I 
116TH CONGRESS 
1ST SESSION H. R. 4398 
To amend the Federal Trade Commission Act to prohibit anticompetitive 
behaviors by drug product manufacturers, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 19, 2019 
Mr. CICILLINE 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’’. 
SEC. 2. PRODUCT HOPPING. 
(a) IN GENERAL.—The Federal Trade Commission 
Act (15 U.S.C. 41 et seq.) is amended by inserting after 
section 26 (15 U.S.C. 57c–2) the following: 
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‘‘SEC. 27. PRODUCT HOPPING. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) ABBREVIATED NEW DRUG APPLICATION.— 
The term ‘abbreviated new drug application’ means 
an application under subsection (b)(2) or (j) of sec-
tion 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355). 
‘‘(2) BIOSIMILAR BIOLOGICAL PRODUCT.—The 
term ‘biosimilar biological product’ means a biologi-
cal product licensed under section 351(k) of the 
Public Health Service Act (42 U.S.C. 262(k)). 
‘‘(3) BIOSIMILAR
BIOLOGICAL
PRODUCT
LI-
CENSE APPLICATION.—The term ‘biosimilar biologi-
cal product license application’ means an application 
submitted under section 351(k) of the Public Health 
Service Act (42 U.S.C. 262(k)). 
‘‘(4) FOLLOW-ON PRODUCT.—The term ‘follow- 
on product’— 
‘‘(A) means a drug approved through an 
application or supplement to an application sub-
mitted under section 505(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
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 
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change, modification, or reformulation to the 
same manufacturer’s previously approved drug 
or biological product that treats the same med-
ical condition; and 
‘‘(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). 
‘‘(5) 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). 
‘‘(6) 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)). 
‘‘(7) MANUFACTURER.—The term ‘manufac-
turer’ means the holder, licensee, or assignee of— 
‘‘(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 
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‘‘(B) a biological product license under sec-
tion 351(a) of the Public Health Service Act 
(42 U.S.C. 262(a)). 
‘‘(8) 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)). 
‘‘(9) 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) if the 
Commission demonstrates by a preponderance of the 
evidence in a proceeding initiated by the Commission 
under subsection (c)(1)(A), or in a suit brought 
under subparagraph (B) or (C) of subsection (c)(1), 
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 
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an abbreviated new drug application or biosimilar bi-
ological product license application and ending on 
the date that is 180 days after the date on which 
that generic drug or biosimilar biological product is 
first marketed, the manufacturer engaged in either 
of the following 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 following actions: 
‘‘(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 the 
manufacturer marketed or sold a follow-on 
product. 
‘‘(ii)(I) The manufacturer of the listed 
drug or reference product— 
‘‘(aa) announced withdrawal of, 
discontinuance of the manufacture of, 
or intent to withdraw the application 
with respect to the drug or reference 
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product in a manner that impedes 
competition from a generic drug or a 
biosimilar biological product, as estab-
lished by objective circumstances; 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 
‘‘(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 actions 
with respect to the listed drug or reference 
product other than those described in sub-
paragraph (A) that unfairly disadvantage 
the listed drug or reference product rel-
ative to the follow-on product described in 
clause (ii) in a manner that impedes com-
petition from a generic drug or a bio-
similar biological product that is highly 
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similar to, and has no clinically meaningful 
difference with respect to safety, purity, 
and potency from, the reference product, 
which may be established by objective cir-
cumstances. 
‘‘(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 
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)(A), or in a suit brought under sub-
paragraph (B) or (C) of subsection (c)(1), 
that— 
‘‘(I) the manufacturer would 
have taken the actions regardless of 
whether a generic drug that ref-
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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), 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-
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-
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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), 
the Commission may— 
‘‘(A) rebut any evidence presented by a 
manufacturer during that justification; or 
‘‘(B) establish by a preponderance of the 
evidence that, on balance, the pro-competitive 
benefits from the conduct described in subpara-
graph (A) or (B) of paragraph (1), as applica-
ble, do not outweigh any anticompetitive effects 
of the conduct, even in consideration of the jus-
tification so offered. 
‘‘(c) ENFORCEMENT.— 
‘‘(1) IN GENERAL.—If the Commission has rea-
son to believe that any manufacturer has violated, is 
violating, or is about to violate this section, the 
Commission may take any of the following actions: 
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‘‘(A) Institute a proceeding— 
‘‘(i) that, except as provided in para-
graph (2), complies with the requirements 
under section 5(b); and 
‘‘(ii) in which the Commission may 
impose on the manufacturer any penalty 
that the Commission may impose for a vio-
lation of section 5. 
‘‘(B) In the same manner and to the same 
extent as provided in section 13(b), bring suit 
in a district court of the United States to tem-
porarily enjoin the action of the manufacturer. 
‘‘(C) Bring suit in a district court of the 
United States, in which the Commission may 
seek— 
‘‘(i) to permanently enjoin the action 
of the manufacturer; 
‘‘(ii) any of the remedies described in 
paragraph (3); and 
‘‘(iii) any other equitable remedy, in-
cluding ancillary equitable relief. 
‘‘(2) JUDICIAL REVIEW.— 
‘‘(A) IN GENERAL.—Notwithstanding any 
provision of section 5, any manufacturer that is 
subject to a final order of the Commission that 
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is issued in a proceeding initiated under para-
graph (1)(A) 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) EQUITABLE REMEDIES.— 
‘‘(A) DISGORGEMENT.— 
‘‘(i) IN GENERAL.—In a suit brought 
under paragraph (1)(C), the Commission 
may seek, and the court may order, 
disgorgement of any unjust enrichment 
that a person obtained as a result of the 
violation that gives rise to the suit. 
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ceives any unjust enrichment from the ef-
fects of the violation that gives rise to the 
suit in which the Commission seeks the 
restitution. 
‘‘(4) 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 
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 
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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-
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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