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ANNOUNCEMENT
FDA Overturns Decision Regarding Unapproved Opioids
Dear All APF members,
FDA Briefing on Unapproved Opioids was held on April 9, 2009.
An emergency stakeholder briefing was convened via conference call by the FDA to address concerns that have been raised by the pain and palliative care communities regarding warnings to nine companies to stop manufacturing and distributing 14 opioid analgesics within 60 days. APF participated in this briefing. A replay of the briefing will be available until April 15, 2009 at 11:59 PM EDT. To hear the replay, callers can dial 1-866-419-2678.
Douglas Throckmorton, M.D., Deputy Director, Center for Drug Evaluation and Research stated that the FDA understands that patients dealing with terminal illness have unique needs that should have been taken into consideration. The FDA reported that they are taking immediate corrective action regarding the availability of the 20mg/ml morphine sulfate solution. They regretted that they failed to include representatives from hospice and palliative care organizations in deliberations over this particular issue and will improve their consultation process with key stakeholders in the future.
The FDA commented that they were not aware of the extent of disruption in patient care because of their ruling or that a critical shortage of some of these medications already exists. We would like to acknowledge them for their swift action in this case as they became aware of the impact this disruption was having on the community. In order to help remedy this; they would like to hear from providers if there are critical shortages in medications to help manage patients optimally.
Action:
The FDA has asked to be notified of drug shortages in your area as they arise. Contact FDA by emailing this information to drugshortages@fda.hhs.gov. All correspondence should include your professional information, name of the drug, your location, name of wholesaler (if available) and identify yourself as an APF member.
To stay informed of drug shortages, visit the FDA website at: http://www.fda.gov/cder/drug/shortages/
Our voices can make a difference.
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Sincerely,
American Pain Foundation
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