FDA regulations as applied to research in cancer centers. Review of problems and possible solutions

The Food and Drug Administration is charged to insure that the general public is not exposed to drugs that are either harmful or ineffective; yet, the regulations issued by the Food and Drug Administration are perceived to be in conflict with therapeutic human research. This article briefly reviews some considerations relevant to the problem. The regulations create both tensions and conflicts, but in themselves are reasonable exercises of the authority under which the FDA acts. However, regulations cannot be made either so general or so detailed that they will apply to all eventualities. A major problem is the degeneration of accountability and evaluation, from a compliance with the spirit of the recommendation to a compliance with documentation. When the review of compliance of documentation is done by inexperienced individuals, adversary relationships develop and the scientific and ethical problems are not addressed. A regulation that is meeting determined and widespread opposition is not enforceable unless it is subjected to continuous official scrutiny and to continuous coercion. The regulating agency must acquaint the regulated with the regulations, but must also convince the regulated of the necessity of the regulations. The research center serves to accentuate the differences and the problems that exist between the FDA and the research community, but is not unique in and of itself.