Title: 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.
Policy area: Health

Summary:
This resolution applauds the growth in research and development into new therapies for rare diseases and 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 116th Congress]
[From the U.S. Government Publishing Office]
[H. Res. 242 Introduced in House (IH)]

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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;
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
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
    Resolved, That the House of Representatives--
            (1) applauds the tremendous growth in research and 
        development into new therapies for rare diseases and the 
        resulting number of therapies for people living with rare 
        diseases approved by the Food and Drug Administration;
            (2) recognizes that significant research and development 
        efforts and related investments are needed to develop therapies 
        to treat and cure the thousands of rare diseases for which no 
        treatment options are currently available; and
            (3) affirms the need to continue supporting public 
        investment and encouraging private investment in research and 
        development of new treatments for rare diseases.
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