Orphan Drug Tax Credit Defense Adds To NORD's Legislative Challenges
Republican tax reform proposal would eliminate research credit; NORD already had its hands full countering 'misinformation' about impact of orphan drugs on drug spend; critics on Capitol Hill argue sponsors are gaming the system.
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Non-profit biotech founder says permanent pediatric rare disease priority review voucher program will boost incentive, but FDA is concerned about resource drain vouchers cause.
Is the lower sale price making the opportunity for a priority review voucher less an incentive for orphan development?
QuintilesIMS Institute study funded by the National Organization for Rare Disorders concludes orphan drugs accounted for only 7.9% of US total drug spending in 2016, bolstering advocacy group's view that rare disease treatments are not responsible for rising healthcare costs. US FDA analysis finds most orphan drugs do not expand their labeled indications into non-rare disease settings.