396 



brand-name drugs there is a generic drug available at a substantially lower 

 price. 



Many manufacturers insist that generics are not equivalent. However, many 

 expert authorities outside the drug industry insist they are equivalent.'*' 



Differences among various brands of generic drngs were found in an 

 investigatipn of the subject at Georgetown University School of Medi- 

 cine. The investigation, conducted under an FDA contract, was re- 

 ported in the Journal of the American Medical Association, August 

 26, 1968. It showed "significant differences in amount and rate of 

 absorption" of different brands of the same generic drug, in the case 

 of three, antibiotics. Seven others were scheduled for future testing.^°^ 

 A^ continuation of research to "determine the biological equivale^ncy 

 of important chemical equivalents should be continued by the De- 

 partment of Health, Education, and Welfare on a high priority basis"' 

 was recommended bv the HEW Task Force on Prescription Dru2:S, 

 August 30, 1968. 



The issue of therapeutic equivalence is now stressed by FDA, which 

 is requiring drug m.anufacturers who seek to produce a new version 

 or brand of an established generic drug to prove that tlieir new brand 

 is equivalent in effect to the approved prototype.^°- 



A report by the HEW Task Force on Prescription Drugs (which 

 C. Joseph Stetler, president of the Pharmaceutical Manufacturers 

 Association, called "an illusion") found that considerable saving to 

 older patients would accrue from ]:)urchasing drugs by generic rather 

 than brand name. The study, of 175 million prescri})tions written for 

 elderly people in 1966, indicated such savings could amount to $41.5 

 million.^°^ 



Problems in the exchange of drug information 



Deficiencies have been alleged to exist in almost every aspect of the 

 communication system by which information is disseminated to physi- 

 cians about drugs and the uses, as well as side effects, of new drugs. 

 The thalidomide episode showed that a considerable number of tragic 

 cases of drug injury could occur simultaneously in a number of clinics 

 (in Germany) without attracting general attention, or sounding a 

 general alarm. It also showed that international communication about 

 a dangerous drug was unsystematic. Information essential to the man- 

 agerial control of tests of new drugs was also shown to Ijc sometimes 

 laxly maintained. Medical reliance on drug advertisements and on the 

 information provided by "detail men" whose employment depended 

 on sales of brand name drugs of the drug houses they represented, was 

 established as a significant factor in medical "education" in the use 

 of prescription drugs. 



The Kefauver-Harris amendments dealt with these deficiencies by 

 requiring formal identification of generic drugs, and strengthening 

 reporting arrangements for tests of new drugs. Other deficiencies 

 seemed more amenable to administrative than legislative action. One 

 early action, announced January 18, 1963, was taken by the World 

 Health Organization of the United Nations, to assure international 

 exchange of information at the official governmental level concerning 



!« Competitive Problems in the Drug Industry. Hearings, op. clt., pt. 1, pp. 2-3. 

 i<a JAMA (Aug. 26. 1968, vol. 20.5. No. 9), pp. 23-24. 30. 



102 "Hard Pill for Drug Makers To Down." Business Weelc (Aug. 10, 106R>. pp. 59-60. 

 3 "Brand-Name Drugs Cost Elderly .$41. .5 Million More in 19/66." Washington Post (Nov. 

 8, 1968), p. A-3. 



