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"Voluntary Education Does Not Work"

 
• By Cole Werble

A lot of people spent a lot of time at FDA working on a proposal for a class-wide opioid REMS: at least 70 people worked on the project over the past 18 months. When an FDA advisory committee considered the plan, though, a very brief statement by a former committee chair may have helped undo a lot of that work.

At least 70 Food & Drug Administration employees worked on the development of a proposed class-wide REMS for the long-acting opioid class. Two dozen pharmaceutical companies have been working in parallel trying to shape the proposal and provide input to the agency.

After 18 months of internal deliberation, public stakeholder meetings, drafting and redrafting, FDA opted for a relatively soft touch, education focused plan; the two dozen companies exhaled a sigh of...

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