I 
116TH CONGRESS 
1ST SESSION H. R. 5133 
To amend the Federal Trade Commission Act to prohibit anticompetitive 
behaviors by drug product manufacturers, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 18, 2019 
Mr. CICILLINE (for himself, Mr. COLLINS of Georgia, Mr. NADLER, and Mr. 
SENSENBRENNER) introduced the following bill; which was referred to the 
Committee on the Judiciary 
A BILL 
To amend the Federal Trade Commission Act to prohibit 
anticompetitive behaviors by drug product manufactur-
ers, 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 ‘‘Affordable Prescrip-
tions for Patients Through Promoting Competition Act of 
2019’’. 
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355(c)) or a biological product licensed through 
an application or supplement to an application 
submitted under section 351(a) of the Public 
Health Service Act (42 U.S.C. 262(a)) for a 
change, modification, or reformulation to the 
same manufacturer’s previously approved drug 
or biological product that treats the same or a 
related indication; 
‘‘(B) excludes such an application or sup-
plement to an application for a change, modi-
fication, or reformulation of a drug or biological 
product that is requested by the Secretary or 
necessary to comply with law, including sections 
505A and 505B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a, 355c); 
‘‘(C) excludes such an application or sup-
plement to an application submitted under sec-
tion 505(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(c)) that has been 
granted New Chemical Entity exclusivity (21 
U.S.C. 355(c)(3)(E)(ii)) by the Food and Drug 
Administration; and 
‘‘(D) excludes such an application or sup-
plement submitted under section 351(a) of the 
Public Health Service Act (42 U.S.C. 262(a)) 
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that has been granted exclusivity pursuant to 
section 351(k)(7) of such Act (42 U.S.C. 
262(k)(7)). 
‘‘(5) COMMISSION.—The term ‘Commission’ 
means the Federal Trade Commission 
‘‘(6) DISADVANTAGE.—The term ‘disadvantage’ 
means to impede the listed drug or reference prod-
uct’s ability to compete on the merits with the fol-
low-on product. This term excludes actions that con-
sist solely of— 
‘‘(A) truthful, non-misleading promotional 
marketing; or 
‘‘(B) ceasing promotional marketing for 
the listed drug or reference product. 
‘‘(7) GENERIC DRUG.—The term ‘generic drug’ 
means a drug approved under an application sub-
mitted under subsection (b)(2) or (j) of section 505 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355). 
‘‘(8) LISTED
DRUG.—The term ‘listed drug’ 
means a drug listed under section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(7)). 
‘‘(9) MANUFACTURER.—The term ‘manufac-
turer’ means the holder, licensee, or assignee of— 
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‘‘(A) an approved application for a drug 
under section 505(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(c)); or 
‘‘(B) a biological product license under sec-
tion 351(a) of the Public Health Service Act 
(42 U.S.C. 262(a)). 
‘‘(10) REFERENCE PRODUCT.—The term ‘ref-
erence product’ has the meaning given the term in 
section 351(i) of the Public Health Service Act (42 
U.S.C. 262(i)). 
‘‘(11) ULTIMATE PARENT ENTITY.—The term 
‘ultimate parent entity’ has the meaning given the 
term in section 801.1 of title 16, Code of Federal 
Regulations, or any successor regulation. 
‘‘(b) PROHIBITION ON PRODUCT HOPPING.— 
‘‘(1) PRIMA
FACIE.—Except as provided in 
paragraph (2), a manufacturer of a reference prod-
uct or listed drug shall be considered to have en-
gaged in an unfair method of competition in or af-
fecting commerce in violation of section 5(a) of the 
Federal Trade Commission Act if complaint counsel 
or the Commission demonstrates by a preponderance 
of the evidence in a proceeding initiated by the Com-
mission under subsection (c)(1), or in a suit brought 
under subparagraph (B) or (C) of subsection (c)(1), 
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that, during the period beginning on the date on 
which the manufacturer of the reference product or 
listed drug first receives notice that an applicant has 
submitted to the Commissioner of Food and Drugs 
an abbreviated new drug application or biosimilar bi-
ological product license application and ending on 
the date that is the earlier of 180 days after the 
date on which that generic drug or biosimilar bio-
logical product or another generic drug or biosimilar 
biological product referencing the listed drug or ref-
erence product is first marketed or 3 years after the 
date on which the follow-on product is first mar-
keted, the manufacturer engaged in either of the fol-
lowing actions: 
‘‘(A) The manufacturer engaged in a hard 
switch, which shall be established by dem-
onstrating that the manufacturer engaged in ei-
ther of the actions described in clause (i) or (ii): 
‘‘(i) Upon the request of the manufac-
turer of the listed drug or reference prod-
uct, the Commissioner of Food and Drugs 
withdrew the approval of the application 
for the listed drug or reference product or 
placed the listed drug or reference product 
on the discontinued products list; and 
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‘‘(I) the manufacturer marketed or 
sold a follow-on product. 
‘‘(ii)(I) The manufacturer of the listed 
drug or reference product— 
‘‘(aa) withdrew, discontinued the 
manufacture of, or withdrew the ap-
plication with respect to, or an-
nounced withdrawal of, discontinuance 
of the manufacture of, or withdrawal 
of the application with respect to, the 
drug or reference product in a manner 
that impedes competition from a ge-
neric drug or a biosimilar biological 
product, as established by objective 
circumstances, unless such actions 
were taken by the manufacturer pur-
suant to a request of the Commis-
sioner of Food and Drugs; or 
‘‘(bb) destroyed the inventory of 
the listed drug or reference product in 
a manner that impedes competition 
from a generic drug or a biosimilar bi-
ological product, which may be estab-
lished by objective circumstances; and 
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‘‘(II) marketed or sold a follow-on 
product. 
‘‘(B) The manufacturer engaged in a soft 
switch, which shall be established by dem-
onstrating that the manufacturer engaged in 
both of the following actions: 
‘‘(i) The manufacturer took one or 
more actions with respect to the listed 
drug or reference product other than those 
described in subparagraph (A) that un-
fairly disadvantage the listed drug or ref-
erence product relative to the follow-on 
product described in clause (ii) in a man-
ner that impedes competition from either a 
generic drug or a biosimilar biological 
product, which may be established by ob-
jective circumstances. 
‘‘(ii) The manufacturer marketed or 
sold a follow-on product. 
‘‘(2) JUSTIFICATION.— 
‘‘(A) IN GENERAL.—Subject to paragraph 
(3), the actions described in paragraph (1) by 
a manufacturer of a listed drug or reference 
product shall not be considered to be an unfair 
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method of competition in or affecting commerce 
if— 
‘‘(i) the manufacturer demonstrates to 
the Commission or a district court of the 
United States, as applicable, by a prepon-
derance of the evidence in a proceeding ini-
tiated by the Commission under subsection 
(c)(1), or in a suit brought under subpara-
graph (B) or (C) of subsection (c)(1), 
that— 
‘‘(I) the manufacturer would 
have taken the actions regardless of 
whether a generic drug that ref-
erences the listed drug or biosimilar 
biological product that references the 
reference product had already entered 
the market; and 
‘‘(II)(aa) with respect to a hard 
switch under paragraph (1)(A)(i), the 
manufacturer took the action for rea-
sons relating to the safety risk to pa-
tients of the listed drug or reference 
product; 
‘‘(bb) with respect to an action 
described in item (aa) or (bb) of para-
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graph (1)(A)(ii)(I), there is a supply 
disruption that— 
‘‘(AA) is outside of the con-
trol of the manufacturer; 
‘‘(BB) prevents the produc-
tion or distribution of the appli-
cable listed drug or reference 
product; and 
‘‘(CC) cannot be remedied 
by reasonable efforts; or 
‘‘(cc) with respect to a soft 
switch under paragraph (1)(B), the 
manufacturer had legitimate pro-com-
petitive reasons, apart from the finan-
cial effects of reduced competition, to 
take the action. 
‘‘(B) RULE OF CONSTRUCTION.—Nothing 
in subparagraph (A) may be construed to limit 
the information that the Commission may oth-
erwise obtain in any proceeding or action insti-
tuted with respect to a violation of this section. 
‘‘(3) RESPONSE.—With respect to a justifica-
tion offered by a manufacturer under paragraph (2), 
complaint counsel or the Commission, as applicable, 
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will prevail in its case if it establishes by a prepon-
derance of the evidence that— 
‘‘(A) the conduct described in subsection 
(b)(1) is not reasonably necessary to address or 
achieve the justifications claimed under para-
graph (2)(A)(II)(aa–cc), or such justifications 
could be reasonably addressed or achieved 
through less anticompetitive means; or 
‘‘(B) the pro-competitive benefits from the 
conduct described in subparagraph (A) or (B) 
of paragraph (1), as applicable, do not outweigh 
any anticompetitive effects of the conduct, even 
in consideration of the justification so offered. 
‘‘(c) ENFORCEMENT.— 
‘‘(1) ENFORCEMENT BY THE FEDERAL TRADE 
COMMISSION.—Except as provided in paragraph (2), 
the Commission shall enforce this section in the 
same manner, by the same means, and with the 
same jurisdiction, powers, duties, and remedies pro-
vided for by all applicable terms and provisions of 
the Federal Trade Commission Act (15 U.S.C. 45 et 
seq.). 
‘‘(2) JUDICIAL REVIEW.— 
‘‘(A) IN GENERAL.—Notwithstanding any 
provision of section 5 of the Federal Trade 
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Commission Act, any manufacturer that is sub-
ject to a final order of the Commission that is 
issued in a proceeding initiated under para-
graph (1) may, not later than 30 days after the 
date on which the Commission issues the order, 
petition for review of the order in— 
‘‘(i) the United States Court of Ap-
peals for the District of Columbia Circuit; 
or 
‘‘(ii) the court of appeals of the 
United States for the circuit in which the 
ultimate parent entity of the manufacturer 
is incorporated. 
‘‘(B) TREATMENT OF FINDINGS.—In a re-
view of an order issued by the Commission con-
ducted by a court of appeals of the United 
States under subparagraph (A), the factual 
findings of the Commission shall be conclusive 
if those facts are supported by the evidence. 
‘‘(3) RULES
OF
CONSTRUCTION.—Nothing in 
this subsection may be construed as— 
‘‘(A) requiring the Commission to bring a 
suit seeking a temporary injunction under para-
graph (1)(B) before bringing a suit seeking a 
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permanent injunction under paragraph (1)(C); 
or 
‘‘(B) affecting any other authority of the 
Commission under this Act to seek relief or ob-
tain a remedy with respect to a violation of this 
Act.’’. 
(b) APPLICABILITY.—Section 27 of the Federal 
Trade Commission Act, as added by subsection (a), shall 
apply with respect to any— 
(1) conduct that occurs on or after the date of 
enactment of this Act; and 
(2) action or proceeding that is commenced on 
or after the date of enactment of this Act. 
(c) ANTITRUST LAWS.—Nothing in this section, or 
the amendments made by this section, shall modify, im-
pair, limit, or supersede the applicability of the antitrust 
laws as defined in subsection (a) of the first section of 
the Clayton Act (15 U.S.C. 12(a)), and of section 5 of 
the Federal Trade Commission Act (15 U.S.C. 45) to the 
extent that it applies to unfair methods of competition. 
(d) RULEMAKING.—The Federal Trade Commission 
may issue rules under section 553 of title 5, United States 
Code, to carry out section 27 of the Federal Trade Com-
mission Act, as added by subsection (a), including by de-
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fining any terms used in such section 27 (other than terms 
that are defined in subsection (a) of such section 27). 
Æ 
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