Oct. 29, 2021
Posted by Rohan Narayanan
The National Organization for Rare Disorders (NORD), the leading independent nonprofit organization representing the 30 million Americans with rare diseases, issued the following statement in response to newly introduced draft of the Build Back Better Act (H.R. 5376):
Peter Saltonstall, CEO and President of NORD, stated: “As negotiations continue on the Build Back Better Act, NORD urges Congress to remove this harmful provision which would gut a key incentive from the 1983 Orphan Drug Act. Attacking the Orphan Drug Tax Credit (ODTC) will result in fewer cures for the 30 million U.S. rare disease patients, the majority of whom do not have access to an FDA-approved treatment.”
“Section 138141 of the Build Back Better Act would dramatically curtail the Orphan Drug Tax Credit for qualified clinical testing expenses by removing this 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. Each time a new orphan use of a drug is added to the label of a drug, more rare disease patients receive assurance that the drug is safe and effective for them. The importance of FDA approval for rare disease patients cannot be understated.
“The ODTC can help to offset the cost of developing and testing orphan therapies as they move through the clinical trial process. This longstanding incentive is particularly important for the many smaller companies focused exclusively on rare diseases.
The ODTC was already diminished in 2017 in the Tax Cut and Jobs Act when Congress reduced the total amount of the tax credit for qualifying clinical testing expenses from 50% to 25%. Given the significant time it takes to conduct clinical trials, the full impact of the changes made by the 2017 law are still unknown. To further reduce availability of the tax credit will hurt rare disease patients and hinder their ability to access treatments found to be safe and effective to treat their specific condition.”
About the National Organization for Rare Disorders (NORD)
The National Organization for Rare Disorders (NORD) is the leading independent advocacy organization representing all patients and families affected by rare diseases in the United States. NORD began as a small group of patient advocates that formed a coalition to unify and mobilize support to pass the Orphan Drug Act of 1983. Since then, the organization has led the way in voicing the needs of the rare disease community, driving supportive policies, furthering education, advancing medical research, and providing patient and family services for those who need them most. Together with over 300 disease-specific member organizations, more than 15,000 Rare Action Network advocates across all 50 states, and national and global partners, NORD delivers on its mission to improve the lives of those impacted by rare diseases. Visit rarediseases.org.