugs * * * are effective for their intended use — 

 as well as safe — before they are placed on the market ; 



"Withdraw approval of any such drug * * * when there is substantial doubt as 

 to its safety or efficacy, and require manufacturers to report any information 

 bearing on its safety or efficacy ; 



Require drug * * * manufacturers to maintain facilities and controls that will 

 assure the reliability of their product ; 



Require batch-by-batch testing and certification of all antibiotics ; 



Assign simple common names to drugs. 



The President also called for "legislation to authorize the Federal 

 Trade Conmiission to recjuire that advertising of prescription drugs 

 directed to physicians disclose the ingredients, the efficacy, and the 

 adverse effects of such drugs." ^^ 



Shortly after the Mintz article had appeared, the President alluded 

 to the thalidomide episode directly. At a meeting with the Consumers' 

 Advisory Council, July 19, he made reference to "the work done by 

 one woman. Dr. Frances Kelsey * * * in regard to saving thousands 

 of babies from crippling deformities by failure to give approval to a 

 suspicious drug." ^^ 



The President opened his August 1 news conference with an an- 

 nouncement that his administration was reviewing the steps that 

 could be taken administratively to make the introduction or investiga- 

 tion of new drugs less dangerous. Also, a 25-percent increase in FDA 

 staff and increased funding had been requested and provided by the 

 Congress. Nevertheless, "additional legislative safeguards are neces- 

 sary." As reported by the Senate Judiciary Connnittee, July 19, he 

 said, S. 1552 "does not go far enough * * *." He gave support to the 

 "administration bill introduced by Congressman Oren Harris, of 

 Arkansas, in the House." It contained such additional safeguards as 

 the right of FDA to remove a new drug from the market immediately 

 "where there is an immediate hazard to public health." *' 



^= U.S. President (John P. Kennedy). Special Messagre to the Conjrress on Proteetinj? the 

 Consumer Interest. Mar. 15, 1962. In Public Papers of the Presidents. John F. Kennedy, 

 1962. (Washington, U.S. Government Printing Office, 1963), pp. 239-240. 



^ U.S. President (John F. Kennedy). Remarlis at a meeting with the Consumers' Advisory 

 Council. July 19, 1962. In ibid., p. 564. 



** U.S. President (John F. Kennedy). The President's news conference of Aug. 1, 1962. 

 In ibid., p. 590. 



