60+ Organizations Sign-On to Letter to Protect Orphan Drug Tax Credit for Individuals Living with Autoimmune Disease

On behalf of the estimated 50 million Americans with autoimmune and immune-mediated diseases, the undersigned 64 organizations write to you regarding the importance of the Orphan Drug Tax Credit (ODTC) for people and families living with autoimmune disease and urge you to protect the ODTC in the Build Back Better legislation. 

Autoimmune and immune-mediated diseases are lifetime afflictions – there are currently no cures and they are among the leading causes of disability in this country. Individuals and families living with these diseases depend on many of the medicines that have come to market since the enactment of the 1983 Orphan Drug Act, and the millions living with a rare autoimmune disease who lack an FDA approved medication are depending on the Orphan Drug Tax Credit as a vital tool for future treatment development. 

Since it was enacted the Orphan Drug Act has spurred the approval of 652 drugs for 1,006 rare diseases. It has been a lifeline for millions of individuals with autoimmune diseases who face significant health challenges and often require a unique combination of drugs to diagnose, treat, and manage their symptoms. In the current draft of ODTC in the Build Back Better legislation, only the first approved orphan use of a drug would be available for the tax credit. This limitation would unnecessarily curb critical incentives for companies to invest in orphan drug development, which are vital given over 90% of rare diseases have no FDA approved treatment. 

The U.S. orphan drug development process is particularly significant for individuals living with rare autoimmune diseases as secondary indications have proven to be indispensable in the development of treatment for these individuals. Since 2016, 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. 

The Autoimmune Association and the undersigned organizations deeply appreciate the hard work you have undertaken to address issues of drug affordability for patients. Let’s continue to work together to find solutions and secure tomorrow’s cures today by investing in the promising pipeline that has already delivered so many vital drugs to patients living with autoimmune disease. 

Please contact Brett McReynolds, Autoimmune Association, VP of Policy at brett@autoimmune.org. We look forward to continuing to work together to advance patient-centered policies that address affordability and access. 



Acromegaly Community, Inc 

Advocacy & Awareness for Immune Disorders Association (AAIDA) 

Advocates for Responsible Care 

Alliance for Aging Research 

Alpha-1 Foundation 

American Academy of Allergy, Asthma, & Immunology 

American Behcet’s Disease Association (ABDA) 

American Liver Foundation 

American Partnership for Eosinophilic Disorders 

APS Foundation of America, Inc 

Arizona United Rheumatology Alliance 

Arthritis Foundation 

Autoimmune Association 

Brain Injury Association of America 

California Chronic Care Coaliton 

Caregiver Action Network 

Caring Ambassadors Program 

Chronic Care Policy Alliance 

Chronic Disease Coalition 

Color of Crohn’s and Chronic Illness 

Conquer Myasthenia Gravis 


Cystic Fibrosis Research Institute 


Fabry Support & Information Group 

Foundation for Sarcoidosis Research (FSR) 

Gaucher Community Alliance 

GBS|CIDP Foundation International 

Global Healthy Living Foundation 

Global Liver Institute 

ICAN, International Cancer Advocacy Network 

Immune Deficiency Foundation 

International Foundation for Autoimmune & Autoinflammatory Arthritis (AiArthritis) 

International Pain Foundation 

International Pemphigus Pemphigoid foundation 

Jeffrey Modell Foundation 

Lupus and Allied Diseases Association, Inc. 

MANA, A National Latina Organization 

Men’s Health Network 

Mississippi Arthritis and Rheumatism Society 

MLD Foundation 

Myasthenia Gravis Foundation of America 

National Alopecia Areata Foundation 

Neuropathy Action Foundation 

Nevada Chronic Care Collaborative 

Patient Advocacy Strategies 

Patients Rising Now 

Prevent Blindness 

Project Sleep 

Pulmonary Hypertension Association 

Relapsing Polychondritis Foundation 


Rheumatology Nurses Society 

Scleroderma Foundation 

Sjogren’s Foundation 

Solve ME/CFS Initiative 

SYNGAP1 Foundation 

Texas Rheumatology Care 

The National Adrenal Diseases Foundation (NADF) 

The Sumaira Foundation 

US Hereditary Angiodema Association 

Vasculitis Foundation 

Wisconsin Rheumatology Association