Update: FDA Press Briefing Opioid REMS
** CREDENTIALED MEDIA ONLY **
A briefing for reporters at the conclusion of the joint meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees discussing the FDA's proposal for reducing inappropriate prescribing, addiction and death related to extended-release and long-acting opioid drugs.
--Douglas C. Throckmorton, M.D., deputy director for regulatory programs, CDER
--John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research (CDER), FDA
--Jane Axelrad, J.D., director, Office for Regulatory Policy, CDER
--Gerald Dal Pan, M.D., M.P.S., director, Office of Surveillance and Epidemiology, CDER
--Bob Rappaport, M.D., director, Division of Anesthesia and Analgesia Products, CDER
---Mary Willy, Pharm. D., director of risk management, CDER
--Jeffrey R. Kirsch, M.D., chairman, Anesthetic and Life Support Drugs Advisory Committee
Friday, July 23, 2010, 4:00 p.m. EDT (or immediately following the conclusion of the meeting)
Room 1101, Marriott Inn and Conference Center, University of Maryland
University College, 3501 University Blvd. East, Adelphi, Md.
Reporters in the United States can participate by calling 888-324-7178. International callers will need to dial 517-308-9353. The passcode is "FDA."
A replay of the briefing will be available approximately one hour after the event ends until August 23, 2010, at Midnight, EDT. To hear the replay, callers in the United States can dial 888-568-0160. International callers can dial 203-369-3903. The passcode is 5495.
The need for adequate pain control is an element of good medical practice. In this context, some persons suffering from pain need access to potent opioid drug products; however, inappropriate prescribing, addiction and death due to prescription opioid abuse and misuse have been increasing over the last decade.
At the joint meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees, the FDA will solicit feedback about the agency's proposal for a class-wide Risk Evaluation and Mitigation Strategy or REMS for extended-release and long-acting opioid drugs. The REMS is aimed at reducing misuse and abuse of these drugs.
For background information, visit: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/ucm217507.htm
CONTACT: Shelly Burgess, of the U.S. Food and Drug Administration, +1-301-796-4651, firstname.lastname@example.org
/PRNewswire-USNewswire -- July 23/
SOURCE U.S. Food and Drug Administration
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