[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 965 Reported in House (RH)]
<DOC>
Union Calendar No. 33
116th CONGRESS
1st Session
H. R. 965
[Report No. 116-55, Parts I and II]
To promote competition in the market for drugs and biological products
by facilitating the timely entry of lower-cost generic and biosimilar
versions of those drugs and biological products.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 5, 2019
Mr. Cicilline (for himself, Mr. Sensenbrenner, Mr. Nadler, Mr. Collins
of Georgia, Mr. Welch, and Mr. McKinley) introduced the following bill;
which was referred to the Committee on Energy and Commerce, and in
addition to the Committee on the Judiciary, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
May 10, 2019
Additional sponsors: Mr. Meadows, Ms. Finkenauer, Mr. Doggett, Mr.
Cole, Mr. Gallagher, Mr. Lipinski, Mr. Rush, Ms. McCollum, Mr. Pallone,
Mr. Perry, Mr. Ruiz, Mrs. Dingell, Ms. Eshoo, Ms. Matsui, Mrs. Craig,
Mr. Tonko, Mr. Gohmert, Mr. Van Drew, Ms. Clarke of New York, Mr.
Courtney, Mr. Allred, Ms. Schakowsky, Mr. Crow, Mr. Gonzalez of Ohio,
Mr. Larson of Connecticut, Mr. McAdams, Mr. Schrader, Mr. Rodney Davis
of Illinois, Mr. Pappas, Mr. Kennedy, Ms. Davids of Kansas, Mr.
Norcross, Ms. Spanberger, Mr. Quigley, Mr. Deutch, Mr. Langevin, Mr.
Cooper, Mrs. McBath, Mr. Raskin, Ms. Mucarsel-Powell, Mr. Stanton, Mr.
Jordan, Ms. Wild, Mr. Cohen, Mr. Kim, Ms. Schrier, Mr. Joyce of Ohio,
Mr. Case, Mr. Khanna, Mr. David Scott of Georgia, Ms. Houlahan, Mr.
Casten of Illinois, Mr. Norman, Ms. Pingree, Mr. Carbajal, Mr. Smith of
Washington, Ms. Wexton, Mr. Cisneros, Mr. Connolly, Ms. Underwood, Ms.
Garcia of Texas, Ms. Meng, and Mrs. Bustos
May 10, 2019
Reported from the Committee on Energy and Commerce with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
May 10, 2019
Reported from the Committee on the Judiciary; committed to the
Committee of the Whole House on the State of the Union and ordered to
be printed
[For text of introduced bill, see copy of bill as introduced on
February 5, 2019]
_______________________________________________________________________
A BILL
To promote competition in the market for drugs and biological products
by facilitating the timely entry of lower-cost generic and biosimilar
versions of those drugs and biological products.
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 ``Creating and Restoring Equal Access
to Equivalent Samples Act of 2019'' or the ``CREATES Act of 2019''.
SEC. 2. ACTIONS FOR DELAYS OF GENERIC DRUGS AND BIOSIMILAR BIOLOGICAL
PRODUCTS.
(a) Definitions.--In this section--
(1) the term ``commercially reasonable, market-based
terms'' means--
(A) a nondiscriminatory price for the sale of the
covered product at or below, but not greater than, the
most recent wholesale acquisition cost for the drug, as
defined in section 1847A(c)(6)(B) of the Social
Security Act (42 U.S.C. 1395w-3a(c)(6)(B));
(B) a schedule for delivery that results in the
transfer of the covered product to the eligible product
developer consistent with the timing under subsection
(b)(2)(A)(iv); and
(C) no additional conditions are imposed on the
sale of the covered product;
(2) the term ``covered product''--
(A) means--
(i) any drug approved under subsection (c)
or (j) of section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) or
biological product licensed under subsection
(a) or (k) of section 351 of the Public Health
Service Act (42 U.S.C. 262);
(ii) any combination of a drug or
biological product described in clause (i); or
(iii) when reasonably necessary to support
approval of an application under section 505 of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), or section 351 of the Public
Health Service Act (42 U.S.C. 262), as
applicable, or otherwise meet the requirements
for approval under either such section, any
product, including any device, that is marketed
or intended for use with such a drug or
biological product; and
(B) does not include any drug or biological product
that appears on the drug shortage list in effect under
section 506E of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356e), unless--
(i) the drug or biological product has been
on the drug shortage list in effect under such
section 506E continuously for more than 6
months; or
(ii) the Secretary determines that
inclusion of the drug or biological product as
a covered product is likely to contribute to
alleviating or preventing a shortage.
(3) the term ``device'' has the meaning given the term in
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321);
(4) the term ``eligible product developer'' means a person
that seeks to develop a product for approval pursuant to an
application for approval under subsection (b)(2) or (j) of
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) or for licensing pursuant to an application under
section 351(k) of the Public Health Service Act (42 U.S.C.
262(k));
(5) the term ``license holder'' means the holder of an
application approved under subsection (c) or (j) of section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
the holder of a license under subsection (a) or (k) of section
351 of the Public Health Service Act (42 U.S.C. 262) for a
covered product;
(6) the term ``REMS'' means a risk evaluation and
mitigation strategy under section 505-1 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355-1);
(7) the term ``REMS with ETASU'' means a REMS that contains
elements to assure safe use under section 505-1(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f));
(8) the term ``Secretary'' means the Secretary of Health
and Human Services;
(9) the term ``single, shared system of elements to assure
safe use'' means a single, shared system of elements to assure
safe use under section 505-1(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355-1(f)); and
(10) the term ``sufficient quantities'' means an amount of
a covered product that the eligible product developer
determines allows it to--
(A) conduct testing to support an application
under--
(i) subsection (b)(2) or (j) of section 505
of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355); or
(ii) section 351(k) of the Public Health
Service Act (42 U.S.C. 262(k)); and
(B) fulfill any regulatory requirements relating to
approval of such an application.
(b) Civil Action for Failure To Provide Sufficient Quantities of a
Covered Product.--
(1) In general.--An eligible product developer may bring a
civil action against the license holder for a covered product
seeking relief under this subsection in an appropriate district
court of the United States alleging that the license holder has
declined to provide sufficient quantities of the covered
product to the eligible product developer on commercially
reasonable, market-based terms.
(2) Elements.--
(A) In general.--To prevail in a civil action
brought under paragraph (1), an eligible product
developer shall prove, by a preponderance of the
evidence--
(i) that--
(I) the covered product is not
subject to a REMS with ETASU; or
(II) if the covered product is
subject to a REMS with ETASU--
(aa) the eligible product
developer has obtained a
covered product authorization
from the Secretary in
accordance with subparagraph
(B); and
(bb) the eligible product
developer has provided a copy
of the covered product
authorization to the license
holder;
(ii) that, as of the date on which the
civil action is filed, the product developer
has not obtained sufficient quantities of the
covered product on commercially reasonable,
market-based terms;
(iii) that the eligible product developer
has requested to purchase sufficient quantities
of the covered product from the license holder;
and
(iv) that the license holder has not
delivered to the eligible product developer
sufficient quantities of the covered product on
commercially reasonable, market-based terms--
(I) for a covered product that is
not subject to a REMS with ETASU, by
the date that is 31 days after the date
on which the license holder received
the request for the covered product;
and
(II) for a covered product that is
subject to a REMS with ETASU, by 31
days after the later of--
(aa) the date on which the
license holder received the
request for the covered
product; or
(bb) the date on which the
license holder received a copy
of the covered product
authorization issued by the
Secretary in accordance with
subparagraph (B).
(B) Authorization for covered product subject to a
rems with etasu.--
(i) Request.--An eligible product developer
may submit to the Secretary a written request
for the eligible product developer to be
authorized to obtain sufficient quantities of
an individual covered product subject to a REMS
with ETASU.
(ii) Authorization.--Not later than 120
days after the date on which a request under
clause (i) is received, the Secretary shall, by
written notice, authorize the eligible product
developer to obtain sufficient quantities of an
individual covered product subject to a REMS
with ETASU for purposes of--
(I) development and testing that
does not involve human clinical trials,
if the eligible product developer has
agreed to comply with any conditions
the Secretary determines necessary; or
(II) development and testing that
involves human clinical trials, if the
eligible product developer has--
(aa)(AA) submitted
protocols, informed consent
documents, and informational
materials for testing that
include protections that
provide safety protections
comparable to those provided by
the REMS for the covered
product; or
(BB) otherwise satisfied
the Secretary that such
protections will be provided;
and
(bb) met any other
requirements the Secretary may
establish.
(iii) Notice.--A covered product
authorization issued under this subparagraph
shall state that the provision of the covered
product by the license holder under the terms
of the authorization will not be a violation of
the REMS for the covered product.
(3) Affirmative defense.--In a civil action brought under
paragraph (1), it shall be an affirmative defense, on which the
defendant has the burden of persuasion by a preponderance of
the evidence--
(A) that, on the date on which the eligible product
developer requested to purchase sufficient quantities
of the covered product from the license holder--
(i) neither the license holder nor any of
its agents, wholesalers, or distributors was
engaged in the manufacturing or commercial
marketing of the covered product; and
(ii) neither the license holder nor any of
its agents, wholesalers, or distributors
otherwise had access to inventory of the
covered product to supply to the eligible
product developer on commercially reasonable,
market-based terms;
(B) that--
(i) the license holder sells the covered
product through agents, distributors, or
wholesalers;
(ii) the license holder has placed no
restrictions, explicit or implicit, on its
agents, distributors, or wholesalers to sell
covered products to eligible product
developers; and
(iii) the covered product can be purchased
by the eligible product developer in sufficient
quantities on commercially reasonable, market-
based terms from the agents, distributors, or
wholesalers of the license holder; or
(C) that the license holder made an offer to sell
sufficient quantities of the covered product to the
eligible product developer at commercially reasonable
market-based terms--
(i) for a covered product that is not
subject to a REMS with ETASU, by the date that
is 14 days after the date on which the license
holder received the request for the covered
product, and the eligible product developer did
not accept such offer by the date that is 7
days after the date on which the eligible
product developer received such offer from the
license holder; or
(ii) for a covered product that is subject
to a REMS with ETASU, by the date that is 20
days after the date on which the license holder
received the request for the covered product,
and the eligible product developer did not
accept such offer by the date that is 10 days
after the date on which the eligible product
developer received such offer from the license
holder.
(4) Methods for transmission of requests for covered
products.--A written request for a covered product, offer to
sell a covered product, or acceptance of such an offer between
the eligible product developer and the license holder shall be
made by--
(A) certified or registered mail with return
receipt requested;
(B) personal delivery; or
(C) electronic means.
(5) Remedies.--
(A) In general.--If an eligible product developer
prevails in a civil action brought under paragraph (1),
the court shall--
(i) order the license holder to provide to
the eligible product developer without delay
sufficient quantities of the covered product on
commercially reasonable, market-based terms;
(ii) award to the eligible product
developer reasonable attorney's fees and costs
of the civil action; and
(iii) award to the eligible product
developer a monetary amount sufficient to deter
the license holder from failing to provide
eligible product developers with sufficient
quantities of a covered product on commercially
reasonable, market-based terms, if the court
finds, by a preponderance of the evidence--
(I) that the license holder delayed
providing sufficient quantities of the
covered product to the eligible product
developer without a legitimate business
justification; or
(II) that the license holder failed
to comply with an order issued under
clause (i).
(B) Maximum monetary amount.--A monetary amount
awarded under subparagraph (A)(iii) shall not be
greater than the revenue that the license holder earned
on the covered product during the period--
(i) beginning on--
(I) for a covered product that is
not subject to a REMS with ETASU, the
date that is 31 days after the date on
which the license holder received the
request; or
(II) for a covered product that is
subject to a REMS with ETASU, the date
that is 31 days after the later of--
(aa) the date on which the
license holder received the
request; or
(bb) the date on which the
license holder received a copy
of the covered product
authorization issued by the
Secretary in accordance with
paragraph (2)(B); and
(ii) ending on the date on which the
eligible product developer received sufficient
quantities of the covered product.
(C) Avoidance of delay.--The court may issue an
order under subparagraph (A)(i) before conducting
further proceedings that may be necessary to determine
whether the eligible product developer is entitled to
an award under clause (ii) or (iii) of subparagraph
(A), or the amount of any such award.
(c) Limitation of Liability.--A license holder for a covered
product shall not be liable for any claim under Federal, State, or
local law arising out of the failure of an eligible product developer
to follow adequate safeguards to assure safe use of the covered product
during development or testing activities described in this section,
including transportation, handling, use, or disposal of the covered
product by the eligible product developer.
(d) No Violation of REMS.--Section 505-1 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355-1) is amended by adding at the end the
following new subsection:
``(l) Provision of Samples Not a Violation of Strategy.--The
provision of samples of a covered product to an eligible product
developer (as those terms are defined in section 2(a) of the Creating
and Restoring Equal Access to Equivalent Samples Act of 2019) shall not
be considered a violation of the requirements of any risk evaluation
and mitigation strategy that may be in place under this section for
such drug.''.
(e) Rule of Construction.--
(1) Definition.--In this subsection, the term ``antitrust
laws''--
(A) has the meaning given the term in subsection
(a) of the first section of the Clayton Act (15 U.S.C.
12); and
(B) includes section 5 of the Federal Trade
Commission Act (15 U.S.C. 45) to the extent that such
section applies to unfair methods of competition.
(2) Antitrust laws.--Nothing in this section shall be
construed to limit the operation of any provision of the
antitrust laws.
SEC. 3. REMS APPROVAL PROCESS FOR SUBSEQUENT FILERS.
Section 505-1 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355-1), as amended by section 2, is further amended--
(1) in subsection (g)(4)(B)--
(A) in clause (i) by striking ``or'' after the
semicolon;
(B) in clause (ii) by striking the period at the
end and inserting ``; or''; and
(C) by adding at the end the following:
``(iii) accommodate different, comparable
aspects of the elements to assure safe use for
a drug that is the subject of an application
under section 505(j), and the applicable listed
drug.'';
(2) in subsection (i)(1), by striking subparagraph (C) and
inserting the following:
``(C)(i) Elements to assure safe use, if required
under subsection (f) for the listed drug, which,
subject to clause (ii), for a drug that is the subject
of an application under section 505(j) may use--
``(I) a single, shared system with the
listed drug under subsection (f); or
``(II) a different, comparable aspect of
the elements to assure safe use under
subsection (f).
``(ii) The Secretary may require a drug that is the
subject of an application under section 505(j) and the
listed drug to use a single, shared system under
subsection (f), if the Secretary determines that no
different, comparable aspect of the elements to assure
safe use could satisfy the requirements of subsection
(f).'';
(3) in subsection (i), by adding at the end the following:
``(3) Shared rems.--If the Secretary approves, in
accordance with paragraph (1)(C)(i)(II), a different,
comparable aspect of the elements to assure safe use under
subsection (f) for a drug that is the subject of an abbreviated
new drug application under section 505(j), the Secretary may
require that such different comparable aspect of the elements
to assure safe use can be used with respect to any other drug
that is the subject of an application under section 505(j) or
505(b) that references the same listed drug.''; and
(4) by adding at the end the following:
``(m) Separate REMS.--When used in this section, the terms
`different, comparable aspect of the elements to assure safe use' or
`different, comparable approved risk evaluation and mitigation
strategies' means a risk evaluation and mitigation strategy for a drug
that is the subject of an application under section 505(j) that uses
different methods or operational means than the strategy required under
subsection (a) for the applicable listed drug, or other application
under section 505(j) with the same such listed drug, but achieves the
same level of safety as such strategy.''.
SEC. 4. RULE OF CONSTRUCTION.
(a) In General.--Nothing in this Act, the amendments made by this
Act, or in section 505-1 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355-1), shall be construed as--
(1) prohibiting a license holder from providing an eligible
product developer access to a covered product in the absence of
an authorization under this Act; or
(2) in any way negating the applicability of a REMS with
ETASU, as otherwise required under such section 505-1, with
respect to such covered product.
(b) Definitions.--In this section, the terms ``covered product'',
``eligible product developer'', ``license holder'', and ``REMS with
ETASU'' have the meanings given such terms in section 3(a).
Union Calendar No. 33
116th CONGRESS
1st Session
H. R. 965
[Report No. 116-55, Parts I and II]
_______________________________________________________________________
A BILL
To promote competition in the market for drugs and biological products
by facilitating the timely entry of lower-cost generic and biosimilar
versions of those drugs and biological products.
_______________________________________________________________________
May 10, 2019
Reported from the Committee on Energy and Commerce with an amendment
May 10, 2019
Reported from the Committee on the Judiciary; committed to the
Committee of the Whole House on the State of the Union and ordered to
be printed