[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2374 Introduced in House (IH)]
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116th CONGRESS
1st Session
H. R. 2374
To enable the Federal Trade Commission to deter filing of sham citizen
petitions to cover an attempt to interfere with approval of a competing
generic drug or biosimilar, to foster competition and facilitate the
efficient review of petitions filed in good faith to raise legitimate
public heath concerns, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 29, 2019
Mr. Jeffries (for himself, Mr. Sensenbrenner, Mr. Nadler, Mr. Collins
of Georgia, Mr. Cicilline, and Mr. Welch) introduced the following
bill; which was referred to the Committee on the Judiciary
_______________________________________________________________________
A BILL
To enable the Federal Trade Commission to deter filing of sham citizen
petitions to cover an attempt to interfere with approval of a competing
generic drug or biosimilar, to foster competition and facilitate the
efficient review of petitions filed in good faith to raise legitimate
public heath concerns, 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 ``Stop Significant and Time-wasting
Abuse Limiting Legitimate Innovation of New Generics Act'' or the
``Stop STALLING Act''.
SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT AGAINST SHAM PETITIONS.
(a) Definitions.--In this section:
(1) Commission.--The term ``Commission'' means the Federal
Trade Commission.
(2) Covered application.--The term ``covered application''
means an application filed pursuant to subsection (b)(2) or (j)
of section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) or section 351(k) of the Public Health Service Act
(42 U.S.C. 262(k)).
(3) Covered petition.--The term ``covered petition'' means
a petition, or a supplement to a petition, filed under section
505(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(q)).
(4) Person.--The term ``person'' means--
(A) an individual or entity;
(B) its directors, officers, employees, agents,
representatives, successors, and assigns; and
(C) the joint ventures, subsidiaries, partnerships,
divisions, groups, and affiliates it controls, and the
respective directors, officers, employees, agents,
representatives, successors, and assigns of each.
(5) Series of covered petitions.--The term ``series of
covered petitions'' means any group of more than one covered
petition.
(6) Sham.--The term ``sham'' means a covered petition that
is objectively baseless and that attempts to use a governmental
process, as opposed to the outcome of that process, to
interfere with the business of a competitor, or a series of
covered petitions, that attempts to use a governmental process,
as opposed to the outcome of that process, to interfere with
the business of a competitor.
(b) Violation.--
(1) In general.--A person submitting or causing the
submission of a covered petition or a series of covered
petitions that is a sham shall be liable for engaging in an
unfair method of competition under section 5(a)(1) of the
Federal Trade Commission Act (15 U.S.C. 45(a)(1)).
(c) Civil Action.--
(1) In general.--If the Commission has reason to believe
that the submission of a covered petition or a series of
covered petitions constitutes a violation of section 5(a)(1) of
the Federal Trade Commission Act (15 U.S.C. 45(a)(1)), the
Commission may commence a civil action to recover a civil
penalty and seek other appropriate relief in a district court
of the United States against any person that submitted or
caused to be submitted such covered petition or such series of
covered petitions, including successors or assigns.
(2) Presumption.--In a civil action under paragraph (1), a
covered petition shall be presumed to be part of a series of
covered petitions that is a sham under subsection (b) of this
section if the Secretary of Health and Human Services has
determined that the covered petition was submitted with the
primary purpose of delaying the approval of a covered
application, was part of a series of covered petitions, and has
referred such determination to the Federal Trade Commission in
writing, with a reasoned basis for the determination.
(3) Exception.--The presumption in paragraph (2) shall not
apply if the defendant establishes, by a preponderance of the
evidence, that the series of covered petitions that includes
the covered petition referred to the Commission by the
Secretary of Health and Human Services is not a sham.
(4) Civil penalty.--In an action under paragraph (1), any
person that has been found liable for a violation of section
5(a)(1) of the Federal Trade Commission Act (15 U.S.C.
45(a)(1)) shall be subject to a civil penalty for each
violation of not more than the greater of--
(A) any revenue earned from the sale by such person
of any drug product, referenced in a covered
application that was the subject of a covered petition
or a series of covered petitions that is a sham, during
the period in which the covered petition or series of
covered petitions was under review by the Secretary of
Health and Human Services; or
(B) $50,000 for each calendar day that each covered
petition that is a sham or that was part of a series of
covered petitions that is a sham was under review by
the Secretary of Health and Human Services.
(5) Antitrust laws.--Nothing in 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.
(6) Rule of construction.--The civil penalty provided in
this subsection is in addition to, and not in lieu of, any
other remedies provided by Federal law, including under section
16 of the Clayton Act (15 U.S.C. 26) or under section 13(b) of
the Federal Trade Commission Act (15 U.S.C. 53(b)). Nothing in
this paragraph shall be construed to affect any authority of
the Commission under any other provision of law.
(d) Applicability.--This section shall apply to any covered
petition submitted on or after the date of enactment of this Act.
SEC. 3. SEVERABILITY.
If any provision of this Act, an amendment made by this Act, or the
application of such provision or amendment to any person or
circumstance is held to be unconstitutional, the remainder of this Act,
the amendments made by this Act, and the application of the provisions
of such Act or amendments to any person or circumstance shall not be
affected.
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