IV 

116TH CONGRESS 

1ST SESSION H. RES. 242 

Affirming the importance of the Orphan Drug Act, celebrating the over 

750 new orphan therapies approved since its creation, and recognizing 

the need to continue supporting research and development for rare diseases. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 18, 2019 

Mr. BUTTERFIELD (for himself and Mr. BILIRAKIS) submitted the following 

resolution; which was referred to the Committee on Energy and Commerce 

RESOLUTION 

Affirming the importance of the Orphan Drug Act, celebrating the over 750 new orphan therapies approved 

since its creation, and recognizing the need to continue 

supporting research and development for rare diseases. 

Whereas 30 million people in the United States, or nearly one 

out of every 10 individuals in the United States, lives 

with at least one of more than 7,000 known rare diseases; 

Whereas the Orphan Drug Act (Public Law 97–414) was enacted to provide research and development incentives to 

encourage the development of new therapies for diseases 

affecting fewer than 200,000 people in the United States; 


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•HRES 242 IH 

Whereas in the 10 years prior to enactment of such Act, only 

10 therapies for rare diseases were developed by private 

industry and approved by the Food and Drug Administration; 

Whereas since enactment of such Act, research and development of therapies addressing rare diseases has resulted 

in more than 750 new therapies for rare diseases; 

Whereas experts estimate that without the tax credit under 

section 45C of the Internal Revenue Code (relating to a 

tax credit for clinical testing expenses for certain drugs 

for rare diseases or conditions), one of the incentives for 

innovation established in the Orphan Drug Act (Public 

Law 97–414), at least one-third of such new therapies 

would likely not have been developed; 

Whereas the Orphan Drug Act (Public Law 97–414) continues to lead to increased research and successful therapeutic development along the full range of rare diseases; 

Whereas people with rare diseases benefit from new orphan 

drugs by having a longer life and a higher quality of life; 

Whereas society benefits from new orphan drugs through increased productivity from individuals affected by rare diseases as well as a potential decline in the resources devoted to health care, disability, caregiving, and related 

spending with respect to those individuals; 

Whereas despite the success of the Orphan Drug Act (Public 

Law 97–414), fewer than 10 percent of the more than 

7,000 identified rare diseases have at least one treatment 

option that is approved by the Food and Drug Administration; and 


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•HRES 242 IH 

Whereas the significant, lifesaving accomplishments of such 

Act over the course of the 36 years since its enactment 

should be recognized: Now, therefore, be it 

1 Resolved, That the House of Representatives— 

2 (1) applauds the tremendous growth in research 

3 and development into new therapies for rare diseases 

4 and the resulting number of therapies for people liv5 ing with rare diseases approved by the Food and 

6 Drug Administration; 

7 (2) recognizes that significant research and de8 velopment efforts and related investments are need9 ed to develop therapies to treat and cure the thou10 sands of rare diseases for which no treatment op11 tions are currently available; and 

12 (3) affirms the need to continue supporting 

13 public investment and encouraging private invest14 ment in research and development of new treatments 

15 for rare diseases. 

Æ 


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