I 

116TH CONGRESS 

1ST SESSION H. R. 3947 

To lower the cost of prescription drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 24, 2019 

Mr. MEADOWS introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on 

Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, 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 lower the cost of prescription drugs, and for other 

purposes. 

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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Competition Prescription Act of 2019’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 this Act is as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—ELIMINATING DELAYS OF GENERIC DRUGS AND 

BIOSIMILAR PRODUCTS 


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Sec. 101. Actions for delays of generic drugs and biosimilar biological products. 

Sec. 102. REMS approval process for subsequent filers. 

TITLE II—INCREASING ACCESS TO DRUGS AND BIOSIMILAR 

PRODUCTS 

Sec. 201. Expedited development and priority review for generic complex drug 

products. 

Sec. 202. Increasing pharmaceutical options to treat an unmet medical need. 

Sec. 203. Preemption of State barriers to the substitution of biosimilar products. 

Sec. 204. Expedited process for biological products authorized for marketing in 

European Union. 

TITLE III—PRESCRIPTION DRUG PRICING AND COMPETITION 

Sec. 301. Medicare drug coverage. 

Sec. 302. Fee transparency between pharmacies and PBMs. 

Sec. 303. Sunset of limit on maximum rebate amount for single source drugs 

and innovator multiple source drugs. 

Sec. 304. Regulation of manufacturer-sponsored copay contributions. 

TITLE IV—PATENT DISCLOSURE REQUIREMENTS 

Sec. 401. Patent disclosure and transparency requirements. 

Sec. 402. Antitrust exemption for health insurance issuers to negotiate wholesale acquisition prices of prescription drugs purchased from 

drug manufacturers. 

Sec. 403. Fair treatment of Medicare part B billing codes for the prescribing 

of biosimilars. 

TITLE V—FIXING GLOBAL FREELOADING 

Sec. 501. Chief Pharmaceutical Negotiator in the Office of the United States 

Trade Representative. 

1 TITLE I—ELIMINATING DELAYS 

2 OF GENERIC DRUGS AND BIO3 SIMILAR PRODUCTS 

4 SEC. 101. ACTIONS FOR DELAYS OF GENERIC DRUGS AND 

5 BIOSIMILAR BIOLOGICAL PRODUCTS. 

6 (a) DEFINITIONS.—In this section— 

7 (1) the term ‘‘commercially reasonable, market8 based terms’’ means— 

9 (A) a nondiscriminatory price for the sale 

10 of the covered product at or below, but not 


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1 greater than, the most recent wholesale acquisi2 tion cost for the drug, as defined in section 

3 1847A(c)(6)(B) of the Social Security Act (42 

4 U.S.C. 1395w–3a(c)(6)(B)); 

5 (B) a schedule for delivery that results in 

6 the transfer of the covered product to the eligi7 ble product developer consistent with the timing 

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

9 (C) no additional conditions are imposed 

10 on the sale of the covered product; 

11 (2) the term ‘‘covered product’’— 

12 (A) means— 

13 (i) any drug approved under sub14 section (c) or (j) of section 505 of the Fed15 eral Food, Drug, and Cosmetic Act (21 

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

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

18 of the Public Health Service Act (42 

19 U.S.C. 262); 

20 (ii) any combination of a drug or bio21 logical product described in clause (i); or 

22 (iii) when reasonably necessary to 

23 support approval of an application under 

24 section 505 of the Federal Food, Drug, 

25 and Cosmetic Act (21 U.S.C. 355), or secVerDate Sep 11 2014 02:33 Aug 09, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3947.IH H3947

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1 tion 351 of the Public Health Service Act 

2 (42 U.S.C. 262), as applicable, or other3 wise meet the requirements for approval 

4 under either such section, any product, in5 cluding any device, that is marketed or in6 tended for use with such a drug or biologi7 cal product; and 

8 (B) does not include any drug or biological 

9 product that appears on the drug shortage list 

10 in effect under section 506E of the Federal 

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

12 356e), unless— 

13 (i) the drug or biological product has 

14 been on the drug shortage list in effect 

15 under such section 506E continuously for 

16 more than 6 months; or 

17 (ii) the Secretary determines that in18 clusion of the drug or biological product as 

19 a covered product is likely to contribute to 

20 alleviating or preventing a shortage; 

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

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

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

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

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1 proval pursuant to an application for approval under 

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

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

4 for licensing pursuant to an application under sec5 tion 351(k) of the Public Health Service Act (42 

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

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

8 of an application approved under subsection (c) or 

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

10 Cosmetic Act (21 U.S.C. 355) or the holder of a li11 cense under subsection (a) or (k) of section 351 of 

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

13 a covered product; 

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

15 and mitigation strategy under section 505–1 of the 

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

17 355–1); 

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

19 REMS that contains elements to assure safe use 

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

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

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

23 of Health and Human Services; 

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

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


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1 of elements to assure safe use under section 505– 

2 1(f) of the Federal Food, Drug, and Cosmetic Act 

3 (21 U.S.C. 355–1(f)); and 

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

5 amount of a covered product that the eligible prod6 uct developer determines allows it to— 

7 (A) conduct testing to support an applica8 tion under— 

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

10 505 of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 355); or 

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

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

14 and 

15 (B) fulfill any regulatory requirements re16 lating to approval of such an application. 

17 (b) CIVIL ACTION FOR FAILURE TO PROVIDE SUFFI18 CIENT QUANTITIES OF A COVERED PRODUCT.— 

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

20 may bring a civil action against the license holder 

21 for a covered product seeking relief under this sub22 section in an appropriate district court of the United 

23 States alleging that the license holder has declined 

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1 uct to the eligible product developer on commercially 

2 reasonable, market-based terms. 

3 (2) ELEMENTS.— 

4 (A) IN GENERAL.—To prevail in a civil ac5 tion brought under paragraph (1), an eligible 

6 product developer shall prove, by a preponder7 ance of the evidence— 

8 (i) that— 

9 (I) the covered product is not 

10 subject to a REMS with ETASU; or 

11 (II) if the covered product is sub12 ject to a REMS with ETASU— 

13 (aa) the eligible product de14 veloper has obtained a covered 

15 product authorization from the 

16 Secretary in accordance with sub17 paragraph (B); and 

18 (bb) the eligible product de19 veloper has provided a copy of 

20 the covered product authorization 

21 to the license holder; 

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

23 civil action is filed, the product developer 

24 has not obtained sufficient quantities of 


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1 the covered product on commercially rea2 sonable, market-based terms; 

3 (iii) that the eligible product developer 

4 has requested to purchase sufficient quan5 tities of the covered product from the li6 cense holder; and 

7 (iv) that the license holder has not de8 livered to the eligible product developer 

9 sufficient quantities of the covered product 

10 on commercially reasonable, market-based 

11 terms— 

12 (I) for a covered product that is 

13 not subject to a REMS with ETASU, 

14 by the date that is 31 days after the 

15 date on which the license holder re16 ceived the request for the covered 

17 product; and 

18 (II) for a covered product that is 

19 subject to a REMS with ETASU, by 

20 31 days after the later of— 

21 (aa) the date on which the 

22 license holder received the re23 quest for the covered product; or 

24 (bb) the date on which the 

25 license holder received a copy of 


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1 the covered product authorization 

2 issued by the Secretary in ac3 cordance with subparagraph (B). 

4 (B) AUTHORIZATION FOR COVERED PROD5 UCT SUBJECT TO A REMS WITH ETASU.— 

6 (i) REQUEST.—An eligible product de7 veloper may submit to the Secretary a 

8 written request for the eligible product de9 veloper to be authorized to obtain suffi10 cient quantities of an individual covered 

11 product subject to a REMS with ETASU. 

12 (ii) AUTHORIZATION.—Not later than 

13 120 days after the date on which a request 

14 under clause (i) is received, the Secretary 

15 shall, by written notice, authorize the eligi16 ble product developer to obtain sufficient 

17 quantities of an individual covered product 

18 subject to a REMS with ETASU for pur19 poses of— 

20 (I) development and testing that 

21 does not involve human clinical trials, 

22 if the eligible product developer has 

23 agreed to comply with any conditions 

24 the Secretary determines necessary; or 


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1 (II) development and testing that 

2 involves human clinical trials, if the 

3 eligible product developer has— 

4 (aa)(AA) submitted proto5 cols, informed consent docu6 ments, and informational mate7 rials for testing that include pro8 tections that provide safety pro9 tections comparable to those pro10 vided by the REMS for the cov11 ered product; or 

12 (BB) otherwise satisfied the 

13 Secretary that such protections 

14 will be provided; and 

15 (bb) met any other require16 ments the Secretary may estab17 lish. 

18 (iii) NOTICE.—A covered product au19 thorization issued under this subparagraph 

20 shall state that the provision of the covered 

21 product by the license holder under the 

22 terms of the authorization will not be a 

23 violation of the REMS for the covered 

24 product. 


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

2 brought under paragraph (1), it shall be an affirma3 tive defense, on which the defendant has the burden 

4 of persuasion by a preponderance of the evidence— 

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

6 product developer requested to purchase suffi7 cient quantities of the covered product from the 

8 license holder— 

9 (i) neither the license holder nor any 

10 of its agents, wholesalers, or distributors 

11 was engaged in the manufacturing or com12 mercial marketing of the covered product; 

13 and 

14 (ii) neither the license holder nor any 

15 of its agents, wholesalers, or distributors 

16 otherwise had access to inventory of the 

17 covered product to supply to the eligible 

18 product developer on commercially reason19 able, market-based terms; 

20 (B) that— 

21 (i) the license holder sells the covered 

22 product through agents, distributors, or 

23 wholesalers; 

24 (ii) the license holder has placed no 

25 restrictions, explicit or implicit, on its 


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1 agents, distributors, or wholesalers to sell 

2 covered products to eligible product devel3 opers; and 

4 (iii) the covered product can be pur5 chased by the eligible product developer in 

6 sufficient quantities on commercially rea7 sonable, market-based terms from the 

8 agents, distributors, or wholesalers of the 

9 license holder; or 

10 (C) that the license holder made an offer 

11 to sell sufficient quantities of the covered prod12 uct to the eligible product developer at commer13 cially reasonable market-based terms— 

14 (i) for a covered product that is not 

15 subject to a REMS with ETASU, by the 

16 date that is 14 days after the date on 

17 which the license holder received the re18 quest for the covered product, and the eli19 gible product developer did not accept such 

20 offer by the date that is 7 days after the 

21 date on which the eligible product devel22 oper received such offer from the license 

23 holder; or 

24 (ii) for a covered product that is sub25 ject to a REMS with ETASU, by the date 


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1 that is 20 days after the date on which the 

2 license holder received the request for the 

3 covered product, and the eligible product 

4 developer did not accept such offer by the 

5 date that is 10 days after the date on 

6 which the eligible product developer re7 ceived such offer from the license holder. 

8 (4) METHODS FOR TRANSMISSION OF RE9 QUESTS FOR COVERED PRODUCTS.—A written re10 quest for a covered product, offer to sell a covered 

11 product, or acceptance of such an offer between the 

12 eligible product developer and the license holder 

13 shall be made by— 

14 (A) certified or registered mail with return 

15 receipt requested; 

16 (B) personal delivery; or 

17 (C) electronic means. 

18 (5) REMEDIES.— 

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

20 developer prevails in a civil action brought 

21 under paragraph (1), the court shall— 

22 (i) order the license holder to provide 

23 to the eligible product developer without 

24 delay sufficient quantities of the covered 


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1 product on commercially reasonable, mar2 ket-based terms; 

3 (ii) award to the eligible product de4 veloper reasonable attorney’s fees and costs 

5 of the civil action; and 

6 (iii) award to the eligible product de7 veloper a monetary amount sufficient to 

8 deter the license holder from failing to pro9 vide eligible product developers with suffi10 cient quantities of a covered product on 

11 commercially reasonable, market-based 

12 terms, if the court finds, by a preponder13 ance of the evidence— 

14 (I) that the license holder delayed 

15 providing sufficient quantities of the 

16 covered product to the eligible product 

17 developer without a legitimate busi18 ness justification; or 

19 (II) that the license holder failed 

20 to comply with an order issued under 

21 clause (i). 

22 (B) MAXIMUM MONETARY AMOUNT.—A 

23 monetary amount awarded under subparagraph 

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


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1 that the license holder earned on the covered 

2 product during the period— 

3 (i) beginning on— 

4 (I) for a covered product that is 

5 not subject to a REMS with ETASU, 

6 the date that is 31 days after the date 

7 on which the license holder received 

8 the request; or 

9 (II) for a covered product that is 

10 subject to a REMS with ETASU, the 

11 date that is 31 days after the later 

12 of— 

13 (aa) the date on which the 

14 license holder received the re15 quest; or 

16 (bb) the date on which the 

17 license holder received a copy of 

18 the covered product authorization 

19 issued by the Secretary in ac20 cordance with paragraph (2)(B); 

21 and 

22 (ii) ending on the date on which the 

23 eligible product developer received suffi24 cient quantities of the covered product. 


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1 (C) AVOIDANCE OF DELAY.—The court 

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

3 before conducting further proceedings that may 

4 be necessary to determine whether the eligible 

5 product developer is entitled to an award under 

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

7 amount of any such award. 

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

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

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

11 an eligible product developer to follow adequate safeguards 

12 to assure safe use of the covered product during develop13 ment or testing activities described in this section, includ14 ing transportation, handling, use, or disposal of the cov15 ered product by the eligible product developer. 

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

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355– 

18 1) is amended by adding at the end the following new sub19 section: 

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

21 STRATEGY.—The provision of samples of a covered prod22 uct to an eligible product developer (as those terms are 

23 defined in section 2(a) of the Creating and Restoring 

24 Equal Access to Equivalent Samples Act of 2019) shall 

25 not be considered a violation of the requirements of any 


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1 risk evaluation and mitigation strategy that may be in 

2 place under this section for such drug.’’. 

3 (e) RULE OF CONSTRUCTION.— 

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

5 ‘‘antitrust laws’’— 

6 (A) has the meaning given the term in 

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

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

9 (B) includes section 5 of the Federal 

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

11 extent that such section applies to unfair meth12 ods of competition. 

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

14 shall be construed to limit the operation of any pro15 vision of the antitrust laws. 

16 SEC. 102. REMS APPROVAL PROCESS FOR SUBSEQUENT 

17 FILERS. 

18 Section 505–1 of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 355–1), as amended by section 101, 

20 is further amended— 

21 (1) in subsection (g)(4)(B)— 

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

23 semicolon; 

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

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


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

2 ‘‘(iii) accommodate different, com3 parable aspects of the elements to assure 

4 safe use for a drug that is the subject of 

5 an application under section 505(j), and 

6 the applicable listed drug.’’; 

7 (2) in subsection (i)(1), by striking subpara8 graph (C) and inserting the following: 

9 ‘‘(C)(i) Elements to assure safe use, if re10 quired under subsection (f) for the listed drug, 

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

12 the subject of an application under section 

13 505(j) may use— 

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

15 listed drug under subsection (f); or 

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

17 the elements to assure safe use under sub18 section (f). 

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

20 that is the subject of an application under sec21 tion 505(j) and the listed drug to use a single, 

22 shared system under subsection (f), if the Sec23 retary determines that no different, comparable 

24 aspect of the elements to assure safe use could 

25 satisfy the requirements of subsection (f).’’; 


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

2 following: 

3 ‘‘(3) SHARED REMS.—If the Secretary ap4 proves, in accordance with paragraph (1)(C)(i)(II), a 

5 different, comparable aspect of the elements to as6 sure safe use under subsection (f) for a drug that 

7 is the subject of an abbreviated new drug application 

8 under section 505(j), the Secretary may require that 

9 such different comparable aspect of the elements to 

10 assure safe use can be used with respect to any 

11 other drug that is the subject of an application 

12 under section 505(j) or 505(b) that references the 

13 same listed drug.’’; and 

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

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

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

17 assure safe use’ or ‘different, comparable approved risk 

18 evaluation and mitigation strategies’ means a risk evalua19 tion and mitigation strategy for a drug that is the subject 

20 of an application under section 505(j) that uses different 

21 methods or operational means than the strategy required 

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

23 other application under section 505(j) with the same such 

24 listed drug, but achieves the same level of safety as such 

25 strategy.’’. 


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1 TITLE II—INCREASING ACCESS 

2 TO DRUGS AND BIOSIMILAR 

3 PRODUCTS 

4 SEC. 201. EXPEDITED DEVELOPMENT AND PRIORITY RE5 VIEW FOR GENERIC COMPLEX DRUG PROD6 UCTS. 

7 Subchapter A of chapter V of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend9 ed by adding at the end the following: 

10 ‘‘SEC. 524B. EXPEDITED DEVELOPMENT AND PRIORITY RE11 VIEW FOR GENERIC COMPLEX DRUG PROD12 UCTS. 

13 ‘‘(a) ESTABLISHMENT OF PROGRAM.—The Secretary 

14 shall establish a program to expedite the development of, 

15 and provide priority review under section 505(j) for, ge16 neric complex drug products. 

17 ‘‘(b) REQUEST FOR DESIGNATION.—A sponsor of a 

18 generic complex drug product may request that the Sec19 retary designate such product for expedited development 

20 and priority review under this section. 

21 ‘‘(c) DESIGNATION PROCESS.— 

22 ‘‘(1) IN GENERAL.—Not later than 60 calendar 

23 days after the receipt of a request under subsection 

24 (c), the Secretary shall determine whether the prod25 uct that is the subject of the request meets the criVerDate Sep 11 2014 02:33 Aug 09, 2019 Jkt 089200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H3947.IH H3947

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1 teria under subsection (e) to be considered a generic 

2 complex drug product. If the Secretary determines 

3 that the product meets the criteria, the Secretary 

4 shall designate the product for expedited develop5 ment and priority review. 

6 ‘‘(2) REVIEW.—Review of a request under sub7 section (b) shall be undertaken by a team that is 

8 composed of experienced staff and senior managers 

9 of the Food and Drug Administration. 

10 ‘‘(3) WITHDRAWAL.—The Secretary may not 

11 withdraw a designation granted under this section 

12 on the basis of the criteria under subsection (e) no 

13 longer applying because of the subsequent clearance 

14 or approval of any other product. 

15 ‘‘(d) EXPEDITED DEVELOPMENT AND PRIORITY RE16 VIEW GUIDANCE.— 

17 ‘‘(1) CONTENT.—Not later than December 31, 

18 2021, the Secretary shall issue guidance on the im19 plementation of this section. Such guidance shall— 

20 ‘‘(A) set forth the process by which a per21 son may seek a designation under subsection 

22 (c); 

23 ‘‘(B) provide a template for requests under 

24 subsection (b); 


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1 ‘‘(C) identify the criteria the Secretary will 

2 use in evaluating a request for designation 

3 under this section; and 

4 ‘‘(D) identify the criteria and processes the 

5 Secretary will use to expedite the development 

6 and review of products designated under this 

7 section. 

8 ‘‘(2) PROCESS.—Prior to finalizing the guid9 ance under paragraph (1), the Secretary shall seek 

10 public comment on a draft version of that guidance. 

11 ‘‘(e) GENERIC COMPLEX DRUG PRODUCT DE12 FINED.—In this section, the term ‘generic complex drug 

13 product’ means a product that represents a complex ther14 apy that consists of or includes a drug for approval under 

15 section 505(j) and that— 

16 ‘‘(1)(A) contains complex active ingredients 

17 (such as peptides, polymeric compounds, complex 

18 mixtures of active ingredients, and naturally sourced 

19 ingredients); 

20 ‘‘(B) is composed of complex formulations (such 

21 as liposomes or colloids); 

22 ‘‘(C) requires a complex route of delivery (such 

23 as locally acting drugs such as dermatological prod24 ucts and complex ophthalmological products and otic 


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1 dosage forms that are formulated as suspensions, 

2 emulsions, or gels); or 

3 ‘‘(D) involves a complex dosage form (such as 

4 transdermals, metered dose inhalers, or extended re5 lease injectables); 

6 ‘‘(2) presents as a complex drug-device com7 bination product (such as auto injectors or metered 

8 dose inhalers); or 

9 ‘‘(3) is a product that would benefit from early 

10 scientific engagement due to complexity or uncer11 tainty concerning the approval pathway under sec12 tion 505(j).’’. 

13 SEC. 202. INCREASING PHARMACEUTICAL OPTIONS TO 

14 TREAT AN UNMET MEDICAL NEED. 

15 Subsection (b) of section 506 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 356) is amended by 

17 adding at the end the following: 

18 ‘‘(4) UNMET MEDICAL NEED.—For purposes of 

19 paragraph (1), a drug shall be deemed to address an 

20 unmet medical need for a disease or condition if 

21 fewer than 3 available drugs exist for the treatment 

22 of such disease or condition.’’. 


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1 SEC. 203. PREEMPTION OF STATE BARRIERS TO THE SUB2 STITUTION OF BIOSIMILAR PRODUCTS. 

3 No State, or any political subdivision thereof, may 

4 prohibit a pharmacy or pharmacist from dispensing, in 

5 place of a biological reference product, any product that, 

6 pursuant to section 351(k) of the Public Health Service 

7 Act (42 U.S.C. 262(k)), has been determined by the Sec8 retary of Health and Human Services to be interchange9 able with the reference product in accordance with sub10 sections (a) and (k)(4) of such Act (42 U.S.C. 262(a), 

11 (k)(4)). 

12 SEC. 204. EXPEDITED PROCESS FOR BIOLOGICAL PROD13 UCTS AUTHORIZED FOR MARKETING IN EU14 ROPEAN UNION. 

15 Section 351(a) of the Public Health Service Act (42 

16 U.S.C. 262(a)) is amended by adding at the end the fol17 lowing new paragraph: 

18 ‘‘(4) PRODUCTS AUTHORIZED FOR MARKETING

19 IN EUROPEAN UNION.—In considering whether to li20 cense a biological product under this subsection or 

21 subsection (k), the Secretary may expedite the li22 censing process if the biological product has been 

23 authorized for marketing by the European Medicines 

24 Agency and such authorization remains in effect.’’. 


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1 TITLE III—PRESCRIPTION DRUG 

2 PRICING AND COMPETITION 

3 SEC. 301. MEDICARE DRUG COVERAGE. 

4 Notwithstanding any other provision of law, the Sec5 retary of Health and Human Services may alter payments 

6 for prescription drugs, including biologicals, provided 

7 through the Medicare part B program by paying at rates 

8 that, based on the average sales price plus 6 percent in 

9 the year of implementation of this Act, grow at the con10 sumer price index (CPI Prescription Drugs). 

11 SEC. 302. FEE TRANSPARENCY BETWEEN PHARMACIES AND 

12 PBMS. 

13 (a) PROHIBITING MEDICARE PDP SPONSORS AND

14 MA–PD ORGANIZATIONS FROM RETROACTIVELY REDUC15 ING PAYMENT ON CLEAN CLAIMS SUBMITTED BY PHAR16 MACIES.— 

17 (1) IN GENERAL.—Section 1860D–12(b)(4)(A) 

18 of the Social Security Act (42 U.S.C. 1395w– 

19 112(b)(4)(A)) is amended by adding at the end the 

20 following new clause: 

21 ‘‘(iv) PROHIBITING RETROACTIVE RE22 DUCTIONS IN PAYMENTS ON CLEAN

23 CLAIMS.—Each contract entered into with 

24 a PDP sponsor under this part with re25 spect to a prescription drug plan offered 


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1 by such sponsor shall provide that after 

2 the date of receipt of a clean claim sub3 mitted by a pharmacy, the PDP sponsor 

4 (or an agent of the PDP sponsor) may not 

5 retroactively reduce payment on such claim 

6 directly or indirectly through aggregated 

7 effective rate or otherwise except in the 

8 case such claim is found to not be a clean 

9 claim (such as in the case of a claim lack10 ing required substantiating documentation) 

11 during the course of a routine audit as 

12 permitted pursuant to written agreement 

13 between the PDP sponsor (or such an 

14 agent) and such pharmacy. The previous 

15 sentence shall not prohibit any retroactive 

16 increase in payment to a pharmacy pursu17 ant to a written agreement between a PDP 

18 sponsor (or an agent of such sponsor) and 

19 such pharmacy.’’. 

20 (2) EFFECTIVE DATE.—The amendment made 

21 by subsection (a) shall apply with respect to con22 tracts entered into on or after January 1, 2021. 

23 (b) ELIMINATION OF DIR FEES.— 


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1 (1) PHARMACY BENEFITS MANAGER STAND2 ARDS UNDER THE MEDICARE PROGRAM FOR PRE3 SCRIPTION DRUG PLANS AND MA–PD PLANS.— 

4 (A) IN GENERAL.—Section 1860D–12(b) 

5 of the Social Security Act (42 U.S.C. 1395w– 

6 112(b)) is amended by adding at the end the 

7 following new paragraph: 

8 ‘‘(7) PHARMACY BENEFITS MANAGER TRANS9 PARENCY REQUIREMENTS.—Each contract entered 

10 into with a PDP sponsor under this part with re11 spect to a prescription drug plan offered by such 

12 sponsor or with an MA organization offering an 

13 MA–PD plan under part C shall provide that the 

14 sponsor or organization, respectively, may not enter 

15 into a contract with any pharmacy benefits manager 

16 (referred to in this paragraph as a ‘PBM’) to man17 age the prescription drug coverage provided under 

18 such plan, or to control the costs of the prescription 

19 drug coverage under such plan, unless the PBM ad20 heres to the following criteria when handling person21 ally identifiable utilization and claims data or other 

22 sensitive patient data: 

23 ‘‘(A) The PBM may not transmit any per24 sonally identifiable utilization, protected health 

25 information, or claims data, with respect to a 


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1 plan enrollee, to a pharmacy owned by a PBM 

2 if the plan enrollee has not voluntarily elected 

3 in writing or via secure electronic means to fill 

4 that particular prescription at the PBM-owned 

5 pharmacy. 

6 ‘‘(B) The PBM may not require that a 

7 plan enrollee use a retail pharmacy, mail order 

8 pharmacy, specialty pharmacy, or other phar9 macy entity providing pharmacy services in 

10 which the PBM has an ownership interest or 

11 that has an ownership interest in the PBM, or 

12 provide an incentive to a plan enrollee to en13 courage the enrollee to use a retail pharmacy, 

14 mail order pharmacy, specialty pharmacy, or 

15 other pharmacy entity providing pharmacy serv16 ices in which the PBM has an ownership inter17 est or that has an ownership interest in the 

18 PBM, if the incentive is applicable only to such 

19 pharmacies.’’. 

20 (B) REGULAR UPDATE OF PRESCRIPTION

21 DRUG PRICING STANDARD.—Paragraph (6) of 

22 section 1860D–12(b) of the Social Security Act 

23 (42 U.S.C. 1395w–112(b)) is amended to read 

24 as follows: 


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1 ‘‘(6) REGULAR UPDATE OF PRESCRIPTION

2 DRUG PRICING STANDARD.— 

3 ‘‘(A) IN GENERAL.—If the PDP sponsor of 

4 a prescription drug plan (or MA organization 

5 offering an MA–PD plan) uses a standard for 

6 reimbursement (as described in subparagraph 

7 (B)) of pharmacies based on the cost of a drug, 

8 each contract entered into with such sponsor 

9 under this part (or organization under part C) 

10 with respect to the plan shall provide that the 

11 sponsor (or organization) shall— 

12 ‘‘(i) update such standard not less fre13 quently than once every 7 days, beginning 

14 with an initial update on January 1 of 

15 each year, to accurately reflect the market 

16 price of acquiring the drug; 

17 ‘‘(ii) disclose to applicable pharmacies 

18 and the contracting entities of such phar19 macies the sources used for making any 

20 such update immediately without require21 ment of request; 

22 ‘‘(iii) if the source for such a standard 

23 for reimbursement is not publicly available, 

24 disclose to the applicable pharmacies and 

25 the respective contracting entities of such 


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1 pharmacies all individual drug prices to be 

2 so updated in advance of the use of such 

3 prices for the reimbursement of claims; 

4 ‘‘(iv) establish a process to appeal, in5 vestigate, and resolve disputes regarding 

6 individual drug prices that are less than 

7 the pharmacy acquisition price for such 

8 drug, which must be adjudicated within 7 

9 days of the pharmacy filing its appeal; and 

10 ‘‘(v) provide all such pricing data in 

11 an .xml spreadsheet format or a com12 parable easily accessible and complete 

13 spreadsheet format. 

14 ‘‘(B) PRESCRIPTION DRUG PRICING

15 STANDARD DEFINED.—For purposes of sub16 paragraph (A), a standard for reimbursement 

17 of a pharmacy is any methodology or formula 

18 for varying the pricing of a drug or drugs dur19 ing the term of the pharmacy reimbursement 

20 contract that is based on the cost of the drug 

21 involved, including drug pricing references and 

22 amounts that are based upon average wholesale 

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1 lowable cost (MAC), or other costs, whether 

2 publicly available or not.’’. 

3 (C) EFFECTIVE DATE.—The amendments 

4 made by this section shall apply to plan years 

5 beginning on or after January 1, 2020. 

6 (2) REGULAR UPDATE OF PRESCRIPTION DRUG

7 PRICING STANDARD UNDER TRICARE RETAIL PHAR8 MACY PROGRAM.—Section 1074g(d) of title 10, 

9 United States Code, is amended by adding at the 

10 end the following new paragraph: 

11 ‘‘(3) To the extent practicable, with respect to the 

12 TRICARE retail pharmacy program described in sub13 section (a)(2)(E)(ii), the Secretary shall ensure that a con14 tract entered into with a TRICARE managed care support 

15 contractor includes requirements described in section 

16 1860D–12(b)(6) of the Social Security Act (42 U.S.C. 

17 1395w–112(b)(6)) to ensure the provision of information 

18 regarding the pricing standard for prescription drugs.’’. 

19 (3) PRESCRIPTION DRUG TRANSPARENCY IN

20 THE FEDERAL EMPLOYEES HEALTH BENEFITS PRO21 GRAM.— 

22 (A) IN GENERAL.—Section 8902 of title 5, 

23 United States Code, is amended by adding at 

24 the end the following new subsections: 


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1 ‘‘(p) A contract may not be made or a plan approved 

2 under this chapter under which a carrier has an agree3 ment with a pharmacy benefits manager (in this sub4 section referred to as a ‘PBM’) to manage prescription 

5 drug coverage or to control the costs of the prescription 

6 drug coverage unless the carrier and PBM adhere to the 

7 following criteria: 

8 ‘‘(1) The PBM may not transmit any personally 

9 identifiable utilization, protected health information, 

10 or claims data with respect to an individual enrolled 

11 under such contract or plan to a pharmacy owned by 

12 the PBM if the individual has not voluntarily elected 

13 in writing or via secure electronic means to fill that 

14 particular prescription at such a pharmacy. 

15 ‘‘(2) The PBM may not require that an indi16 vidual enrolled under such contract or plan use a re17 tail pharmacy, mail order pharmacy, specialty phar18 macy, or other pharmacy entity providing pharmacy 

19 services in which the PBM has an ownership interest 

20 or that has an ownership interest in the PBM or 

21 provide an incentive to a plan enrollee to encourage 

22 the enrollee to use a retail pharmacy, mail order 

23 pharmacy, specialty pharmacy, or other pharmacy 

24 entity providing pharmacy services in which the 

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1 ership interest in the PBM, if the incentive is appli2 cable only to such pharmacies. 

3 ‘‘(q)(1) If a contract made or plan approved under 

4 this chapter provides for a standard for reimbursement 

5 (as described in paragraph (2)) with respect to a prescrip6 tion drug plan, such contract or plan shall provide that 

7 the applicable carrier— 

8 ‘‘(A) update such standard not less frequently 

9 than once every 7 days, beginning with an initial up10 date on January 1 of each year, to accurately reflect 

11 the market price of acquiring the drug; 

12 ‘‘(B) disclose to applicable pharmacies and the 

13 contracting entities of such pharmacies the sources 

14 used for making any such update immediately with15 out requirement of request; 

16 ‘‘(C) if the source for such a standard for reim17 bursement is not publicly available, disclose to the 

18 applicable pharmacies and contracting entities of 

19 such pharmacies all individual drug prices to be so 

20 updated in advance of the use of such prices for the 

21 reimbursement of claims; 

22 ‘‘(D) establish a process to appeal, investigate, 

23 and resolve disputes regarding individual drug prices 

24 that are less than the pharmacy acquisition price for 


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1 such drug, which must be adjudicated within 7 days 

2 of the pharmacy filing its appeal; and 

3 ‘‘(E) provide all such pricing data in an .xml 

4 spreadsheet format or a comparable easily accessible 

5 and complete spreadsheet format. 

6 ‘‘(2) For purposes of paragraph (1), a standard for 

7 reimbursement of a pharmacy is any methodology or for8 mula for varying the pricing of a drug or drugs during 

9 the term of the pharmacy reimbursement contract that is 

10 based on the cost of the drug involved, including drug pric11 ing references and amounts that are based upon average 

12 wholesale price, wholesale average cost, average manufac13 turer price, average sales price, maximum allowable cost, 

14 or other costs, whether publicly available or not.’’. 

15 (B) APPLICATION.—The amendment made 

16 by subparagraph (A) shall apply to any contract 

17 entered into under section 8902 of title 5, 

18 United States Code, on or after the date of en19 actment of this section. 

20 SEC. 303. SUNSET OF LIMIT ON MAXIMUM REBATE AMOUNT 

21 FOR SINGLE SOURCE DRUGS AND INNO22 VATOR MULTIPLE SOURCE DRUGS. 

23 Section 1927(c)(2)(D) of the Social Security Act (42 

24 U.S.C. 1396r–8(c)(2)(D)) is amended by inserting after 


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1 ‘‘December 31, 2009,’’ the following: ‘‘and before Decem2 ber 31, 2024,’’. 

3 SEC. 304. REGULATION OF MANUFACTURER-SPONSORED 

4 COPAY CONTRIBUTIONS. 

5 Notwithstanding any other provision of law, the Sec6 retary of Health and Human Services may establish a 

7 mechanism prohibiting drug manufacturers from contrib8 uting financially to patient copays, and establish a system 

9 of penalizing such behavior. 

10 TITLE IV—PATENT DISCLOSURE 

11 REQUIREMENTS 

12 SEC. 401. PATENT DISCLOSURE AND TRANSPARENCY RE13 QUIREMENTS. 

14 (a) IN GENERAL.— 

15 (1) IN GENERAL.—Section 351 of the Public 

16 Health Service Act (42 U.S.C. 262) is amended by 

17 adding at the end the following: 

18 ‘‘(o) ADDITIONAL REQUIREMENTS WITH RESPECT

19 TO PATENTS.— 

20 ‘‘(1) PUBLICATION OF INFORMATION.— 

21 ‘‘(A) IN GENERAL.—Within 1 year of the 

22 date of enactment of the Biologic Patent Trans23 parency Act, the Secretary shall publish and 

24 make available to the public a single, easily 

25 searchable list that includes— 


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1 ‘‘(i) the proper and proprietary name 

2 of each biological product licensed or 

3 deemed to be licensed under subsection (a) 

4 or (k); 

5 ‘‘(ii) the date of approval and applica6 tion number for each such biological prod7 uct; 

8 ‘‘(iii) the marketing status, dosage 

9 form, route of administration, strength, 

10 and, if applicable, reference product, for 

11 each such biological product; 

12 ‘‘(iv) the licensure status for each 

13 such biological product, including whether 

14 the license at the time of listing is ap15 proved, withdrawn, or revoked; 

16 ‘‘(v) for each such biological product 

17 that is a reference product for which an 

18 exclusivity period applies, and for which 

19 the Secretary has determined the dates of 

20 such exclusivity period, under subsection 

21 (k)(7)(A) or subsection (k)(7)(B) of this 

22 section or under section 527 of the Federal 

23 Food, Drug, and Cosmetic Act, including 

24 any extension of such exclusivity period in 

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1 tion, the date on which such exclusivity pe2 riod expires; 

3 ‘‘(vi) any determination of biosimi4 larity or interchangeability for each such 

5 biological product; and 

6 ‘‘(vii) information regarding approved 

7 indications for each such biological prod8 uct, in such manner as the Secretary de9 termines appropriate. 

10 ‘‘(B) UPDATES.—Every 30 days after the 

11 publication of the first list under subparagraph 

12 (A), the Secretary shall revise the list to in13 clude— 

14 ‘‘(i)(I) each biological product licensed 

15 under subsection (a) or (k) during the 30- 

16 day period; and 

17 ‘‘(II) with respect to each biological 

18 product described in subclause (I), the in19 formation described in clauses (i) through 

20 (vii) of subparagraph (A); and 

21 ‘‘(ii) any updates to information pre22 viously published in accordance with sub23 paragraph (A).’’. 

24 (2) PUBLIC LISTING OF PATENT INFORMA25 TION.— 


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1 (A) IN GENERAL.—The Secretary of 

2 Health and Human Services shall include in the 

3 recommendations transmitted to Congress 

4 under section 744I(f) of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 379j–53(f)) 

6 recommendations with respect to the collection 

7 and publication of patent information in the list 

8 described in section 351(o) of the Public Health 

9 Service Act (42 U.S.C. 262), as added by para10 graph (1). 

11 (B) DEVELOPMENT.—In developing rec12 ommendations under subparagraph (A), the 

13 Secretary of Health and Human Services may 

14 consult with the Federal Trade Commission, 

15 the Director of the United States Patent and 

16 Trademark Office, and the Federal Trade Com17 mission, in addition to the entities listed in sec18 tion 744I(f)(1) of the Federal Food, Drug, and 

19 Cosmetic Act (21 U.S.C. 379j–53(f)(1)). 

20 (b) RULE OF CONSTRUCTION.—Nothing in this sec21 tion, including the amendment made by this section, shall 

22 be construed to require or allow the Secretary of Health 

23 and Human Services to delay the review or approval of 

24 a biologic license application under section 351 of the Pub25 lic Health Service Act (42 U.S.C. 262). 


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1 SEC. 402. ANTITRUST EXEMPTION FOR HEALTH INSURANCE 

2 ISSUERS TO NEGOTIATE WHOLESALE ACQUI3 SITION PRICES OF PRESCRIPTION DRUGS 

4 PURCHASED FROM DRUG MANUFACTURERS. 

5 (a) EXEMPTION.—It shall not be a violation of the 

6 antitrust laws for one or more health insurance issuers 

7 or their designated agents to jointly negotiate wholesale 

8 acquisition prices of a prescription drug with a manufac9 turer of a prescription drug with regards to the reimburse10 ment policies of the insurers of the manufacturer’s drugs 

11 so long as no single wholesale acquisition price is jointly 

12 determined between the insurance issuers or their des13 ignated agents. 

14 (b) DEFINITIONS.—For purposes of this section: 

15 (1) ANTITRUST LAWS.—The term ‘‘antitrust 

16 laws’’ has the meaning given it in subsection (a) of 

17 the 1st section of the Clayton Act (15 U.S.C. 12(a)), 

18 except that such term includes section 5 of the Fed19 eral Trade Commission Act (15 U.S.C. 45) to the 

20 extent such section 5 applies to unfair methods of 

21 competition. 

22 (2) HEALTH INSURANCE ISSUER.—The term 

23 ‘‘health insurance issuer’’ has the meaning given 

24 that term in section 2791(b) of the Public Health 

25 Service Act (42 U.S.C. 300gg–91(b)). 


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1 (3) HEALTH MAINTENANCE ORGANIZATION.— 

2 The term ‘‘health maintenance organization’’ 

3 means— 

4 (A) a federally qualified health mainte5 nance organization (as defined in section 

6 300e(a) of title 42 of the Code of Federal Reg7 ulations), 

8 (B) an organization recognized under State 

9 law as a health maintenance organization, or 

10 (C) a similar organization regulated under 

11 State law for solvency in the same manner and 

12 to the same extent as such a health mainte13 nance organization. 

14 (4) MANUFACTURER.—The term ‘‘manufac15 turer’’ means anyone who is engaged in manufac16 turing, preparing, propagating, compounding, proc17 essing, packaging, repackaging, or labeling of a pre18 scription drug. 

19 (5) PRESCRIPTION DRUG.—The term ‘‘prescrip20 tion drug’’ means a drug for human use subject to 

21 section 503(b)(1) of the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 353(b)(1)). 

23 (c) EFFECTIVE DATE.—This section shall take effect 

24 on the date of the enactment of this Act but shall not 

25 apply with respect to conduct that occurs before such date. 


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1 SEC. 403. FAIR TREATMENT OF MEDICARE PART B BILLING 

2 CODES FOR THE PRESCRIBING OF 

3 BIOSIMILARS. 

4 Section 1847A of the Social Security Act (42 U.S.C. 

5 1395w–3a) is amended by adding at the end the following 

6 new subsection: 

7 ‘‘(h) USE OF CERTAIN CODES.—Notwithstanding 

8 any previous provision of this section, for purposes of pay9 ment of biological biosimilar product the Secretary of 

10 Health and Human Services shall assign a uniform Com11 mon Procedure System code to describe all such products 

12 that share a common reference product.’’. 

13 TITLE V—FIXING GLOBAL 

14 FREELOADING 

15 SEC. 501. CHIEF PHARMACEUTICAL NEGOTIATOR IN THE 

16 OFFICE OF THE UNITED STATES TRADE REP17 RESENTATIVE. 

18 (a) IN GENERAL.—Section 141 of the Trade Act of 

19 1974 (19 U.S.C. 2171) is amended— 

20 (1) in subsection (b)(2)— 

21 (A) by striking ‘‘and one Chief Innovation 

22 and Intellectual Property Negotiator’’ and in23 serting ‘‘one Chief Innovation and Intellectual 

24 Property Negotiator, and one Chief Pharma25 ceutical Negotiator’’; 


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1 (B) by striking ‘‘or the Chief Innovation 

2 and Intellectual Property Negotiator’’ and in3 serting ‘‘the Chief Innovation and Intellectual 

4 Property Negotiator, or the Chief Pharma5 ceutical Negotiator’’; and 

6 (C) by striking ‘‘and the Chief Innovation 

7 and Intellectual Property Negotiator’’ and in8 serting ‘‘the Chief Innovation and Intellectual 

9 Property Negotiator, and the Chief Pharma10 ceutical Negotiator’’; and 

11 (2) in subsection (c), by adding at the end the 

12 following new paragraph: 

13 ‘‘(7) The principal function of the Chief Phar14 maceutical Negotiator shall be to conduct trade ne15 gotiations and to enforce trade agreements relating 

16 to United States pharmaceutical products and serv17 ices. The Chief Pharmaceutical Negotiator shall be 

18 a vigorous advocate on behalf of United States phar19 maceutical interests, including patients and United 

20 States pharmaceutical workers. The Chief Pharma21 ceutical Negotiator shall perform such other func22 tions as the United States Trade Representative 

23 may direct.’’. 

24 (b) COMPENSATION.—Section 5314 of title 5, United 

25 States Code is amended by striking ‘‘Chief Innovation and 


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1 Intellectual Property Negotiator, Office of the United 

2 States Trade Representative.’’ and inserting the following: 

3 ‘‘Chief Innovation and Intellectual Property Nego4 tiator, Office of the United States Trade Representative. 

5 ‘‘Chief Pharmaceutical Negotiator, Office of the 

6 United States Trade Representative.’’. 

7 (c) REPORT REQUIRED.—Not later than one year 

8 after the appointment of the first Chief Pharmaceutical 

9 Negotiator pursuant to paragraph (2) of section 141(b) 

10 of the Trade Act of 1974, as amended by subsection (a), 

11 and annually thereafter, the United States Trade Rep12 resentative shall submit to the Committee on Finance of 

13 the Senate and the Committee on Ways and Means of the 

14 House of Representatives a report describing in detail— 

15 (1) enforcement actions taken by the Trade 

16 Representative during the one-year period preceding 

17 the submission of the report to ensure the protection 

18 of United States pharmaceutical products and serv19 ices; and 

20 (2) other actions taken by the Trade Represent21 ative to advance United States pharmaceutical prod22 ucts and services. 

Æ 


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