FDA amends unapproved drug action to allow distribution of medically necessary opioid

ROCKVILLE, Md. The Food and Drug Administration has made a slight change of plans in its efforts to halt the production and distribution of unapproved opioid medications, amid concerns that it could lead to shortages of one deemed medically necessary.

The FDA said Friday that it had amended its March 30 action warning nine manufacturers to stop producing and selling the drugs, in order to allow the continued marketing and distribution of high-concentrate morphine sulfate oral solution on an interim basis.

The agency is responding to concerns among patients and healthcare professionals in the palliative care community that the original action could lead to a shortage of morphine sulfate oral solution in the 20 mg per milliliter strength.

“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,” FDA Center for Drug Evaluation and Research deputy director Douglas Throckmorton stated. “In light of the concerns raised by these patients and their healthcare providers, we have adjusted our actions with regard to these particular products.”