I 
115TH CONGRESS 
1ST SESSION H. R. 2212 
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 
APRIL 27, 2017 
Mr. MARINO (for himself and Mr. CICILLINE) 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 subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To promote competition in the market for drugs and biologi-
cal 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 Representa-
tives 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 2017’’ or the 
‘‘CREATES Act of 2017’’. 
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SEC. 2. FINDINGS. 
Congress finds the following: 
(1) It is the policy of the United States to pro-
mote competition in the market for drugs and bio-
logical products by facilitating the timely entry of 
low-cost generic and biosimilar versions of those 
drugs and biological products. 
(2) Since their enactment in 1984 and 2010, 
respectively, the Drug Price Competition and Patent 
Term Restoration Act of 1984 (Public Law 98–417; 
98 Stat. 1585) and the Biologics Price Competition 
and Innovation Act of 2009 (Subtitle A of title VII 
of Public Law 111–148; 124 Stat. 804), have pro-
vided pathways for making lower-cost versions of 
previously approved drugs and previously licensed bi-
ological products available to the people of the 
United States in a timely manner, thereby lowering 
overall prescription drug costs for patients and tax-
payers by billions of dollars each year. 
(3) In order for these pathways to function as 
intended, developers of generic drugs and biosimilar 
biological products (referred to in this section as 
‘‘generic product developers’’) must be able to obtain 
quantities of the reference listed drug or biological 
product with which the generic drug or biosimilar bi-
ological product is intended to compete (referred to 
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in this section as a ‘‘covered product’’) for purposes 
of supporting an application for approval by the 
Food and Drug Administration, including for testing 
to show that— 
(A) a prospective generic drug is bioequiva-
lent to the covered product in accordance with 
subsection (j) of section 505 of the Federal, 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355), or meets the requirements for approval of 
an application submitted under subsection 
(b)(2) of that section; or 
(B) a prospective biosimilar biological 
product is biosimilar to or interchangeable with 
its reference biological product under section 
351(k) of the Public Health Service Act (42 
U.S.C. 262(k)), as applicable. 
(4) For drugs and biological products that are 
subject to a risk evaluation and mitigation strategy, 
another essential component in the creation of low- 
cost generic and biosimilar versions of covered prod-
ucts is the ability of generic product developers to 
join the manufacturer of the covered product (re-
ferred to in this section as the ‘‘license holder’’) in 
a single, shared system of elements to assure safe 
use and supporting agreements, or secure a variance 
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therefrom, as required by section 505–1 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355– 
1). 
(5) Contrary to the policy of the United States 
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, certain license holders 
are preventing generic product developers from ob-
taining quantities of the covered product necessary 
for the generic product developer to support an ap-
plication for approval by the Food and Drug Admin-
istration, including testing to show bioequivalence, 
biosimilarity, or interchangeability to the covered 
product, in some instances based on the justification 
that the covered product is subject to a risk evalua-
tion and mitigation strategy with elements to assure 
safe use under section 505–1 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355–1). 
(6) The Director of the Center for Drug Eval-
uation and Research at the Food and Drug Admin-
istration has testified that some manufacturers of 
covered products have used REMS and distribution 
restrictions adopted by the manufacturer on their 
own behalf as reasons to not sell quantities of a cov-
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ered product to generic product developers, causing 
barriers and delays in getting generic products on 
the market. The Food and Drug Administration has 
reported receiving significant numbers of inquiries 
from generic product developers who were unable to 
obtain samples of covered products to conduct nec-
essary testing and otherwise meet requirements for 
approval of generic drugs. 
(7) The Chairwoman of the Federal Trade 
Commission has testified that the Federal Trade 
Commission continues to be very concerned about 
potential abuses by manufacturers of brand drugs of 
REMS or other closed distribution systems to im-
pede generic competition. 
(8) Also contrary to the policy of the United 
States 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, cer-
tain license holders are impeding the prompt nego-
tiation and development on commercially reasonable 
terms of a single, shared system of elements to as-
sure safe use, which may be necessary for the ge-
neric product developer to gain approval for its drug 
or licensing for its biological product. 
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(9) While the antitrust laws may address the 
refusal by some license holders to provide quantities 
of a covered product to a generic product developer, 
a more tailored legal pathway would help ensure 
that generic product developers can obtain necessary 
quantities of a covered product in a timely way for 
purposes of developing a generic drug or biosimilar 
biological product, facilitating competition in the 
marketplace for drugs and biological products. 
(10) The antitrust laws may address actions by 
license holders who impede the prompt negotiation 
and development of a single, shared system of ele-
ments to assure safe use, and the Food and Drug 
Administration has some authority to waive the re-
quirement of a single, shared system. Clearer regu-
latory authority to approve different systems that 
meet the statutory requirements to ensure patient 
safety, however, would limit the effectiveness of bad 
faith negotiations over single, shared systems to 
delay generic approval. At the same time, clearer 
regulatory authority would ensure all systems pro-
tect patient safety. 
SEC. 3. ACTIONS FOR DELAYS OF GENERIC DRUGS AND 
BIOSIMILAR BIOLOGICAL PRODUCTS. 
(a) DEFINITIONS.—In this section— 
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(1) the term ‘‘covered product’’— 
(A) means— 
(i) any drug approved under sub-
section (b) or (j) of section 505 of the Fed-
eral 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 bio-
logical product described in clause (i); or 
(iii) when reasonably necessary to 
demonstrate sameness, biosimilarity, or 
interchangeability for purposes of section 
505 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355), or section 351 
of the Public Health Service Act (42 
U.S.C. 262), as applicable, any product, 
including any device, that is marketed or 
intended for use with such drug or biologi-
cal product; and 
(B) does not include any drug or biological 
product that the Secretary has determined to be 
currently in shortage and that appears on the 
drug shortage list in effect under section 506E 
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of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 356e), unless the shortage will not 
be promptly resolved— 
(i) as demonstrated by the fact that 
the drug or biological product has been in 
shortage for more than 6 months; or 
(ii) as otherwise determined by the 
Secretary; 
(2) 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); 
(3) the term ‘‘eligible product developer’’ means 
a person that seeks to develop a product for ap-
proval 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 sec-
tion 351(k) of the Public Health Service Act (42 
U.S.C. 262(k)); 
(4) 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 li-
cense under subsection (a) or (k) of section 351 of 
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the Public Health Service Act (42 U.S.C. 262) for 
a covered product; 
(5) 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); 
(6) the term ‘‘REMS with ETASU’’ means a 
REMS that contains elements to assure safe use 
under section 505–1 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355–1); 
(7) the term ‘‘Secretary’’ means the Secretary 
of Health and Human Services; 
(8) 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 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355–1); and 
(9) the term ‘‘sufficient quantities’’ means an 
amount of a covered product that allows the eligible 
product developer to— 
(A) conduct testing to support an applica-
tion— 
(i) for approval under subsection 
(b)(2) or (j) of section 505 of the Federal 
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Food, Drug, and Cosmetic Act (21 U.S.C. 
355); or 
(ii) for licensing under section 351(k) 
of the Public Health Service Act (42 
U.S.C. 262(k)); and 
(B) fulfill any regulatory requirements re-
lating to such an application for approval or li-
censing. 
(b) CIVIL ACTION FOR FAILURE TO PROVIDE SUFFI-
CIENT 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 sub-
section in an appropriate district court of the United 
States alleging that the license holder has declined 
to provide sufficient quantities of the covered prod-
uct to the eligible product developer on commercially 
reasonable, market-based terms. 
(2) ELEMENTS.— 
(A) IN GENERAL.—To prevail in a civil ac-
tion brought under paragraph (1), an eligible 
product developer shall prove, by a preponder-
ance of the evidence— 
(i) that— 
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(I) the covered product is not 
subject to a REMS with ETASU; or 
(II) if the covered product is sub-
ject to a REMS with ETASU— 
(aa) the eligible product de-
veloper has obtained a covered 
product authorization from the 
Secretary in accordance with sub-
paragraph (B); and 
(bb) the eligible product de-
veloper 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 rea-
sonable, market-based terms; 
(iii) that the eligible product developer 
has requested to purchase sufficient quan-
tities of the covered product from the li-
cense holder; and 
(iv) that the license holder has not de-
livered to the eligible product developer 
sufficient quantities of the covered product 
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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 re-
ceived 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 re-
quest 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 ac-
cordance with subparagraph (B). 
(B) AUTHORIZATION FOR COVERED PROD-
UCT SUBJECT TO A REMS WITH ETASU.— 
(i) REQUEST.—An eligible product de-
veloper may submit to the Secretary a 
written request for the eligible product de-
veloper to be authorized to obtain suffi-
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cient quantities of an individual covered 
product subject to a REMS with ETASU. 
(ii) AUTHORIZATION.—Not later than 
90 days after the date on which a request 
under clause (i) is received, the Secretary 
shall, by written notice, authorize the eligi-
ble product developer to obtain sufficient 
quantities of an individual covered product 
subject to a REMS with ETASU for pur-
poses 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 proto-
cols, 
informed 
consent 
docu-
ments, and informational mate-
rials for testing that include pro-
tections that provide safety pro-
tections comparable to those pro-
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vided by the REMS for the cov-
ered product; or 
(BB) otherwise satisfied the 
Secretary that such protections 
will be provided; and 
(bb) met any other require-
ments the Secretary may estab-
lish. 
(iii) NOTICE.—A covered product au-
thorization 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 affirma-
tive 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 suffi-
cient quantities of the covered product from the 
license holder— 
(i) neither the license holder nor any 
of its agents, wholesalers, or distributors 
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was engaged in the manufacturing or com-
mercial 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 reason-
able, market-based terms; or 
(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 devel-
opers; and 
(iii) the covered product can be pur-
chased by the eligible product developer in 
sufficient quantities on commercially rea-
sonable, market-based terms from the 
agents, distributors, or wholesalers of the 
license holder. 
(4) REMEDIES.— 
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(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, mar-
ket-based terms; 
(ii) award to the eligible product de-
veloper reasonable attorney fees and costs 
of the civil action; and 
(iii) award to the eligible product de-
veloper a monetary amount sufficient to 
deter the license holder from failing to pro-
vide other eligible product developers with 
sufficient quantities of a covered product 
on commercially reasonable, market-based 
terms, if the court finds, by a preponder-
ance of the evidence— 
(I) that the license holder delayed 
providing sufficient quantities of the 
covered product to the eligible product 
developer without a legitimate busi-
ness justification; or 
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