Abstract
FDA’s March 30 decision to force from the market unapproved versions of morphine sulfate, including concentrated liquid formulations widely used to ease the suffering of hospice patients, sparked a fast reversal and a pledge from FDA to do better research before undertaking such actions in the future. Douglas Throckmorton, deputy director of FDA’s Center for Drug Evaluation and Research, told attendees of the National Hospice and Palliative Care Organization’s Management and Leadership Conference on April 23 that the agency “had missed a very appropriate need for these products.” “We missed the uses of these concentrated morphine sulfate solutions in palliative and cancer pain treatment. We underestimated the market for these products,” Throckmorton said. FDA, he said, “had not appreciated the move towards home care and away from . . . localized institutionalized care.” “We’re sorry that happened,” said Throckmorton. “That was a mistake. We needed to rectify it.” Throckmorton said FDA is changing its processes to ensure that the agency speaks with appropriate stakeholders and learns about all uses of a product before taking action of the type used against the unapproved opioids.
Published Version
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