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Executive Summary

SANDOZ CONSIDERING CLOZARIL PILOT MONITORING PROJECTS to allow entities other than Baxter subsidiary Caremark to take on the monitoring of blood levels of patients receiving the antischizophrenia drug (clozepine). Sandoz VP-Operations Dennis Grady indicated that the company may be willing to move away from its exclusive relationship with Caremark during testimony at June 28 hearing before the House Veterans Affairs/Hospitals and Health Care Subcommittee. Sandoz has "an exclusive contract at this point" with Caremark, Grady said. However, "we are have potential pilot projects based on levels of monitoring, and we have discussed this with the V-A and we have discussed it with other health care providers. Liability concerns, Grady said, have led Sandoz to reject proposals by the Veterans Affairs Department and other health care entities to conduct the required monitoring of blood levels in Clozaril patients. "On paper many other organizations have the potential for a workable [monitoring] system, but Sandoz maintains the responsibility for the accuracy and quality of those systems," he said. FDA-approved drug labeling requires that white blood cell counts be checked each week before Clozaril is dispensed in weekly supplies to be sure patients do not develop potentially fatal agranulocytosis. FDA does not restrict Sandoz to using Caremark or any single, nationwide provider of monitoring services for Clozaril administration. However, Grady testified that Sandoz searched for such a system to cover its liability in instances where a patient travels across the country. "We looked at other potential providers of health care who were unable or unwilling to make the type of investment necessary to develop a national system," Grady said. Although Caremark is a large organization, it "had to hire 300 people and open 30-some offices to make this system work." FDA Neuropharmacological Drugs Division Director Paul Leber, MD, explained that, although the agency requires Sandoz as a condition of product approval to provide for regular blood monitoring with administration, it did not require the company to enter into an exclusive, nationwide contract for the required monitoring services. Sandoz can choose "to distribute the drug through any vendor they want that accomplishes" the blood monitoring requirements of the labeling, Leber said. The company did "not have to have a single vendor" to be responsible for nationwide monitoring under an exclusive contract. Rep. Rowland (D-Ga.), the subcommittee's acting chairman for the hearing, urged Sandoz and FDA to consider a proposal from the V-A. rowland, a physician, asked that "Sandoz and FDA look at what the V-A proposes to see whether or not that is acceptable under the requirements" for patient monitoring outlined in the antischizophrenia drug's labeling. APhA Executive VP John Gans maintained the V-A proposal is superior to the Caremark system in terms of the extent of monitoring. The Caremark program, Gans said, is limited to white cell counts for agranulocytosis. The V-A proposes to monitor Clozaril patients for all adverse drug reactions. In a June 28 press statement, Sen. Pryor (D-Ark.) derided the company's distribution system as a ploy designed for profits. Referring to the Clozaril Patient Management System (CPMS) as the "Corporate Profit Maximization Scheme," Pryor said he objected not to patient monitoring, but to "our government having to pay for a system which is markedly overpriced, outside the normal channels of patient care, and monopolistic." The senator's Medicaid drug price discount bill (S 2605) includes a provision to exempt hospitals receiving Medicaid funds from having to pay Caremark for Clozaril monitoring services. Pryor was scheduled to testify at the House hearing but cancelled.

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