501 



tablishing habits of brand loyalty among prescribing physicians; and 

 by dividing up the drug specialities among producers so that in each 

 category of medications only a small number competed. It was a 

 peculiarity of the practice of medicine that expenditures for drugs 

 were made by the patient but selection was made by the physician. 



Prohlem.—To decide whether (and what kind of) Federal control 

 of the drug industry, its commerce, and its products, should be im- 

 posed for the protection of the public as patients or consumers. 



Access to Congress. — Senator Kefauver took the initiative to or- 

 ganize a subcommittee investigation of administered prices in various 

 industries, including the production of prescription drugs. The m- 

 vestigation afforded opportimity for expressions of professional crit- 

 icism of existing standards of drug safety and testing, and led to 

 legislative proposals for reform in these areas. 



^The fcucts. — Testimony about the drug industry and drug control 

 collected by Senator Kefauver's subcommittee, 1959-61, took some 

 8,000 pages of testunony and exhibits ; hearings on the resultant drug 

 bill, 1961-62, took another 4,000 pages. The investigation was spurred 

 by an initial observation that the markup of prescription drugs was 

 considerable. The subcommittee reported that drug prices were unrea- 

 sonably high, that patents were used to support monopolistic posi- 

 tions, that profits in the industry were exorbitant, that the proprietary 

 drug industry was heavily commercialized, that the use of generic 

 names of drugs would benefit purchasers, and that advertising of 

 drugs was costly, voluminous, unreliable, time consuming, and en- 

 couraged numerous abuses. A bill aimed at economic aspects of the 

 drug industry was introduced by Senator Kefauver. A number of oth- 

 er bills were also introduced, including one in the House, with Pres- 

 ident Kennedy's endorsement. The President's main concern was the 

 safety aspect. Drug safety became a headline issue, July 15, 1962, 

 with the appearance of a sensational news account describing the 

 disastrous side effects of a German sedative, thalidomide, and the 

 fact that it had been kept from the U.S. market by the skepticism 

 and stubbornness" of a "heroine" in FDA. The emotional impact of 

 the story was maintained by followup accounts of experiences with 

 thalidomide. The story was credited generally with motivating pas- 

 sage of drug reform legislation, which the President approved, 

 October 10. 



Soyn'ces^ kinds of technical information for Congress. — A crush- 

 ing weight of testimony accumulated in congressional committees on 

 drug problems. Witnesses spoke for the FDA, the American Medical 

 Association (AMA), drug manufacturers, and pharmacology depart- 

 ments in hospitals and medical schools. AMA spokesmen stressed the 

 capability and value of medical self -regulation ; the medical school 

 pharmacologists questioned the ability of the individual physician 

 to derive proper guidance from the voluminous and unselective drug 

 literature; drug manufacturing representatives defended their eco- 

 nomic structures but agreed as to the desirability of closer regulation 

 of drugs in the interest of public safety. The thalidomide episode was 

 not touched upon in either the investigative or legislative hearings 

 by Senator Kefauver's subcommittee; in the House, Representative 

 Celler obtained detailed testimony from Dr. Helen B. Taussig about 



