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Union Calendar No. 577 

116TH CONGRESS 

2D SESSION H. R. 2374 

[Report No. 116–694] 

To enable the Federal Trade Commission to deter filing of sham citizen 

petitions to cover an attempt to interfere with approval of a competing 

generic drug or biosimilar, to foster competition and facilitate the efficient review of petitions filed in good faith to raise legitimate public 

heath concerns, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 29, 2019 

Mr. JEFFRIES (for himself, Mr. SENSENBRENNER, Mr. NADLER, Mr. COLLINS

of Georgia, Mr. CICILLINE, and Mr. WELCH) introduced the following 

bill; which was referred to the Committee on the Judiciary 

DECEMBER 24, 2020 

Additional sponsors: Mr. COHEN and Mr. POSEY

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 


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A BILL 

To enable the Federal Trade Commission to deter filing 

of sham citizen petitions to cover an attempt to interfere 

with approval of a competing generic drug or biosimilar, 

to foster competition and facilitate the efficient review 

of petitions filed in good faith to raise legitimate public 

heath concerns, and for other purposes. 


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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 ‘‘Stop Significant and 

5 Time-wasting Abuse Limiting Legitimate Innovation of 

6 New Generics Act’’ or the ‘‘Stop STALLING Act’’. 

7 SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT 

8 AGAINST SHAM PETITIONS. 

9 (a) DEFINITIONS.—In this section: 

10 (1) COMMISSION.—The term ‘‘Commission’’ 

11 means the Federal Trade Commission. 

12 (2) COVERED APPLICATION.—The term ‘‘cov13 ered application’’ means an application filed pursu14 ant to subsection (b)(2) or (j) of section 505 of the 

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

16 355) or section 351(k) of the Public Health Service 

17 Act (42 U.S.C. 262(k)). 

18 (3) COVERED PETITION.—The term ‘‘covered 

19 petition’’ means a petition, or a supplement to a pe20 tition, filed under section 505(q) of the Federal 

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

22 (4) PERSON.—The term ‘‘person’’ means— 

23 (A) an individual or entity; 


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1 (B) its directors, officers, employees, 

2 agents, representatives, successors, and assigns; 

3 and 

4 (C) the joint ventures, subsidiaries, part5 nerships, divisions, groups, and affiliates it con6 trols, and the respective directors, officers, em7 ployees, agents, representatives, successors, and 

8 assigns of each. 

9 (5) SERIES OF COVERED PETITIONS.—The 

10 term ‘‘series of covered petitions’’ means any group 

11 of more than one covered petition. 

12 (6) SHAM.—The term ‘‘sham’’ means a covered 

13 petition that is objectively baseless and that at14 tempts to use a governmental process, as opposed to 

15 the outcome of that process, to interfere with the 

16 business of a competitor, or a series of covered peti17 tions, that attempts to use a governmental process, 

18 as opposed to the outcome of that process, to inter19 fere with the business of a competitor. 

20 (b) VIOLATION.— 

21 (1) IN GENERAL.—A person submitting or 

22 causing the submission of a covered petition or a se23 ries of covered petitions that is a sham shall be lia24 ble for engaging in an unfair method of competition 


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1 under section 5(a)(1) of the Federal Trade Commis2 sion Act (15 U.S.C. 45(a)(1)). 

3 (c) CIVIL ACTION.— 

4 (1) IN GENERAL.—If the Commission has rea5 son to believe that the submission of a covered peti6 tion or a series of covered petitions constitutes a vio7 lation of section 5(a)(1) of the Federal Trade Com8 mission Act (15 U.S.C. 45(a)(1)), the Commission 

9 may commence a civil action to recover a civil pen10 alty and seek other appropriate relief in a district 

11 court of the United States against any person that 

12 submitted or caused to be submitted such covered 

13 petition or such series of covered petitions, including 

14 successors or assigns. 

15 (2) PRESUMPTION.—In a civil action under 

16 paragraph (1), a covered petition shall be presumed 

17 to be part of a series of covered petitions that is a 

18 sham under subsection (b) of this section if the Sec19 retary of Health and Human Services has deter20 mined that the covered petition was submitted with 

21 the primary purpose of delaying the approval of a 

22 covered application, was part of a series of covered 

23 petitions, and has referred such determination to the 

24 Federal Trade Commission in writing, with a rea25 soned basis for the determination. 


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1 (3) EXCEPTION.—The presumption in para2 graph (2) shall not apply if the defendant estab3 lishes, by a preponderance of the evidence, that the 

4 series of covered petitions that includes the covered 

5 petition referred to the Commission by the Secretary 

6 of Health and Human Services is not a sham. 

7 (4) CIVIL PENALTY.—In an action under para8 graph (1), any person that has been found liable for 

9 a violation of section 5(a)(1) of the Federal Trade 

10 Commission Act (15 U.S.C. 45(a)(1)) shall be sub11 ject to a civil penalty for each violation of not more 

12 than the greater of— 

13 (A) any revenue earned from the sale by 

14 such person of any drug product, referenced in 

15 a covered application that was the subject of a 

16 covered petition or a series of covered petitions 

17 that is a sham, during the period in which the 

18 covered petition or series of covered petitions 

19 was under review by the Secretary of Health 

20 and Human Services; or 

21 (B) $50,000 for each calendar day that 

22 each covered petition that is a sham or that was 

23 part of a series of covered petitions that is a 

24 sham was under review by the Secretary of 

25 Health and Human Services. 


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1 (5) ANTITRUST LAWS.—Nothing in this section 

2 shall modify, impair, limit, or supersede the applica3 bility of the antitrust laws as defined in subsection 

4 (a) of the first section of the Clayton Act (15 U.S.C. 

5 12(a)), and of section 5 of the Federal Trade Com6 mission Act (15 U.S.C. 45) to the extent that it ap7 plies to unfair methods of competition. 

8 (6) RULE OF CONSTRUCTION.—The civil pen9 alty provided in this subsection is in addition to, and 

10 not in lieu of, any other remedies provided by Fed11 eral law, including under section 16 of the Clayton 

12 Act (15 U.S.C. 26) or under section 13(b) of the 

13 Federal Trade Commission Act (15 U.S.C. 53(b)). 

14 Nothing in this paragraph shall be construed to af15 fect any authority of the Commission under any 

16 other provision of law. 

17 (d) APPLICABILITY.—This section shall apply to any 

18 covered petition submitted on or after the date of enact19 ment of this Act. 

20 SEC. 3. SEVERABILITY. 

21 If any provision of this Act, an amendment made by 

22 this Act, or the application of such provision or amend23 ment to any person or circumstance is held to be unconsti24 tutional, the remainder of this Act, the amendments made 

25 by this Act, and the application of the provisions of such 


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1 Act or amendments to any person or circumstance shall 

2 not be affected. 


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Union Calendar No. 577 

116TH CONGRESS 

2D SESSION H. R. 2374 

[Report No. 116–694] 

A BILL 

To enable the Federal Trade Commission to deter 

concerns, and for other purposes. filed in good faith to raise legitimate public heath and facilitate the efficient review of petitions generic drug or biosimilar, to foster competition tempt to interfere with approval of a competing filing of sham citizen petitions to cover an atDECEMBER 24, 2020 

Committed to the Committee of the Whole House on the 

State of the Union and ordered to be printed 


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