Well I guess it all came down to the *potential* of people to abuse the drug once it is sold to a larger population.
A panel of experts voted 20-2 that the Food and Drug Administration should not approve a powerful sedative to treat fibromyalgia, a type of chronic pain. The news is a blow to maker Jazz Pharmaceuticals.
I think this might be a new era in risk-mitigation form the FDA. This REMS is now as important (or in this case much more important) than the efficacy data:
The panel vote is more confirmation of what I wrote this morning (see: The FDA’s New Power): That risk management programs, known as Risk Evaluation and Mitigation Strategies or REMS, are becoming one of the pivotal issues when it comes to the approval of new drugs. These have resulted in delays for Johnson & Johnson, Theravance, and Amgen, and are increasingly the major factor in FDA drug approvals. REMS are one of the most important factors for biotechnology investors to track.
I guess the fear of lawsuits and having to pull the drug off the market is just too great now. Oh well, I guess fibromyalgia sufferers have that much longer to wait for their relief.
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