II 

116TH CONGRESS 

1ST SESSION S. 1224 

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 SENATE OF THE UNITED STATES 

APRIL 29, 2019 

Ms. KLOBUCHAR (for herself and Mr. GRASSLEY) introduced the following bill; 

which was read twice and 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 Significant and 

5 Time-wasting Abuse Limiting Legitimate Innovation of 

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


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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’’— 

17 (A) means an individual or entity; and 

18 (B) includes— 

19 (i) a director, officer, employee, agent, 

20 representative, successor, and assign of an 

21 entity; 

22 (ii) a joint venture, subsidiary, part23 nership, division, group, and affiliate con24 trolled by an entity; and 

25 (iii) a director, officer, employee, 

26 agent, representative, successor, and assign 


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1 of a joint venture, subsidiary, partnership, 

2 division, group, and affiliate controlled by 

3 an entity. 

4 (5) SERIES OF COVERED PETITIONS.—The 

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

6 of more than 1 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.—A person submitting or causing the 

16 submission of a covered petition or a series of covered peti17 tions that is a sham shall be liable for engaging in an 

18 unfair method of competition under section 5(a)(1) of the 

19 Federal Trade Commission Act (15 U.S.C. 45(a)(1)). 

20 (c) CIVIL ACTION.— 

21 (1) IN GENERAL.—If the Commission has rea22 son to believe that the submission of a covered peti23 tion or a series of covered petitions constitutes a vio24 lation of section 5(a)(1) of the Federal Trade Com25 mission Act (15 U.S.C. 45(a)(1)), the Commission 


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1 may commence a civil action to recover a civil pen2 alty and seek other appropriate relief in a district 

3 court of the United States against any person that 

4 submitted or caused to be submitted such covered 

5 petition or such series of covered petitions, including 

6 successors or assigns. 

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

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

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

10 sham under subsection (b) of this section if the Sec11 retary of Health and Human Services has deter12 mined that the covered petition was submitted with 

13 the primary purpose of delaying the approval of a 

14 covered application and was part of a series of cov15 ered petitions, and has referred such determination 

16 to the Federal Trade Commission in writing, with a 

17 reasoned basis for the determination. 

18 (3) EXCEPTION.—The presumption in para19 graph (2) shall not apply if the defendant estab20 lishes, by a preponderance of the evidence, that the 

21 series of covered petitions that includes the covered 

22 petition referred to the Commission by the Secretary 

23 of Health and Human Services is not a sham. 

24 (4) CIVIL PENALTY.—In an action under para25 graph (1), any person that has been found liable for 


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

2 Commission Act (15 U.S.C. 45(a)(1)) shall be sub3 ject to a civil penalty for each violation of not more 

4 than the greater of— 

5 (A) any revenue earned from the sale by 

6 such person of any drug product, referenced in 

7 a covered application that was the subject of a 

8 covered petition or a series of covered petitions 

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

10 covered petition or series of covered petitions 

11 was under review by the Secretary of Health 

12 and Human Services; or 

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

14 each covered petition that is a sham or that was 

15 part of a series of covered petitions that is a 

16 sham was under review by the Secretary of 

17 Health and Human Services. 

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

19 shall modify, impair, limit, or supersede the applica20 bility of the antitrust laws as defined in subsection 

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

22 12(a)), and of section 5 of the Federal Trade Com23 mission Act (15 U.S.C. 45) to the extent that it ap24 plies to unfair methods of competition. 


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1 (6) RULE OF CONSTRUCTION.—The civil pen2 alty provided in this subsection is in addition to, and 

3 not in lieu of, any other remedies provided by Fed4 eral law, including under section 16 of the Clayton 

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

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

7 Nothing in this paragraph shall be construed to af8 fect any authority of the Commission under any 

9 other provision of law. 

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

11 covered petition submitted on or after the date of enact12 ment of this Act. 

13 SEC. 3. SEVERABILITY. 

14 If any provision of this Act or the application of such 

15 provision to any person or circumstance is held to be un16 constitutional, the remainder of this Act and the applica17 tion of the provisions of such Act to any person or cir18 cumstance shall not be affected. 

Æ 


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