The tranylcypromine (Parnate) sulfate incident of 1964 has helped to crystallize several divisions of responsibility for drug safety among manufacturers, the Food and Drug Administration, and practicing physicians. Whereas recent literature and news reports have been devoted primarily to duties of and relationships between drug firms and the government, the purpose of this communication is to identify some of the more significant impacts these duties and relationships will have on the medical profession.
The FDA now possesses broad powers to decide new drug marketability by evaluating both safety and efficacy. New drug applications can be rejected not only in the absence of sufficient evidence to establish safety, but also if substantial evidence is lacking to support represented drug effects under conditions of use recommended in proposed labelings.1 This permits the FDA to balance risks against benefits to determine whether or not a new drug will be made available for
Mills DH. Physician Responsibility for Drug Prescription. JAMA. 1965;192(6):460–463. doi:10.1001/jama.1965.03080190026007
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