Stop STALLING Act

IB 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 effi- cient 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 VerDate Sep 11 2014 18:10 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H2374.RH H2374 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 2374 RH 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. VerDate Sep 11 2014 18:10 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6652 E:\BILLS\H2374.RH H2374 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 2374 RH Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Stop Significant and 4 Time-wasting Abuse Limiting Legitimate Innovation of 5 New Generics Act’’ or the ‘‘Stop STALLING Act’’. 6 SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT 7 AGAINST SHAM PETITIONS. 8 (a) DEFINITIONS.—In this section: 9 (1) COMMISSION.—The term ‘‘Commission’’ 10 means the Federal Trade Commission. 11 (2) COVERED APPLICATION.—The term ‘‘cov- 12 ered application’’ means an application filed pursu- 13 ant to subsection (b)(2) or (j) of section 505 of the 14 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 15 355) or section 351(k) of the Public Health Service 16 Act (42 U.S.C. 262(k)). 17 (3) COVERED PETITION.—The term ‘‘covered 18 petition’’ means a petition, or a supplement to a pe- 19 tition, filed under section 505(q) of the Federal 20 Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)). 21 (4) PERSON.—The term ‘‘person’’ means— 22 (A) an individual or entity; 23 VerDate Sep 11 2014 18:10 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2374.RH H2374 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 2374 RH (B) its directors, officers, employees, 1 agents, representatives, successors, and assigns; 2 and 3 (C) the joint ventures, subsidiaries, part- 4 nerships, divisions, groups, and affiliates it con- 5 trols, and the respective directors, officers, em- 6 ployees, agents, representatives, successors, and 7 assigns of each. 8 (5) SERIES OF COVERED PETITIONS.—The 9 term ‘‘series of covered petitions’’ means any group 10 of more than one covered petition. 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.— 20 (1) IN GENERAL.—A person submitting or 21 causing the submission of a covered petition or a se- 22 ries of covered petitions that is a sham shall be lia- 23 ble for engaging in an unfair method of competition 24 VerDate Sep 11 2014 18:10 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2374.RH H2374 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 2374 RH under section 5(a)(1) of the Federal Trade Commis- 1 sion Act (15 U.S.C. 45(a)(1)). 2 (c) CIVIL ACTION.— 3 (1) IN GENERAL.—If the Commission has rea- 4 son to believe that the submission of a covered peti- 5 tion or a series of covered petitions constitutes a vio- 6 lation of section 5(a)(1) of the Federal Trade Com- 7 mission Act (15 U.S.C. 45(a)(1)), the Commission 8 may commence a civil action to recover a civil pen- 9 alty and seek other appropriate relief in a district 10 court of the United States against any person that 11 submitted or caused to be submitted such covered 12 petition or such series of covered petitions, including 13 successors or assigns. 14 (2) PRESUMPTION.—In a civil action under 15 paragraph (1), a covered petition shall be presumed 16 to be part of a series of covered petitions that is a 17 sham under subsection (b) of this section if the Sec- 18 retary of Health and Human Services has deter- 19 mined that the covered petition was submitted with 20 the primary purpose of delaying the approval of a 21 covered application, was part of a series of covered 22 petitions, and has referred such determination to the 23 Federal Trade Commission in writing, with a rea- 24 soned basis for the determination. 25 VerDate Sep 11 2014 18:10 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2374.RH H2374 pbinns on DSKJLVW7X2PROD with BILLS 6 •HR 2374 RH (3) EXCEPTION.—The presumption in para- 1 graph (2) shall not apply if the defendant estab- 2 lishes, by a preponderance of the evidence, that the 3 series of covered petitions that includes the covered 4 petition referred to the Commission by the Secretary 5 of Health and Human Services is not a sham. 6 (4) CIVIL PENALTY.—In an action under para- 7 graph (1), any person that has been found liable for 8 a violation of section 5(a)(1) of the Federal Trade 9 Commission Act (15 U.S.C. 45(a)(1)) shall be sub- 10 ject to a civil penalty for each violation of not more 11 than the greater of— 12 (A) any revenue earned from the sale by 13 such person of any drug product, referenced in 14 a covered application that was the subject of a 15 covered petition or a series of covered petitions 16 that is a sham, during the period in which the 17 covered petition or series of covered petitions 18 was under review by the Secretary of Health 19 and Human Services; or 20 (B) $50,000 for each calendar day that 21 each covered petition that is a sham or that was 22 part of a series of covered petitions that is a 23 sham was under review by the Secretary of 24 Health and Human Services. 25 VerDate Sep 11 2014 18:10 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2374.RH H2374 pbinns on DSKJLVW7X2PROD with BILLS 7 •HR 2374 RH (5) ANTITRUST LAWS.—Nothing in this section 1 shall modify, impair, limit, or supersede the applica- 2 bility of the antitrust laws as defined in subsection 3 (a) of the first section of the Clayton Act (15 U.S.C. 4 12(a)), and of section 5 of the Federal Trade Com- 5 mission Act (15 U.S.C. 45) to the extent that it ap- 6 plies to unfair methods of competition. 7 (6) RULE OF CONSTRUCTION.—The civil pen- 8 alty provided in this subsection is in addition to, and 9 not in lieu of, any other remedies provided by Fed- 10 eral law, including under section 16 of the Clayton 11 Act (15 U.S.C. 26) or under section 13(b) of the 12 Federal Trade Commission Act (15 U.S.C. 53(b)). 13 Nothing in this paragraph shall be construed to af- 14 fect any authority of the Commission under any 15 other provision of law. 16 (d) APPLICABILITY.—This section shall apply to any 17 covered petition submitted on or after the date of enact- 18 ment of this Act. 19 SEC. 3. SEVERABILITY. 20 If any provision of this Act, an amendment made by 21 this Act, or the application of such provision or amend- 22 ment to any person or circumstance is held to be unconsti- 23 tutional, the remainder of this Act, the amendments made 24 by this Act, and the application of the provisions of such 25 VerDate Sep 11 2014 18:10 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2374.RH H2374 pbinns on DSKJLVW7X2PROD with BILLS 8 •HR 2374 RH Act or amendments to any person or circumstance shall 1 not be affected. 2 VerDate Sep 11 2014 18:10 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2374.RH H2374 pbinns on DSKJLVW7X2PROD with BILLS VerDate Sep 11 2014 18:10 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2374.RH H2374 pbinns on DSKJLVW7X2PROD with BILLS 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 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 heath concerns, and for other purposes. DECEMBER 24, 2020 Committed to the Committee of the Whole House on the State of the Union and ordered to be printed VerDate Sep 11 2014 18:10 Dec 26, 2020 Jkt 019200 PO 00000 Frm 00010 Fmt 6651 Sfmt 6651 E:\BILLS\H2374.RH H2374 pbinns on DSKJLVW7X2PROD with BILLS