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
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
"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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