IV 
115TH CONGRESS 
2D SESSION 
H. RES. 1154 
Affirming the importance of the Orphan Drug Act, applauding its lifesaving 
contributions over its 35-year history, and recognizing the need to con-
tinue supporting research and development for rare diseases. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 16, 2018 
Mr. LANCE (for himself, Mr. BUTTERFIELD, and Ms. ESHOO) submitted the 
following resolution; which was referred to the Committee on Energy and 
Commerce 
RESOLUTION 
Affirming the importance of the Orphan Drug Act, applaud-
ing its lifesaving contributions over its 35-year history, 
and recognizing the need to continue supporting research 
and development for rare diseases. 
Whereas 30,000,000 people in the United States, or nearly 
1 out of every 10 Americans, lives with at least 1 of more 
than 7,000 known rare diseases; 
Whereas the Orphan Drug Act of 1983 (Orphan Drug Act) 
was enacted to provide research and development incen-
tives to encourage the development of new therapies for 
diseases affecting fewer than 200,000 people in the 
United States; 
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•HRES 1154 IH 
Whereas in the 10 years prior to enactment of the Orphan 
Drug Act, only 10 therapies for rare diseases were devel-
oped by private industry and approved for patients; 
Whereas since enactment of the Orphan Drug Act, research 
and development of therapies addressing rare diseases 
has resulted in more than 650 new therapies for rare dis-
eases; 
Whereas experts estimate that without the Orphan Drug Tax 
Credit, one of the Orphan Drug Act’s incentives, at least 
a third of the new treatments would likely not have been 
developed; 
Whereas the Orphan Drug Act continues to result in in-
creased research and successful therapeutic development 
along the full range of rare diseases, including the rarest 
diseases; 
Whereas people with rare diseases benefit from new orphan 
drugs through longer and higher quality of life; 
Whereas society benefits from new orphan drugs through in-
creased productivity from those affected as well as a po-
tential decline in the resources devoted to health care, 
disability, caregiving, and related spending; 
Whereas despite the success of the Orphan Drug Act, only 
approximately 5 percent of the more than 7,000 identi-
fied rare diseases have at least one FDA-approved treat-
ment option; and 
Whereas the significant, lifesaving accomplishments of the 
Orphan Drug Act over the course of its 35 years should 
be recognized: Now, therefore, be it 
Resolved, That the House of Representatives— 
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•HRES 1154 IH 
(1) applauds the tremendous growth in research 
and development into new therapies for rare diseases 
and the resulting number of FDA-approved thera-
pies for people living with rare diseases; 
(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 and encouraging private investment in re-
search and development of new treatments for rare 
diseases. 
Æ 
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