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Executive Summary

POST-1962 GENERICS DEMONSTRATING "SAMENESS" TO ORIGINAL BRANDED DRUGS should not be required to undergo carcinogenicity and teratology studies for approval, the Barrows Research Group maintained in an Aug. 3 citizen's petition to FDA. "It is unscientific for the FDA to believe that the same drug entity produced by another synthesizer, or the same synthesizer, would have a different toxicological effect," Barrows maintains. "If in fact the agency questions the validity of the original data filed by the approved NDA holder then they should remove the innovator's product from the market," Joseph Barrows stated. "On the other hand, if they permit the original NDA holder to continue to market the drug, evidence to show the sameness of the chemical entity should suffice to permit competitive forces to enter the marketplace once the patent has expired." Barrows maintained that with the sophisticated methodology available today to demonstrate chemical equivalency, "the sameness of the chemical entity can be definitely established in the same manner that the compendial cmte. sanctions and makes available a reference standard." The most prominent example of the agency's current policy of requiring some generics to undergo carcinogenicity testing when the innovator's studies are not in the public domain is Inderal (propranolol). However, the issue is likely to become moot should the ANDA/patent legislation become law. In addition, Borrows contended that the cost of carcinogenicity and teratogenicity studies in two species was much lower at time that most original NDAs now off patent were submitted since GLP regs were not yet in effect and FDA surveillance of animal studies "was sadly lacking." The petition notes that "lifetime carcinogenicity studies and teratology tests in two species would cost today approximately $2 mil. combined." In support of his argument, Barrows pointed out that since Oct. 10, 1962, FDA has reviewed over 3,000 ANDAs for pre-1962 drugs without toxicological study data. Barrows maintained that there "has been no [instance] where the generic drug dosage form was found to cause carcinogenic or teratogenic effects at variance to the innovator's dosage form of the same chemical entity."

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