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posted on 26 Aug 2012 01:41 by cheapnexiumaj
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now been added to the bill concerning Cheap Nexium what would constitute such evidence The Cheap Nexium amendment provides that 'substantial evidence' means evidence consisting of adequate and well-controlled investigations, including clinical investigations bv experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairlv and respon.siblv be concluded by such experts that the drug will have the effect it purports or is repre.sented to have under the conditions of use prescribed, recommended or suggested m the labeling or proposed labeling thereof. That is to say, a claim could be rejected if it were found (a) have the investigations were not 'adequate' (b) that the.y were not 'well controlled' ; Cheap Nexium (c) that they had been conducted bv experts not qualified to evaluate the effectiveness of the drug for which the application IS made ; or (d) that the conclusions drawn by such experts could not fairiy and COMPETITIVE PROBLEMS IN THE DRUG INDUSTRY 3367 responsibly be derived from their investigations." S. Rep. No. 1744. I'art 2, STtii Conp., 2d Ses5?. p. 6. ,.,.,. i Tlu' KeiKirt of the House Committee on Interstate and I'oreign ( ommerc-e and the Conference Report " do not elaborate further on the substantial evidence concept. The legislative hi.story could not be more clear in e.stablishing that (Congress understood the wide range of opinion that exists in the medical profession as to the effeorteCheap Nexium intended or was not as efficacious as one might ideally wish. "The bill furni.shes no basis for such apprehensions. The proposed amendments would merely require a .showing that the new drug described in the application is safe Cheap Nexium for use and is effective in use, under con(Utions prescribed ret-ommended. or suggested in the labeling thereof. This would not require a showing of rela- tively greater efficacv than that of other drugs. It would merely require that a drug claimed to be effective for a particular purpose has been demonstrated by sound scientific procedures to be effective for that purpose. In short, it must live up to the claims made for it. , ^ v "It shmild also be pointetl out that this proposal Cheap Nexium does not contemplate any basic change in Cheap Nexium the established pattern of testing the effectiveness of drugs. . . Testimony of Secretarv Ribicoff before Senate Subcommittee on Antitrust and Monopolv. September 13. 1961, pp. 2585-2586 (emphasis added). _^ . , The subject itself is extremely complicated, as the testimony of Dr. David l . Barr illu.strated : ^ , ,. ,. ,. . "Every one who has tried to test drugs knows how extremely difficult it is to determine whether a drug is or is not effective, and the establishment of its effectiveness requires extensive facilities and team efforts which may require joint services of manv participants, phy.sicians. certainly, and pharmacologists, and others." Testimony before Senate Subcommittee on Antitrust and Monopoly. .July 1!), 1061. p. 259. ^ ^. ^, That differences of opinion among responsible clinicians as to effectiveness ana testing occur frequently was amply demonstrated in the cour.se of the legisla- tive history. . . . . "The committee recognized that legitimate difference of opinion may exi.sr among responsible clinicians with respect to the effectiveness of a particular 1 H.R. Rep. No. 2464. R7th ConE., 2d Sess. 2 H.R. Rep. No. 2526, S7th Cong., 2d Sess. 3368 COMPETITIVE PROBLEMS IN THE DRUG INDUSTRY new drug. Experience has shown that a majority of so-called experts has often been wrong in initially condemning a new drug, just as new inventions in other fields are usually regarded with skepticism and often with hostility. The new ground for rejection of a new drug application is therefore expressed in terms of 'a lack of substantial evidence,' evaluated on the basis of all the information be- fore him, that the drug will have the effect claimed for it. The term 'substantial evidence' is detined in Cheap Nexium terms of the kind and quality of the investigations that must support the claims." Statement by Senator Eastland, 108 Ck)ng. Rec. 16304 (Augu.st23, 1962). "In the entire realm of medical science nothing is more diflScult Cheap Nexium and more subject to honest differences of competent opinion than the determination of the therapeutic merits of drugs in human beings. Experts have sharply opposed views concerning the proper treatment of many common diseases, and each school of thought has strong champions. Many highly qualified physicians are convniced of the value of Cheap Nexium corticosteroid drugs in relieving rheumatoid arthritis ; there are others who prefer aspirin ; still others are proponents of a variety of other treatments." Testimony of Eugene N. Beesley before Senate Subcommit- tee on Antitrust and Monopoly, December 7, 1961, p. 1998. "Mr. Beesley. . . . By 'substantial' evidence we mean less than preponder-
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posted on 25 Aug 2012 01:41 by cheapnexiumaj

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