Autoimmune Association Leads Sign-On Letter, 64 Patient Groups Ask Congress to Protect Rare Disease Drug Development

December 2021– In a letter sent December 14 to congressional leadership, 64 patient organizations signed on to the Autoimmune Association’s letter asking congress to remove a provision from the currently drafted text of the Build Back Better Act that would dramatically curtail the Orphan Drug Tax Credit for qualified clinical testing expenses by removing a critical incentive for all but the first approved orphan use of a new drug.

Over 90% of rare diseases lack an FDA-approved treatment indicated for the specific rare disease, and since 2016 alone, 23 secondary orphan drug indications have been FDA approved for rare autoimmune diseases. At such a promising time, Congress should be protecting and investing in the future of those without a current FDA approved treatment, rather than removing incentives for the development of future therapies for those who depend on it the most.  Click here to read the full letter.