Orphan Drug Pricing Doesn't Drive Healthcare Costs, NORD Argues
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.
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Government price negotiations, financial transparency in the drug supply chain and changes to orphan drug incentives would go a long way toward making drugs more affordable, a National Academies committee says in a new report; dissent authored by two pharma industry veterans warns of 'unintended consequences' if recommendations are implemented.
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.
Commissioner Gottlieb hopes accomplish through guidance a policy change that advocates failed to get included in user fee legislation passed earlier this year.