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Cole Werble is the former owner and editorial director of FDC Reports, Inc., the publisher of The Pink Sheet, The Gray Sheet, and other leading news publications for the health care industry. He has more than 35 years of experience analyzing business critical developments affecting the biopharma sector and developing world class information products for the sector.
Search for solutions to chronic drug shortages may require policymakers to push for payment policies that run counter to the current drug pricing themes, like retrofitting US Medicare’s New Technology Add-On Payments to apply to old, off-patent therapies.
X-Linked Hypophosphatemia patient feedback meeting follows recent approval of Ultragenyx’ Crysvita. Like an SMA meeting in 2017, it showed how post-approval meetings can help sustain momentum in a new class.
Chronic problem with drug shortages is driving the Cleveland Clinic to consider registering as a 503B “outsourcing” facility. That could be a milestone in FDA’s efforts to encourage the model for high volume compounders.