I 

117TH CONGRESS 

1ST SESSION H. R. 2873 

To amend the Federal Trade Commission Act to prohibit product hopping, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 28, 2021 

Mr. CICILLINE (for himself, Mr. NADLER, Mr. BUCK, and Mrs. CAROLYN B. 

MALONEY of New York) introduced the following bill; which was referred 

to the Committee on the Judiciary 

A BILL 

To amend the Federal Trade Commission Act to prohibit 

product hopping, 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 2021’’. 

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: 


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1 ‘‘SEC. 27. PRODUCT HOPPING. 

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

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

4 The term ‘abbreviated new drug application’ means 

5 any application under subsection (j) of section 505 

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

7 U.S.C. 355) or an application under subsection 

8 (b)(2) of such section 505 that seeks a therapeutic 

9 equivalence rating to the reference product. 

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

11 term ‘biosimilar biological product’ means a biologi12 cal product licensed under section 351(k) of the 

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

14 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT LI15 CENSE APPLICATION.—The term ‘biosimilar biologi16 cal product license application’ means an application 

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

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

19 ‘‘(4) FOLLOW-ON PRODUCT.—The term ‘follow20 on product’— 

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

22 application or supplement to an application sub23 mitted under section 505(b) of the Federal 

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

25 355(b)) or a biological product licensed through 

26 an application or supplement to an application 


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1 submitted under section 351(a) of the Public 

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

3 change, modification, or reformulation to the 

4 same manufacturer’s previously approved drug 

5 or biological product that shares an indication, 

6 in whole or in part, with the same manufactur7 er’s previously approved drug or biological prod8 uct; and 

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

17 means any drug approved under an application sub18 mitted under subsection (j) of section 505 of the 

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

20 355) or an application under subsection (b)(2) of 

21 such section 505 that seeks a therapeutic equiva22 lence rating to the reference product. 

23 ‘‘(6) LISTED DRUG.—The term ‘listed drug’ 

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


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

2 355(j)(7)). 

3 ‘‘(7) MANUFACTURER.—The term ‘manufac4 turer’ means the holder, licensee, or assignee of— 

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

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

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

8 ‘‘(B) a biological product license under sec9 tion 351(a) of the Public Health Service Act 

10 (42 U.S.C. 262(a)). 

11 ‘‘(8) REFERENCE PRODUCT.—The term ‘ref12 erence product’ has the meaning given the term in 

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

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

15 ‘‘(9) ULTIMATE PARENT ENTITY.—The term 

16 ‘ultimate parent entity’ has the meaning given the 

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

18 Regulations, or any successor regulation. 

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

20 ‘‘(1) PRIMA FACIE.—A manufacturer of a ref21 erence product or listed drug shall be considered to 

22 have engaged in an unfair method of competition in 

23 or affecting commerce in violation of section 5(a) if 

24 complaint counsel or the Commission demonstrates 

25 in an action or proceeding initiated by the CommisVerDate Sep 11 2014 02:52 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2873.IH H2873

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1 sion under subsection (c) that, during the period be2 ginning on the date on which the manufacturer of 

3 the reference product or listed drug first receives no4 tice that an applicant has submitted to the Commis5 sioner of Food and Drugs an abbreviated new drug 

6 application or biosimilar biological product license 

7 application referencing the reference product or list8 ed drug and ending on the date that is the earlier 

9 of 180 days after the date on which that generic 

10 drug or biosimilar biological product or another ge11 neric drug or biosimilar biological product ref12 erencing the listed drug or reference product is first 

13 marketed or 3 years after the date on which the fol14 low-on product is first marketed, the manufacturer 

15 engaged in either of the following actions: 

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

17 switch, which shall be established by dem18 onstrating that the manufacturer engaged in ei19 ther of the following actions: 

20 ‘‘(i) Upon the request of the manufac21 turer of the listed drug or reference prod22 uct, the Commissioner of Food and Drugs 

23 withdrew the approval of the application 

24 for the listed drug or reference product or 

25 placed the listed drug or reference product 


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1 on the discontinued products list and the 

2 manufacturer marketed or sold a follow-on 

3 product. 

4 ‘‘(ii) The manufacturer of the listed 

5 drug or reference product— 

6 ‘‘(I)(aa) withdrew, discontinued 

7 the manufacture of, or announced 

8 withdrawal of, discontinuance of the 

9 manufacture of, or intent to withdraw 

10 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, which may be established by 

15 objective circumstances, unless such 

16 actions were taken by the manufac17 turer pursuant to a request of the 

18 Commissioner 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 actions 

8 with respect to the listed drug or reference 

9 product other than those described in sub10 paragraph (A) that unfairly disadvantage 

11 the listed drug or reference product rel12 ative to the follow-on product described in 

13 clause (ii) in a manner that impedes com14 petition from a generic drug or a bio15 similar biological product, which may be 

16 established by objective circumstances. 

17 ‘‘(ii) The manufacturer marketed or 

18 sold a follow-on product. 

19 ‘‘(2) EXCLUSIONS.—Nothing in this section 

20 shall prohibit actions that consist solely of— 

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

22 marketing; or 

23 ‘‘(B) ceasing promotional marketing for 

24 the listed drug or reference product. 

25 ‘‘(3) JUSTIFICATION.— 


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

2 (4), the actions described in paragraph (1) by 

3 a manufacturer of a listed drug or reference 

4 product shall not be considered to be an unfair 

5 method of competition in or affecting commerce 

6 if the manufacturer demonstrates to the Com7 mission or a district court of the United States, 

8 as applicable, in an action, suit or proceeding 

9 initiated by the Commission under subsection 

10 (c)(1) that— 

11 ‘‘(i) the manufacturer would have 

12 taken the actions regardless of whether a 

13 generic drug that references the listed drug 

14 or biosimilar biological product that ref15 erences the reference product had already 

16 entered the market; and 

17 ‘‘(ii)(I) with respect to a hard switch 

18 under paragraph (1)(A), the manufacturer 

19 took the action for reasons relating to the 

20 safety risk to patients of the listed drug or 

21 reference product; 

22 ‘‘(II) with respect to an action de23 scribed in item (aa) of paragraph 

24 (1)(A)(ii)(I), there is a supply disruption 

25 that— 


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1 ‘‘(aa) is outside of the control of 

2 the manufacturer; 

3 ‘‘(bb) prevents the production or 

4 distribution of the applicable listed 

5 drug or reference product; and 

6 ‘‘(cc) cannot be remedied by rea7 sonable efforts; or 

8 ‘‘(III) with respect to a soft switch 

9 under paragraph (1)(B), the manufacturer 

10 had legitimate pro-competitive reasons, 

11 apart from the financial effects of reduced 

12 competition, to take the action. 

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

14 in subparagraph (A) may be construed to limit 

15 the information that the Commission may oth16 erwise obtain in any proceeding or action insti17 tuted with respect to a violation of this section. 

18 ‘‘(4) RESPONSE.—With respect to a justifica19 tion offered by a manufacturer under paragraph (3), 

20 the Commission may— 

21 ‘‘(A) rebut any evidence presented by a 

22 manufacturer during that justification; or 

23 ‘‘(B) establish by a preponderance of the 

24 evidence that— 


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1 ‘‘(i) on balance, the pro-competitive 

2 benefits from the conduct described in sub3 paragraph (A) or (B) of paragraph (1), as 

4 applicable, do not outweigh any anti5 competitive effects of the conduct, even in 

6 consideration of the justification so offered; 

7 or 

8 ‘‘(ii)(I) the conduct described in para9 graph (1) is not reasonably necessary to 

10 address or achieve the justifications de11 scribed in clause (ii) of paragraph (2)(A); 

12 or 

13 ‘‘(II) the justifications described in 

14 clause (ii) of paragraph (2)(A) could be 

15 reasonably addressed or achieved through 

16 less anticompetitive means. 

17 ‘‘(c) ENFORCEMENT.— 

18 ‘‘(1) IN GENERAL.—If the Commission has rea19 son to believe that any manufacturer has violated, is 

20 violating, or is about to violate this section, or a rule 

21 promulgated under this section, the Commission 

22 may take any of the following actions: 

23 ‘‘(A) Institute a proceeding under section 

24 5(b). 


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1 ‘‘(B) In the same manner and to the same 

2 extent as provided in section 13(b), bring suit 

3 in a district court of the United States to tem4 porarily enjoin the action of the manufacturer. 

5 ‘‘(C) Bring suit in a district court of the 

6 United States, in which the Commission may 

7 seek— 

8 ‘‘(i) to permanently enjoin the action 

9 of the manufacturer; 

10 ‘‘(ii) any of the remedies described in 

11 paragraph (3); and 

12 ‘‘(iii) any other equitable remedy, in13 cluding ancillary equitable relief. 

14 ‘‘(2) JUDICIAL REVIEW.— 

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

16 provision of section 5, any manufacturer that is 

17 subject to a final cease and desist order issued 

18 in a proceeding to enforce this section, or a rule 

19 promulgated under this section, may, not later 

20 than 30 days after the date on which the Com21 mission issues the order, petition for review of 

22 the order in— 

23 ‘‘(i) the United States Court of Ap24 peals for the District of Columbia Circuit; 

25 or 


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1 ‘‘(ii) the court of appeals of the 

2 United States for the circuit in which the 

3 ultimate parent entity of the manufacturer 

4 is incorporated. 

5 ‘‘(B) TREATMENT OF FINDINGS.—In a re6 view of a final cease and desist order conducted 

7 by a court of appeals of the United States 

8 under subparagraph (A), the factual findings of 

9 the Commission shall be conclusive if those 

10 facts are supported by the evidence. 

11 ‘‘(3) EQUITABLE REMEDIES.— 

12 ‘‘(A) DISGORGEMENT.— 

13 ‘‘(i) IN GENERAL.—In a suit brought 

14 under paragraph (1)(C), the Commission 

15 may seek, and the court may order, 

16 disgorgement of any unjust enrichment 

17 that a person obtained as a result of the 

18 violation that gives rise to the suit. 

19 ‘‘(ii) CALCULATION.—Any 

20 disgorgement that is ordered with respect 

21 to a person under clause (i) shall be offset 

22 by any amount of restitution ordered 

23 under subparagraph (B). 

24 ‘‘(iii) LIMITATIONS PERIOD.—The 

25 Commission may seek disgorgement under 


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1 this subparagraph not later than 5 years 

2 after the latest date on which the person 

3 from which the disgorgement is sought re4 ceives any unjust enrichment from the ef5 fects of the violation that gives rise to the 

6 suit in which the Commission seeks the 

7 disgorgement. 

8 ‘‘(B) RESTITUTION.— 

9 ‘‘(i) IN GENERAL.—In a suit brought 

10 under paragraph (1)(C), the Commission 

11 may seek, and the court may order, res12 titution with respect to the violation that 

13 gives rise to the suit. 

14 ‘‘(ii) LIMITATIONS PERIOD.—The 

15 Commission may seek restitution under 

16 this subparagraph not later than 5 years 

17 after the latest date on which the person 

18 from which the restitution is sought re19 ceives any unjust enrichment from the ef20 fects of the violation that gives rise to the 

21 suit in which the Commission seeks the 

22 restitution. 

23 ‘‘(4) RULES OF CONSTRUCTION.—Nothing in 

24 this subsection may be construed as— 


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

2 suit seeking a temporary injunction under para3 graph (1)(B) before bringing a suit seeking a 

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

5 or 

6 ‘‘(B) affecting the authority of the Federal 

7 Trade Commission under any other provision of 

8 law.’’. 

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

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

11 apply with respect to any— 

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

13 enactment of this Act; and 

14 (2) action or proceeding that is commenced on 

15 or after the date of enactment of this Act. 

16 (c) ANTITRUST LAWS.—Except to the extent sub17 section (a) establishes an additional basis for liability 

18 under the Federal Trade Commission Act (15 U.S.C. 41 

19 et seq.), nothing in this section, or the amendments made 

20 by this section, shall modify, impair, limit, or supersede 

21 the applicability of the antitrust laws as defined in sub22 section (a) of the first section of the Clayton Act (15 

23 U.S.C. 12(a)), and of section 5 of the Federal Trade Com24 mission Act (15 U.S.C. 45) to the extent that it applies 

25 to unfair methods of competition. 


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1 (d) RULEMAKING.—The Federal Trade Commission 

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

3 Code, to carry out section 27 of the Federal Trade Com4 mission Act, as added by subsection (a), including by de5 fining any terms used in such section 27 (other than terms 

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

Æ 


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