I 

116TH CONGRESS 

1ST SESSION H. R. 2374 

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 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Stop Significant and 

3 Time-wasting Abuse Limiting Legitimate Innovation of 

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

5 SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT 

6 AGAINST SHAM PETITIONS. 

7 (a) DEFINITIONS.—In this section: 

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

9 means the Federal Trade Commission. 

10 (2) COVERED APPLICATION.—The term ‘‘cov11 ered application’’ means an application filed pursu12 ant to subsection (b)(2) or (j) of section 505 of the 

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

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

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

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

17 petition’’ means a petition, or a supplement to a pe18 tition, filed under section 505(q) of the Federal 

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

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

21 (A) an individual or entity; 

22 (B) its directors, officers, employees, 

23 agents, representatives, successors, and assigns; 

24 and 

25 (C) the joint ventures, subsidiaries, part26 nerships, divisions, groups, and affiliates it conVerDate Sep 11 2014 00:23 Apr 30, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2374.IH H2374

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1 trols, and the respective directors, officers, em2 ployees, agents, representatives, successors, and 

3 assigns of each. 

4 (5) SERIES OF COVERED PETITIONS.—The 

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

6 of more than one covered petition. 

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

8 petition that is objectively baseless and that at9 tempts to use a governmental process, as opposed to 

10 the outcome of that process, to interfere with the 

11 business of a competitor, or a series of covered peti12 tions, that attempts to use a governmental process, 

13 as opposed to the outcome of that process, to inter14 fere with the business of a competitor. 

15 (b) VIOLATION.— 

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

17 causing the submission of a covered petition or a se18 ries of covered petitions that is a sham shall be lia19 ble for engaging in an unfair method of competition 

20 under section 5(a)(1) of the Federal Trade Commis21 sion Act (15 U.S.C. 45(a)(1)). 

22 (c) CIVIL ACTION.— 

23 (1) IN GENERAL.—If the Commission has rea24 son to believe that the submission of a covered peti25 tion or a series of covered petitions constitutes a vioVerDate Sep 11 2014 00:23 Apr 30, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2374.IH H2374

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1 lation of section 5(a)(1) of the Federal Trade Com2 mission Act (15 U.S.C. 45(a)(1)), the Commission 

3 may commence a civil action to recover a civil pen4 alty and seek other appropriate relief in a district 

5 court of the United States against any person that 

6 submitted or caused to be submitted such covered 

7 petition or such series of covered petitions, including 

8 successors or assigns. 

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

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

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

12 sham under subsection (b) of this section if the Sec13 retary of Health and Human Services has deter14 mined that the covered petition was submitted with 

15 the primary purpose of delaying the approval of a 

16 covered application, was part of a series of covered 

17 petitions, and has referred such determination to the 

18 Federal Trade Commission in writing, with a rea19 soned basis for the determination. 

20 (3) EXCEPTION.—The presumption in para21 graph (2) shall not apply if the defendant estab22 lishes, by a preponderance of the evidence, that the 

23 series of covered petitions that includes the covered 

24 petition referred to the Commission by the Secretary 

25 of Health and Human Services is not a sham. 


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1 (4) CIVIL PENALTY.—In an action under para2 graph (1), any person that has been found liable for 

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

4 Commission Act (15 U.S.C. 45(a)(1)) shall be sub5 ject to a civil penalty for each violation of not more 

6 than the greater of— 

7 (A) any revenue earned from the sale by 

8 such person of any drug product, referenced in 

9 a covered application that was the subject of a 

10 covered petition or a series of covered petitions 

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

12 covered petition or series of covered petitions 

13 was under review by the Secretary of Health 

14 and Human Services; or 

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

16 each covered petition that is a sham or that was 

17 part of a series of covered petitions that is a 

18 sham was under review by the Secretary of 

19 Health and Human Services. 

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

21 shall modify, impair, limit, or supersede the applica22 bility of the antitrust laws as defined in subsection 

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

24 12(a)), and of section 5 of the Federal Trade ComVerDate Sep 11 2014 00:23 Apr 30, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2374.IH H2374

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1 mission Act (15 U.S.C. 45) to the extent that it ap2 plies to unfair methods of competition. 

3 (6) RULE OF CONSTRUCTION.—The civil pen4 alty provided in this subsection is in addition to, and 

5 not in lieu of, any other remedies provided by Fed6 eral law, including under section 16 of the Clayton 

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

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

9 Nothing in this paragraph shall be construed to af10 fect any authority of the Commission under any 

11 other provision of law. 

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

13 covered petition submitted on or after the date of enact14 ment of this Act. 

15 SEC. 3. SEVERABILITY. 

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

17 this Act, or the application of such provision or amend18 ment to any person or circumstance is held to be unconsti19 tutional, the remainder of this Act, the amendments made 

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

21 Act or amendments to any person or circumstance shall 

22 not be affected. 

Æ 


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