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BIOAVAILABILITY PROOF SHOULD BE DEMONSTRATED AS CONDITION FOR MD-AUTHORIZED SUBSTITUTION OF PRE-1962 GENERIC DRUGS, AMA RECOMMENDS IN ADOPTED REPORT

Executive Summary

Bioequivalence proof should be a prerequisite before physicians okay substitution of pre-1962 drugs, the American Medical Association (AMA) recommended in a report adopted at its annual meeting of the House of Delegates held June 21-25 in Chicago. The report states that when "multiple refills for chronic diseases are anticipated for drug products approved prior to 1938 or between 1938 and 1962, the physician should avoid substitution unless the products have been proven to be bioequivalent." The resolution adds that "once medication has been prescribed, no further 'generic' substitution [should] be made." The report contains three specific recommendations concerning substitution. The association considered the report as a replacement for previous resolutions considered by the Board of Trustees within the past two years. AMA said that "until the methodology for approval of bioequivalence for all drug products is resolved" the 1987 report will represent the association's position on drug substitution. One of the earlier positions, identified as Resolution 46 and referred to AMA's Board of Trustees at the 1985 Interim Meeting, requests that the association along with the appropriate pharmaceutical associations study and evaluate the pharmacologic equivalence of generics with the brandname products to ensure safe and effective treatment. Resolution 15, a second previous resolution, asks AMA to pursue legislation that would change the FD&C Act to allow proper labeling and classification of generics that are not therapeutically equivalent. The final resolution (78) requests that AMA notify FDA of the risks to patients from the use of generics that have not been tested in compliance with scientific guidelines, and asks that FDA write guidelines for generics incorporating input from practicing physicians. Both Resolutions 15 and 78 were referred to the Board at the 1986 Interim Meeting. AMA declared in the report that doses of any medication should "continue to be titrated for optimum efficacy and safety, especially in patients with chronic disorders who require prolonged therapy or patients in special population groups not expected to respond to a drug in the normal manner." The association decided that any adverse reactions that may be related to drug substitution should be documented. AMA pointed out the availability of the physician reporting form 1639 on the last page of the FDA Bulletin. FDA's 1986 Bioequivalence Conference held last year, in which proposals were made to increase standards for generic drug bioequivalence, was cited by AMA in their drug substitution report. AMA's recommendation against the substitution of pre-1962 drugs which have not proven to be bioequivalent, is similiar to a proposal that the Pharmaceutical Manufacturers Association made at the Bioequivalence Conference. AMA concluded that the means of identifying generics is lacking in comparison with innovator products and that identification may be critical for proper evaluation of unfamiliar patients. AMA adopted a resolution stating that it will work with the appropriate organizations to "develop a coding system for the identification of all solid medication forms." The association also decided that when possible each tablet, capsule or other solid dosage form of a generic prescription drug be imprinted "with its unique code and the name or other distinctive mark identifying the manufacturer." AMA said it will "compile this coding system into a reference and disseminate it to physicians, pharmacists and law enforcement agencies in an appropriate manner." Acknowledging the growing problem of unwanted pregnancies in the U.S., the AMA adopted a resolution concerning contraceptive advertising. The resolution says that AMA "approve[s] the concept of providing accurate and balanced information on the effectiveness, safety and risks/benefits of contraception in all public media." In background material on the resolution, AMA noted that in all forms of educational efforts about contraception it is important to include information about both prescription and OTC methods. AMA added that it wants to emphasize the educational aspects of such information in the resolution, "while remaining consistent with AMA's opposition to prescription drug advertising." AMA also proposed a resolution that the association study the impact of product liability lawsuits on the availability of drugs and other medical therapies, AMA said that "the denial of public access to important drugs and medical devices, like non-steroid containing IUDs and vaccines, for non-medical and liability reasons is an increasing common problem and therefore an important issue for the medical community."
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