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The Rare Disease Company Coalition Issues Statement Citing Proposed Changes to Orphan Drug Tax Credit in Build Back Better Act Would Deliver Devastating Blow to Rare Disease Patients and Companies Dedicated to Delivering Innovative Treatments for Them

WASHINGTON – September 14, 2021 – The Rare Disease Company Coalition, a unified voice of life science companies committed to discovering, developing and delivering rare disease treatments, today issued the following statement criticizing the draft legislation to amend the Orphan Drug Tax Credit included in the Build Back Better Act which will be considered in the U.S. House of Representatives Committee on Ways and Means this week. 

“As one of America’s most underserved medical populations with extraordinarily high unmet medical needs, people living with rare diseases simply cannot shoulder the burden of American economic recovery and infrastructure development, and it is disappointing that Congress continues to advance policies that would limit their access to life-changing therapies,” said Taylor Mason, Executive Director of the Rare Disease Company Coalition. “The proposed changes to the Orphan Drug Tax Credit would directly limit the ability for innovator companies to invest in research and development for the nearly 30 million people battling debilitating and potentially fatal rare diseases, of which 93 percent do not have available treatments. The Rare Disease Company Coalition strongly urges Congress to consider the devastating impact of this legislation.”

The 1983 Orphan Drug Act was passed and built upon to help incentivize investment in rare disease research and therapeutic development where there was little research being done and nearly no treatment options for those diagnosed with a rare disease. Over the last several decades, the Act has proven to be a universal success, enabling life science companies to address a growing number of unmet needs for people living with rare diseases that once were untreatable. Since implementation of the Orphan Drug Act in 1983, there have been more than 1,000 FDA approvals for rare disease treatments, with over 25 percent of those approvals occurring in the last three years. The Orphan Drug Tax Credit, already diminished in 2017 under the Tax Cut and Jobs Act from 50 percent to 25 percent, remains a critical program for sustained innovation and investment for innovator companies that exclusively focus on life-changing development programs for treatments for rare diseases.

The Rare Disease Company Coalition was established in 2021 to help advance policies and regulations that enable the cost-effective and timely development and commercialization of rare disease treatments by educating policymakers on the distinct considerations of life science companies operating in the rare disease space. To learn more about the Coalition and its commitment to rare disease treatment development and commercialization, please visit


The Rare Disease Company Coalition represents life science companies committed to discovering, developing and delivering rare disease treatments for the patients we serve. As an education and advocacy-focused coalition of companies, our goal is to inform policymakers of the unique challenges and promises of rare disease drug discovery, development and manufacturing for small population sizes in order for critical innovation to continue. To achieve this goal, we will use our unified voice to advocate for long-term, consistent, equitable and sustainable government policies that enable life science companies to continue to bring hope and provide access to approved treatments to people living with rare diseases. For more information, please visit

Media Contact:

Anna Stallmann