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During the last several years there has been continued pressure from consumers, legislators, and health administrators to mandate generic prescribing. It has been proposed that requiring physicians to prescribe by generic rather than brand name and allowing pharmacists to substitute generically equivalent drug products would save consumers millions of dollars. These assumptions and the following events have stimulated the American Academy of Pediatrics to bring this issue to the attention of its membership.
(1) The report of the Office of Technology Assessment, Drug Bioequivalence Study Panel, entitled "Drug Bioequivalence," concluded that current standards and regulatory practices do not ensure bioequivalence for drug products, although most of the analytical methodology and experimental procedures for the conduct of bioavailability studies in man are available.1 Additional work may be required to develop the means of applying them to certain drugs and to special situations of drug use.
(2) The Drug Research Board of the National Academy of Sciences (October 25, 1974) recommended that the physician "should be required to delegate to the pharmacist, or explicitly to retain to himself, selection of the particular drug product to be dispensed."2
(3) The Maximum Allowable Cost Proposal published in the Federal Register (November 15, 1974)3 would establish a system to fix a "maximum allowable cost" for reimbursement for drugs dispensed under health financing and service programs of the Department of Health, Education, and Welfare which have multiple sources and are deemed bioequivalent. Other provisions of this proposal call for a fixed dispensing fee and supplying comparative price information to physicians and pharmacists.
The following policy statement is a revision:
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