III 

115TH CONGRESS 

2D SESSION S. RES. 690 

Affirming the importance of the Orphan Drug Act, applauding the lifesaving accomplishments of the Act during its 35-year history, and recognizing the need to continue support for research and development of 

new therapies for rare diseases. 

IN THE SENATE OF THE UNITED STATES 

NOVEMBER 15, 2018 

Mr. HATCH submitted the following resolution; which was referred to the 

Committee on Health, Education, Labor, and Pensions 

RESOLUTION 

Affirming the importance of the Orphan Drug Act, applauding the life-saving accomplishments of the Act during 

its 35-year history, and recognizing the need to continue 

support for research and development of new therapies 

for rare diseases. 

Whereas 30,000,000 people in the United States, or nearly 

1 out of every 10 individuals in the United States, live 

with at least 1 of more than 7,000 known rare diseases; 

Whereas, in 1983, the Orphan Drug Act (Public Law 97– 

414; 96 Stat. 2049) was enacted to provide research and 

development incentives to encourage the development of 

new therapies for diseases affecting less than 200,000 

people in the United States; 


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•SRES 690 IS 

Whereas, in the 10 years prior to the enactment of the Orphan Drug Act, only 10 therapies for rare diseases were 

developed by private industry and approved for patients; 

Whereas, since the enactment of the Orphan Drug Act, research and development of therapies for rare diseases has 

resulted in more than 650 new therapies for rare diseases; 

Whereas experts estimate that without the tax credit for testing expenses for drugs for rare diseases, known as the 

‘‘Orphan Drug Tax Credit’’, one of the incentives of the 

Orphan Drug Act, at least 1⁄3 of those new therapies 

would likely not have been developed; 

Whereas the Orphan Drug Act continues to lead to increased 

research and successful therapeutic development along 

the full range of rare diseases, including the rarest diseases; 

Whereas new therapies for rare diseases benefit the individuals affected by such diseases through increased life expectancy and improved quality of life; 

Whereas new therapies for rare diseases benefit society 

through increased productivity of the individuals affected 

by such diseases and a potential decline in the resources 

devoted to health care, disability, caregiving, and related 

spending; and 

Whereas, despite the success of the Orphan Drug Act, only 

approximately 5 percent of the more than 7,000 identified rare diseases have at least one treatment option approved by the Food and Drug Administration: Now, 

therefore, be it 

1 Resolved, That the Senate— 


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•SRES 690 IS 

1 (1) affirms the importance of the Orphan Drug 

2 Act; 

3 (2) applauds the significant, life-saving accom4 plishments of the Orphan Drug Act during the 

5 course of the 35-year history of the Act, including 

6 the tremendous growth in research and development 

7 of new therapies for rare diseases and the resulting 

8 number of therapies approved by the Food and Drug 

9 Administration for people living with rare diseases; 

10 (3) recognizes that significant research and de11 velopment efforts and related investments are need12 ed to develop therapies to treat and cure thousands 

13 of rare diseases for which no treatment options are 

14 currently available; and 

15 (4) recognizes the need to continue supporting 

16 public investment, and encouraging private invest17 ment, in research and development of new therapies 

18 for rare diseases. 

Æ 


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