[Congressional Record Volume 170, Number 115 (Thursday, July 11, 2024)]
[Senate]
[Pages S5082-S5083]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 2871. Ms. KLOBUCHAR (for herself and Mr. Grassley) submitted an
amendment intended to be proposed by her to the bill S. 4638, to
authorize appropriations for fiscal year 2025 for military activities
of the Department of Defense, for military construction, and for
defense activities of the Department of Energy, to prescribe military
personnel strengths for such fiscal year, and for other purposes; which
was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. _____. 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''--
(A) means an individual or entity; and
(B) includes--
(i) a successor or an assign of an entity;
(ii) a joint venture, subsidiary, partnership, division,
group, or affiliate controlled by an entity; and
(iii) a successor or an assign of a joint venture,
subsidiary, partnership, division, group, or affiliate
controlled by an entity.
(5) Series of covered petitions.--The term ``series of
covered petitions'' means any group of more than 1 covered
petition relating to the same covered application.
(6) Sham.--The term ``sham'' means--
(A) a covered petition that--
(i) is objectively baseless; and
(ii) attempts to use a governmental process, as opposed to
the outcome of that process, to interfere with the business
of a competitor; or
(B) 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.--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.
(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--
(A) the Secretary of Health and Human Services--
(i) has determined that the covered petition was submitted
with the primary purpose of delaying the approval of a
covered application; and
(ii) has referred such determination to the Commission in
writing, including a reasoned basis for the determination;
and
(B) the covered petition was part of a series of covered
petitions.
(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
[[Page S5083]]
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 during 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) Review of referral.--No referral by the Secretary of
Health and Human Services under paragraph (2)(A) shall be
subject to judicial review, except as a third-party claim
asserted by the defendant under section 706(2)(A) of title 5,
United States Code, against the Secretary of Health and Human
Services or the Department of Health and Human Services, as
part of a civil action commenced under paragraph (1).
(6) 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), 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.
(7) 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)).
(d) Applicability.--This section shall apply to any covered
petition submitted on or after the date of enactment of this
Act.
(e) Rule of Construction.--Nothing in this section shall be
construed to limit any authority of the Commission under any
other provision of law.
(f) Severability.--If any provision of this section or the
application of such provision to any person or circumstance
is held to be unconstitutional, the remainder of this section
and the application of the provisions of such section to any
person or circumstance shall not be affected.
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