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Executive Summary

ROBINS REGLAN REFLUX INDICATION EXCLUSIVITY IS FOR LABELING and promotion only, under terms of the Drug Price Competition and Patent Term Restoration Act, Robins acknowledged in a Feb. 7 letter to state Medicaid Drug Program Administrators. "The new act prohibits generic mfrs. from labeling or promoting their product for a two-year period for an exclusive indication. It does not address the substitution of a therapeutically equivalent generic product lacking this exclusive indication," Robins stated. Only Robins'Reglan brand of metoclopramide has in its product labeling an indication for treatment of gastroesophageal reflux disease (GERD). The letter is Robins' response to an FDA request that the company amend its Sept. 17 correspondence to 50 Medicaid administrators around the country. Robins' earlier letter implied that under Waxman/Hatch, prescriptions written for Reglan or metoclopramide should be filled only with Reglan for the treatment of symptomatic gastroesophageal reflux disease. In the Sept. 17 letter, Robins asserted that Congress passed the Waxman/Hatch law to provide "that generic copies be limited, for a reasonable period of time, from certain indications." Robins suggested that pharmacists restrict filling methoclopramide with generics, since the only generic indication, for diabetic gastroparesis, "according to market research data . . . constitutes less than 5% of all prescriptions written for metoclopramide by brand and generic name." Robins pointed out that its exclusivity for gastroesophageal reflex labeling does not expire until 1986. Robins explained in the Feb. 7 correspondence that it was attempting "to clarify certain statements made in our September 1985 letter . . . [and] to avoid possible misinterpretation" of the Waxman/Hatch law. In addition, the Feb. 7 letter addressed the pharmacist liability issue raised in the earlier letter. "Substitution is governed primarily by state laws on pharmacists' dispensing practices," Robins explained. "The specific issue of pharmacist liability for substituting a generic drug product for an exclusive indication has not been addressed by the courts." In the September correspondence, Robins had questioned "whether the pharmacist's liability insurance will provide coverage" for generic substitution "if a prescription is written for Reglan to treat an exclusive indication."

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