Merck's US. Managed Distribution Program For The HIV Drug Crixivan
2004 | Case No. BME9
Pharmaceutical company Merck had created the U.S. Managed Distribution Team to handle a unique problem. In March, 1996, the U.S. Food and Drug Administration (FDA) had approved Merck’s new drug application for Crixivan, a novel antiviral drug to fight acquired immunodeficiency syndrome (AIDS). Driven by positive early data from the clinical studies, a tremendous medical need for new human immunodeficiency virus (HIV) treatments, and the demands of AIDS activists to make new medicines available as quickly as possible, the FDA had approved Merck’s application in a record-setting 42 days from submission. Since Merck’s manufacturing facilities would not be ready to produce the drug at capacity for at least six months, a small pilot plant facility would immediately supply Crixivan for an estimated 25,000 to 30,000 patients. Propelled by the need to make Crixivan quickly available, but concerned about ensuring a continuous supply to individual patients so that immune resistance to the drug would not develop as a result of insufficient dosage, the team had grappled with the issue of how to distribute a drug in limited supply. The worst situation would be to start patients on therapy only to discontinue treatment because Merck could not continue to supply the drug. Such a situation was a setup for the emergence of viral resistance, which would markedly exacerbate the AIDS epidemic. After much consideration, the U.S. Managed Distribution Team decided to: (1) abandon traditional distribution channels; (2) manage distribution from one source; and (3) track all patients starting on therapy with Crixivan. The team had gathered to review the progress and success of its plan.
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