397 



dangerous new drugs, as well as proposing the establisliment of "basic 

 principles and minimum requirements" for evaluating the safety and 

 efficacy of drugs.^°* 



A Conference of Professional and Scientific Societies on Drug 

 Safety, meeting in Chicago, 1963, under the sponsorship of the Phar- 

 maceutical Manufacturers Association, led to a conclusion that there 

 was a need for consolidation of pertinent, reliable information for 

 groups of related drugs in review articles directed to physicians by 

 field of special interest; and for a compendium of objective drug data 

 in a single source book containing information pertinent to the sj^ecific 

 clinical decision. ^°^ 



A report on drug literature prepared for tlie Humphrey subcom- 

 mittee by the National Library of Medicine, August 30, 1963, con- 

 cluded: 



It is difficult to try to summarize the findings of this report in terms which 

 are simple, yet not simplLstic. One can only say that there is a great amount 

 and variety of publication in what may be called the "drug literature" ; that 

 there are a great many secondary sources of information ; that no single source 

 is all-embracing in the needs it serves. This is not surprising ; a problem involving 

 many complex substances, varied biological activities under varying circum- 

 stances, different aspects, different uses, different audiences, millions of words, 

 dozens of languages, not to say differences of judgment and differences of inter- 

 pretation, and a myriad nomenclature, is not a problem which is susceptible 

 to easy solution, or solution that is readily apparent. It is probable that there 

 is no solution, only solutions. It is certain that a wide variety of tasks remain 

 to challenge the best talents which chemists, biologists, pharmacologists, physi- 

 cians, documentalists, and libraries can bring to bear.^'*^ 



Many of the recommendations of the Humphrey subcommittee dealt 

 with the problem of information exchange : calling for strengthened 

 medical education in drug therapy, information centers on drugs, 

 modernized files of drug data, a Federal network of automated infor- 

 mation management, reporting systems for adverse reactions, mater- 

 nity and birth records, and "international cooperation in drug re- 

 search, regulation, education, and information." ^'^ 



In the field of drug advertising, the FDA has apparently been active 

 in applying the powers conferred by the 1962 amendments. There were 

 33 formal public actions against 26 manufacturers, involving 45 drug 

 products, under the regulations against false and deceptive advertising, 

 mostly in 1967-68. ^Slore effective, according to one report, is the device 

 of an obligatoiy "corrective letter" which the manufacturer agrees to 

 send to correct a major untruth ; tliese are mailed to 280,000 individual 

 physicians in each, instance. Between Fel^ruary 1967 and Julj' 1968, 21 

 companies had sent 24 of these letters. (The alternative is for FDA to 

 seize shipments of the drugs in question.)"^ 



"♦"U.X. Group To Set Watch on Drugs." New York Times. West coast edition. (Jan. 19, 

 190?,). p. 2. 



1"' American Enterprise Institute for Pulilie Policy Research. .Special Analysis : The Drug 

 Safety Problem. (Washington. American Enterprise Institute for Public Policy Research, 

 Sept. 17, 1964, (Rpt. 12)), pp. 18, 21 



1'^ U.S. Congress. Senate. Committee on Government Operations. Drug literature. Report 

 prepared for the study of "Interagency Coordination in Drug Research and Regulation." by 

 the Subcommittee on Reorganization and International Organizations of the * * *. A 

 factual survey on "The Nature and Magnitude of Drug Literature," bv the National Library 

 of Medicine. Aug. 20, 196.3, R8th Cong., 1st sess. Committee print. (Washington, U.S. 

 Government Printing Office, 196.3). p. 39. 



^''^ Interagency Drug Coordinntion. Report * * *. (1966), op. cit., pp. Si— S. 



'<» Morton Mintz. "Drugs: Deceptive Advertising." New Republic. (July 6, 196S), pp. 

 19-21. 



