IB 

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


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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 lowercost generic and biosimilar versions of those drugs and 

biological products. 


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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’’. 

7 SEC. 2. ACTIONS FOR DELAYS OF GENERIC DRUGS AND BIO8 SIMILAR BIOLOGICAL PRODUCTS. 

9 (a) DEFINITIONS.—In this section— 

10 (1) the term ‘‘commercially reasonable, market11 based terms’’ means— 

12 (A) a nondiscriminatory price for the sale 

13 of the covered product at or below, but not great14 er than, the most recent wholesale acquisition 

15 cost for the drug, as defined in section 

16 1847A(c)(6)(B) of the Social Security Act (42 

17 U.S.C. 1395w–3a(c)(6)(B)); 

18 (B) a schedule for delivery that results in 

19 the transfer of the covered product to the eligible 

20 product developer consistent with the timing 

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

22 (C) no additional conditions are imposed 

23 on the sale of the covered product; 

24 (2) the term ‘‘covered product’’— 

25 (A) means— 


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1 (i) any drug approved under sub2 section (c) or (j) of section 505 of the Fed3 eral Food, Drug, and Cosmetic Act (21 

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

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

6 the Public Health Service Act (42 U.S.C. 

7 262); 

8 (ii) any combination of a drug or bio9 logical product described in clause (i); or 

10 (iii) when reasonably necessary to sup11 port approval of an application under sec12 tion 505 of the Federal Food, Drug, and 

13 Cosmetic Act (21 U.S.C. 355), or section 

14 351 of the Public Health Service Act (42 

15 U.S.C. 262), as applicable, or otherwise 

16 meet the requirements for approval under 

17 either such section, any product, including 

18 any device, that is marketed or intended for 

19 use with such a drug or biological product; 

20 and 

21 (B) does not include any drug or biological 

22 product that appears on the drug shortage list in 

23 effect under section 506E of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 356e), un25 less— 


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1 (i) the drug or biological product has 

2 been on the drug shortage list in effect 

3 under such section 506E continuously for 

4 more than 6 months; or 

5 (ii) the Secretary determines that in6 clusion of the drug or biological product as 

7 a covered product is likely to contribute to 

8 alleviating or preventing a shortage. 

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

10 term in section 201 of the Federal Food, Drug, and 

11 Cosmetic Act (21 U.S.C. 321); 

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

13 a person that seeks to develop a product for approval 

14 pursuant to an application for approval under sub15 section (b)(2) or (j) of section 505 of the Federal 

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

17 licensing pursuant to an application under section 

18 351(k) of the Public Health Service Act (42 U.S.C. 

19 262(k)); 

20 (5) the term ‘‘license holder’’ means the holder of 

21 an application approved under subsection (c) or (j) of 

22 section 505 of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 355) or the holder of a license under 

24 subsection (a) or (k) of section 351 of the Public 


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1 Health Service Act (42 U.S.C. 262) for a covered 

2 product; 

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

4 and mitigation strategy under section 505–1 of the 

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

6 355–1); 

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

8 REMS that contains elements to assure safe use under 

9 section 505–1(f) of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 355–1(f)); 

11 (8) the term ‘‘Secretary’’ means the Secretary of 

12 Health and Human Services; 

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

14 assure safe use’’ means a single, shared system of ele15 ments to assure safe use under section 505–1(f) of the 

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

17 355–1(f)); and 

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

19 amount of a covered product that the eligible product 

20 developer determines allows it to— 

21 (A) conduct testing to support an applica22 tion under— 

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

24 505 of the Federal Food, Drug, and Cos25 metic Act (21 U.S.C. 355); or 


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1 (ii) section 351(k) of the Public Health 

2 Service Act (42 U.S.C. 262(k)); and 

3 (B) fulfill any regulatory requirements re4 lating to approval of such an application. 

5 (b) CIVIL ACTION FOR FAILURE TO PROVIDE SUFFI6 CIENT QUANTITIES OF A COVERED PRODUCT.— 

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

8 may bring a civil action against the license holder for 

9 a covered product seeking relief under this subsection 

10 in an appropriate district court of the United States 

11 alleging that the license holder has declined to provide 

12 sufficient quantities of the covered product to the eli13 gible product developer on commercially reasonable, 

14 market-based terms. 

15 (2) ELEMENTS.— 

16 (A) IN GENERAL.—To prevail in a civil ac17 tion brought under paragraph (1), an eligible 

18 product developer shall prove, by a preponder19 ance of the evidence— 

20 (i) that— 

21 (I) the covered product is not sub22 ject to a REMS with ETASU; or 

23 (II) if the covered product is sub24 ject to a REMS with ETASU— 


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1 (aa) the eligible product de2 veloper has obtained a covered 

3 product authorization from the 

4 Secretary in accordance with sub5 paragraph (B); and 

6 (bb) the eligible product de7 veloper has provided a copy of the 

8 covered product authorization to 

9 the license holder; 

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

11 civil action is filed, the product developer 

12 has not obtained sufficient quantities of the 

13 covered product on commercially reasonable, 

14 market-based terms; 

15 (iii) that the eligible product developer 

16 has requested to purchase sufficient quan17 tities of the covered product from the license 

18 holder; and 

19 (iv) that the license holder has not de20 livered to the eligible product developer suf21 ficient quantities of the covered product on 

22 commercially reasonable, market-based 

23 terms— 

24 (I) for a covered product that is 

25 not subject to a REMS with ETASU, 


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1 by the date that is 31 days after the 

2 date on which the license holder re3 ceived the request for the covered prod4 uct; and 

5 (II) for a covered product that is 

6 subject to a REMS with ETASU, by 

7 31 days after the later of— 

8 (aa) the date on which the li9 cense holder received the request 

10 for the covered product; or 

11 (bb) the date on which the li12 cense holder received a copy of the 

13 covered product authorization 

14 issued by the Secretary in accord15 ance with subparagraph (B). 

16 (B) AUTHORIZATION FOR COVERED PROD17 UCT SUBJECT TO A REMS WITH ETASU.— 

18 (i) REQUEST.—An eligible product de19 veloper may submit to the Secretary a writ20 ten request for the eligible product developer 

21 to be authorized to obtain sufficient quan22 tities of an individual covered product sub23 ject to a REMS with ETASU. 

24 (ii) AUTHORIZATION.—Not later than 

25 120 days after the date on which a request 


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1 under clause (i) is received, the Secretary 

2 shall, by written notice, authorize the eligi3 ble product developer to obtain sufficient 

4 quantities of an individual covered product 

5 subject to a REMS with ETASU for pur6 poses of— 

7 (I) development and testing that 

8 does not involve human clinical trials, 

9 if the eligible product developer has 

10 agreed to comply with any conditions 

11 the Secretary determines necessary; or 

12 (II) development and testing that 

13 involves human clinical trials, if the 

14 eligible product developer has— 

15 (aa)(AA) submitted protocols, 

16 informed consent documents, and 

17 informational materials for test18 ing that include protections that 

19 provide safety protections com20 parable to those provided by the 

21 REMS for the covered product; or 

22 (BB) otherwise satisfied the 

23 Secretary that such protections 

24 will be provided; and 


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1 (bb) met any other require2 ments the Secretary may estab3 lish. 

4 (iii) NOTICE.—A covered product au5 thorization issued under this subparagraph 

6 shall state that the provision of the covered 

7 product by the license holder under the 

8 terms of the authorization will not be a vio9 lation of the REMS for the covered product. 

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

11 brought under paragraph (1), it shall be an affirma12 tive defense, on which the defendant has the burden 

13 of persuasion by a preponderance of the evidence— 

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

15 product developer requested to purchase sufficient 

16 quantities of the covered product from the license 

17 holder— 

18 (i) neither the license holder nor any of 

19 its agents, wholesalers, or distributors was 

20 engaged in the manufacturing or commer21 cial marketing of the covered product; and 

22 (ii) neither the license holder nor any 

23 of its agents, wholesalers, or distributors 

24 otherwise had access to inventory of the cov25 ered product to supply to the eligible prodVerDate Sep 11 2014 01:50 May 11, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6203 E:\BILLS\H965.RH H965

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1 uct developer on commercially reasonable, 

2 market-based terms; 

3 (B) that— 

4 (i) the license holder sells the covered 

5 product through agents, distributors, or 

6 wholesalers; 

7 (ii) the license holder has placed no re8 strictions, explicit or implicit, on its agents, 

9 distributors, or wholesalers to sell covered 

10 products to eligible product developers; and 

11 (iii) the covered product can be pur12 chased by the eligible product developer in 

13 sufficient quantities on commercially rea14 sonable, market-based terms from the 

15 agents, distributors, or wholesalers of the li16 cense holder; or 

17 (C) that the license holder made an offer to 

18 sell sufficient quantities of the covered product to 

19 the eligible product developer at commercially 

20 reasonable market-based terms— 

21 (i) for a covered product that is not 

22 subject to a REMS with ETASU, by the 

23 date that is 14 days after the date on which 

24 the license holder received the request for the 

25 covered product, and the eligible product deVerDate Sep 11 2014 01:50 May 11, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6203 E:\BILLS\H965.RH H965

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1 veloper did not accept such offer by the date 

2 that is 7 days after the date on which the 

3 eligible product developer received such offer 

4 from the license holder; or 

5 (ii) for a covered product that is sub6 ject to a REMS with ETASU, by the date 

7 that is 20 days after the date on which the 

8 license holder received the request for the 

9 covered product, and the eligible product de10 veloper did not accept such offer by the date 

11 that is 10 days after the date on which the 

12 eligible product developer received such offer 

13 from the license holder. 

14 (4) METHODS FOR TRANSMISSION OF REQUESTS

15 FOR COVERED PRODUCTS.—A written request for a 

16 covered product, offer to sell a covered product, or ac17 ceptance of such an offer between the eligible product 

18 developer and the license holder shall be made by— 

19 (A) certified or registered mail with return 

20 receipt requested; 

21 (B) personal delivery; or 

22 (C) electronic means. 

23 (5) REMEDIES.— 


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1 (A) IN GENERAL.—If an eligible product de2 veloper prevails in a civil action brought under 

3 paragraph (1), the court shall— 

4 (i) order the license holder to provide 

5 to the eligible product developer without 

6 delay sufficient quantities of the covered 

7 product on commercially reasonable, mar8 ket-based terms; 

9 (ii) award to the eligible product devel10 oper reasonable attorney’s fees and costs of 

11 the civil action; and 

12 (iii) award to the eligible product de13 veloper a monetary amount sufficient to 

14 deter the license holder from failing to pro15 vide eligible product developers with suffi16 cient quantities of a covered product on 

17 commercially reasonable, market-based 

18 terms, if the court finds, by a preponder19 ance of the evidence— 

20 (I) that the license holder delayed 

21 providing sufficient quantities of the 

22 covered product to the eligible product 

23 developer without a legitimate business 

24 justification; or 


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1 (II) that the license holder failed 

2 to comply with an order issued under 

3 clause (i). 

4 (B) MAXIMUM MONETARY AMOUNT.—A 

5 monetary amount awarded under subparagraph 

6 (A)(iii) shall not be greater than the revenue that 

7 the license holder earned on the covered product 

8 during the period— 

9 (i) beginning on— 

10 (I) for a covered product that is 

11 not subject to a REMS with ETASU, 

12 the date that is 31 days after the date 

13 on which the license holder received the 

14 request; or 

15 (II) for a covered product that is 

16 subject to a REMS with ETASU, the 

17 date that is 31 days after the later of— 

18 (aa) the date on which the li19 cense holder received the request; 

20 or 

21 (bb) the date on which the li22 cense holder received a copy of the 

23 covered product authorization 

24 issued by the Secretary in accord25 ance with paragraph (2)(B); and 


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1 (ii) ending on the date on which the el2 igible product developer received sufficient 

3 quantities of the covered product. 

4 (C) AVOIDANCE OF DELAY.—The court may 

5 issue an order under subparagraph (A)(i) before 

6 conducting further proceedings that may be nec7 essary to determine whether the eligible product 

8 developer is entitled to an award under clause 

9 (ii) or (iii) of subparagraph (A), or the amount 

10 of any such award. 

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

12 covered product shall not be liable for any claim under Fed13 eral, State, or local law arising out of the failure of an 

14 eligible product developer to follow adequate safeguards to 

15 assure safe use of the covered product during development 

16 or testing activities described in this section, including 

17 transportation, handling, use, or disposal of the covered 

18 product by the eligible product developer. 

19 (d) NO VIOLATION OF REMS.—Section 505–1 of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1) 

21 is amended by adding at the end the following new sub22 section: 

23 ‘‘(l) PROVISION OF SAMPLES NOT A VIOLATION OF

24 STRATEGY.—The provision of samples of a covered product 

25 to an eligible product developer (as those terms are defined 


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1 in section 2(a) of the Creating and Restoring Equal Access 

2 to Equivalent Samples Act of 2019) shall not be considered 

3 a violation of the requirements of any risk evaluation and 

4 mitigation strategy that may be in place under this section 

5 for such drug.’’. 

6 (e) RULE OF CONSTRUCTION.— 

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

8 ‘‘antitrust laws’’— 

9 (A) has the meaning given the term in sub10 section (a) of the first section of the Clayton Act 

11 (15 U.S.C. 12); and 

12 (B) includes section 5 of the Federal Trade 

13 Commission Act (15 U.S.C. 45) to the extent that 

14 such section applies to unfair methods of com15 petition. 

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

17 shall be construed to limit the operation of any provi18 sion of the antitrust laws. 

19 SEC. 3. REMS APPROVAL PROCESS FOR SUBSEQUENT FIL20 ERS. 

21 Section 505–1 of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 355–1), as amended by section 2, is 

23 further amended— 

24 (1) in subsection (g)(4)(B)— 


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

2 semicolon; 

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

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

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

6 ‘‘(iii) accommodate different, com7 parable aspects of the elements to assure 

8 safe use for a drug that is the subject of an 

9 application under section 505(j), and the 

10 applicable listed drug.’’; 

11 (2) in subsection (i)(1), by striking subpara12 graph (C) and inserting the following: 

13 ‘‘(C)(i) Elements to assure safe use, if re14 quired under subsection (f) for the listed drug, 

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

16 the subject of an application under section 505(j) 

17 may use— 

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

19 listed drug under subsection (f); or 

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

21 the elements to assure safe use under sub22 section (f). 

23 ‘‘(ii) The Secretary may require a drug that 

24 is the subject of an application under section 

25 505(j) and the listed drug to use a single, shared 


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1 system under subsection (f), if the Secretary de2 termines that no different, comparable aspect of 

3 the elements to assure safe use could satisfy the 

4 requirements of subsection (f).’’; 

5 (3) in subsection (i), by adding at the end the 

6 following: 

7 ‘‘(3) SHARED REMS.—If the Secretary approves, 

8 in accordance with paragraph (1)(C)(i)(II), a dif9 ferent, comparable aspect of the elements to assure 

10 safe use under subsection (f) for a drug that is the 

11 subject of an abbreviated new drug application under 

12 section 505(j), the Secretary may require that such 

13 different comparable aspect of the elements to assure 

14 safe use can be used with respect to any other drug 

15 that is the subject of an application under section 

16 505(j) or 505(b) that references the same listed drug.’’; 

17 and 

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

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

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

21 assure safe use’ or ‘different, comparable approved risk eval22 uation and mitigation strategies’ means a risk evaluation 

23 and mitigation strategy for a drug that is the subject of 

24 an application under section 505(j) that uses different 

25 methods or operational means than the strategy required 


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1 under subsection (a) for the applicable listed drug, or other 

2 application under section 505(j) with the same such listed 

3 drug, but achieves the same level of safety as such strategy.’’. 

4 SEC. 4. RULE OF CONSTRUCTION. 

5 (a) IN GENERAL.—Nothing in this Act, the amend6 ments made by this Act, or in section 505–1 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 355–1), shall be 

8 construed as— 

9 (1) prohibiting a license holder from providing 

10 an eligible product developer access to a covered prod11 uct in the absence of an authorization under this Act; 

12 or 

13 (2) in any way negating the applicability of a 

14 REMS with ETASU, as otherwise required under 

15 such section 505–1, with respect to such covered prod16 uct. 

17 (b) DEFINITIONS.—In this section, the terms ‘‘covered 

18 product’’, ‘‘eligible product developer’’, ‘‘license holder’’, and 

19 ‘‘REMS with ETASU’’ have the meanings given such terms 

20 in section 3(a). 


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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 

versions of those drugs and biological products. entry of lower-cost generic and biosimilar and biological products by facilitating the timely 

MAY 10, 2019 

Reported from the Committee on Energy and Commerce 

with an amendment 

MAY 10, 2019 

Reported from the Committee on the Judiciary; comState of the Union and ordered to be printed mitted to the Committee of the Whole House on the 


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