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Executive Summary

Burroughs Wellcome will begin shipping Retrovir (AZT, zidovudine) to pharmacists in "two-to-three weeks," the company said. The first shipments will be in response to orders from pharmacists under the firm's unique distribution system for Retrovir. Under the Retrovir distribution system, physicians must "submit an enrollment application to the Retrovir Center [located in Washington, D.C.] for each new patient who is a candidate for the drug," Burroughs Wellcome explained in a March 23 release. The firm said it has already received telephone requests for patient enrollment forms and hopes to ship Retrovir for those patients in the next two or three weeks. The company will be mailing patient enrollment forms and information packets describing the Retrovir distribution system to physicians over the next few weeks. Burroughs Wellcome said it will ship Retrovir directly to pharmacies until supplies of the drug are adequate to meet demand. "During the period of limited supply, Burroughs Wellcome will drop-ship Retrovir to hospitals, pharmacies and government accounts and bill through the wholesaler," Burroughs Wellcome said. The company noted that "for the initial four months, wholesalers will be offered extended dating." Patient enrollment forms "will be reviewed by [a panel of] medical specialists" to ensure that patients are qualified to receive the drug under the labeled indications, i.e., AIDS and advanced ARC patients who have had pneumocystis carinii or who have a T4 lymphocyte count less than 200/mm, Burroughs Wellcome said. "The Retrovir Center will inform physicians within one week if the patient meets the enrollment criteria and sufficient drug is available." If the patient is enrolled, the company will assign the patient an enrollment number that the physician will use in writing a prescription. Patients then take the prescriptions to a pharmacist who calls in an order for a one month supply of Retrovir. Burroughs Wellcome noted that the sales department must verify the patient enrollment number and physician name during the order process. Burroughs Wellcome has explained its distribution system as a way to control who receives the drug while supplies are limited. Once the company has enough drug to meet demand, "the distribution network will dissolve into more traditional drug distribution channels," Burroughs Wellcome said. The company first proposed a restrictive distribution system for Retrovir to FDA's Anti-Infective Drugs Advisory Committee at a Jan. 16 meeting. The committee had expressed concern that approval of Retrovir might lead to its use in patients who had not been shown to benefit from the drug, particularly in certain ARC patients in whom the benefits might not outweigh the risks ("The Pink Sheet" Jan. 19, p. 11). Burroughs Wellcome told the committee that its proposed distribution system would cut down on the risks of Retrovir misuse. Chart omitted.

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