‘‘(C) the size of prizes awarded under this 
section and the effectiveness of such prizes in 
stimulating innovation. 
‘‘(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
For the purpose of carrying out this subsection, 
there are authorized to be appropriated, and there 
are appropriated, $3,000,000 for fiscal year 2018. 
Such funds shall remain available until expended.’’. 
SEC. 302. PUBLIC FUNDING FOR CLINICAL TRIALS. 
(a) IN GENERAL.—Part E of title IV of the Public 
Health Service Act (42 U.S.C. 287 et seq.) is amended 
by adding at the end the following: 
‘‘Subpart 6—Center for Clinical Research 
‘‘SEC. 485E. CENTER FOR CLINICAL RESEARCH. 
‘‘(a) IN GENERAL.—There is established within the 
National Institutes of Health the Center for Clinical Re-
search, for the purpose of conducting clinical trials on 
drugs, as described in subsection (b), with the intention 
of obtaining approval of such drug under section 505 of 
the Federal Food, Drug, and Cosmetic Act or section 351 
of this Act. The Director of NIH shall appoint a Director 
of the Center for Clinical Research referred to in this sec-
tion as the ‘Director’) not later than 90 days after the 
date of enactment of the Improving Access To Affordable 
Prescription Drugs Act. 
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‘‘(b) CLINICAL TRIALS.— 
‘‘(1) IN GENERAL.—Each year, beginning not 
later than 1 year after the date of enactment of the 
Improving Access To Affordable Prescription Drugs 
Act, the Director shall select at least 2 molecules, 
compounds, drugs, or biological products and con-
duct clinical trials on such molecules, compounds, 
drugs, or biological products, or enter into contracts 
with other entities to conduct such clinical trials. 
‘‘(2) SELECTION OF DRUGS.— 
‘‘(A) CRITERIA.—The Director shall estab-
lish criteria, which shall be made public, for ac-
quiring the patent rights for, and selecting, 
drugs under paragraph (1) to ensure that the 
drugs selected for clinical trials through the 
Center— 
‘‘(i) have the potential to address an 
existing or emerging need, including drugs 
that can be repurposed to treat a new con-
dition in the case of a national emergency; 
and 
‘‘(ii) are not solely drugs that private 
sector researchers with access to all avail-
able information on such drugs chose not 
to develop. 
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‘‘(B) PROCESS.—The Director shall secure 
all patent rights to each drug selected under 
paragraph (1), as applicable, and perform the 
clinical trials at NIH or subcontract with an-
other entity to conduct the clinical trials. 
‘‘(c) TREATMENT OF APPROVED DRUGS.—If a drug 
for which clinical trials have been conducted by the Center 
for Clinical Research is approved by the Food and Drug 
Administration under section 505 of the Federal Food, 
Drug, and Cosmetic Act or section 351 of this Act, the 
Director shall— 
‘‘(1) execute non-exclusive licenses to allow 
drug manufacturers to manufacture the drug; or 
‘‘(2) in collaboration with other Federal agen-
cies as appropriate, enter into purchasing contracts. 
‘‘(d) PUBLIC INFORMATION.— 
‘‘(1) RESEARCH DATA AND FINDINGS.—Subject 
to applicable patient privacy protections, the Sec-
retary shall— 
‘‘(A)(i) submit all completed studies (and 
terminated studies, if terminated for safety or 
ethical reasons) for publication in a peer-re-
viewed publication within 180 days of comple-
tion or termination; and 
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‘‘(ii) if a study submitted as described in 
clause (i) is not selected for publication, pub-
licly disclose all de-identified primary clinical 
data not later than 180 days after the Sec-
retary’s final decision not to pursue further 
submissions for publication; and 
‘‘(B) publicly disclose all de-identified pri-
mary clinical data upon publication of a study 
as described in subparagraph (A)(i). 
‘‘(2) FINANCIAL INFORMATION.—The Director 
shall make public all costs to the Federal Govern-
ment associated with carrying out clinical trials by 
the Center for Clinical Research and with sub-
contract agreements under this section. 
‘‘(e) DEFINITION.—In this section, the term ‘drug’ 
has the meaning given such term in section 201(g) of the 
Federal Food, Drug, and Cosmetic Act. 
‘‘(f) APPROPRIATIONS.—For the purpose of carrying 
out this section, in addition to any other funds available 
for such purpose, there are authorized to be appropriated, 
and there are appropriated, $1,000,000,000 for each of 
fiscal years 2017 through 2027, to remain available until 
expended.’’. 
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(b) CLERICAL AMENDMENT.—Section 401(b) of the 
Public Health Service Act (42 U.S.C. 281(b)) is amend-
ed— 
(1) by redesignating paragraph (25) as para-
graph (26); and 
(2) by inserting after paragraph (24) the fol-
lowing: 
‘‘(25) The Center for Clinical Research.’’. 
SEC. 303. REWARDING INNOVATIVE DRUG DEVELOPMENT. 
(a) DRUG EXCLUSIVITY.— 
(1) NEW CHEMICAL ENTITY EXCLUSIVITY.— 
(A) IN
GENERAL.—Section 505(j)(5) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)) is amended— 
(i) in subparagraph (B)— 
(I) in clause (i), by inserting ‘‘ex-
cept that such approval may not be 
made effective before the date that is 
5 years after the date on which the 
drug to which the application refers 
was approved under subsection (c)’’ 
before the period; and 
(II) in clause (ii), by inserting 
‘‘except that such approval may not 
be made effective before the date that 
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