196802
Generic Versus Proprietary Drugs
POSITION STATEMENT
Approved by the Council, February 1968
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"Policy documents are approved by the APA Assembly and Board of Trustees… These are …position statements that define APA official policy on specific subjects…" -- APA Operations Manual. |
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The profession of psychiatry at this time is less directly concerned with the problems of generic versus proprietary drugs than are other branches of medicine. Within the next few years, however, when patents for many of the major drugs used by psychiatrists expire, they will be as much concerned as other physicians. In any case the social implications of the problem make it appropriate now for the American Psychiatric Association to present a considered view of the matter.
The objective of proposed legislation governing generic versus proprietary drugs is to offer the consumer an adequate product without excessive cost. It has been charged that manufacturers of proprietary drugs sometimes acquire what appear to be unreasonable profits from high charges for the drugs they market.
The proposed legislative remedy, however, providing for sudden transition from proprietary to generic products, oversimplifies a problem which is in fact complex.
To begin with, the same chemicals compounded in different vehicles may differ significantly in therapeutic potency. If generic drugs were to be substituted for drugs, it would first be necessary to ensure that the generic products of different manufacturers were uniform and equal in therapeutic potency to proprietary product. To achieve this, the enabling legislation would need to establish procedures designed to assess the therapeutic potency of the finished products and to guarantee that both proprietary and generic drugs met prescribed standards before being administered to a patient. Similarly, how to ensure quality control based on intermittent sampling of all dosage forms, criteria for shelf-life stability, penalties for failure to maintain controls, and related considerations would have to be spelled out. The establishment of such safeguards might prove extremely difficult to legislate and also extremely expensive--so expensive, in fact, that it could eliminate some small drug manufacturers who ould not compete with larger ones in underwriting the cost.
In sum, the American Psychiatric Association believes that the problem does not lend tself to solution by a simple and arbitrary transition from proprietary to generic drugs.