[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1224 Reported in Senate (RS)]
<DOC>
Calendar No. 130
116th CONGRESS
1st Session
S. 1224
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 SENATE OF THE UNITED STATES
April 29, 2019
Ms. Klobuchar (for herself and Mr. Grassley) introduced the following
bill; which was read twice and referred to the Committee on the
Judiciary
June 28 (legislative day, June 27), 2019
Reported by Mr. Graham, with an amendment and an amendment to the title
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> 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''.</DELETED>
<DELETED>SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT AGAINST SHAM
PETITIONS.</DELETED>
<DELETED> (a) Definitions.--In this section:</DELETED>
<DELETED> (1) Commission.--The term ``Commission'' means the
Federal Trade Commission.</DELETED>
<DELETED> (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)).</DELETED>
<DELETED> (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)).</DELETED>
<DELETED> (4) Person.--The term ``person''--</DELETED>
<DELETED> (A) means an individual or entity;
and</DELETED>
<DELETED> (B) includes--</DELETED>
<DELETED> (i) a director, officer, employee,
agent, representative, successor, and assign of
an entity;</DELETED>
<DELETED> (ii) a joint venture, subsidiary,
partnership, division, group, and affiliate
controlled by an entity; and</DELETED>
<DELETED> (iii) a director, officer,
employee, agent, representative, successor, and
assign of a joint venture, subsidiary,
partnership, division, group, and affiliate
controlled by an entity.</DELETED>
<DELETED> (5) Series of covered petitions.--The term
``series of covered petitions'' means any group of more than 1
covered petition.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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)).</DELETED>
<DELETED> (c) Civil Action.--</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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 and 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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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--</DELETED>
<DELETED> (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</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (d) Applicability.--This section shall apply to any
covered petition submitted on or after the date of enactment of this
Act.</DELETED>
<DELETED>SEC. 3. SEVERABILITY.</DELETED>
<DELETED> If any provision of this Act or the application of such
provision to any person or circumstance is held to be unconstitutional,
the remainder of this Act and the application of the provisions of such
Act to any person or circumstance shall not be affected.</DELETED>
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''--
(A) means an individual or entity; and
(B) includes--
(i) a successor and an assign of an entity;
and
(ii) a joint venture, subsidiary,
partnership, division, group, and affiliate
controlled by an entity, and
(iii) a successor and an assign of a joint
venture, subsidiary, partnership, division,
group, and 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 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.--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--
(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
Federal Trade 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 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 or the application of such provision
to any person or circumstance is held to be unconstitutional, the
remainder of this Act and the application of the provisions of such Act
to any person or circumstance shall not be affected.
Amend the title so as to read: ``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 health concerns, and for other
purposes.''.
Calendar No. 130
116th CONGRESS
1st Session
S. 1224
_______________________________________________________________________
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.
_______________________________________________________________________
June 28 (legislative day, June 27), 2019
Reported with an amendment and an amendment to the title