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FDA Adopts Interim Plan to Avoid Shortage of Medically Necessary Opioid

April 9, 2009 -- The U.S Food and Drug Administration today amended its March 30, 2009, action warning manufacturers to stop the production and distribution of certain unapproved prescription opioids, to allow the continued marketing and distribution of one particular type of opioid -- a high concentrate morphine sulfate oral solution -- on an interim basis.

The FDA took this action in response to concerns from patients and health care professionals in the palliative care community that the action taken on March 30 would cause a shortage of 20 mg/ml morphine sulfate oral solution. This product is widely used to alleviate pain in terminally-ill patients. The agency has determined that this dosage form is medically necessary, and should remain on the market until an approved alternative becomes available to the patients that need it.

“While the FDA remains committed to ultimately ensuring that all prescription drugs on the market are FDA approved, we have to balance that goal with flexibility and compassion for patients who have few alternatives for the alleviation of their pain,” said Douglas Throckmorton, M.D., deputy director, FDA’s Center for Drug Evaluation and Research. "In light of the concerns raised by these patients and their healthcare providers, we have adjusted our actions with regard to these particular products."

To address the needs of palliative care patients, the FDA will allow companies that are currently manufacturing and distributing versions of this unapproved prescription product to continue to do so on an interim basis until an FDA-approved version of this product or another acceptable alternative therapy becomes available for this patient population.

“The FDA appreciates the help we received from the palliative care community about how this drug is being used today to help patients,” said Theresa Toigo, director, FDA’s Office of Special Health Issues. “We want to continue to talk to them as we move forward on this difficult issue.”

Today’s decision only affects the high concentrate morphine sulfate solution. Companies that received warning letters from the FDA on March 30 concerning other unapproved prescription opioid products will still be required to cease production and distribution of those products within the timeframes set out in those letters. The other products affected by the enforcement action are: immediate release tablets containing morphine sulfate, hydromorphone, and oxycodone.

The March 30 action is part of the FDA’s Unapproved Drugs Initiative, which seeks to ensure that all drugs available on the U.S. market have met FDA’s standards for safety, efficacy, and quality.

For more information about this action:
https://www.fda.gov/cder/drug/unapproved_drugs/morphine_extension.htm

To learn more about the FDA’s initiative against unapproved drugs see the FDA’s Compliance Policy Guide at:
https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074382.htm.

Drug Shortages web page:
https://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

For drug safety information, see:
FDA's Drug Safety Initiative

Information on FDA-approved drugs:
https://www.accessdata.fda.gov/scripts/cder/daf/

Drugs Marketed in the United States That Do Not Have Required FDA Approval:
https://www.fda.gov/cder/drug/unapproved_drugs

Source: Food and Drug Administration

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