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FDA Seeks Better Regulation of Painkillers
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Page: << Prev | 1 | 2 Patient advocacy groups and health professionals involved with the treatment of pain and addiction will also be consulted during the development of the new drug protocols, which are officially known as "Risk Evaluation and Mitigation Strategies," or REMS.
This is "our attempt to try and ensure that the benefits of the products outweigh their risks," Jenkins said. To that end, he said, the FDA will try to strike an "appropriate balance" between legitimate patient need for access to such drugs and the very real threat posed by their abuse and intentional or unintentional misuse.
Also speaking at the press conference, Dr. Bob Rappaport, director of the FDA's division of anesthesia, analgesia, and rheumatology products, underscored the agency's growing concern over the inappropriate use of opiates by citing several alarming statistics.
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For example, he noted a just released national survey that found that in 2007, 5.2 million Americans aged 12 or older said they had used prescription pain relievers in the prior month for non-medical purposes.
"So this is an ongoing problem, and it's getting worse," Rappaport said.
More information
To learn more about pain control and pain medications, visit the American Academy of Family Physicians.
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Copyright © 2009 ScoutNews, LLC. All rights reserved.
Last updated 2/9/2009
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SOURCES: Feb. 9, 2009, teleconference with John Jenkins, M.D., director of the Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, and Bob Rappaport, M.D., director of the division of anesthesia, analgesia, and rheumatology products, U.S. Food and Drug Administration
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