The Food and Drug Administration is authorized by Congress to regulate how manufacturers promote a product, but not how a physician prescribes it. The medicolegal viewpoint is that it is only necessary to establish if a given practice meets the standard of care for the community.
These precepts provide maximum flexibility for the clinician to prescribe effective and safe medications without approval from the FDA. Of course, this freedom should be based on evidence published in scientific peer-review journals documenting the validity of such prescribing patterns. Hence, the establishment of sound standards of care is fundamentally related to and dependent on data obtained from carefully designed clinical trials.
The admirable flexibility provided by these regulations can be exploited by naive or avaricious segments of the medical community. We have observed the tragic consequences of the misuse of freedom of choice as witness recent episodes of therapeutic fads, ie, laetrile, bizarre
Soffer A. Chelation Clinics: An Abuse of the Physician's Freedom of Choice. Arch Intern Med. 1984;144(9):1741–1742. doi:10.1001/archinte.1984.00350210053004
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