BAXTER DISCONTINUES DISTRIBUTION OF RECOMPOUNDED CANCER DRUGS to hospitals until the regulatory status of the products is resolved, the company informed its customers in a March 2 letter. Baxter said it will continue to distribute the recompounded products to home care and physician's offices, since those markets are regulated at the state level, and not by FDA. "As you know, we have been in continuing discussions with the FDA concerning the regulatory status of these chemotherapy products," Baxter told its hospital customers. "At this time, we have decided to voluntarily withdraw our chemotherapy products repackaged in the Regional Compounding facilities until our regulatory issues are resolved." Baxter said it met with FDA during the first week of March to discuss the discontinuation of Baxter's distribution of the ani-cancer products to hospitals. The move to discontinue distribution of the reconstituted chemotherapeutics follows almost three years of discussions between the firm and FDA over the new drug status of the drugs. The company is still in litigation with FDA over the new drug status of 15 reconstituted products that were seized in May 1987 ("The Pink Sheet" June 1, T&G-6). FDA has continued to maintain that the reconstituted products require approved ANDAs for continued marketing. However, several reconstituted agents marketed by Baxter are still patent protected, including Bristol's Platinol and Adria's Adriamycin. Baxter recently signed an agreement with Erbamont for the distribution rights to reconstututed Adriamycin (doxirubicin) ("The Pink Sheet" Feb. 22, T&G-4). Baxter suffered another setback in getting its reconstituted products approved when FDA told the company that it could not file and ANDA for doxirubicin, but should seek approval through the antibiotic monograph ("The Pink Sheet" March 7, "In Brief"). The firm said it expects to file an antibiotic application for the product "in the next few weeks." The firm is in discussions with Erbamont and other companies to obtain approvals for other reconstituted cancer drugs. Baxter's reconstituted chemotherapeutic program includes: Bristol-Myers' Platinol (cisplatin), Blenoxane (bleomycin), and Mutamycin (mitomycin); and cyclophosphamide, fluorourcil, methotrexate, and vincristine, which are available from generic manufacturers. Baxter has reportedly been in negotiations with Bristol-Myers for the rights to market cisplatin in a reconstituted form. According to the letter, Baxter will continue to accept hospital orders for the reconstituted cancer products until March 24. The final date for shipments is March 31.
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