II 

115TH CONGRESS 

1ST SESSION S. 974 

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 SENATE OF THE UNITED STATES 

APRIL 27, 2017 

Mr. LEAHY (for himself, Mr. GRASSLEY, Ms. KLOBUCHAR, Mr. LEE, Mrs. 

FEINSTEIN, Mrs. MCCASKILL, Ms. COLLINS, Mr. MCCAIN, Mr. 

BLUMENTHAL, Mr. WHITEHOUSE, Mr. COTTON, and Mr. DURBIN) introduced the following bill; which was read twice and referred to the Committee on the Judiciary 

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 2017’’ or the 

6 ‘‘CREATES Act of 2017’’. 

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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 

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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, or secure a variance 

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1 therefrom, as required by section 505–1 of the Fed2 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355– 

3 1). 

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 at the Food and Drug Admin22 istration has testified that some manufacturers of 

23 covered products have used REMS and distribution 

24 restrictions adopted by the manufacturer on their 

25 own behalf as reasons to not sell quantities of a covmstockstill on DSK30JT082PROD with BILLS

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1 ered product to generic product developers, causing 

2 barriers and delays in getting generic products on 

3 the market. The Food and Drug Administration has 

4 reported receiving significant numbers of inquiries 

5 from generic product developers who were unable to 

6 obtain samples of covered products to conduct nec7 essary testing and otherwise meet requirements for 

8 approval of generic drugs. 

9 (7) The Chairwoman of the Federal Trade 

10 Commission has testified that the Federal Trade 

11 Commission continues to be very concerned about 

12 potential abuses by manufacturers of brand drugs of 

13 REMS or other closed distribution systems to im14 pede generic competition. 

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

16 States to promote competition in the market for 

17 drugs and biological products by facilitating the 

18 timely entry of lower-cost generic and biosimilar 

19 versions of those drugs and biological products, cer20 tain license holders are impeding the prompt nego21 tiation and development on commercially reasonable 

22 terms of a single, shared system of elements to as23 sure safe use, which may be necessary for the ge24 neric product developer to gain approval for its drug 

25 or licensing for its biological product. 

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1 (9) While the antitrust laws may address the 

2 refusal by some license holders to provide quantities 

3 of a covered product to a generic product developer, 

4 a more tailored legal pathway would help ensure 

5 that generic product developers can obtain necessary 

6 quantities of a covered product in a timely way for 

7 purposes of developing a generic drug or biosimilar 

8 biological product, facilitating competition in the 

9 marketplace for drugs and biological products. 

10 (10) The antitrust laws may address actions by 

11 license holders who impede the prompt negotiation 

12 and development of a single, shared system of ele13 ments to assure safe use, and the Food and Drug 

14 Administration has some authority to waive the re15 quirement of a single, shared system. Clearer regu16 latory authority to approve different systems that 

17 meet the statutory requirements to ensure patient 

18 safety, however, would limit the effectiveness of bad 

19 faith negotiations over single, shared systems to 

20 delay generic approval. At the same time, clearer 

21 regulatory authority would ensure all systems pro22 tect patient safety. 

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

24 BIOSIMILAR BIOLOGICAL PRODUCTS. 

25 (a) DEFINITIONS.—In this section— 

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1 (1) the term ‘‘covered product’’— 

2 (A) means— 

3 (i) any drug approved under sub4 section (b) or (j) of section 505 of the Fed5 eral Food, Drug, and Cosmetic Act (21 

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

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

8 of the Public Health Service Act (42 

9 U.S.C. 262); 

10 (ii) any combination of a drug or bio11 logical product described in clause (i); or 

12 (iii) when reasonably necessary to 

13 demonstrate sameness, biosimilarity, or 

14 interchangeability for purposes of section 

15 505 of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 355), or section 351 

17 of the Public Health Service Act (42 

18 U.S.C. 262), as applicable, any product, 

19 including any device, that is marketed or 

20 intended for use with such drug or biologi21 cal product; and 

22 (B) does not include any drug or biological 

23 product that the Secretary has determined to be 

24 currently in shortage and that appears on the 

25 drug shortage list in effect under section 506E 

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1 of the Federal Food, Drug, and Cosmetic Act 

2 (21 U.S.C. 356e), unless the shortage will not 

3 be promptly resolved— 

4 (i) as demonstrated by the fact that 

5 the drug or biological product has been in 

6 shortage for more than 6 months; or 

7 (ii) as otherwise determined by the 

8 Secretary; 

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

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

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

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

13 a person that seeks to develop a product for ap14 proval pursuant to an application for approval under 

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

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

17 for licensing pursuant to an application under sec18 tion 351(k) of the Public Health Service Act (42 

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

20 (4) the term ‘‘license holder’’ means the holder 

21 of an application approved under subsection (c) or 

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

23 Cosmetic Act (21 U.S.C. 355) or the holder of a li24 cense under subsection (a) or (k) of section 351 of 

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

2 a covered product; 

3 (5) 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 (6) the term ‘‘REMS with ETASU’’ means a 

8 REMS that contains elements to assure safe use 

9 under section 505–1 of the Federal Food, Drug, and 

10 Cosmetic Act (21 U.S.C. 355–1); 

11 (7) the term ‘‘Secretary’’ means the Secretary 

12 of Health and Human Services; 

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

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

15 of elements to assure safe use under section 505–1 

16 of the Federal Food, Drug, and Cosmetic Act (21 

17 U.S.C. 355–1); and 

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

19 amount of a covered product that allows the eligible 

20 product developer to— 

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

23 (i) for approval under subsection 

24 (b)(2) or (j) of section 505 of the Federal 

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

2 355); or 

3 (ii) for licensing under section 351(k) 

4 of the Public Health Service Act (42 

5 U.S.C. 262(k)); and 

6 (B) fulfill any regulatory requirements re7 lating to such an application for approval or li8 censing. 

9 (b) CIVIL ACTION FOR FAILURE TO PROVIDE SUFFI10 CIENT QUANTITIES OF A COVERED PRODUCT.— 

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

12 may bring a civil action against the license holder 

13 for a covered product seeking relief under this sub14 section in an appropriate district court of the United 

15 States alleging that the license holder has declined 

16 to provide sufficient quantities of the covered prod17 uct to the eligible product developer on commercially 

18 reasonable, market-based terms. 

19 (2) ELEMENTS.— 

20 (A) IN GENERAL.—To prevail in a civil ac21 tion brought under paragraph (1), an eligible 

22 product developer shall prove, by a preponder23 ance of the evidence— 

24 (i) that— 

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1 (I) the covered product is not 

2 subject to a REMS with ETASU; or 

3 (II) if the covered product is sub4 ject to a REMS with ETASU— 

5 (aa) the eligible product de6 veloper has obtained a covered 

7 product authorization from the 

8 Secretary in accordance with sub9 paragraph (B); and 

10 (bb) the eligible product de11 veloper has provided a copy of 

12 the covered product authorization 

13 to the license holder; 

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

15 civil action is filed, the product developer 

16 has not obtained sufficient quantities of 

17 the covered product on commercially rea18 sonable, market-based terms; 

19 (iii) that the eligible product developer 

20 has requested to purchase sufficient quan21 tities of the covered product from the li22 cense holder; and 

23 (iv) that the license holder has not de24 livered to the eligible product developer 

25 sufficient quantities of the covered product 

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1 on commercially reasonable, market-based 

2 terms— 

3 (I) for a covered product that is 

4 not subject to a REMS with ETASU, 

5 by the date that is 31 days after the 

6 date on which the license holder re7 ceived the request for the covered 

8 product; and 

9 (II) for a covered product that is 

10 subject to a REMS with ETASU, by 

11 31 days after the later of— 

12 (aa) the date on which the 

13 license holder received the re14 quest for the covered product; or 

15 (bb) the date on which the 

16 license holder received a copy of 

17 the covered product authorization 

18 issued by the Secretary in ac19 cordance with subparagraph (B). 

20 (B) AUTHORIZATION FOR COVERED PROD21 UCT SUBJECT TO A REMS WITH ETASU.— 

22 (i) REQUEST.—An eligible product de23 veloper may submit to the Secretary a 

24 written request for the eligible product de25 veloper to be authorized to obtain suffimstockstill on DSK30JT082PROD with BILLS

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1 cient quantities of an individual covered 

2 product subject to a REMS with ETASU. 

3 (ii) AUTHORIZATION.—Not later than 

4 90 days after the date on which a request 

5 under clause (i) is received, the Secretary 

6 shall, by written notice, authorize the eligi7 ble product developer to obtain sufficient 

8 quantities of an individual covered product 

9 subject to a REMS with ETASU for pur10 poses of— 

11 (I) development and testing that 

12 does not involve human clinical trials, 

13 if the eligible product developer has 

14 agreed to comply with any conditions 

15 the Secretary determines necessary; or 

16 (II) development and testing that 

17 involves human clinical trials, if the 

18 eligible product developer has— 

19 (aa)(AA) submitted proto20 cols, informed consent docu21 ments, and informational mate22 rials for testing that include pro23 tections that provide safety pro24 tections comparable to those promstockstill on DSK30JT082PROD with BILLS

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1 vided by the REMS for the cov2 ered product; or 

3 (BB) otherwise satisfied the 

4 Secretary that such protections 

5 will be provided; and 

6 (bb) met any other require7 ments the Secretary may estab8 lish. 

9 (iii) NOTICE.—A covered product au10 thorization issued under this subparagraph 

11 shall state that the provision of the covered 

12 product by the license holder under the 

13 terms of the authorization will not be a 

14 violation of the REMS for the covered 

15 product. 

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

17 brought under paragraph (1), it shall be an affirma18 tive defense, on which the defendant has the burden 

19 of persuasion by a preponderance of the evidence— 

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

21 product developer requested to purchase suffi22 cient quantities of the covered product from the 

23 license holder— 

24 (i) neither the license holder nor any 

25 of its agents, wholesalers, or distributors 

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1 was engaged in the manufacturing or com2 mercial marketing of the covered product; 

3 and 

4 (ii) neither the license holder nor any 

5 of its agents, wholesalers, or distributors 

6 otherwise had access to inventory of the 

7 covered product to supply to the eligible 

8 product developer on commercially reason9 able, market-based terms; or 

10 (B) that— 

11 (i) the license holder sells the covered 

12 product through agents, distributors, or 

13 wholesalers; 

14 (ii) the license holder has placed no 

15 restrictions, explicit or implicit, on its 

16 agents, distributors, or wholesalers to sell 

17 covered products to eligible product devel18 opers; and 

19 (iii) the covered product can be pur20 chased by the eligible product developer in 

21 sufficient quantities on commercially rea22 sonable, market-based terms from the 

23 agents, distributors, or wholesalers of the 

24 license holder. 

25 (4) REMEDIES.— 

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

2 developer prevails in a civil action brought 

3 under 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 de10 veloper reasonable attorney fees and costs 

11 of 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 other eligible product developers with 

16 sufficient quantities of a covered product 

17 on 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 busi24 ness 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 

7 that the license holder earned on the covered 

8 product 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 

14 the 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 

18 of— 

19 (aa) the date on which the 

20 license holder received the re21 quest; or 

22 (bb) the date on which the 

23 license holder received a copy of 

24 the covered product authorization 

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1 cordance with paragraph (2)(B); 

2 and 

3 (ii) ending on the date on which the 

4 eligible product developer received suffi5 cient quantities of the covered product. 

6 (C) AVOIDANCE OF DELAY.—The court 

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

8 before conducting further proceedings that may 

9 be necessary to determine whether the eligible 

10 product developer is entitled to an award under 

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

12 amount of any such award. 

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

14 a covered product shall not be liable for any claim arising 

15 out of the failure of an eligible product developer to follow 

16 adequate safeguards to assure safe use of the covered 

17 product during development or testing activities described 

18 in this section, including transportation, handling, use, or 

19 disposal of the covered product by the eligible product de20 veloper. 

21 (d) RULE OF CONSTRUCTION.— 

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

23 ‘‘antitrust laws’’— 

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1 (A) has the meaning given the term in 

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

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

4 (B) includes section 5 of the Federal 

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

6 extent that such section applies to unfair meth7 ods of competition. 

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

9 shall be construed to limit the operation of any pro10 vision of the antitrust laws. 

11 SEC. 4. REMS APPROVAL PROCESS FOR SUBSEQUENT FIL12 ERS. 

13 Section 505–1 of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 355–1) is amended— 

15 (1) in subsection (g)(4)(B)— 

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

17 semicolon; 

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

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

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

21 ‘‘(iii) accommodate different approved 

22 risk evaluation and mitigation strategies 

23 for a reference drug product and a drug 

24 that is the subject of an abbreviated new 

25 drug application.’’; and 

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1 (2) in subsection (i)(1), by striking subpara2 graph (B) and inserting the following: 

3 ‘‘(B) Elements to assure safe use, if re4 quired under subsection (f) for the listed drug. 

5 ‘‘(i) Subject to clause (ii), a drug that 

6 is the subject of an abbreviated new drug 

7 application may use— 

8 ‘‘(I) a single, shared system with 

9 the listed drug under subsection (f); 

10 or 

11 ‘‘(II) a different, comparable as12 pect of the elements to assure safe use 

13 under subsection (f). 

14 ‘‘(ii) The Secretary may require a 

15 drug that is the subject of an abbreviated 

16 new drug application and the listed drug to 

17 use a single, shared system under sub18 section (f), if the Secretary determines 

19 that no different, comparable aspect of the 

20 elements to assure safe use could satisfy 

21 the requirements of subsection (f).’’. 

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