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REGLAN HAS EXCLUSIVE INDICATION FOR GASTRO REFLUX, ROBINS TELLS STATE MEDICAID ADMINISTRATORS; COMPANY RAISES LIABILITY ISSUE FOR PHARMACISTS

Executive Summary

Metoclopramide Rxs for symptomatic relief of gastroesophageal reflux disease should be filled with Robins' brand, Reglan, the company reminded state Medicaid administrators and drug program directors in a recent letter. Robins pointed out that Reglan has an exclusive indication for that use under the market exclusivity provision of the Waxman/Hatch Act. "This exclusivity does not expire until late in 1986," Robins told the Medicaid officials. The first generic versions of metoclopramide were approved in late July and carry indications for relief of symptoms associated with acute and recurrent diabetic gastric stasis. Robins pointed out in its letter to Medicaid officials that the diabetic indication represents a small portion of the drug's use. "According to independent market research data," Robins said, "this indication constitutes less than 5% of all Rxs written for metoclopramide by brand and generic name." The pharmacist liability issue was also raised by Robins in relation to substitution of a generic for an exclusive brandname indication. "Another important question," Robins wrote, "is whether the pharmacist's liability insurance will provide coverage if a prescription is written for Reglan to treat an excluvie indication for symptomatic gastroesophageal reflux disease." The liability issue with exclusive indications has been raised previously. In California a mini-debate raged between Pharmacists Planning Service, Inc. and the California Pharmacists Assn. over pharmacist liability for the substitution of generic propranolol for Inderal for the prevention of myocardial reinfarction. PPSI warned pharmacists of a potential liability problem, but the state assn. president rejected that concern ("The Pink Sheet" Sept. 30, T&G-5). House Health Subcmte. Chairman Waxman (D-Calif.) recently stated that pharmacists are not in jeopardy for dispensing a generic for patients with an Rx for Inderal. "The generic versions are therapeutically equivalent for all of Inderal's indications and will be so labeled beginning Sept. 24, 1986, without any change in the current generic products." Waxman further noted: "Under California law, since the reason for the different labels has nothing to do with bioequivalence, you have followed the law as I understand it. Therefore, I do not understand how your insurance coverage could be affected." Waxman has indicated, however, that the exclusive indication situation needs clarification.
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