I 
114TH CONGRESS 
1ST SESSION H. R. 1353 
To amend the Federal Food, Drug, and Cosmetic Act to extend the period 
of exclusivity with respect to certain drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 13, 2015 
Mr. BILIRAKIS (for himself, Mr. CONNOLLY, Mr. ISRAEL, and Mr. GRIFFITH) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
extend the period of exclusivity with respect to certain 
drugs, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Promoting Access for 
Treatments Ideal in Enhancing New Therapies Act of 
2015’’, or the ‘‘PATIENT Act of 2015’’. 
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SEC. 2. EXTENDED EXCLUSIVITY PERIOD FOR CERTAIN 
NEW 
DRUG 
APPLICATIONS 
AND 
ABBRE-
VIATED NEW DRUG APPLICATIONS. 
(a) 
NEW
DRUG
APPLICATIONS.—Section 
505(c)(3)(E) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(c)(3)(E)) is amended by adding at 
the end the following new clause: 
‘‘(vi) With respect to an application described 
in clause (iii) or a supplement to an application de-
scribed in clause (iv), the three-year period specified 
in such clause shall be extended for an additional 
24-month period if the person submitting such appli-
cation or supplement provides documentation to the 
Secretary demonstrating that— 
‘‘(I) the new clinical investigations essen-
tial to the approval of the application or supple-
ment and conducted or sponsored by the person 
submitting the application or supplement sup-
port the approval of a new indication or use for 
the drug that is the subject of the application 
or supplement; or 
‘‘(II) the drug that is the subject of the 
application or supplement has been reformu-
lated or redesigned so that the drug can reason-
ably (as determined by the Secretary in con-
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sultation with the person submitting such appli-
cation or supplement) be expected— 
‘‘(aa) to promote greater patient ad-
herence to an approved treatment regime 
relative to the previously approved formu-
lation or design of the drug; 
‘‘(bb) to reduce the public-health risks 
associated with the drug relative to the 
previously approved formulation or design 
of the drug; 
‘‘(cc) to reduce the manner or extent 
of side effects or adverse events associated 
with the previously approved formulation 
or design of the drug; 
‘‘(dd) to provide systemic benefits to 
the health-care system relative to the pre-
viously approved formulation or design of 
the drug; or 
‘‘(ee) to provide other patient benefits 
that are comparable to the benefits de-
scribed in items (aa) through (dd).’’. 
(b) ABBREVIATED NEW DRUG APPLICATIONS.—Sec-
tion 505(j)(5)(F) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)(5)(F)) is amended by adding 
at the end the following new clause: 
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‘‘(vi) With respect to an application described in 
clause (iii) or a supplement to an application described 
in clause (iv), the three-year period specified in such 
clause shall be extended for an additional 24-month period 
if the person submitting such application or supplement 
provides documentation to the Secretary demonstrating 
that— 
‘‘(I) the new clinical investigations essential to 
the approval of the application or supplement and 
conducted or sponsored by the person submitting the 
application or supplement support the approval of a 
new indication or use for the drug that is the subject 
of the application or supplement; or 
‘‘(II) the drug that is the subject of the applica-
tion or supplement has been reformulated or rede-
signed so that the drug may reasonably (as deter-
mined by the Secretary in consultation with the per-
son submitting such application or supplement) be 
expected— 
‘‘(aa) to promote greater patient adherence 
to an approved treatment regime relative to the 
previously approved formulation or design of 
the drug; 
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