Executive Summary

FDA is allowing seven manufacturers and distributors of unapproved high concentration oral morphine sulfate to continue production in an effort to avoid a shortage of the medically necessary opioid. Last month FDA took action against a number of unapproved prescription opioids, asking them to cease their operations. Now the agency is amending this request and will allow 20 mg/mL morphine sulfate oral solution to be produced on an interim basis as a result of concerns from patients and health care professionals in the palliative care community; the agency was swayed by feedback that the discontinuation of the drug would cause a shortage of the opioid that is widely used to alleviate pain in terminally-ill patients. CDER is encouraging drug companies to submit applications for the opioid so it can be approved, noting that it's a "very high-priority product for the agency" and "if a product comes to us, we are going to devote whatever resources we have to make that review efficient, timely and successful.