FDA Reverses On Roxanol.

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Seems the FDA got it wrong on the manufacturers of 20mg/ml morphine. They will evidently not be removed from the market. You have to scroll down a bit on the linked page:

http://www.pallimed.org/

So, is the FDA that disorganized? I wonder since they seem to be on a kick to tighten access to opioid pain meds.

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Specializes in Hospice, Palliative Care, Gero, dementia.

This is the version I just got in my "briefings" from the Journal of Palliative Medicine. It's not a reversal as much as a recognition (after being pushed by the palliative/hospice community) that they can't pull a med that is widely used and leave the situation w/no alternative. So raising a fuss can make a difference!

FDA amends action pertaining to liquid morphine

Responding to concerns about a possible liquid morphine shortage from patients and palliative care health professionals, the U.S. Food and Drug Administration amended its action warning manufacturers to stop producing and distributing unapproved prescription opioids. The agency will allow continued production of a high-concentrate morphine sulfate oral solution, determining that the 20 mg/ml morphine sulfate oral solution, widely used to alleviate pain in terminally ill patients, was medically necessary. It will remain on the market until an FDA-approved version of this product or another acceptable alternative therapy becomes available for this patient population. The change affects only the liquid morphine, not the immediate release tablets containing morphine sulfate, hydromorphone, and oxycodone included in the enforcement action. http://www.fda.gov/bbs/topics/...

When I go to the link you get a little more:

FDA Adopts Interim Plan to Avoid Shortage of Medically Necessary Opioid FDA News

FOR IMMEDIATE RELEASE

April 9, 2009

Media Inquiries:

Rita Chappelle, 301-796-4672

Consumer Inquiries:

888-INFO-FDA

FDA Adopts Interim Plan to Avoid Shortage of Medically Necessary Opioid

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: http://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:

http://www.fda.gov/cder/Guidance/6911fnl.htm.

Drug Shortages web page

http://www.fda.gov/cder/drug/shortages/default.htm

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

Information on FDA-approved drugs: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Drugs Marketed in the United States That Do Not Have Required FDA Approval:

http://www.fda.gov/cder/drug/unapproved_drugs

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Specializes in Hospice, Palliative Care, Gero, dementia.

And reading the OP, I realize I've been very neglectful of my pals over at Pallimed. Christian really pointed out the power of social media and the public voice -- and rngolfer53, I think I saw your post over there too -- good work at plugging AN there :)

The Role of Social Networks in FDA Morphine Reversal

Thanks to all the people who emailed, called, and talked about the FDA's memo on stopping production of highly concentrated liquid morphine and other opioids. The comments came very quickly after the post went up on Pallimed on April 1st. As Drew noted, the FDA reversed the decision. From listening to the teleconference, I thought Dennis Throckmorton and the FDA were immensely conciliatory and apologetic in not discussing the matter with the hospice and palliative medicine community. I imagine there will be many more discussions in the future now that they realize we are here.

It was pretty amazing the FDA reversed their decision in only 9 days. Obviously a lot of it has to do with the efforts of the AAHPM, NHPCO, and the HPNA leaders getting together to present a united front. But behind that is another important story. The role of social networking in getting this message out. It was fax, email, Twitter, Facebook, face to face, phone calls, and blogs. So I put together a slide show to review the order of events from my viewpoint; how I came to find out about the memo, how that message was passed on, how we can learn from this event. (best viewed in full screen)

Pallimed readers were an important part of the leverage of the social network. Could this have happened without Pallimed, Twitter or Facebook? Of course. But an argument could be made for developing more robust and dynamic social networks in our field to help spread the messages important to our field.

Do you have any stories about how you heard or passed on information from the FDA memo reversal?

http://www.pallimed.org/2009/04/role-of-social-networks-in-fda-morphine.html

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And reading the OP, I realize I've been very neglectful of my pals over at Pallimed. Christian really pointed out the power of social media and the public voice -- and rngolfer53, I think I saw your post over there too -- good work at plugging AN there :)

T

I

http://www.pallimed.org/2009/04/role-of-social-networks-in-fda-morphine.html

Yes, that was me, in one of my many DB aliases. I've got more a/k/as than most Mafia hoods. :lol2:

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Specializes in Hospice, Palliative Care, Gero, dementia.
Yes, that was me, in one of my many DB aliases. I've got more a/k/as than most Mafia hoods. :lol2:

a/k/a it may be but I was able to figure it out :smokin:

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