Earl Warren

“ Respondent's primary contention here is that the sensitivity discs are not subject to any of the provisions of the Act because Congress did not intend it to cover articles used so indirectly in the 'cure, mitigation, (and) treatment' of disease. Respondent uses the same two-step analysis relied on by the courts below: (1) Congress did not intend to write the drug definition more broadly than does the medical profession, and (2) the medical concept of drug is limited to articles that are administered to man either internally or externally. ”

“ It is enough for us that the expert agency charged with the enforcement of remedial legislation has determined that such regulation is desirable for the public health, for we are hardly qualified to second-guess the Secretary's medical judgment. Our sole concern is whether the statute's definition of 'drug' authorizes the disc regulations contested here ”

“ Since the patient will tend to derive less benefit and perhaps some harm from a particular antibiotic if, though the drug itself was properly batch-tested, it was not the proper antibiotic to use, it was entirely reasonable for the Secretary to determine that the discs, like the antibiotics they serve, are drugs and similarly subject to pre-clearance certification under § 507. ”

“ In answer to Senator Clark's remark that a bathroom scale would be classified as a drug, Senator Copeland made the following comment:
'Mr. President, I desire to state the effect of this amendment. There are on the market certain electrical devices. A man takes hold of the handles of the machine, and the indicator spins around. ”

“ In this test, a round paper disc, which has been impregnated with a specific antibiotic, is placed in contact with sample cultures, or isolates, of a patient's virus, grown in a special culture medium (agar) from a specimen of the patient's fluid (blood, spinal fluid, sputum, urine, etc.) ”

“ Despite Senator Copeland's proffered explanation, there was continued criticism during the Senate debates (79 Cong.Rec. 4905 4920, 5215-5234) [10] of the definition on the ground that it would lead to the incongruous result of calling the following items 'drugs': shoulder braces (id., at 4841) , radium belts (ibid.) , electrical devices (id., at 4842) , bathroom weight scales (ibid.) , and hospital air conditioning apparatus (id., at 5231) . [11] The opposition finally settled on 'crutches' (id., at 4913) [12] to signify the ultimate absurdity of the drug definition's broad coverage. ”

“ As the inclusion of the word 'diagnosis' came before the Senate for consideration, a controversy developed on the floor, aimed more at the word 'devices,' which was not then before the Senate, than at the word 'diagnosis.' 79 Cong.Rec. ”