Article preview from "The Pink Sheet" DAILY April 21, 2009
The class-wide opioid Risk Evaluation and Mitigation Strategy should include a certification process for prescribers, pharmacists and other heath care providers, a strong patient education component, and prescriber-patient agreements, according to questions posed by FDA in advance of a two-day public meeting set for May 27-28. Read on...
Article preview from "The Pink Sheet" DAILY April 21, 2009
The public meeting is the next step in a process started by FDA in February to forge class labeling for the various marketers and products in the long-acting and extended-release opioid category. The project is a major experiment by FDA in the establishment of REMS requirements addressing multiple products with a new and restrictive post-marketing control system under the new FDA Amendments Act authority.
Since FDA's announcement that it intended to seek the class-wide REMS in February, pharmaceutical companies have been charting new territory as they try to work together to develop a REMS framework for the whole class.
The evolution of the opioid class-wide REMS will set an important precedent for trying to get competitors to work together on post-marketing programs in the future.
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The class-wide opioid Risk Evaluation and Mitigation Strategy should include a certification process for prescribers, pharmacists and other heath care providers, a strong patient education component, and prescriber-patient agreements, according to questions posed by FDA in advance of a two-day public meeting set for May 27-28.
