[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5133 Introduced in House (IH)]
<DOC>
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 manufacturers, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Affordable Prescriptions 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:
``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 section 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 biological product licensed under
section 351(k) of the Public Health Service Act (42 U.S.C.
262(k)).
``(3) Biosimilar biological product license application.--
The term `biosimilar biological 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 submitted 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 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 supplement to
an application for a change, modification, 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 supplement to
an application submitted under section 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 supplement
submitted under section 351(a) of the Public Health
Service Act (42 U.S.C. 262(a)) 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 product's ability to
compete on the merits with the follow-on product. This term
excludes actions that consist 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 submitted 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 `manufacturer' 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
``(B) a biological product license under section
351(a) of the Public Health Service Act (42 U.S.C.
262(a)).
``(10) Reference product.--The term `reference 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 product or listed drug shall be
considered to have engaged in an unfair method of competition
in or affecting 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 Commission under subsection (c)(1),
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 an abbreviated
new drug application or biosimilar biological 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
biological product or another generic drug or biosimilar
biological product referencing the listed drug or reference
product is first marketed or 3 years after the date on which
the follow-on 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 demonstrating that the
manufacturer engaged in either of the actions described
in clause (i) or (ii):
``(i) Upon the request of the manufacturer
of the listed drug or reference product, 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
``(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
application with respect to, or
announced 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 generic
drug or a biosimilar biological
product, as established by objective
circumstances, unless such actions were
taken by the manufacturer pursuant to a
request of the Commissioner 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
biological product, which may be
established 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 demonstrating 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 unfairly disadvantage the
listed drug or reference product relative to
the follow-on product described in clause (ii)
in a manner that impedes competition from
either a generic drug or a biosimilar
biological product, which may be established by
objective 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 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 preponderance of
the evidence in a proceeding initiated by the
Commission under subsection (c)(1), or in a
suit brought under subparagraph (B) or (C) of
subsection (c)(1), that--
``(I) the manufacturer would have
taken the actions regardless of whether
a generic drug that references 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
reasons relating to the safety risk to
patients of the listed drug or
reference product;
``(bb) with respect to an action
described in item (aa) or (bb) of
paragraph (1)(A)(ii)(I), there is a
supply disruption that--
``(AA) is outside of the
control of the manufacturer;
``(BB) prevents the
production or distribution of
the applicable 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-
competitive reasons, apart from the
financial 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 otherwise obtain in
any proceeding or action instituted with respect to a
violation of this section.
``(3) Response.--With respect to a justification offered by
a manufacturer under paragraph (2), complaint counsel or the
Commission, as applicable, will prevail in its case if it
establishes by a preponderance of the evidence that--
``(A) the conduct described in subsection (b)(1) is
not reasonably necessary to address or achieve the
justifications claimed under paragraph (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 provided 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 Commission Act, any
manufacturer that is subject to a final order of the
Commission that is issued in a proceeding initiated
under paragraph (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 Appeals
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 review of an
order issued by the Commission conducted 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 paragraph (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 obtain 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, impair, 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 Commission Act, as added by subsection (a), including
by defining any terms used in such section 27 (other than terms that
are defined in subsection (a) of such section 27).
<all>