Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act

I 116TH CONGRESS 1ST SESSION H. R. 2700 To incentivize low-cost drug options and generic competition, and to provide extensions for community health centers and the National Health Service Corps, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MAY 14, 2019 Mr. BURGESS (for himself, Mr. WALDEN, Mr. UPTON, Mr. MCKINLEY, Mr. CARTER of Georgia, Mr. BUCSHON, Mr. BILIRAKIS, Mr. MULLIN, Mrs. RODGERS of Washington, Mr. LONG, Mr. FLORES, Mr. HUDSON, Mr. SHIMKUS, Mr. WALBERG, Mr. KINZINGER, Mr. OLSON, Mr. JOHNSON of Ohio, Mr. GUTHRIE, Mr. GRIFFITH, Mr. DUNCAN, Mrs. BROOKS of Indi- ana, Mr. GIANFORTE, Mr. LATTA, Mr. SCALISE, Mr. SENSENBRENNER, Mr. COLLINS of Georgia, Mr. STIVERS, Mr. HILL of Arkansas, Mr. MITCHELL, and Mr. HURD of Texas) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently deter- mined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To incentivize low-cost drug options and generic competition, and to provide extensions for community health centers and the National Health Service Corps, 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 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2700.IH H2700 kjohnson on DSK79L0C42 with BILLS 2 •HR 2700 IH SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Lowering Prescription 2 Drug Costs and Extending Community Health Centers 3 and Other Public Health Priorities Act’’. 4 SEC. 2. TABLE OF CONTENTS. 5 The table of contents of this Act is as follows: 6 Sec. 1. Short title. Sec. 2. Table of contents. TITLE I—LOWERING PRESCRIPTION DRUG COSTS Subtitle A—Bringing Low-Cost Options and Competition While Keeping Incentives for New Generics Sec. 101. Change conditions of first generic exclusivity to spur access and com- petition. Subtitle B—Protecting Consumer Access to Generic Drugs Sec. 111. Unlawful agreements. Sec. 112. Notice and certification of agreements. Sec. 113. Forfeiture of 180-day exclusivity period. Sec. 114. Commission litigation authority. Sec. 115. Statute of limitations. Subtitle C—Creating and Restoring Equal Access to Equivalent Samples Sec. 121. Actions for delays of generic drugs and biosimilar biological products. Sec. 122. REMS approval process for subsequent filers. Sec. 123. Rule of construction. TITLE II—EXTENSION OF PUBLIC HEALTH PROGRAMS Sec. 201. Extension for community health centers, the National Health Service Corps, and teaching health centers that operate GME pro- grams. Sec. 202. Extension for special diabetes programs. Sec. 203. Extension for family-to-family health information centers. Sec. 204. Extension for sexual risk avoidance education and personal responsi- bility education. VerDate Sep 11 2014 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6211 E:\BILLS\H2700.IH H2700 kjohnson on DSK79L0C42 with BILLS 3 •HR 2700 IH TITLE I—LOWERING 1 PRESCRIPTION DRUG COSTS 2 Subtitle A—Bringing Low-Cost Op- 3 tions and Competition While 4 Keeping Incentives for New 5 Generics 6 SEC. 101. CHANGE CONDITIONS OF FIRST GENERIC EXCLU- 7 SIVITY TO SPUR ACCESS AND COMPETITION. 8 Section 505(j)(5)(B)(iv) of the Federal Food, Drug, 9 and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amend- 10 ed— 11 (1) in subclause (I), by striking ‘‘180 days 12 after’’ and all that follows through the period at the 13 end and inserting the following: ‘‘180 days after the 14 earlier of— 15 ‘‘(aa) the date of the first com- 16 mercial marketing of the drug (includ- 17 ing the commercial marketing of the 18 listed drug) by any first applicant; or 19 ‘‘(bb) the applicable date speci- 20 fied in subclause (III).’’; and 21 (2) by adding at the end the following new sub- 22 clause: 23 ‘‘(III) APPLICABLE DATE.—The appli- 24 cable date specified in this subclause, with 25 VerDate Sep 11 2014 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2700.IH H2700 kjohnson on DSK79L0C42 with BILLS 4 •HR 2700 IH respect to an application for a drug de- 1 scribed in subclause (I), is the date on 2 which each of the following conditions is 3 first met: 4 ‘‘(aa) The approval of such an 5 application could be made effective, 6 but for the eligibility of a first appli- 7 cant for 180-day exclusivity under 8 this clause. 9 ‘‘(bb) At least 30 months have 10 passed since the date of submission of 11 an application for the drug by at least 12 one first applicant. 13 ‘‘(cc) Approval of an application 14 for the drug submitted by at least one 15 first applicant is not precluded under 16 clause (iii). 17 ‘‘(dd) No application for the drug 18 submitted by any first applicant is ap- 19 proved at the time the conditions 20 under items (aa), (bb), and (cc) are 21 all met, regardless of whether such an 22 application is subsequently ap- 23 proved.’’. 24 VerDate Sep 11 2014 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2700.IH H2700 kjohnson on DSK79L0C42 with BILLS 5 •HR 2700 IH Subtitle B—Protecting Consumer 1 Access to Generic Drugs 2 SEC. 111. UNLAWFUL AGREEMENTS. 3 (a) AGREEMENTS PROHIBITED.—Subject to sub- 4 sections (b) and (c), it shall be unlawful for an NDA or 5 BLA holder and a subsequent filer (or for two subsequent 6 filers) to enter into, or carry out, an agreement resolving 7 or settling a covered patent infringement claim on a final 8 or interim basis if under such agreement— 9 (1) a subsequent filer directly or indirectly re- 10 ceives from such holder (or in the case of such an 11 agreement between two subsequent filers, the other 12 subsequent filer) anything of value, including a li- 13 cense; and 14 (2) the subsequent filer agrees to limit or fore- 15 go research on, or development, manufacturing, 16 marketing, or sales, for any period of time, of the 17 covered product that is the subject of the application 18 described in subparagraph (A) or (B) of subsection 19 (g)(8). 20 (b) EXCLUSION.—It shall not be unlawful under sub- 21 section (a) if a party to an agreement described in such 22 subsection demonstrates by clear and convincing evidence 23 that the value described in subsection (a)(1) is compensa- 24 VerDate Sep 11 2014 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2700.IH H2700 kjohnson on DSK79L0C42 with BILLS 6 •HR 2700 IH tion solely for other goods or services that the subsequent 1 filer has promised to provide. 2 (c) LIMITATION.—Nothing in this section shall pro- 3 hibit an agreement resolving or settling a covered patent 4 infringement claim in which the consideration granted by 5 the NDA or BLA holder to the subsequent filer (or from 6 one subsequent filer to another) as part of the resolution 7 or settlement includes only one or more of the following: 8 (1) The right to market the covered product 9 that is the subject of the application described in 10 subparagraph (A) or (B) of subsection (g)(8) in the 11 United States before the expiration of— 12 (A) any patent that is the basis of the cov- 13 ered patent infringement claim; or 14 (B) any patent right or other statutory ex- 15 clusivity that would prevent the marketing of 16 such covered product. 17 (2) A payment for reasonable litigation ex- 18 penses not to exceed $7,500,000 in the aggregate. 19 (3) A covenant not to sue on any claim that 20 such covered product infringes a patent. 21 (d) ENFORCEMENT BY FEDERAL TRADE COMMIS- 22 SION.— 23 VerDate Sep 11 2014 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2700.IH H2700 kjohnson on DSK79L0C42 with BILLS 7 •HR 2700 IH (1) GENERAL APPLICATION.—The requirements 1 of this section apply, according to their terms, to an 2 NDA or BLA holder or subsequent filer that is— 3 (A) a person, partnership, or corporation 4 over which the Commission has authority pur- 5 suant to section 5(a)(2) of the Federal Trade 6 Commission Act (15 U.S.C. 45(a)(2)); or 7 (B) a person, partnership, or corporation 8 over which the Commission would have author- 9 ity pursuant to such section but for the fact 10 that such person, partnership, or corporation is 11 not organized to carry on business for its own 12 profit or that of its members. 13 (2) UNFAIR OR DECEPTIVE ACTS OR PRACTICES 14 ENFORCEMENT AUTHORITY.— 15 (A) IN GENERAL.—A violation of this sec- 16 tion shall be treated as an unfair or deceptive 17 act or practice in violation of section 5(a)(1) of 18 the Federal Trade Commission Act (15 U.S.C. 19 45(a)(1)). 20 (B) POWERS OF COMMISSION.—Except as 21 provided in subparagraph (C) and paragraphs 22 (1)(B) and (3)— 23 (i) the Commission shall enforce this 24 section in the same manner, by the same 25 VerDate Sep 11 2014 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2700.IH H2700 kjohnson on DSK79L0C42 with BILLS 8 •HR 2700 IH means, and with the same jurisdiction, 1 powers, and duties as though all applicable 2 terms and provisions of the Federal Trade 3 Commission Act (15 U.S.C. 41 et seq.) 4 were incorporated into and made a part of 5 this section; and 6 (ii) any NDA or BLA holder or subse- 7 quent filer that violates this section shall 8 be subject to the penalties and entitled to 9 the privileges and immunities provided in 10 the Federal Trade Commission Act. 11 (C) JUDICIAL REVIEW.—In the case of a 12 cease and desist order issued by the Commis- 13 sion under section 5 of the Federal Trade Com- 14 mission Act (15 U.S.C. 45) for violation of this 15 section, a party to such order may obtain judi- 16 cial review of such order as provided in such 17 section 5, except that— 18 (i) such review may only be obtained 19 in— 20 (I) the United States Court of 21 Appeals for the District of Columbia 22 Circuit; 23 (II) the United States Court of 24 Appeals for the circuit in which the 25 VerDate Sep 11 2014 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2700.IH H2700 kjohnson on DSK79L0C42 with BILLS 9 •HR 2700 IH ultimate parent entity, as defined in 1 section 801.1(a)(3) of title 16, Code 2 of Federal Regulations, or any suc- 3 cessor thereto, of the NDA or BLA 4 holder (if any such holder is a party 5 to such order) is incorporated as of 6 the date that the application described 7 in subparagraph (A) or (B) of sub- 8 section (g)(8) or an approved applica- 9 tion that is deemed to be a license for 10 a biological product under section 11 351(k) of the Public Health Service 12 Act (42 U.S.C. 262(k)) pursuant to 13 section 7002(e)(4) of the Biologics 14 Price Competition and Innovation Act 15 of 2009 (Public Law 111–148; 124 16 Stat. 817) is submitted to the Com- 17 missioner of Food and Drugs; or 18 (III) the United States Court of 19 Appeals for the circuit in which the 20 ultimate parent entity, as so defined, 21 of any subsequent filer that is a party 22 to such order is incorporated as of the 23 date that the application described in 24 subparagraph (A) or (B) of subsection 25 VerDate Sep 11 2014 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2700.IH H2700 kjohnson on DSK79L0C42 with BILLS 10 •HR 2700 IH (g)(8) is submitted to the Commis- 1 sioner of Food and Drugs; and 2 (ii) the petition for review shall be 3 filed in the court not later than 30 days 4 after such order is served on the party 5 seeking review. 6 (3) ADDITIONAL ENFORCEMENT AUTHORITY.— 7 (A) CIVIL PENALTY.—The Commission 8 may commence a civil action to recover a civil 9 penalty in a district court of the United States 10 against any NDA or BLA holder or subsequent 11 filer that violates this section. 12 (B) SPECIAL RULE FOR RECOVERY OF 13 PENALTY IF CEASE AND DESIST ORDER 14 ISSUED.— 15 (i) IN GENERAL.—If the Commission 16 has issued a cease and desist order in a 17 proceeding under section 5 of the Federal 18 Trade Commission Act (15 U.S.C. 45) for 19 violation of this section— 20 (I) the Commission may com- 21 mence a civil action under subpara- 22 graph (A) to recover a civil penalty 23 against any party to such order at 24 any time before the expiration of the 25 VerDate Sep 11 2014 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2700.IH H2700 kjohnson on DSK79L0C42 with BILLS 11 •HR 2700 IH 1-year period beginning on the date 1 on which such order becomes final 2 under section 5(g) of such Act (15 3 U.S.C. 45(g)); and 4 (II) in such civil action, the find- 5 ings of the Commission as to the ma- 6 terial facts in such proceeding shall be 7 conclusive, unless— 8 (aa) the terms of such order 9 expressly provide that the Com- 10 mission’s findings shall not be 11 conclusive; or 12 (bb) such order became final 13 by reason of section 5(g)(1) of 14 such Act (15 U.S.C. 45(g)(1)), in 15 which case such findings shall be 16 conclusive if supported by evi- 17 dence. 18 (ii) RELATIONSHIP TO PENALTY FOR 19 VIOLATION OF AN ORDER.—The penalty 20 provided in clause (i) for violation of this 21 section is separate from and in addition to 22 any penalty that may be incurred for viola- 23 tion of an order of the Commission under 24 VerDate Sep 11 2014 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H2700.IH H2700 kjohnson on DSK79L0C42 with BILLS 12 •HR 2700 IH section 5(l) of the Federal Trade Commis- 1 sion Act (15 U.S.C. 45(l)). 2 (C) AMOUNT OF PENALTY.— 3 (i) IN GENERAL.—The amount of a 4 civil penalty imposed in a civil action under 5 subparagraph (A) on a party to an agree- 6 ment described in subsection (a) shall be 7 sufficient to deter violations of this section, 8 but in no event greater than— 9 (I) if such party is the NDA or 10 BLA holder (or, in the case of an 11 agreement between two subsequent fil- 12 ers, the subsequent filer who gave the 13 value described in subsection (a)(1)), 14 the greater of— 15 (aa) 3 times the value re- 16 ceived by such NDA or BLA 17 holder (or by such subsequent 18 filer) that is reasonably attrib- 19 utable to the violation of this sec- 20 tion; or 21 (bb) 3 times the value given 22 to the subsequent filer (or to the 23 other subsequent filer) reason- 24 VerDate Sep 11 2014 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H2700.IH H2700 kjohnson on DSK79L0C42 with BILLS 13 •HR 2700 IH ably attributable to the violation 1 of this section; and 2 (II) if such party is the subse- 3 quent filer (or, in the case of an 4 agreement between two subsequent fil- 5 ers, the subsequent filer who received 6 the value described in subsection 7 (a)(1)), 3 times the value rece [Text truncated for display. 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