Stop STALLING Act

II Calendar No. 179 117TH CONGRESS 1ST SESSION S. 1425 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 effi- cient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes. IN THE SENATE OF THE UNITED STATES APRIL 28, 2021 Ms. KLOBUCHAR (for herself, Mr. GRASSLEY, Mr. BLUMENTHAL, Ms. ERNST, Mr. LEAHY, Mr. DURBIN, Mr. OSSOFF, Mr. BOOKER, Mr. CRUZ, and Mr. BRAUN) introduced the following bill; which was read twice and referred to the Committee on the Judiciary DECEMBER 8, 2021 Reported by Mr. DURBIN, without amendment 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 health concerns, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 02:47 Dec 09, 2021 Jkt 029200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1425.RS S1425 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 1425 RS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Stop Significant and 2 Time-wasting Abuse Limiting Legitimate Innovation of 3 New Generics Act’’ or the ‘‘Stop STALLING Act’’. 4 SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT 5 AGAINST SHAM PETITIONS. 6 (a) DEFINITIONS.—In this section: 7 (1) COMMISSION.—The term ‘‘Commission’’ 8 means the Federal Trade Commission. 9 (2) COVERED APPLICATION.—The term ‘‘cov- 10 ered application’’ means an application filed pursu- 11 ant to subsection (b)(2) or (j) of section 505 of the 12 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 13 355) or section 351(k) of the Public Health Service 14 Act (42 U.S.C. 262(k)). 15 (3) COVERED PETITION.—The term ‘‘covered 16 petition’’ means a petition, or a supplement to a pe- 17 tition, filed under section 505(q) of the Federal 18 Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)). 19 (4) PERSON.—The term ‘‘person’’— 20 (A) means an individual or entity; and 21 (B) includes— 22 (i) a successor and an assign of an 23 entity; 24 VerDate Sep 11 2014 02:47 Dec 09, 2021 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1425.RS S1425 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 1425 RS (ii) a joint venture, subsidiary, part- 1 nership, division, group, and affiliate con- 2 trolled by an entity, and 3 (iii) a successor and an assign of a 4 joint venture, subsidiary, partnership, divi- 5 sion, group, and affiliate controlled by an 6 entity. 7 (5) SERIES OF COVERED PETITIONS.—The 8 term ‘‘series of covered petitions’’ means any group 9 of more than 1 covered petition relating to the same 10 covered application. 11 (6) SHAM.—The term ‘‘sham’’ means a covered 12 petition that is objectively baseless and that at- 13 tempts to use a governmental process, as opposed to 14 the outcome of that process, to interfere with the 15 business of a competitor, or a series of covered peti- 16 tions that attempts to use a governmental process, 17 as opposed to the outcome of that process, to inter- 18 fere with the business of a competitor. 19 (b) VIOLATION.—A person submitting or causing the 20 submission of a covered petition or a series of covered peti- 21 tions that is a sham shall be liable for engaging in an 22 unfair method of competition under section 5(a)(1) of the 23 Federal Trade Commission Act (15 U.S.C. 45(a)(1)). 24 (c) CIVIL ACTION.— 25 VerDate Sep 11 2014 02:47 Dec 09, 2021 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1425.RS S1425 pbinns on DSKJLVW7X2PROD with BILLS 4 •S 1425 RS (1) IN GENERAL.—If the Commission has rea- 1 son to believe that the submission of a covered peti- 2 tion or a series of covered petitions constitutes a vio- 3 lation of section 5(a)(1) of the Federal Trade Com- 4 mission Act (15 U.S.C. 45(a)(1)), the Commission 5 may commence a civil action to recover a civil pen- 6 alty and seek other appropriate relief in a district 7 court of the United States against any person that 8 submitted or caused to be submitted such covered 9 petition or such series of covered petitions, including 10 successors or assigns. 11 (2) PRESUMPTION.—In a civil action under 12 paragraph (1), a covered petition shall be presumed 13 to be part of a series of covered petitions that is a 14 sham under subsection (b) of this section if— 15 (A) the Secretary of Health and Human 16 Services— 17 (i) has determined that the covered 18 petition was submitted with the primary 19 purpose of delaying the approval of a cov- 20 ered application; and 21 (ii) has referred such determination to 22 the Federal Trade Commission in writing, 23 including a reasoned basis for the deter- 24 mination; and 25 VerDate Sep 11 2014 02:47 Dec 09, 2021 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1425.RS S1425 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 1425 RS (B) the covered petition was part of a se- 1 ries of covered petitions. 2 (3) EXCEPTION.—The presumption in para- 3 graph (2) shall not apply if the defendant estab- 4 lishes, by a preponderance of the evidence, that the 5 series of covered petitions that includes the covered 6 petition referred to the Commission by the Secretary 7 of Health and Human Services is not a sham. 8 (4) CIVIL PENALTY.—In an action under para- 9 graph (1), any person that has been found liable for 10 a violation of section 5(a)(1) of the Federal Trade 11 Commission Act (15 U.S.C. 45(a)(1)) shall be sub- 12 ject to a civil penalty for each violation of not more 13 than the greater of— 14 (A) any revenue earned from the sale by 15 such person of any drug product, referenced in 16 a covered application that was the subject of a 17 covered petition or a series of covered petitions 18 that is a sham, during the period in which the 19 covered petition or series of covered petitions 20 was under review by the Secretary of Health 21 and Human Services; or 22 (B) $50,000 for each calendar day that 23 each covered petition that is a sham or that was 24 part of a series of covered petitions that is a 25 VerDate Sep 11 2014 02:47 Dec 09, 2021 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1425.RS S1425 pbinns on DSKJLVW7X2PROD with BILLS 6 •S 1425 RS sham was under review by the Secretary of 1 Health and Human Services. 2 (5) ANTITRUST LAWS.—Nothing in this section 3 shall modify, impair, limit, or supersede the applica- 4 bility of the antitrust laws, as defined in subsection 5 (a) of the first section of the Clayton Act (15 U.S.C. 6 12(a)), and of section 5 of the Federal Trade Com- 7 mission Act (15 U.S.C. 45) to the extent that it ap- 8 plies to unfair methods of competition. 9 (6) RULE OF CONSTRUCTION.—The civil pen- 10 alty provided in this subsection is in addition to, and 11 not in lieu of, any other remedies provided by Fed- 12 eral law, including under section 16 of the Clayton 13 Act (15 U.S.C. 26) or under section 13(b) of the 14 Federal Trade Commission Act (15 U.S.C. 53(b)). 15 Nothing in this paragraph shall be construed to af- 16 fect any authority of the Commission under any 17 other provision of law. 18 (d) APPLICABILITY.—This section shall apply to any 19 covered petition submitted on or after the date of enact- 20 ment of this Act. 21 SEC. 3. SEVERABILITY. 22 If any provision of this Act or the application of such 23 provision to any person or circumstance is held to be un- 24 constitutional, the remainder of this Act and the applica- 25 VerDate Sep 11 2014 02:47 Dec 09, 2021 Jkt 029200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1425.RS S1425 pbinns on DSKJLVW7X2PROD with BILLS 7 •S 1425 RS tion of the provisions of such Act to any person or cir- 1 cumstance shall not be affected. 2 VerDate Sep 11 2014 02:47 Dec 09, 2021 Jkt 029200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1425.RS S1425 pbinns on DSKJLVW7X2PROD with BILLS Calendar No. 179 117TH CONGRESS 1ST SESSION S. 1425 A BILL To enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an at- tempt 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 health concerns, and for other purposes. DECEMBER 8, 2021 Reported without amendment VerDate Sep 11 2014 02:47 Dec 09, 2021 Jkt 029200 PO 00000 Frm 00008 Fmt 6651 Sfmt 6651 E:\BILLS\S1425.RS S1425 pbinns on DSKJLVW7X2PROD with BILLS