III 

114TH CONGRESS 

2D SESSION S. RES. 380 

Designating February 29, 2016 as ‘‘Rare Disease Day’’. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 29, 2016 

Mr. BROWN (for himself, Mr. BARRASSO, Mr. WICKER, Mr. WHITEHOUSE, 

Ms. WARREN, Mr. COONS, and Mr. HATCH) submitted the following resolution; which was referred to the Committee on the Judiciary 

RESOLUTION 

Designating February 29, 2016 as ‘‘Rare Disease Day’’. 

Whereas a rare disease or disorder is one that affects a small 

number of patients and, in the United States, typically 

fewer than 200,000 individuals annually are affected by 

a rare disease or disorder; 

Whereas, as of the date of approval of this resolution, nearly 

7,000 rare diseases affect approximately 30,000,000 people in the United States and their families; 

Whereas children with rare genetic diseases account for about 

1⁄2 of the population affected by rare diseases in the 

United States; 

Whereas many rare diseases are serious and life-threatening 

and lack an effective treatment; 


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•SRES 380 IS 

Whereas, as a result of the Orphan Drug Act (Public Law 

97–414; 96 Stat. 2049), there have been important advances made in the research of and treatment for rare 

diseases; 

Whereas the Food and Drug Administration (in this preamble referred to as the ‘‘FDA’’) has made great strides 

in involving the patient in the drug review process as 

part of the Patient-Focused Drug Development program, 

an initiative that originated in the Food and Drug Administration Safety and Innovation Act (Public Law 

112–144; 126 Stat. 993); 

Whereas, although approximately 500 drugs and biological 

products for the treatment of rare diseases have been approved by the FDA, millions of people in the United 

States have a rare disease for which there is no such approved treatment; 

Whereas lack of access to effective treatments and difficulty 

in obtaining reimbursement for life-altering, and even 

life-saving, treatments still exist and remain significant 

challenges for people with rare diseases and their families; 

Whereas rare diseases and conditions include epidermolysis 

bullosa, progeria, sickle cell anemia, spinal muscular atrophy, Duchenne muscular dystrophy, Tay-Sachs disease, 

cystic fibrosis, pulmonary fibrosis, many childhood cancers, fibrodysplasia ossificans progressiva, Smith-Magenis 

syndrome, Batten disease, and hemophilia; 

Whereas people with rare diseases experience challenges that 

include difficulty in obtaining accurate diagnoses, limited 

treatment options, and difficulty finding physicians or 

treatment centers with expertise in the rare diseases; 


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•SRES 380 IS 

Whereas the rare disease community made significant 

progress during the 113th Congress, including the passage of the National Pediatric Research Network Act of 

2013 (Public Law 113–55; 127 Stat. 644), which calls 

special attention to rare diseases and directs the National 

Institutes of Health (in this preamble referred to as the 

‘‘NIH’’) to facilitate greater collaboration among researchers; 

Whereas the rare disease community continued this progress 

through the first session of the 114th Congress, including 

the passage of the Ensuring Access to Clinical Trials Act 

of 2015 (Public Law 114–63; 129 Stat. 549) and 

through increased funding for orphan products and rare 

disease research; 

Whereas both the FDA and the NIH have established special 

offices to advocate for rare disease research and treatments; 

Whereas the National Organization for Rare Disorders (in 

this preamble referred to as ‘‘NORD’’), a nonprofit organization established in 1983 to provide services to and 

advocate on behalf of patients with rare diseases, remains 

a critical public voice for people with rare diseases; 

Whereas 2016 marks the 33rd anniversary of the enactment 

of the Orphan Drug Act and the establishment of 

NORD; 

Whereas NORD sponsors Rare Disease Day in the United 

States and partners with many other major rare disease 

organizations to increase public awareness of rare diseases; 

Whereas Rare Disease Day is observed each year on the last 

day of February; 


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•SRES 380 IS 

Whereas Rare Disease Day is a global event, first observed 

in the United States on February 28, 2009, and observed 

in more than 80 countries in 2015; and 

Whereas Rare Disease Day is expected to be observed globally for years to come, providing hope and information 

for rare disease patients around the world: Now, therefore, be it 

1 Resolved, That the Senate— 

2 (1) designates February 29, 2016, as ‘‘Rare 

3 Disease Day’’; 

4 (2) recognizes the importance of improving 

5 awareness and encouraging accurate and early diag6 nosis of rare diseases and disorders; and 

7 (3) supports a national and global commitment 

8 to improving access to and developing new treat9 ments, diagnostics, and cures for rare diseases and 

10 disorders. 

Æ 


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