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AAFP ADOPTS RESOLUTION OPPOSING "BLANKET" GENERIC SUBSTITUTION; GPIA CRITICIZES POLICY AS "SERIOUSLY FLAWED" AND A REVERSAL OF LAST YEAR's POSITION

Executive Summary

The American Academy of Family Physicians adopted a resolution opposing "blanket" generic substitution in certain "critical" drug categories at the group's Sept. 16-21 annual meeting in Los Angeles. The committee report designates critical drugs, critical diseases, and critical patients "in which there should never be mandatory substitution of a generic drug." The official policy was recommended in a report by AAFP's Drugs and Devices Committee and adopted by academy delegates Sept. 18. The physicians academy said it is concerned "that there is no way of knowing that our patients' medication has been 'switched' from the brandname to a generic or from one generic to another or from a generic to the brandname product." Consequently, AAFP said, the physician is "not . . . in control of the patient's treatment program." The academy designated patients aged 75 years or older or "females living alone with multiple pathology on multiple drug regimens" as "critical." Diseases that are "difficult to stabilize and those for which concurrent therapy can be a destabilizing factor" were designated as "critical" by the academy. Critical drugs include antipsychotics and loop diuretics, such as furosemide. Lasix-manufacturer Hoechst-Roussel contracted for a national public relations firm to publicize and distribute the committee report and arrange interviews for reporters with Philadelphia's Pennsylvania Hospital cardiologist Jacob Zatuchni, MD, about congestive heart failure. Lasix labeling was enclosed with copies of the committee report. In a Sept. 12 response to the academy vote, the Generic Pharmaceutical Industry Association contended that "both the methodology and substance of the report is seriously flawed, resulting in conclusions which over many years have been refuted, rejected and discredited by responsible scientific bodies." The white paper was based on a two-year literature search, but the search ignored FDA's Bioequivalence Task Force Report, GPIA said. Last year, AAFP's Drugs and Devices Committee examined the report "and concluded that 'drugs approved by the FDA as generically equivalent . . . are as safe and effective as their brandname counterparts.'" Furthermore, GPIA continued, "many citations in the committee's 1989 report refer to clinical studies that have demonstrated the therapeutic equivalence or interchangeability of brand and generic products; other citations have been refuted in subsequent literature, without AAFP notice of the refutation; many are editorial opinions or anecdotal reports of single practitioners; some are foreign studies of foreign products not marketed in the U.S.; and others are in other ways not relevant to the therapeutic equivalence of brand and generic drugs." Not only is the policy based on an incomplete literature search, the association charged, but the studies cited were probably not read by the committee. "In many instances, the articles cited refute directly the committee's opinions and recommendations, making it highly likely that the committee failed to read the literature cited." GPIA further suggested that the AAFP policy is based on "recycled" negative advertising sponsored by the brandname drug industry. "The text of the report simply restates the discredited arguments against generic drugs that brandname companies periodically recycle in their promotional campaigns to prevent competition and the lowering of prescription drug prices," the generic drug makers maintained.

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