Drug Combinations:  A Critique of Proposed New Federal Regulations

F. Gilbert McMahon, MD
JAMA. 1971;216(6):1008-1010. doi:10.1001/jama.1971.03180320052010.
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The Federal Register of Feb 18, 1971, contained the new Food and Drug Administration (FDA) policy statement on fixed drug combinations. Physicians were solicited for comments within 30 days. The principal effect of the proposed new regulations is to threaten removal from the market of hundreds of prescription drug combinations and most of the socalled over-the-counter (OTC) drugs, ie, nonprescription drugs. Unless each active ingredient can be shown to enhance drug efficacy or diminish side effects, the combination will be removed. Whether one agrees with the proposed regulations or not, the removal of these drugs will have a profound effect on American medicine as now practiced.

There are some obviously irrational combination drugs still on the market, such as Ritonic (containing androgen, estrogen, vitamins, minerals, and methylphenidate hydrochloride), which simply represent bad medicine. The avaricious marketing of such nostrums in the 1960's has helped create the present problem for the


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