ROBINS REGLAN REFLUX INDICATION EXCLUSIVITY IS FOR LABELING
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."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth