The Orphan Drug Tax Credit has assisted in the creation of an increased number of orphan drug treatments since its inception in 1983 but definitely over the past few years. Some say the pace of annual novel orphan approvals has doubled since 2011 and no one can argue that new orphan drug indication approvals have greatly increased beginning in 2013. The FDA reports 14 treatments received CY Orphan Designated NDA Approvals in 2016. And there is an estimated $2.8 billion in orphan drug tax credits expected in 2018. I think the response to Congress from the 200 nonpartisan patient groups signals the continuation of a high stakes, juicy debate between the government and the pharmaceutical industry.
Today, more than 200 nonpartisan patient groups sent a letter to Congress urging policymakers to not repeal the Orphan Drug Tax Credit in the Tax Cuts and Jobs Act. The proposed change to repeal the Orphan Drug Tax Credit would result in one-third fewer new treatments for rare diseases going forward