I 

116TH CONGRESS 

1ST SESSION H. R. 965 

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 

A BILL 

To promote competition in the market for drugs and biological products by facilitating the timely entry of lowercost generic and biosimilar versions of those drugs and 

biological products. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Creating and Restoring 

5 Equal Access to Equivalent Samples Act of 2019’’ or the 

6 ‘‘CREATES Act of 2019’’. 


pbinns on DSK79D2C42PROD with BILLS
2 

•HR 965 IH

1 SEC. 2. FINDINGS. 

2 Congress finds the following: 

3 (1) It is the policy of the United States to pro4 mote competition in the market for drugs and bio5 logical products by facilitating the timely entry of 

6 low-cost generic and biosimilar versions of those 

7 drugs and biological products. 

8 (2) Since their enactment in 1984 and 2010, 

9 respectively, the Drug Price Competition and Patent 

10 Term Restoration Act of 1984 (Public Law 98–417; 

11 98 Stat. 1585) and the Biologics Price Competition 

12 and Innovation Act of 2009 (subtitle A of title VII 

13 of Public Law 111–148; 124 Stat. 804), have pro14 vided pathways for making lower-cost versions of 

15 previously approved drugs and previously licensed bi16 ological products available to the people of the 

17 United States in a timely manner, thereby lowering 

18 overall prescription drug costs for patients and tax19 payers by billions of dollars each year. 

20 (3) In order for these pathways to function as 

21 intended, developers of generic drugs and biosimilar 

22 biological products (referred to in this section as 

23 ‘‘generic product developers’’) must be able to obtain 

24 quantities of the reference listed drug or biological 

25 product with which the generic drug or biosimilar bi26 ological product is intended to compete (referred to 


pbinns on DSK79D2C42PROD with BILLS
3 

•HR 965 IH

1 in this section as a ‘‘covered product’’) for purposes 

2 of supporting an application for approval by the 

3 Food and Drug Administration, including for testing 

4 to show that— 

5 (A) a prospective generic drug is bioequiva6 lent to the covered product in accordance with 

7 subsection (j) of section 505 of the Federal, 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 

9 355), or meets the requirements for approval of 

10 an application submitted under subsection 

11 (b)(2) of that section; or 

12 (B) a prospective biosimilar biological 

13 product is biosimilar to or interchangeable with 

14 its reference biological product under section 

15 351(k) of the Public Health Service Act (42 

16 U.S.C. 262(k)), as applicable. 

17 (4) For drugs and biological products that are 

18 subject to a risk evaluation and mitigation strategy, 

19 another essential component in the creation of low20 cost generic and biosimilar versions of covered prod21 ucts is the ability of generic product developers to 

22 join the manufacturer of the covered product (re23 ferred to in this section as the ‘‘license holder’’) in 

24 a single, shared system of elements to assure safe 

25 use and supporting agreements as required by secVerDate Sep 11 2014 22:03 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H965.IH H965

pbinns on DSK79D2C42PROD with BILLS
4 

•HR 965 IH

1 tion 505–1 of the Federal Food, Drug, and Cosmetic 

2 Act (21 U.S.C. 355–1), or secure a variance there3 from. 

4 (5) Contrary to the policy of the United States 

5 to promote competition in the market for drugs and 

6 biological products by facilitating the timely entry of 

7 lower-cost generic and biosimilar versions of those 

8 drugs and biological products, certain license holders 

9 are preventing generic product developers from ob10 taining quantities of the covered product necessary 

11 for the generic product developer to support an ap12 plication for approval by the Food and Drug Admin13 istration, including testing to show bioequivalence, 

14 biosimilarity, or interchangeability to the covered 

15 product, in some instances based on the justification 

16 that the covered product is subject to a risk evalua17 tion and mitigation strategy with elements to assure 

18 safe use under section 505–1 of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 355–1). 

20 (6) The Director of the Center for Drug Eval21 uation and Research of the Food and Drug Adminis22 tration has testified that some manufacturers of cov23 ered products have used risk evaluation and mitiga24 tion strategies and distribution restrictions adopted 

25 by the manufacturer on their own behalf as reasons 


pbinns on DSK79D2C42PROD with BILLS
5 

•HR 965 IH

1 to not sell quantities of a covered product to generic 

2 product developers, causing barriers and delays in 

3 getting generic products on the market. The Food 

4 and Drug Administration has reported receiving sig5 nificant numbers of inquiries from generic product 

6 developers who were unable to obtain samples of cov7 ered products to conduct necessary testing and oth8 erwise meet requirements for approval of generic 

9 drugs. 

10 (7) In 2018, the Acting Chairman of the Fed11 eral Trade Commission testified that the Federal 

12 Trade Commission continues to be very concerned 

13 about potential abuses by manufacturers of brand 

14 drugs of risk evaluation and mitigation strategies or 

15 other closed distribution systems to impede generic 

16 competition. 

17 (8) Also contrary to the policy of the United 

18 States to promote competition in the market for 

19 drugs and biological products by facilitating the 

20 timely entry of lower-cost generic and biosimilar 

21 versions of those drugs and biological products, cer22 tain license holders are impeding the prompt nego23 tiation and development on commercially reasonable 

24 terms of a single, shared system of elements to as25 sure safe use, which may be necessary for the geVerDate Sep 11 2014 22:03 Feb 16, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H965.IH H965

pbinns on DSK79D2C42PROD with BILLS
6 

•HR 965 IH

1 neric product developer to gain approval for its drug 

2 or licensing for its biological product. 

3 (9) While the antitrust laws may address the 

4 refusal by some license holders to provide quantities 

5 of a covered product to a generic product developer, 

6 a more tailored legal pathway would help ensure 

7 that generic product developers can obtain necessary 

8 quantities of a covered product in a timely way for 

9 purposes of developing a generic drug or biosimilar 

10 biological product, facilitating competition in the 

11 marketplace for drugs and biological products. 

12 (10) The antitrust laws may address actions by 

13 license holders who impede the prompt negotiation 

14 and development of a single, shared system of ele15 ments to assure safe use, and the Food and Drug 

16 Administration has some authority to waive the re17 quirement of a single, shared system. Clearer regu18 latory authority to approve different systems that 

19 meet the statutory requirements to ensure patient 

20 safety, however, would limit the effectiveness of bad 

21 faith negotiations over single, shared systems to 

22 delay generic approval. At the same time, clearer 

23 regulatory authority would ensure all systems pro24 tect patient safety. 


pbinns on DSK79D2C42PROD with BILLS
7 

•HR 965 IH

1 SEC. 3. ACTIONS FOR DELAYS OF GENERIC DRUGS AND 

2 BIOSIMILAR BIOLOGICAL PRODUCTS. 

3 (a) DEFINITIONS.—In this section— 

4 (1) the term ‘‘commercially reasonable, market5 based terms’’ means— 

6 (A) a nondiscriminatory price for the sale 

7 of the covered product at or below, but not 

8 greater than, the most recent wholesale acquisi9 tion cost for the drug, as defined in section 

10 1847A(c)(6)(B) of the Social Security Act (42 

11 U.S.C. 1395w–3a(c)(6)(B)); 

12 (B) a schedule for delivery that results in 

13 the transfer of the covered product to the eligi14 ble product developer consistent with the timing 

15 under subsection (b)(2)(A)(iv); and 

16 (C) no additional conditions are imposed 

17 on the sale of the covered product; 

18 (2) the term ‘‘covered product’’— 

19 (A) means— 

20 (i) any drug approved under sub21 section (c) or (j) of section 505 of the Fed22 eral Food, Drug, and Cosmetic Act (21 

23 U.S.C. 355) or biological product licensed 

24 under subsection (a) or (k) of section 351 

25 of the Public Health Service Act (42 

26 U.S.C. 262); 


pbinns on DSK79D2C42PROD with BILLS
8 

•HR 965 IH

1 (ii) any combination of a drug or bio2 logical product described in clause (i); or 

3 (iii) when reasonably necessary to 

4 support approval of an application under 

5 section 505 of the Federal Food, Drug, 

6 and Cosmetic Act (21 U.S.C. 355), or sec7 tion 351 of the Public Health Service Act 

8 (42 U.S.C. 262), as applicable, or other9 wise meet the requirements for approval 

10 under either such section, any product, in11 cluding any device, that is marketed or in12 tended for use with such a drug or biologi13 cal product; and 

14 (B) does not include any drug or biological 

15 product that appears on the drug shortage list 

16 in effect under section 506E of the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 

18 356e), unless the shortage will not be promptly 

19 resolved— 

20 (i) as demonstrated by the fact that 

21 the drug or biological product has been in 

22 shortage for more than 6 months; or 

23 (ii) as otherwise determined by the 

24 Secretary; 


pbinns on DSK79D2C42PROD with BILLS
9 

•HR 965 IH

1 (3) the term ‘‘device’’ has the meaning given 

2 the term in section 201 of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 321); 

4 (4) the term ‘‘eligible product developer’’ means 

5 a person that seeks to develop a product for ap6 proval pursuant to an application for approval under 

7 subsection (b)(2) or (j) of section 505 of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 

9 for licensing pursuant to an application under sec10 tion 351(k) of the Public Health Service Act (42 

11 U.S.C. 262(k)); 

12 (5) the term ‘‘license holder’’ means the holder 

13 of an application approved under subsection (c) or 

14 (j) of section 505 of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 355) or the holder of a li16 cense under subsection (a) or (k) of section 351 of 

17 the Public Health Service Act (42 U.S.C. 262) for 

18 a covered product; 

19 (6) the term ‘‘REMS’’ means a risk evaluation 

20 and mitigation strategy under section 505–1 of the 

21 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

22 355–1); 

23 (7) the term ‘‘REMS with ETASU’’ means a 

24 REMS that contains elements to assure safe use 


pbinns on DSK79D2C42PROD with BILLS
10 

•HR 965 IH

1 under section 505–1(f) of the Federal Food, Drug, 

2 and Cosmetic Act (21 U.S.C. 355–1(f)); 

3 (8) the term ‘‘Secretary’’ means the Secretary 

4 of Health and Human Services; 

5 (9) the term ‘‘single, shared system of elements 

6 to assure safe use’’ means a single, shared system 

7 of elements to assure safe use under section 505– 

8 1(f) of the Federal Food, Drug, and Cosmetic Act 

9 (21 U.S.C. 355–1(f)); and 

10 (10) the term ‘‘sufficient quantities’’ means an 

11 amount of a covered product that allows the eligible 

12 product developer to— 

13 (A) conduct testing to support an applica14 tion under— 

15 (i) subsection (b)(2) or (j) of section 

16 505 of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 355); or 

18 (ii) section 351(k) of the Public 

19 Health Service Act (42 U.S.C. 262(k)); 

20 and 

21 (B) fulfill any regulatory requirements re22 lating to approval of such an application. 

23 (b) CIVIL ACTION FOR FAILURE TO PROVIDE SUFFI24 CIENT QUANTITIES OF A COVERED PRODUCT.— 


pbinns on DSK79D2C42PROD with BILLS
11 

•HR 965 IH

1 (1) IN GENERAL.—An eligible product developer 

2 may bring a civil action against the license holder 

3 for a covered product seeking relief under this sub4 section in an appropriate district court of the United 

5 States alleging that the license holder has declined 

6 to provide sufficient quantities of the covered prod7 uct to the eligible product developer on commercially 

8 reasonable, market-based terms. 

9 (2) ELEMENTS.— 

10 (A) IN GENERAL.—To prevail in a civil ac11 tion brought under paragraph (1), an eligible 

12 product developer shall prove, by a preponder13 ance of the evidence— 

14 (i) that— 

15 (I) the covered product is not 

16 subject to a REMS with ETASU; or 

17 (II) if the covered product is sub18 ject to a REMS with ETASU— 

19 (aa) the eligible product de20 veloper has obtained a covered 

21 product authorization from the 

22 Secretary in accordance with sub23 paragraph (B); and 

24 (bb) the eligible product de25 veloper has provided a copy of 


pbinns on DSK79D2C42PROD with BILLS
12 

•HR 965 IH

1 the covered product authorization 

2 to the license holder; 

3 (ii) that, as of the date on which the 

4 civil action is filed, the product developer 

5 has not obtained sufficient quantities of 

6 the covered product on commercially rea7 sonable, market-based terms; 

8 (iii) that the eligible product developer 

9 has requested to purchase sufficient quan10 tities of the covered product from the li11 cense holder; and 

12 (iv) that the license holder has not de13 livered to the eligible product developer 

14 sufficient quantities of the covered product 

15 on commercially reasonable, market-based 

16 terms— 

17 (I) for a covered product that is 

18 not subject to a REMS with ETASU, 

19 by the date that is 31 days after the 

20 date on which the license holder re21 ceived the request for the covered 

22 product; and 

23 (II) for a covered product that is 

24 subject to a REMS with ETASU, by 

25 31 days after the later of— 


pbinns on DSK79D2C42PROD with BILLS
13 

•HR 965 IH

1 (aa) the date on which the 

2 license holder received the re3 quest for the covered product; or 

4 (bb) the date on which the 

5 license holder received a copy of 

6 the covered product authorization 

7 issued by the Secretary in ac8 cordance with subparagraph (B). 

9 (B) AUTHORIZATION FOR COVERED PROD10 UCT SUBJECT TO A REMS WITH ETASU.— 

11 (i) REQUEST.—An eligible product de12 veloper may submit to the Secretary a 

13 written request for the eligible product de14 veloper to be authorized to obtain suffi15 cient quantities of an individual covered 

16 product subject to a REMS with ETASU. 

17 (ii) AUTHORIZATION.—Not later than 

18 120 days after the date on which a request 

19 under clause (i) is received, the Secretary 

20 shall, by written notice, authorize the eligi21 ble product developer to obtain sufficient 

22 quantities of an individual covered product 

23 subject to a REMS with ETASU for pur24 poses of— 


pbinns on DSK79D2C42PROD with BILLS
14 

•HR 965 IH

1 (I) development and testing that 

2 does not involve human clinical trials, 

3 if the eligible product developer has 

4 agreed to comply with any conditions 

5 the Secretary determines necessary; or 

6 (II) development and testing that 

7 involves human clinical trials, if the 

8 eligible product developer has— 

9 (aa)(AA) submitted proto10 cols, informed consent docu11 ments, and informational mate12 rials for testing that include pro13 tections that provide safety pro14 tections comparable to those pro15 vided by the REMS for the cov16 ered product; or 

17 (BB) otherwise satisfied the 

18 Secretary that such protections 

19 will be provided; and 

20 (bb) met any other require21 ments the Secretary may estab22 lish. 

23 (iii) NOTICE.—A covered product au24 thorization issued under this subparagraph 

25 shall state that the provision of the covered 


pbinns on DSK79D2C42PROD with BILLS
15 

•HR 965 IH

1 product by the license holder under the 

2 terms of the authorization will not be a 

3 violation of the REMS for the covered 

4 product. 

5 (3) AFFIRMATIVE DEFENSE.—In a civil action 

6 brought under paragraph (1), it shall be an affirma7 tive defense, on which the defendant has the burden 

8 of persuasion by a preponderance of the evidence— 

9 (A) that, on the date on which the eligible 

10 product developer requested to purchase suffi11 cient quantities of the covered product from the 

12 license holder— 

13 (i) neither the license holder nor any 

14 of its agents, wholesalers, or distributors 

15 was engaged in the manufacturing or com16 mercial marketing of the covered product; 

17 and 

18 (ii) neither the license holder nor any 

19 of its agents, wholesalers, or distributors 

20 otherwise had access to inventory of the 

21 covered product to supply to the eligible 

22 product developer on commercially reason23 able, market-based terms; or 

24 (B) that— 


pbinns on DSK79D2C42PROD with BILLS
16 

•HR 965 IH

1 (i) the license holder sells the covered 

2 product through agents, distributors, or 

3 wholesalers; 

4 (ii) the license holder has placed no 

5 restrictions, explicit or implicit, on its 

6 agents, distributors, or wholesalers to sell 

7 covered products to eligible product devel8 opers; and 

9 (iii) the covered product can be pur10 chased by the eligible product developer in 

11 sufficient quantities on commercially rea12 sonable, market-based terms from the 

13 agents, distributors, or wholesalers of the 

14 license holder. 

15 (4) REMEDIES.— 

16 (A) IN GENERAL.—If an eligible product 

17 developer prevails in a civil action brought 

18 under paragraph (1), the court shall— 

19 (i) order the license holder to provide 

20 to the eligible product developer without 

21 delay sufficient quantities of the covered 

22 product on commercially reasonable, mar23 ket-based terms; 


pbinns on DSK79D2C42PROD with BILLS
17 

•HR 965 IH

1 (ii) award to the eligible product de2 veloper reasonable attorney’s fees and costs 

3 of the civil action; and 

4 (iii) award to the eligible product de5 veloper a monetary amount sufficient to 

6 deter the license holder from failing to pro7 vide other eligible product developers with 

8 sufficient quantities of a covered product 

9 on commercially reasonable, market-based 

10 terms, if the court finds, by a preponder11 ance of the evidence— 

12 (I) that the license holder delayed 

13 providing sufficient quantities of the 

14 covered product to the eligible product 

15 developer without a legitimate busi16 ness justification; or 

17 (II) that the license holder failed 

18 to comply with an order issued under 

19 clause (i). 

20 (B) MAXIMUM MONETARY AMOUNT.—A 

21 monetary amount awarded under subparagraph 

22 (A)(iii) shall not be greater than the revenue 

23 that the license holder earned on the covered 

24 product during the period— 

25 (i) beginning on— 


pbinns on DSK79D2C42PROD with BILLS
18 

•HR 965 IH

1 (I) for a covered product that is 

2 not subject to a REMS with ETASU, 

3 the date that is 31 days after the date 

4 on which the license holder received 

5 the request; or 

6 (II) for a covered product that is 

7 subject to a REMS with ETASU, the 

8 date that is 31 days after the later 

9 of— 

10 (aa) the date on which the 

11 license holder received the re12 quest; or 

13 (bb) the date on which the 

14 license holder received a copy of 

15 the covered product authorization 

16 issued by the Secretary in ac17 cordance with paragraph (2)(B); 

18 and 

19 (ii) ending on the date on which the 

20 eligible product developer received suffi21 cient quantities of the covered product. 

22 (C) AVOIDANCE OF DELAY.—The court 

23 may issue an order under subparagraph (A)(i) 

24 before conducting further proceedings that may 

25 be necessary to determine whether the eligible 


pbinns on DSK79D2C42PROD with BILLS
19 

•HR 965 IH

1 product developer is entitled to an award under 

2 clause (ii) or (iii) of subparagraph (A), or the 

3 amount of any such award. 

4 (c) LIMITATION OF LIABILITY.—A license holder for 

5 a covered product shall not be liable for any claim under 

6 Federal, State, or local law arising out of the failure of 

7 an eligible product developer to follow adequate safeguards 

8 to assure safe use of the covered product during develop9 ment or testing activities described in this section, includ10 ing transportation, handling, use, or disposal of the cov11 ered product by the eligible product developer. 

12 (d) NO VIOLATION OF REMS.—The provision of 

13 samples of a drug pursuant to an authorization under sub14 section (b)(2)(B) shall not be considered a violation of the 

15 requirements of any risk evaluation and mitigation strat16 egy that may be in place under section 505–1 of the Fed17 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) for 

18 such drug. 

19 (e) RULE OF CONSTRUCTION.— 

20 (1) DEFINITION.—In this subsection, the term 

21 ‘‘antitrust laws’’— 

22 (A) has the meaning given the term in 

23 subsection (a) of the first section of the Clayton 

24 Act (15 U.S.C. 12); and 


pbinns on DSK79D2C42PROD with BILLS
20 

•HR 965 IH

1 (B) includes section 5 of the Federal 

2 Trade Commission Act (15 U.S.C. 45) to the 

3 extent that such section applies to unfair meth4 ods of competition. 

5 (2) ANTITRUST LAWS.—Nothing in this section 

6 shall be construed to limit the operation of any pro7 vision of the antitrust laws. 

8 SEC. 4. REMS APPROVAL PROCESS FOR SUBSEQUENT FIL9 ERS. 

10 Section 505–1 of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 355–1) is amended— 

12 (1) in subsection (g)(4)(B)— 

13 (A) in clause (i) by striking ‘‘or’’ after the 

14 semicolon; 

15 (B) in clause (ii) by striking the period at 

16 the end and inserting ‘‘; or’’; and 

17 (C) by adding at the end the following: 

18 ‘‘(iii) accommodate different, com19 parable approved risk evaluation and miti20 gation strategies for a drug that is the 

21 subject of an application under section 

22 505(j), and the applicable listed drug.’’; 

23 (2) in subsection (i)(1), by striking subpara24 graph (C) and inserting the following: 


pbinns on DSK79D2C42PROD with BILLS
21 

•HR 965 IH

1 ‘‘(C)(i) Elements to assure safe use, if re2 quired under subsection (f) for the listed drug, 

3 which, subject to clause (ii), for a drug that is 

4 the subject of an application under section 

5 505(j) may use— 

6 ‘‘(I) a single, shared system with the 

7 listed drug under subsection (f); or 

8 ‘‘(II) a different, comparable aspect of 

9 the elements to assure safe use under sub10 section (f). 

11 ‘‘(ii) The Secretary may require a drug 

12 that is the subject of an application under sec13 tion 505(j) and the listed drug to use a single, 

14 shared system under subsection (f), if the Sec15 retary determines that no different, comparable 

16 aspect of the elements to assure safe use could 

17 satisfy the requirements of subsection (f).’’; and 

18 (3) by adding at the end the following: 

19 ‘‘(l) SEPARATE REMS.—When used in this section, 

20 the terms ‘‘different, comparable aspect of the elements 

21 to assure safe use’’ or ‘‘different, comparable approved 

22 risk evaluation and mitigation strategies’’ means a risk 

23 evaluation and mitigation strategy for a drug that is the 

24 subject of an application under section 505(j) that uses 

25 different methods or operational means than the strategy 


pbinns on DSK79D2C42PROD with BILLS
22 

•HR 965 IH

1 required under subsection (a) for the applicable listed 

2 drug, or other application under section 505(j) with the 

3 same such listed drug, but achieves the same level of safe4 ty as such strategy.’’. 

Æ 


pbinns on DSK79D2C42PROD with BILLS