395 



The case of the bioflavonoids is highly siiprnificant for the future of the re- 

 Aiew. The question it poses is : What legal weiglit do the scientific judgments of 

 the NAS carry? If the FDA, or a hearing examiner, or the courts were to rule 

 that the drugs were even possibly effective, a great shadow of doubt would be 

 thrown over the entire scientific credence of the review and would create a strong 

 scientific backlash against the entire project.*" 



The issue of generic verms hrand-name drugs; clinical equivalence 



A persistent question concerning the regulation of prescription drug 

 information is whether drugs should be identified, advertised, and 

 l^romoted by brand name or by generic name. The issue involves both 

 safety and economics. It was asserted, for example, that thalidomide 

 had been marketed under something like 100 different trade names. 

 The prolixity of aliases had seriously complicated the urgent and 

 important task of tracking down and removing from the market 

 all the different brands, which might or might not have had the 

 word thalidomide appearing on the label. Attempts to warn the pur- 

 chasers of such dangerous drugs encountered similar difficulties. A 

 related question was as to whether physicians should be permitted, in 

 collaboration with pharmacists, to identify prescriptions only by num- 

 ber (perhaps in order to withhold dangerous knowledge from the 

 patient) or whetlier it should be mandatory to disclose the prescription 

 to the patient. A further question was as to whether the disclosure 

 (mandatory where feasible, under the Kefauver-Harris amendments) 

 to the patient that an experimental drug was to be used, should include 

 reference to the drug by generic name. 



From the economic standpoint, it was claimed that w^hen physicians 

 prescribed, they frequently specified a particular brand, which denied 

 the patient the opportunity of purchasing the least expensive available 

 form of the generic drug. This raised the question as to the practical 

 equivalence of different brands of the same generic drugs. It was dem- 

 onstrated in the Kefauver hearings that the same drug was sold by 

 brands at widely differing prices. It was also asserted by some physi- 

 cians that they regarded some brands as more reliable than others, and 

 that patients' reactions differed with different brands of the same gen- 

 eric drug. 



The Kefauver-Harris amendments sought to correct the confusion 

 over drug nomenclature by authorizing the Secretary of Health, Edu- 

 cation, and Welfare to intervene to establish "official" generic names of 

 drugs, and required that when such names had been established — by 

 Government or other action — the names should appear on drug labels 

 and in drug advertising. 



Both major issues — the establishment of and prescribing by official 

 generic name, and the issue of biological, clinical, or therapeutic equiv- 

 alence of various brands within a single generic drug — were recently 

 under review by the Nelson subcommittee. The chairman declared, at 

 the opening of his hearings. May 15, 1967 : 



It has been frequently asserted by respected authorities that doctors quite 

 commonly prescribe expensive brand-name drugs when cheaper equivalent ge- 

 neric drugs are available because the doctor is not informed that there actually 

 is a cheaper equivalent available. 



There has been a continuous and vigorous controversy over the question of the 

 therapeutic equivalency of brand-name drugs versus generic drugs. This is an 

 important question because for a substantial number of the most widely used 



»9 The Hard, Long Look at 3,600 Older Drugs. Medical World News. (July 5. 1968). p. 34. 



