I 

116TH CONGRESS 

1ST SESSION H. R. 5133 

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 

A BILL 

To amend the Federal Trade Commission Act to prohibit 

anticompetitive behaviors by drug product manufacturers, 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. 

4 This Act may be cited as the ‘‘Affordable Prescrip5 tions for Patients Through Promoting Competition Act of 

6 2019’’. 


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1 SEC. 2. PRODUCT HOPPING. 

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

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

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

5 ‘‘SEC. 27. PRODUCT HOPPING. 

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

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

8 The term ‘abbreviated new drug application’ means 

9 an application under subsection (b)(2) or (j) of sec10 tion 505 of the Federal Food, Drug, and Cosmetic 

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

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

13 term ‘biosimilar biological product’ means a biologi14 cal product licensed under section 351(k) of the 

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

16 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT LI17 CENSE APPLICATION.—The term ‘biosimilar biologi18 cal product license application’ means an application 

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

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

21 ‘‘(4) FOLLOW-ON PRODUCT.—The term ‘follow22 on product’— 

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

24 application or supplement to an application sub25 mitted under section 505(b) of the Federal 

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


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1 355(c)) or a biological product licensed through 

2 an application or supplement to an application 

3 submitted under section 351(a) of the Public 

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

5 change, modification, or reformulation to the 

6 same manufacturer’s previously approved drug 

7 or biological product that treats the same or a 

8 related indication; 

9 ‘‘(B) excludes such an application or sup10 plement to an application for a change, modi11 fication, or reformulation of a drug or biological 

12 product that is requested by the Secretary or 

13 necessary to comply with law, including sections 

14 505A and 505B of the Federal Food, Drug, 

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

16 ‘‘(C) excludes such an application or sup17 plement to an application submitted under sec18 tion 505(b) of the Federal Food, Drug, and 

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

20 granted New Chemical Entity exclusivity (21 

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

22 Administration; and 

23 ‘‘(D) excludes such an application or sup24 plement submitted under section 351(a) of the 

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


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1 that has been granted exclusivity pursuant to 

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

3 262(k)(7)). 

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

5 means the Federal Trade Commission 

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

7 means to impede the listed drug or reference prod8 uct’s ability to compete on the merits with the fol9 low-on product. This term excludes actions that con10 sist solely of— 

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

12 marketing; or 

13 ‘‘(B) ceasing promotional marketing for 

14 the listed drug or reference product. 

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

16 means a drug approved under an application sub17 mitted under subsection (b)(2) or (j) of section 505 

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

19 U.S.C. 355). 

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

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

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

23 355(j)(7)). 

24 ‘‘(9) MANUFACTURER.—The term ‘manufac25 turer’ means the holder, licensee, or assignee of— 


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

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

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

4 ‘‘(B) a biological product license under sec5 tion 351(a) of the Public Health Service Act 

6 (42 U.S.C. 262(a)). 

7 ‘‘(10) REFERENCE PRODUCT.—The term ‘ref8 erence product’ has the meaning given the term in 

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

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

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

12 ‘ultimate parent entity’ has the meaning given the 

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

14 Regulations, or any successor regulation. 

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

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

17 paragraph (2), a manufacturer of a reference prod18 uct or listed drug shall be considered to have en19 gaged in an unfair method of competition in or af20 fecting commerce in violation of section 5(a) of the 

21 Federal Trade Commission Act if complaint counsel 

22 or the Commission demonstrates by a preponderance 

23 of the evidence in a proceeding initiated by the Com24 mission under subsection (c)(1), or in a suit brought 

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


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1 that, during the period beginning on the date on 

2 which the manufacturer of the reference product or 

3 listed drug first receives notice that an applicant has 

4 submitted to the Commissioner of Food and Drugs 

5 an abbreviated new drug application or biosimilar bi6 ological product license application and ending on 

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

8 date on which that generic drug or biosimilar bio9 logical product or another generic drug or biosimilar 

10 biological product referencing the listed drug or ref11 erence product is first marketed or 3 years after the 

12 date on which the follow-on product is first mar13 keted, the manufacturer engaged in either of the fol14 lowing actions: 

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

16 switch, which shall be established by dem17 onstrating that the manufacturer engaged in ei18 ther of the actions described in clause (i) or (ii): 

19 ‘‘(i) Upon the request of the manufac20 turer of the listed drug or reference prod21 uct, the Commissioner of Food and Drugs 

22 withdrew the approval of the application 

23 for the listed drug or reference product or 

24 placed the listed drug or reference product 

25 on the discontinued products list; and 


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1 ‘‘(I) the manufacturer marketed or 

2 sold a follow-on product. 

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

4 drug or reference product— 

5 ‘‘(aa) withdrew, discontinued the 

6 manufacture of, or withdrew the ap7 plication with respect to, or an8 nounced withdrawal of, discontinuance 

9 of the manufacture of, or withdrawal 

10 of the application with respect to, the 

11 drug or reference product in a manner 

12 that impedes competition from a ge13 neric drug or a biosimilar biological 

14 product, as established by objective 

15 circumstances, unless such actions 

16 were taken by the manufacturer pur17 suant to a request of the Commis18 sioner of Food and Drugs; or 

19 ‘‘(bb) destroyed the inventory of 

20 the listed drug or reference product in 

21 a manner that impedes competition 

22 from a generic drug or a biosimilar bi23 ological product, which may be estab24 lished by objective circumstances; and 


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

2 product. 

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

4 switch, which shall be established by dem5 onstrating that the manufacturer engaged in 

6 both of the following actions: 

7 ‘‘(i) The manufacturer took one or 

8 more actions with respect to the listed 

9 drug or reference product other than those 

10 described in subparagraph (A) that un11 fairly disadvantage the listed drug or ref12 erence product relative to the follow-on 

13 product described in clause (ii) in a man14 ner that impedes competition from either a 

15 generic drug or a biosimilar biological 

16 product, which may be established by ob17 jective circumstances. 

18 ‘‘(ii) The manufacturer marketed or 

19 sold a follow-on product. 

20 ‘‘(2) JUSTIFICATION.— 

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

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

23 a manufacturer of a listed drug or reference 

24 product shall not be considered to be an unfair 


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1 method of competition in or affecting commerce 

2 if— 

3 ‘‘(i) the manufacturer demonstrates to 

4 the Commission or a district court of the 

5 United States, as applicable, by a prepon6 derance of the evidence in a proceeding ini7 tiated by the Commission under subsection 

8 (c)(1), or in a suit brought under subpara9 graph (B) or (C) of subsection (c)(1), 

10 that— 

11 ‘‘(I) the manufacturer would 

12 have taken the actions regardless of 

13 whether a generic drug that ref14 erences the listed drug or biosimilar 

15 biological product that references the 

16 reference product had already entered 

17 the market; and 

18 ‘‘(II)(aa) with respect to a hard 

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

20 manufacturer took the action for rea21 sons relating to the safety risk to pa22 tients of the listed drug or reference 

23 product; 

24 ‘‘(bb) with respect to an action 

25 described in item (aa) or (bb) of paraVerDate Sep 11 2014 21:26 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H5133.IH H5133

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1 graph (1)(A)(ii)(I), there is a supply 

2 disruption that— 

3 ‘‘(AA) is outside of the con4 trol of the manufacturer; 

5 ‘‘(BB) prevents the produc6 tion or distribution of the appli7 cable listed drug or reference 

8 product; and 

9 ‘‘(CC) cannot be remedied 

10 by reasonable efforts; or 

11 ‘‘(cc) with respect to a soft 

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

13 manufacturer had legitimate pro-com14 petitive reasons, apart from the finan15 cial effects of reduced competition, to 

16 take the action. 

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

18 in subparagraph (A) may be construed to limit 

19 the information that the Commission may oth20 erwise obtain in any proceeding or action insti21 tuted with respect to a violation of this section. 

22 ‘‘(3) RESPONSE.—With respect to a justifica23 tion offered by a manufacturer under paragraph (2), 

24 complaint counsel or the Commission, as applicable, 


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1 will prevail in its case if it establishes by a prepon2 derance of the evidence that— 

3 ‘‘(A) the conduct described in subsection 

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

5 achieve the justifications claimed under para6 graph (2)(A)(II)(aa–cc), or such justifications 

7 could be reasonably addressed or achieved 

8 through less anticompetitive means; or 

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

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

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

12 any anticompetitive effects of the conduct, even 

13 in consideration of the justification so offered. 

14 ‘‘(c) ENFORCEMENT.— 

15 ‘‘(1) ENFORCEMENT BY THE FEDERAL TRADE

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

17 the Commission shall enforce this section in the 

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

19 same jurisdiction, powers, duties, and remedies pro20 vided for by all applicable terms and provisions of 

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

22 seq.). 

23 ‘‘(2) JUDICIAL REVIEW.— 

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

25 provision of section 5 of the Federal Trade 


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1 Commission Act, any manufacturer that is sub2 ject to a final order of the Commission that is 

3 issued in a proceeding initiated under para4 graph (1) may, not later than 30 days after the 

5 date on which the Commission issues the order, 

6 petition for review of the order in— 

7 ‘‘(i) the United States Court of Ap8 peals for the District of Columbia Circuit; 

9 or 

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

11 United States for the circuit in which the 

12 ultimate parent entity of the manufacturer 

13 is incorporated. 

14 ‘‘(B) TREATMENT OF FINDINGS.—In a re15 view of an order issued by the Commission con16 ducted by a court of appeals of the United 

17 States under subparagraph (A), the factual 

18 findings of the Commission shall be conclusive 

19 if those facts are supported by the evidence. 

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

21 this subsection may be construed as— 

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

23 suit seeking a temporary injunction under para24 graph (1)(B) before bringing a suit seeking a 


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

2 or 

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

4 Commission under this Act to seek relief or ob5 tain a remedy with respect to a violation of this 

6 Act.’’. 

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

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

9 apply with respect to any— 

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

11 enactment of this Act; and 

12 (2) action or proceeding that is commenced on 

13 or after the date of enactment of this Act. 

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

15 the amendments made by this section, shall modify, im16 pair, limit, or supersede the applicability of the antitrust 

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

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

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

20 extent that it applies to unfair methods of competition. 

21 (d) RULEMAKING.—The Federal Trade Commission 

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

23 Code, to carry out section 27 of the Federal Trade Com24 mission Act, as added by subsection (a), including by deVerDate Sep 11 2014 21:26 Nov 19, 2019 Jkt 099200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H5133.IH H5133

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1 fining any terms used in such section 27 (other than terms 

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

Æ 


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