[Congressional Record (Bound Edition), Volume 148 (2002), Part 15]
[Senate]
[Pages 21124-21125]
[From the U.S. Government Publishing Office, www.gpo.gov]




                 AMENDING THE PUBLIC HEALTH SERVICE ACT

  Mr. REID. Mr. President, I ask unanimous consent that the Senate now 
proceed to the consideration of H.R. 4013.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (H.R. 4013) to amend the Public Health Service Act 
     to establish an Office of Rare Diseases at the National 
     Institutes of Health, and for other purposes.

  There being no objection, the Senate proceeded to the consideration 
of the bill.
  Mr. KENNEDY. Mr. President, I commend the Senate today for its 
bipartisan action in approving the Rare Diseases Act of 2002 and the 
Rare Diseases Orphan Product Development Act of 2002. These two 
measures will enhance the prospects for developing effective care, 
treatments and cures for literally thousands of rare diseases and 
disorders.
  Congress has a longstanding commitment to provide this support. In 
1983, we passed the Orphan Drug Act to improve the development of 
treatments for rare diseases and disorders. These diseases affect small 
patient populations, typically smaller than 200,000 individuals in the 
United States. They include Huntington's disease, myoclonus, ALS (Lou 
Gehrig's disease), Tourette syndrome, and muscular dystrophy.
  The Rare Diseases Act and the Rare Diseases Orphan Product 
Development Act build upon the enormous success of the original Orphan 
Drug Act, which encouraged the development of over 220 treatments for 
rare diseases and disorders.
  The Rare Diseases Act of 2002 provides a statutory authorization for 
the existing Office of Rare Diseases at the National Institutes of 
Health and authorizes regional centers of excellence for research and 
training with respect to rare diseases. This proposal originated with 
the NIH, in recommendations of a Special Emphasis Panel convened to 
examine the state of rare disease research. The Panel itself was 
convened in response to a request of the Senate Appropriations 
Committee in 1996, and it is appropriate that we are today introducing 
legislation which represents the fruition of a long, deliberative 
process involving both Congress and the NIH.
  The Rare Diseases Orphan Product Development Act increases funding 
for the Food and Drug Administration's Orphan Product Research Grant 
program, which provides vital support for clinical research on new 
treatments for rare diseases and disorders. This funding will encourage 
many more commercial sponsors to investigate and develop vital new 
medicines.
  Although each rare disease may not affect many patients, 25 million 
Americans today suffer from the 6,000 known rare diseases and 
disorders, including more than 600,000 in Massachusetts. Anyone who has 
a family member or friend who suffers from a rare disease or disorder 
knows the importance of developing new treatments and helping patients 
to obtain these potential cures. Today's passage of these two bills 
will provide the resources necessary to continue to develop new 
treatments and even cures for millions of Americans.
  I would also add that these bills are intended to build upon previous 
congressional efforts to expand research

[[Page 21125]]

and development for all rare diseases and disorders. Senator Hatch and 
I introduced the Rare Diseases Act, upon which these bills are based, 
to expand and enhance existing initiatives underway at the various 
institutes of NIH with respect to different rare diseases, including 
but not limited to muscular dystrophy, Huntington's disease, and ALS 
(Lou Gehrig's disease). I believe the NIH will act upon these new bills 
in the appropriate spirit, by building upon current activities and 
investments on rare diseases and disorders.
  I commend the National Organization for Rare Diseases for its 
tireless and continuing leadership on these basic issues. I also 
commend Senator Hatch for his leadership on this issue in the Senate, 
and I commend Congressmen Waxman, Shimkus, and Foley for their 
leadership in the House of Representatives. I know that all of us look 
forward to the implementation of these important measures we are 
approving today.
  Mr. REID. Mr. President, I ask unanimous consent that the bill be 
read three times, passed, the motion to reconsider be laid upon the 
table, and that any statements relating to this matter be printed in 
the Record, with no intervening action or debate.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.
  The bill (H.R. 4013) was read the third time and passed.

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