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Executive Summary

ONE-LINE Rx FORM LEGISLATION PASSES NEW YORK STATE ASSEMBLY April 29, and has been forwarded to the state senate. Sponsored by Assemblyman Alexander Grannis, the legislation provides that Rx forms contain a single line for the prescribing MD's signature and that generic substitution is allowed unless the MD specifies "DAW" (dispense as written) on the form. Under current state law, Rx forms contain two signature lines; the MD must sign on the left one to indicate that the brandname must be dispensed or on the right to permit substitution. The proposal, which is expected to facilitate generic substitution in New York, is part of a broad pharmaceutical assistance for the elderly legislative package. Assembly debate on the legislation sparked correspondence between the bill's sponsor and U.S. Rep. Waxman (D-Calif.) regarding the merits of the FDA approval process for post-1962 generic drugs under the patent/ANDA bill. In an April 8 letter to Waxman, Assemblyman Grannis maintained that representatives of the Pharmaceutical Mfrs. Assn. (PMA) and several brandname drug mfrs. lobbied against the state bill by questioning the therapeutic equivalence of generics. Waxman replied on April 25: "I was quite surprised to learn that representatives of the PMA and some pharmaceutical companies are arguing that generic drugs approved under the act by FDA are in any way unsafe, ineffective, or not therapeutically equivalent." Noting that negotiations, which lasted eight months, gained support for the bill from PMA, FDA, generic drug mfrs., consumer and elderly organizations, and labor unions; Waxman continued: "If representatives of the PMA or major brandname drug companies are now claiming that the quality, safety, or therapeutic equivalence of generic drugs is doubtful, they are directly contradicting their position of seven months ago and they are wrong." Waxman said he views "with skepticism any complaint by the PMA or its member companies that our generic drug approval system is unsound or jeopardizes consumer safety." Brandname drug mfrs. "have an economic interest in dissuading consumers from using generic durgs," he pointed out, adding: "I am confident that the Congress and the President did not fail the American public."

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