IB 

Union Calendar No. 578 

116TH CONGRESS 

2D SESSION H. R. 5133 

[Report No. 116–695] 

To amend the Federal Trade Commission Act to prohibit anticompetitive 

behaviors by drug product manufacturers, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 18, 2019 

Mr. CICILLINE (for himself, Mr. COLLINS of Georgia, Mr. NADLER, and Mr. 

SENSENBRENNER) introduced the following bill; which was referred to the 

Committee on the Judiciary 

DECEMBER 24, 2020 

Additional sponsors: Mrs. MCBATH and Mr. CLINE

DECEMBER 24, 2020 

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 


pbinns on DSKJLVW7X2PROD with BILLS
2 

•HR 5133 RH

A BILL 

To amend the Federal Trade Commission Act to prohibit 

anticompetitive behaviors by drug product manufacturers, and for other purposes. 


pbinns on DSKJLVW7X2PROD with BILLS
3 

•HR 5133 RH

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 ‘‘Affordable Prescrip5 tions for Patients Through Promoting Competition Act of 

6 2019’’. 

7 SEC. 2. PRODUCT HOPPING. 

8 (a) IN GENERAL.—The Federal Trade Commission 

9 Act (15 U.S.C. 41 et seq.) is amended by inserting after 

10 section 26 (15 U.S.C. 57c–2) the following: 

11 ‘‘SEC. 27. PRODUCT HOPPING. 

12 ‘‘(a) DEFINITIONS.—In this section: 

13 ‘‘(1) ABBREVIATED NEW DRUG APPLICATION.— 

14 The term ‘abbreviated new drug application’ means 

15 an application under subsection (b)(2) or (j) of sec16 tion 505 of the Federal Food, Drug, and Cosmetic 

17 Act (21 U.S.C. 355). 

18 ‘‘(2) BIOSIMILAR BIOLOGICAL PRODUCT.—The 

19 term ‘biosimilar biological product’ means a biologi20 cal product licensed under section 351(k) of the 

21 Public Health Service Act (42 U.S.C. 262(k)). 

22 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT LI23 CENSE APPLICATION.—The term ‘biosimilar biologi24 cal product license application’ means an application 


pbinns on DSKJLVW7X2PROD with BILLS
4 

•HR 5133 RH

1 submitted under section 351(k) of the Public Health 

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

3 ‘‘(4) FOLLOW-ON PRODUCT.—The term ‘follow4 on product’— 

5 ‘‘(A) means a drug approved through an 

6 application or supplement to an application sub7 mitted under section 505(b) of the Federal 

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

9 355(c)) or a biological product licensed through 

10 an application or supplement to an application 

11 submitted under section 351(a) of the Public 

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

13 change, modification, or reformulation to the 

14 same manufacturer’s previously approved drug 

15 or biological product that treats the same or a 

16 related indication; 

17 ‘‘(B) excludes such an application or sup18 plement to an application for a change, modi19 fication, or reformulation of a drug or biological 

20 product that is requested by the Secretary or 

21 necessary to comply with law, including sections 

22 505A and 505B of the Federal Food, Drug, 

23 and Cosmetic Act (21 U.S.C. 355a, 355c); 

24 ‘‘(C) excludes such an application or sup25 plement to an application submitted under secVerDate Sep 11 2014 18:12 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5133.RH H5133

pbinns on DSKJLVW7X2PROD with BILLS
5 

•HR 5133 RH

1 tion 505(b) of the Federal Food, Drug, and 

2 Cosmetic Act (21 U.S.C. 355(c)) that has been 

3 granted New Chemical Entity exclusivity (21 

4 U.S.C. 355(c)(3)(E)(ii)) by the Food and Drug 

5 Administration; and 

6 ‘‘(D) excludes such an application or sup7 plement submitted under section 351(a) of the 

8 Public Health Service Act (42 U.S.C. 262(a)) 

9 that has been granted exclusivity pursuant to 

10 section 351(k)(7) of such Act (42 U.S.C. 

11 262(k)(7)). 

12 ‘‘(5) COMMISSION.—The term ‘Commission’ 

13 means the Federal Trade Commission 

14 ‘‘(6) DISADVANTAGE.—The term ‘disadvantage’ 

15 means to impede the listed drug or reference prod16 uct’s ability to compete on the merits with the fol17 low-on product. This term excludes actions that con18 sist solely of— 

19 ‘‘(A) truthful, non-misleading promotional 

20 marketing; or 

21 ‘‘(B) ceasing promotional marketing for 

22 the listed drug or reference product. 

23 ‘‘(7) GENERIC DRUG.—The term ‘generic drug’ 

24 means a drug approved under an application sub25 mitted under subsection (b)(2) or (j) of section 505 


pbinns on DSKJLVW7X2PROD with BILLS
6 

•HR 5133 RH

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

2 U.S.C. 355). 

3 ‘‘(8) LISTED DRUG.—The term ‘listed drug’ 

4 means a drug listed under section 505(j)(7) of the 

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

6 355(j)(7)). 

7 ‘‘(9) MANUFACTURER.—The term ‘manufac8 turer’ means the holder, licensee, or assignee of— 

9 ‘‘(A) an approved application for a drug 

10 under section 505(c) of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 355(c)); or 

12 ‘‘(B) a biological product license under sec13 tion 351(a) of the Public Health Service Act 

14 (42 U.S.C. 262(a)). 

15 ‘‘(10) REFERENCE PRODUCT.—The term ‘ref16 erence product’ has the meaning given the term in 

17 section 351(i) of the Public Health Service Act (42 

18 U.S.C. 262(i)). 

19 ‘‘(11) ULTIMATE PARENT ENTITY.—The term 

20 ‘ultimate parent entity’ has the meaning given the 

21 term in section 801.1 of title 16, Code of Federal 

22 Regulations, or any successor regulation. 

23 ‘‘(b) PROHIBITION ON PRODUCT HOPPING.— 

24 ‘‘(1) PRIMA FACIE.—Except as provided in 

25 paragraph (2), a manufacturer of a reference prodVerDate Sep 11 2014 18:12 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5133.RH H5133

pbinns on DSKJLVW7X2PROD with BILLS
7 

•HR 5133 RH

1 uct or listed drug shall be considered to have en2 gaged in an unfair method of competition in or af3 fecting commerce in violation of section 5(a) of the 

4 Federal Trade Commission Act if complaint counsel 

5 or the Commission demonstrates by a preponderance 

6 of the evidence in a proceeding initiated by the Com7 mission under subsection (c)(1), or in a suit brought 

8 under subparagraph (B) or (C) of subsection (c)(1), 

9 that, during the period beginning on the date on 

10 which the manufacturer of the reference product or 

11 listed drug first receives notice that an applicant has 

12 submitted to the Commissioner of Food and Drugs 

13 an abbreviated new drug application or biosimilar bi14 ological product license application and ending on 

15 the date that is the earlier of 180 days after the 

16 date on which that generic drug or biosimilar bio17 logical product or another generic drug or biosimilar 

18 biological product referencing the listed drug or ref19 erence product is first marketed or 3 years after the 

20 date on which the follow-on product is first mar21 keted, the manufacturer engaged in either of the fol22 lowing actions: 

23 ‘‘(A) The manufacturer engaged in a hard 

24 switch, which shall be established by demVerDate Sep 11 2014 18:12 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5133.RH H5133

pbinns on DSKJLVW7X2PROD with BILLS
8 

•HR 5133 RH

1 onstrating that the manufacturer engaged in ei2 ther of the actions described in clause (i) or (ii): 

3 ‘‘(i) Upon the request of the manufac4 turer of the listed drug or reference prod5 uct, the Commissioner of Food and Drugs 

6 withdrew the approval of the application 

7 for the listed drug or reference product or 

8 placed the listed drug or reference product 

9 on the discontinued products list; and 

10 ‘‘(I) the manufacturer marketed or 

11 sold a follow-on product. 

12 ‘‘(ii)(I) The manufacturer of the listed 

13 drug or reference product— 

14 ‘‘(aa) withdrew, discontinued the 

15 manufacture of, or withdrew the ap16 plication with respect to, or an17 nounced withdrawal of, discontinuance 

18 of the manufacture of, or withdrawal 

19 of the application with respect to, the 

20 drug or reference product in a manner 

21 that impedes competition from a ge22 neric drug or a biosimilar biological 

23 product, as established by objective 

24 circumstances, unless such actions 

25 were taken by the manufacturer purVerDate Sep 11 2014 18:12 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5133.RH H5133

pbinns on DSKJLVW7X2PROD with BILLS
9 

•HR 5133 RH

1 suant to a request of the Commis2 sioner of Food and Drugs; or 

3 ‘‘(bb) destroyed the inventory of 

4 the listed drug or reference product in 

5 a manner that impedes competition 

6 from a generic drug or a biosimilar bi7 ological product, which may be estab8 lished by objective circumstances; and 

9 ‘‘(II) marketed or sold a follow-on 

10 product. 

11 ‘‘(B) The manufacturer engaged in a soft 

12 switch, which shall be established by dem13 onstrating that the manufacturer engaged in 

14 both of the following actions: 

15 ‘‘(i) The manufacturer took one or 

16 more actions with respect to the listed 

17 drug or reference product other than those 

18 described in subparagraph (A) that un19 fairly disadvantage the listed drug or ref20 erence product relative to the follow-on 

21 product described in clause (ii) in a man22 ner that impedes competition from either a 

23 generic drug or a biosimilar biological 

24 product, which may be established by ob25 jective circumstances. 


pbinns on DSKJLVW7X2PROD with BILLS
10 

•HR 5133 RH

1 ‘‘(ii) The manufacturer marketed or 

2 sold a follow-on product. 

3 ‘‘(2) JUSTIFICATION.— 

4 ‘‘(A) IN GENERAL.—Subject to paragraph 

5 (3), the actions described in paragraph (1) by 

6 a manufacturer of a listed drug or reference 

7 product shall not be considered to be an unfair 

8 method of competition in or affecting commerce 

9 if— 

10 ‘‘(i) the manufacturer demonstrates to 

11 the Commission or a district court of the 

12 United States, as applicable, by a prepon13 derance of the evidence in a proceeding ini14 tiated by the Commission under subsection 

15 (c)(1), or in a suit brought under subpara16 graph (B) or (C) of subsection (c)(1), 

17 that— 

18 ‘‘(I) the manufacturer would 

19 have taken the actions regardless of 

20 whether a generic drug that ref21 erences the listed drug or biosimilar 

22 biological product that references the 

23 reference product had already entered 

24 the market; and 


pbinns on DSKJLVW7X2PROD with BILLS
11 

•HR 5133 RH

1 ‘‘(II)(aa) with respect to a hard 

2 switch under paragraph (1)(A)(i), the 

3 manufacturer took the action for rea4 sons relating to the safety risk to pa5 tients of the listed drug or reference 

6 product; 

7 ‘‘(bb) with respect to an action 

8 described in item (aa) or (bb) of para9 graph (1)(A)(ii)(I), there is a supply 

10 disruption that— 

11 ‘‘(AA) is outside of the con12 trol of the manufacturer; 

13 ‘‘(BB) prevents the produc14 tion or distribution of the appli15 cable listed drug or reference 

16 product; and 

17 ‘‘(CC) cannot be remedied 

18 by reasonable efforts; or 

19 ‘‘(cc) with respect to a soft 

20 switch under paragraph (1)(B), the 

21 manufacturer had legitimate pro-com22 petitive reasons, apart from the finan23 cial effects of reduced competition, to 

24 take the action. 


pbinns on DSKJLVW7X2PROD with BILLS
12 

•HR 5133 RH

1 ‘‘(B) RULE OF CONSTRUCTION.—Nothing 

2 in subparagraph (A) may be construed to limit 

3 the information that the Commission may oth4 erwise obtain in any proceeding or action insti5 tuted with respect to a violation of this section. 

6 ‘‘(3) RESPONSE.—With respect to a justifica7 tion offered by a manufacturer under paragraph (2), 

8 complaint counsel or the Commission, as applicable, 

9 will prevail in its case if it establishes by a prepon10 derance of the evidence that— 

11 ‘‘(A) the conduct described in subsection 

12 (b)(1) is not reasonably necessary to address or 

13 achieve the justifications claimed under para14 graph (2)(A)(II)(aa–cc), or such justifications 

15 could be reasonably addressed or achieved 

16 through less anticompetitive means; or 

17 ‘‘(B) the pro-competitive benefits from the 

18 conduct described in subparagraph (A) or (B) 

19 of paragraph (1), as applicable, do not outweigh 

20 any anticompetitive effects of the conduct, even 

21 in consideration of the justification so offered. 

22 ‘‘(c) ENFORCEMENT.— 

23 ‘‘(1) ENFORCEMENT BY THE FEDERAL TRADE

24 COMMISSION.—Except as provided in paragraph (2), 

25 the Commission shall enforce this section in the 


pbinns on DSKJLVW7X2PROD with BILLS
13 

•HR 5133 RH

1 same manner, by the same means, and with the 

2 same jurisdiction, powers, duties, and remedies pro3 vided for by all applicable terms and provisions of 

4 the Federal Trade Commission Act (15 U.S.C. 45 et 

5 seq.). 

6 ‘‘(2) JUDICIAL REVIEW.— 

7 ‘‘(A) IN GENERAL.—Notwithstanding any 

8 provision of section 5 of the Federal Trade 

9 Commission Act, any manufacturer that is sub10 ject to a final order of the Commission that is 

11 issued in a proceeding initiated under para12 graph (1) may, not later than 30 days after the 

13 date on which the Commission issues the order, 

14 petition for review of the order in— 

15 ‘‘(i) the United States Court of Ap16 peals for the District of Columbia Circuit; 

17 or 

18 ‘‘(ii) the court of appeals of the 

19 United States for the circuit in which the 

20 ultimate parent entity of the manufacturer 

21 is incorporated. 

22 ‘‘(B) TREATMENT OF FINDINGS.—In a re23 view of an order issued by the Commission con24 ducted by a court of appeals of the United 

25 States under subparagraph (A), the factual 


pbinns on DSKJLVW7X2PROD with BILLS
14 

•HR 5133 RH

1 findings of the Commission shall be conclusive 

2 if those facts are supported by the evidence. 

3 ‘‘(3) RULES OF CONSTRUCTION.—Nothing in 

4 this subsection may be construed as— 

5 ‘‘(A) requiring the Commission to bring a 

6 suit seeking a temporary injunction under para7 graph (1)(B) before bringing a suit seeking a 

8 permanent injunction under paragraph (1)(C); 

9 or 

10 ‘‘(B) affecting any other authority of the 

11 Commission under this Act to seek relief or ob12 tain a remedy with respect to a violation of this 

13 Act.’’. 

14 (b) APPLICABILITY.—Section 27 of the Federal 

15 Trade Commission Act, as added by subsection (a), shall 

16 apply with respect to any— 

17 (1) conduct that occurs on or after the date of 

18 enactment of this Act; and 

19 (2) action or proceeding that is commenced on 

20 or after the date of enactment of this Act. 

21 (c) ANTITRUST LAWS.—Nothing in this section, or 

22 the amendments made by this section, shall modify, im23 pair, limit, or supersede the applicability of the antitrust 

24 laws as defined in subsection (a) of the first section of 

25 the Clayton Act (15 U.S.C. 12(a)), and of section 5 of 


pbinns on DSKJLVW7X2PROD with BILLS
15 

•HR 5133 RH

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

2 extent that it applies to unfair methods of competition. 

3 (d) RULEMAKING.—The Federal Trade Commission 

4 may issue rules under section 553 of title 5, United States 

5 Code, to carry out section 27 of the Federal Trade Com6 mission Act, as added by subsection (a), including by de7 fining any terms used in such section 27 (other than terms 

8 that are defined in subsection (a) of such section 27). 


pbinns on DSKJLVW7X2PROD with BILLS
Union Calendar No. 578 

116TH CONGRESS 

2D SESSION H. R. 5133 

[Report No. 116–695] 

A BILL 

To amend the Federal Trade Commission Act to 

uct manufacturers, and for other purposes. prohibit anticompetitive behaviors by drug prodDECEMBER 24, 2020 

Committed to the Committee of the Whole House on the 

State of the Union and ordered to be printed 


pbinns on DSKJLVW7X2PROD with BILLS