70.998 Generic Drug Substitution:
The members of the Medical Society of the State of New York are as interested as any other group of citizens in the State, if not more so, in eliminating unnecessary costs in the delivery of health care and are actively engaged in developing measures that will lead to the most effective use of the dollars expended on health care, provided that none of these measures results in a lowering of the quality of medical care available to and afforded the public. Two measures that could lead to a wider use of generic drugs should be considered:
(1) The first is to conduct controlled, scientifically valid studies to conclusively establish that generic drug substitutes are equivalent in bio-availability and therapeutic equivalence. Disturbing reports have appeared in scientific medical literature that seriously question whether generic drugs approved by the FDA do, in fact, satisfy these criteria. In the face of such doubts, it is understandable that physicians will be reluctant to authorize drug substitutes for medications with which they are familiar by experience. The necessary studies do entail expenditure of money and delays, but these are small prices to pay when one is primarily concerned with providing the very best available drug to an ill patient.
(2) A second major deterrent to physicians readily agreeing to generic drug substitution is the question of their liability if a substitute, of which they have insufficient knowledge and no control in choice, should prove to be ineffective for the purpose intended and the patient suffers thereby. Our Society has had correspondence with both the State and Federal governments to determine the limitations of a physician’s liability and the responses have been equivocal. It is our interpretation, as the Law now stands, that the physician may still be liable. An unequivocal statement of acceptance, of complete liability, by either the Federal or State government, in the event of untoward effects developing solely from the use of a generic drug substitute such as was promulgated for the swine flu immunization program, would remove this anxiety from the physician’s mind and encourage wider use of generic substitution.
There is a basic principle to be stressed in the consideration of this subject, namely, that no law should curb the professional judgment of a physician in the treatment of his patient. Years of intensive schooling and training mark the education of a physician and his licensure. It is such training that establishes the physician as the one best able to determine the most effective means of therapy for the individual problems of a particular patient. It is most earnestly hoped that no inadequate substitute for this professional judgment, based solely on cost, will ever be enacted. (HOD 1983 Reaffirmed HOD 2013)
