373 



As to new legislation, he said, ''we support, in substance, those pro- 

 visions of S. 1552 which would serve to advance health progress," His 

 organization also favored some additional proposals. The PJVIA po- 

 sition is summarized as follows [paraphrase] : 



1. PMA "believes strongly that a drug should be effective for the uses which 

 the manufacturer claims for it." Therefore the manufacturer should be required 

 to submit to FDA "substantial evidence" that the drug was safe and that it 

 produced the results claimed for it. 



2. Drug manufacturers bhould be required to register with FDA. 



3. Drug manufacturers should be "subjected to regular mandatory inspec- 

 tion by FDA at least once every 2 years '■= * *." 



4. FDA inspection powers should be broadened "to enable it to determine ade- 

 quately whether there is a violation or potential violation of the Federal Food, 

 Drug, and Cosmetic Act." 



5. "Increased funds should be provided to enable FDA to undertake these 

 broadened responsibilities." '" 



With respect to the issue as to whether "efficacy" of new drugs 

 should be made a matter for FDA determination, Mr. Beesley offered 

 tlie following observations : "In the entire realm of medical science," 

 he said, "nothing is more difficult and more subject to honest differ- 

 ences of competent opinion than the determination of the therapeutic 

 merits of drugs in human beings." He was concerned that "premature 

 or arbitrary judgments, or judgments based on imprecise standards, 

 could deprive the American people of many important health bene- 

 fits." There were different schools of thought in medical practice; the 

 FDA should not impose its own views on the medical profession, and 

 therefore — 



The only sound standard * * * jg ^■j^^^^ ^j^g drug must be safe and that there 

 must be substantial — but not necessarily preponderant — evidence showing that 

 the drug has produced the .specific physiological effects claimed for it.^ 



Dr. Lasagna, who returned to testify at the second set of hearings, 

 contributed further thoughts on the problem of drug safety : 



It was pointless to divorce safety and efficacy. A drug's safety could not be 

 .iudged in vacuo, but only in relation to its purpose. 



One must have reliable evidence of therapy, just as one must demand adequate 

 evidence of safety. 



The history of medicine is, unhappily, replete with examples of useless drugs 

 employed for years, decades, or centuries, by countless physicians before a few 

 properly conducted experiments proved the drugs to be without value. 



If a drug is very poisonous but may cure cancer, that drug should be on the 

 market. If the drug is very poisonous but only may cure mild headache, it 

 should not be on the market. 



* * * Modern therapeutics is too difficult and too dangerous for today's 

 doctor to go it alone. He needs help, and from many sources, including the 

 Government. 



Dr. Lasagna described for the subcommittee the "unsatisfactory 

 atmosphere now surrounding new drug developments." 



At present, when a drug of unquestioned merit is put on the market, the com- 

 pany whose imagination and know-how has been responsible for the break- 

 through is faced with the possibility that within a short period of time a half- 

 dozen or more pharmacologic shadows will be introduced by comix'ting firms, 

 almost all of them representing minor advances or no advance at all. but one or 

 more of which may purloin a good share of the market away from the first 

 drug. The result is a fantastic pres.sure on drug houses to assemble data in a 

 huri-y and to market at the earliest possible date. 



Were this pressure merely to speed up the process of drug development, no 

 one would have any serious objection. But the stage is also set for hasty and 



" Ibid., pt. 4. pp. 1996-1997. 

 3«Ibid.. pp. 1998-1999. 



