[Congressional Record Volume 164, Number 181 (Thursday, November 15, 2018)]
[Senate]
[Pages S7055-S7056]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




SENATE RESOLUTION 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

  Mr. HATCH submitted the following resolution; which was referred to 
the Committee on Health, Education, Labor, and Pensions:

                              S. Res. 690

       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

[[Page S7056]]

     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.

                          ____________________