April 10, 2009
FDA Reverses Marketing Ban On Unapproved Morphine
Oh Thursday, the Food and Drug Administration reversed its initial plan to remove unapproved liquid morphine from being sold in the US.
On March 30, the FDA decided to disallow the marketing of 14 medications, including morphine elixir, which has long been used to relieve pain in patients that are near-death.
Nine companies were informed not to market the 14 unapproved narcotic pain medicines within 60 days of notification. Seven of those companies make or distribute the liquid morphine, according to Reuters.
But On Thursday, the FDA reversed its decision in a new set of letters to the companies telling them that they could continue to market liquid morphine on "an interim basis."
"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," he said in a statement.
Last week, the agency warned that unapproved drugs may not be safe, but supporters of the highly concentrated liquid morphine, such as Dr. Diane Meier, director of the Center to Advance Palliative Care at the Mount Sinai School of Medicine in New York, argue that an estimated 2 million Americans rely on the drug each year.
Dr. Meier told the Associated Press that the FDA's reversal made her "hopeful about our government."
"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."
"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 agency said in a statement.
On the Net:
- FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml
- FDA Drug Safety Initiative
- Drugs Marketed in the United States That Do Not Have Required FDA Approval