The proposal is…apparently directed against an uncooperative small minority, yet, these are the exactly the businesses that would be least likely to maintain adequate or accurate records. Thus, the privacy of the great majority of respectable businessmen is to be prejudicially invaded because of the misbehavior of a small minority….It cannot be too strongly stated that inspection of these factories as provided by this section , by outsiders, can expose to the world trade secrets….This technology is, in the truest sense, the property of its owners.
It should be enough if responsible and qualified clinicians have found that the drug produces the claimed effect…FDA should not be the arbiter of such conflicting views which necessarily involve large elements of subjective opinion by qualified scientists. Otherwise, we face the serious danger to medical progress inherent in a central authority where conflicting viewpoints in medicine will be indirectly resolved, as they are under a totalitarian system, and we run the very grave risk of recasting our system in a sterile, foreign mold…
It is important to public health, therefore, that Government regulations should not hamstring the medical advances produced by the industry. Disease and death can result from unnecessary delay in permitting a lifesaving drug to reach the public…
An unfettered exercise of power is certainly beneficial to no one, and governmental departments are no exception to this rule.
I feel that additional legislation…is only helpful to large industry and has a tendency to throttle small industry...
If overcautious and restrictive Government regulation had blocked [penicillin] testing and introduction twenty years ago, some lives would have been saved while a multitude of lives would have been lost.
