Stop Stalling Access to Affordable Medications

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 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 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. 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 Stalling Access 4 to Affordable Medications’’. 5 VerDate Sep 11 2014 23:32 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2883.IH H2883 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 2883 IH SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT 1 AGAINST SHAM PETITIONS. 2 (a) DEFINITIONS.—In this section: 3 (1) COMMISSION.—The term ‘‘Commission’’ 4 means the Federal Trade Commission. 5 (2) COVERED APPLICATION.—The term ‘‘cov- 6 ered application’’ means an application filed pursu- 7 ant to subsection (b)(2) or (j) of section 505 of the 8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 9 355) or section 351(k) of the Public Health Service 10 Act (42 U.S.C. 262(k)). 11 (3) COVERED PETITION.—The term ‘‘covered 12 petition’’ means a petition, or a supplement to a pe- 13 tition, filed under section 505(q) of the Federal 14 Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)). 15 (4) PERSON.—The term ‘‘person’’ means— 16 (A) an individual or entity; 17 (B) its directors, officers, employees, 18 agents, representatives, successors, and assigns; 19 and 20 (C) the joint ventures, subsidiaries, part- 21 nerships, divisions, groups, and affiliates it con- 22 trols, and the respective directors, officers, em- 23 ployees, agents, representatives, successors, and 24 assigns of each. 25 VerDate Sep 11 2014 23:32 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2883.IH H2883 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 2883 IH (5) SERIES OF COVERED PETITIONS.—The 1 term ‘‘series of covered petitions’’ means any group 2 of more than one covered petition. 3 (6) SHAM.—The term ‘‘sham’’ means a covered 4 petition that is objectively baseless and that at- 5 tempts to use a governmental process, as opposed to 6 the outcome of that process, to interfere with the 7 business of a competitor, or a series of covered peti- 8 tions, that attempts to use a governmental process, 9 as opposed to the outcome of that process, to inter- 10 fere with the business of a competitor. 11 (b) VIOLATION.— 12 (1) IN GENERAL.—A person submitting or 13 causing the submission of a covered petition or a se- 14 ries of covered petitions that is a sham shall be lia- 15 ble for engaging in an unfair method of competition 16 under section 5(a)(1) of the Federal Trade Commis- 17 sion Act (15 U.S.C. 45(a)(1)). 18 (c) CIVIL ACTION.— 19 (1) IN GENERAL.—If the Commission has rea- 20 son to believe that the submission of a covered peti- 21 tion or a series of covered petitions constitutes a vio- 22 lation of section 5(a)(1) of the Federal Trade Com- 23 mission Act (15 U.S.C. 45(a)(1)), the Commission 24 may commence a civil action to recover a civil pen- 25 VerDate Sep 11 2014 23:32 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2883.IH H2883 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 2883 IH alty and seek other appropriate relief in a district 1 court of the United States against any person that 2 submitted or caused to be submitted such covered 3 petition or such series of covered petitions, including 4 successors or assigns. 5 (2) PRESUMPTION.—In a civil action under 6 paragraph (1), a covered petition shall be presumed 7 to be part of a series of covered petitions that is a 8 sham under subsection (b) of this section if the Sec- 9 retary of Health and Human Services has deter- 10 mined that the covered petition was submitted with 11 the primary purpose of delaying the approval of a 12 covered application, was part of a series of covered 13 petitions, and has referred such determination to the 14 Federal Trade Commission in writing, with a rea- 15 soned basis for the determination. 16 (3) EXCEPTION.—The presumption in para- 17 graph (2) shall not apply if the defendant estab- 18 lishes, by a preponderance of the evidence, that the 19 series of covered petitions that includes the covered 20 petition referred to the Commission by the Secretary 21 of Health and Human Services is not a sham. 22 (4) CIVIL PENALTY.—In an action under para- 23 graph (1), any person that has been found liable for 24 a violation of section 5(a)(1) of the Federal Trade 25 VerDate Sep 11 2014 23:32 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2883.IH H2883 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 2883 IH Commission Act (15 U.S.C. 45(a)(1)) shall be sub- 1 ject to a civil penalty for each violation of not more 2 than the greater of— 3 (A) any revenue earned from the sale by 4 such person of any drug product, referenced in 5 a covered application that was the subject of a 6 covered petition or a series of covered petitions 7 that is a sham, during the period in which the 8 covered petition or series of covered petitions 9 was under review by the Secretary of Health 10 and Human Services; or 11 (B) $50,000 for each calendar day that 12 each covered petition that is a sham or that was 13 part of a series of covered petitions that is a 14 sham was under review by the Secretary of 15 Health and Human Services. 16 (5) ANTITRUST LAWS.—Nothing in this section 17 shall modify, impair, limit, or supersede the applica- 18 bility of the antitrust laws as defined in subsection 19 (a) of the first section of the Clayton Act (15 U.S.C. 20 12(a)), and of section 5 of the Federal Trade Com- 21 mission Act (15 U.S.C. 45) to the extent that it ap- 22 plies to unfair methods of competition. 23 (6) RULE OF CONSTRUCTION.—The civil pen- 24 alty provided in this subsection is in addition to, and 25 VerDate Sep 11 2014 23:32 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2883.IH H2883 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 2883 IH not in lieu of, any other remedies provided by Fed- 1 eral law, including under section 16 of the Clayton 2 Act (15 U.S.C. 26) or under section 13(b) of the 3 Federal Trade Commission Act (15 U.S.C. 53(b)). 4 Nothing in this paragraph shall be construed to af- 5 fect any authority of the Commission under any 6 other provision of law. 7 (d) APPLICABILITY.—This section shall apply to any 8 covered petition submitted on or after the date of enact- 9 ment of this Act. 10 SEC. 3. SEVERABILITY. 11 If any provision of this Act, an amendment made by 12 this Act, or the application of such provision or amend- 13 ment to any person or circumstance is held to be unconsti- 14 tutional, the remainder of this Act, the amendments made 15 by this Act, and the application of the provisions of such 16 Act or amendments to any person or circumstance shall 17 not be affected. 18 Æ VerDate Sep 11 2014 23:32 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H2883.IH H2883 kjohnson on DSK79L0C42PROD with BILLS