I 

117TH CONGRESS 

1ST SESSION H. R. 2883 

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 28, 2021 

Mr. JEFFRIES (for himself, Mr. BUCK, Mr. NADLER, Mr. CICILLINE, and Mrs. 

CAROLYN B. MALONEY of New York) 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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Stop Stalling Access 

5 to Affordable Medications’’. 


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1 SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT 

2 AGAINST SHAM PETITIONS. 

3 (a) DEFINITIONS.—In this section: 

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

5 means the Federal Trade Commission. 

6 (2) COVERED APPLICATION.—The term ‘‘cov7 ered application’’ means an application filed pursu8 ant to subsection (b)(2) or (j) of section 505 of the 

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

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

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

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

13 petition’’ means a petition, or a supplement to a pe14 tition, filed under section 505(q) of the Federal 

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

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

17 (A) an individual or entity; 

18 (B) its directors, officers, employees, 

19 agents, representatives, successors, and assigns; 

20 and 

21 (C) the joint ventures, subsidiaries, part22 nerships, divisions, groups, and affiliates it con23 trols, and the respective directors, officers, em24 ployees, agents, representatives, successors, and 

25 assigns of each. 


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1 (5) SERIES OF COVERED PETITIONS.—The 

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

3 of more than one covered petition. 

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

5 petition that is objectively baseless and that at6 tempts to use a governmental process, as opposed to 

7 the outcome of that process, to interfere with the 

8 business of a competitor, or a series of covered peti9 tions, that attempts to use a governmental process, 

10 as opposed to the outcome of that process, to inter11 fere with the business of a competitor. 

12 (b) VIOLATION.— 

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

14 causing the submission of a covered petition or a se15 ries of covered petitions that is a sham shall be lia16 ble for engaging in an unfair method of competition 

17 under section 5(a)(1) of the Federal Trade Commis18 sion Act (15 U.S.C. 45(a)(1)). 

19 (c) CIVIL ACTION.— 

20 (1) IN GENERAL.—If the Commission has rea21 son to believe that the submission of a covered peti22 tion or a series of covered petitions constitutes a vio23 lation of section 5(a)(1) of the Federal Trade Com24 mission Act (15 U.S.C. 45(a)(1)), the Commission 

25 may commence a civil action to recover a civil penVerDate Sep 11 2014 23:32 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2883.IH H2883

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1 alty and seek other appropriate relief in a district 

2 court of the United States against any person that 

3 submitted or caused to be submitted such covered 

4 petition or such series of covered petitions, including 

5 successors or assigns. 

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

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

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

9 sham under subsection (b) of this section if the Sec10 retary of Health and Human Services has deter11 mined that the covered petition was submitted with 

12 the primary purpose of delaying the approval of a 

13 covered application, was part of a series of covered 

14 petitions, and has referred such determination to the 

15 Federal Trade Commission in writing, with a rea16 soned basis for the determination. 

17 (3) EXCEPTION.—The presumption in para18 graph (2) shall not apply if the defendant estab19 lishes, by a preponderance of the evidence, that the 

20 series of covered petitions that includes the covered 

21 petition referred to the Commission by the Secretary 

22 of Health and Human Services is not a sham. 

23 (4) CIVIL PENALTY.—In an action under para24 graph (1), any person that has been found liable for 

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


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1 Commission Act (15 U.S.C. 45(a)(1)) shall be sub2 ject to a civil penalty for each violation of not more 

3 than the greater of— 

4 (A) any revenue earned from the sale by 

5 such person of any drug product, referenced in 

6 a covered application that was the subject of a 

7 covered petition or a series of covered petitions 

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

9 covered petition or series of covered petitions 

10 was under review by the Secretary of Health 

11 and Human Services; or 

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

13 each covered petition that is a sham or that was 

14 part of a series of covered petitions that is a 

15 sham was under review by the Secretary of 

16 Health and Human Services. 

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

18 shall modify, impair, limit, or supersede the applica19 bility of the antitrust laws as defined in subsection 

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

21 12(a)), and of section 5 of the Federal Trade Com22 mission Act (15 U.S.C. 45) to the extent that it ap23 plies to unfair methods of competition. 

24 (6) RULE OF CONSTRUCTION.—The civil pen25 alty provided in this subsection is in addition to, and 


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1 not in lieu of, any other remedies provided by Fed2 eral law, including under section 16 of the Clayton 

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

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

5 Nothing in this paragraph shall be construed to af6 fect any authority of the Commission under any 

7 other provision of law. 

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

9 covered petition submitted on or after the date of enact10 ment of this Act. 

11 SEC. 3. SEVERABILITY. 

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

13 this Act, or the application of such provision or amend14 ment to any person or circumstance is held to be unconsti15 tutional, the remainder of this Act, the amendments made 

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

17 Act or amendments to any person or circumstance shall 

18 not be affected. 

Æ 


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