Title: A 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.
Policy area: Health

Summary:
Affirms the importance of the Orphan Drug Act.
Recognizes that significant research and development efforts and related investments are needed to develop therapies to treat and cure thousands of rare diseases for which no treatment options are currently available.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. Res. 690 Introduced in Senate (IS)]

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115th CONGRESS
  2d Session
S. RES. 690

 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.


_______________________________________________________________________


                   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;
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
    Resolved, That the Senate--
            (1) affirms the importance of the Orphan Drug Act;
            (2) applauds the significant, life-saving accomplishments 
        of the Orphan Drug Act during the course of the 35-year history 
        of the Act, including the tremendous growth in research and 
        development of new therapies for rare diseases and the 
        resulting number of therapies approved by the Food and Drug 
        Administration for people living with rare diseases;
            (3) recognizes that significant research and development 
        efforts and related investments are needed to develop therapies 
        to treat and cure thousands of rare diseases for which no 
        treatment options are currently available; and
            (4) recognizes the need to continue supporting public 
        investment, and encouraging private investment, in research and 
        development of new therapies for rare diseases.
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