IV 
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 dis-
eases. 
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, cele-
brating 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 dis-
eases; 
Whereas the Orphan Drug Act (Public Law 97–414) was en-
acted 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; 
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•HRES 242 IH 
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 Adminis-
tration; 
Whereas since enactment of such Act, research and develop-
ment 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) con-
tinues to lead to increased research and successful thera-
peutic 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 in-
creased productivity from individuals affected by rare dis-
eases as well as a potential decline in the resources de-
voted 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 Adminis-
tration; and 
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•HRES 242 IH 
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 liv-
ing with rare diseases approved by the Food and 
Drug Administration; 
(2) recognizes that significant research and de-
velopment efforts and related investments are need-
ed to develop therapies to treat and cure the thou-
sands of rare diseases for which no treatment op-
tions are currently available; and 
(3) affirms the need to continue supporting 
public investment and encouraging private invest-
ment in research and development of new treatments 
for rare diseases. 
Æ 
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