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 Indiana, 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 determined 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Lowering Prescription 

3 Drug Costs and Extending Community Health Centers 

4 and Other Public Health Priorities Act’’. 

5 SEC. 2. TABLE OF CONTENTS. 

6 The table of contents of this Act is as follows: 

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 competition. 

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 programs. 

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 responsibility education. 


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1 TITLE I—LOWERING 

2 PRESCRIPTION DRUG COSTS 

3 Subtitle A—Bringing Low-Cost Op4 tions and Competition While 

5 Keeping Incentives for New 

6 Generics 

7 SEC. 101. CHANGE CONDITIONS OF FIRST GENERIC EXCLU8 SIVITY TO SPUR ACCESS AND COMPETITION. 

9 Section 505(j)(5)(B)(iv) of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amend11 ed— 

12 (1) in subclause (I), by striking ‘‘180 days 

13 after’’ and all that follows through the period at the 

14 end and inserting the following: ‘‘180 days after the 

15 earlier of— 

16 ‘‘(aa) the date of the first com17 mercial marketing of the drug (includ18 ing the commercial marketing of the 

19 listed drug) by any first applicant; or 

20 ‘‘(bb) the applicable date speci21 fied in subclause (III).’’; and 

22 (2) by adding at the end the following new sub23 clause: 

24 ‘‘(III) APPLICABLE DATE.—The appli25 cable date specified in this subclause, with 


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1 respect to an application for a drug de2 scribed in subclause (I), is the date on 

3 which each of the following conditions is 

4 first met: 

5 ‘‘(aa) The approval of such an 

6 application could be made effective, 

7 but for the eligibility of a first appli8 cant for 180-day exclusivity under 

9 this clause. 

10 ‘‘(bb) At least 30 months have 

11 passed since the date of submission of 

12 an application for the drug by at least 

13 one first applicant. 

14 ‘‘(cc) Approval of an application 

15 for the drug submitted by at least one 

16 first applicant is not precluded under 

17 clause (iii). 

18 ‘‘(dd) No application for the drug 

19 submitted by any first applicant is ap20 proved at the time the conditions 

21 under items (aa), (bb), and (cc) are 

22 all met, regardless of whether such an 

23 application is subsequently ap24 proved.’’. 


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1 Subtitle B—Protecting Consumer 

2 Access to Generic Drugs 

3 SEC. 111. UNLAWFUL AGREEMENTS. 

4 (a) AGREEMENTS PROHIBITED.—Subject to sub5 sections (b) and (c), it shall be unlawful for an NDA or 

6 BLA holder and a subsequent filer (or for two subsequent 

7 filers) to enter into, or carry out, an agreement resolving 

8 or settling a covered patent infringement claim on a final 

9 or interim basis if under such agreement— 

10 (1) a subsequent filer directly or indirectly re11 ceives from such holder (or in the case of such an 

12 agreement between two subsequent filers, the other 

13 subsequent filer) anything of value, including a li14 cense; and 

15 (2) the subsequent filer agrees to limit or fore16 go research on, or development, manufacturing, 

17 marketing, or sales, for any period of time, of the 

18 covered product that is the subject of the application 

19 described in subparagraph (A) or (B) of subsection 

20 (g)(8). 

21 (b) EXCLUSION.—It shall not be unlawful under sub22 section (a) if a party to an agreement described in such 

23 subsection demonstrates by clear and convincing evidence 

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1 tion solely for other goods or services that the subsequent 

2 filer has promised to provide. 

3 (c) LIMITATION.—Nothing in this section shall pro4 hibit an agreement resolving or settling a covered patent 

5 infringement claim in which the consideration granted by 

6 the NDA or BLA holder to the subsequent filer (or from 

7 one subsequent filer to another) as part of the resolution 

8 or settlement includes only one or more of the following: 

9 (1) The right to market the covered product 

10 that is the subject of the application described in 

11 subparagraph (A) or (B) of subsection (g)(8) in the 

12 United States before the expiration of— 

13 (A) any patent that is the basis of the cov14 ered patent infringement claim; or 

15 (B) any patent right or other statutory ex16 clusivity that would prevent the marketing of 

17 such covered product. 

18 (2) A payment for reasonable litigation ex19 penses not to exceed $7,500,000 in the aggregate. 

20 (3) A covenant not to sue on any claim that 

21 such covered product infringes a patent. 

22 (d) ENFORCEMENT BY FEDERAL TRADE COMMIS23 SION.— 


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1 (1) GENERAL APPLICATION.—The requirements 

2 of this section apply, according to their terms, to an 

3 NDA or BLA holder or subsequent filer that is— 

4 (A) a person, partnership, or corporation 

5 over which the Commission has authority pur6 suant to section 5(a)(2) of the Federal Trade 

7 Commission Act (15 U.S.C. 45(a)(2)); or 

8 (B) a person, partnership, or corporation 

9 over which the Commission would have author10 ity pursuant to such section but for the fact 

11 that such person, partnership, or corporation is 

12 not organized to carry on business for its own 

13 profit or that of its members. 

14 (2) UNFAIR OR DECEPTIVE ACTS OR PRACTICES

15 ENFORCEMENT AUTHORITY.— 

16 (A) IN GENERAL.—A violation of this sec17 tion shall be treated as an unfair or deceptive 

18 act or practice in violation of section 5(a)(1) of 

19 the Federal Trade Commission Act (15 U.S.C. 

20 45(a)(1)). 

21 (B) POWERS OF COMMISSION.—Except as 

22 provided in subparagraph (C) and paragraphs 

23 (1)(B) and (3)— 

24 (i) the Commission shall enforce this 

25 section in the same manner, by the same 


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1 means, and with the same jurisdiction, 

2 powers, and duties as though all applicable 

3 terms and provisions of the Federal Trade 

4 Commission Act (15 U.S.C. 41 et seq.) 

5 were incorporated into and made a part of 

6 this section; and 

7 (ii) any NDA or BLA holder or subse8 quent filer that violates this section shall 

9 be subject to the penalties and entitled to 

10 the privileges and immunities provided in 

11 the Federal Trade Commission Act. 

12 (C) JUDICIAL REVIEW.—In the case of a 

13 cease and desist order issued by the Commis14 sion under section 5 of the Federal Trade Com15 mission Act (15 U.S.C. 45) for violation of this 

16 section, a party to such order may obtain judi17 cial review of such order as provided in such 

18 section 5, except that— 

19 (i) such review may only be obtained 

20 in— 

21 (I) the United States Court of 

22 Appeals for the District of Columbia 

23 Circuit; 

24 (II) the United States Court of 

25 Appeals for the circuit in which the 


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1 ultimate parent entity, as defined in 

2 section 801.1(a)(3) of title 16, Code 

3 of Federal Regulations, or any suc4 cessor thereto, of the NDA or BLA 

5 holder (if any such holder is a party 

6 to such order) is incorporated as of 

7 the date that the application described 

8 in subparagraph (A) or (B) of sub9 section (g)(8) or an approved applica10 tion that is deemed to be a license for 

11 a biological product under section 

12 351(k) of the Public Health Service 

13 Act (42 U.S.C. 262(k)) pursuant to 

14 section 7002(e)(4) of the Biologics 

15 Price Competition and Innovation Act 

16 of 2009 (Public Law 111–148; 124 

17 Stat. 817) is submitted to the Com18 missioner of Food and Drugs; or 

19 (III) the United States Court of 

20 Appeals for the circuit in which the 

21 ultimate parent entity, as so defined, 

22 of any subsequent filer that is a party 

23 to such order is incorporated as of the 

24 date that the application described in 

25 subparagraph (A) or (B) of subsection 


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1 (g)(8) is submitted to the Commis2 sioner of Food and Drugs; and 

3 (ii) the petition for review shall be 

4 filed in the court not later than 30 days 

5 after such order is served on the party 

6 seeking review. 

7 (3) ADDITIONAL ENFORCEMENT AUTHORITY.— 

8 (A) CIVIL PENALTY.—The Commission 

9 may commence a civil action to recover a civil 

10 penalty in a district court of the United States 

11 against any NDA or BLA holder or subsequent 

12 filer that violates this section. 

13 (B) SPECIAL RULE FOR RECOVERY OF

14 PENALTY IF CEASE AND DESIST ORDER

15 ISSUED.— 

16 (i) IN GENERAL.—If the Commission 

17 has issued a cease and desist order in a 

18 proceeding under section 5 of the Federal 

19 Trade Commission Act (15 U.S.C. 45) for 

20 violation of this section— 

21 (I) the Commission may com22 mence a civil action under subpara23 graph (A) to recover a civil penalty 

24 against any party to such order at 

25 any time before the expiration of the 


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1 1-year period beginning on the date 

2 on which such order becomes final 

3 under section 5(g) of such Act (15 

4 U.S.C. 45(g)); and 

5 (II) in such civil action, the find6 ings of the Commission as to the ma7 terial facts in such proceeding shall be 

8 conclusive, unless— 

9 (aa) the terms of such order 

10 expressly provide that the Com11 mission’s findings shall not be 

12 conclusive; or 

13 (bb) such order became final 

14 by reason of section 5(g)(1) of 

15 such Act (15 U.S.C. 45(g)(1)), in 

16 which case such findings shall be 

17 conclusive if supported by evi18 dence. 

19 (ii) RELATIONSHIP TO PENALTY FOR

20 VIOLATION OF AN ORDER.—The penalty 

21 provided in clause (i) for violation of this 

22 section is separate from and in addition to 

23 any penalty that may be incurred for viola24 tion of an order of the Commission under 


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1 section 5(l) of the Federal Trade Commis2 sion Act (15 U.S.C. 45(l)). 

3 (C) AMOUNT OF PENALTY.— 

4 (i) IN GENERAL.—The amount of a 

5 civil penalty imposed in a civil action under 

6 subparagraph (A) on a party to an agree7 ment described in subsection (a) shall be 

8 sufficient to deter violations of this section, 

9 but in no event greater than— 

10 (I) if such party is the NDA or 

11 BLA holder (or, in the case of an 

12 agreement between two subsequent fil13 ers, the subsequent filer who gave the 

14 value described in subsection (a)(1)), 

15 the greater of— 

16 (aa) 3 times the value re17 ceived by such NDA or BLA 

18 holder (or by such subsequent 

19 filer) that is reasonably attrib20 utable to the violation of this sec21 tion; or 

22 (bb) 3 times the value given 

23 to the subsequent filer (or to the 

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1 ably attributable to the violation 

2 of this section; and 

3 (II) if such party is the subse4 quent filer (or, in the case of an 

5 agreement between two subsequent fil6 ers, the subsequent filer who received 

7 the value described in subsection 

8 (a)(1)), 3 times the value received by 

9 such subsequent filer that is reason10 ably attributable to the violation of 

11 this section. 

12 (ii) FACTORS FOR CONSIDERATION.— 

13 In determining such amount, the court 

14 shall take into account— 

15 (I) the nature, circumstances, ex16 tent, and gravity of the violation; 

17 (II) with respect to the violator, 

18 the degree of culpability, any history 

19 of violations, the ability to pay, any 

20 effect on the ability to continue doing 

21 business, profits earned by the NDA 

22 or BLA holder (or, in the case of an 

23 agreement between two subsequent fil24 ers, the subsequent filer who gave the 

25 value described in subsection (a)(1)), 


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1 compensation received by the subse2 quent filer (or, in the case of an 

3 agreement between two subsequent fil4 ers, the subsequent filer who received 

5 the value described in subsection 

6 (a)(1)), and the amount of commerce 

7 affected; and 

8 (III) other matters that justice 

9 requires. 

10 (D) INJUNCTIONS AND OTHER EQUITABLE

11 RELIEF.—In a civil action under subparagraph 

12 (A), the United States district courts are em13 powered to grant mandatory injunctions and 

14 such other and further equitable relief as they 

15 deem appropriate. 

16 (4) REMEDIES IN ADDITION.—Remedies pro17 vided in this subsection are in addition to, and not 

18 in lieu of, any other remedy provided by Federal 

19 law. 

20 (5) PRESERVATION OF AUTHORITY OF COMMIS21 SION.—Nothing in this section shall be construed to 

22 affect any authority of the Commission under any 

23 other provision of law. 

24 (e) FEDERAL TRADE COMMISSION RULEMAKING.— 

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1 gated under section 553 of title 5, United States Code, 

2 exempt from this section certain agreements described in 

3 subsection (a) if the Commission finds such agreements 

4 to be in furtherance of market competition and for the 

5 benefit of consumers. 

6 (f) ANTITRUST LAWS.—Nothing in this section shall 

7 modify, impair, limit, or supersede the applicability of the 

8 antitrust laws as defined in subsection (a) of the first sec9 tion of the Clayton Act (15 U.S.C. 12(a)), and of section 

10 5 of the Federal Trade Commission Act (15 U.S.C. 45) 

11 to the extent that such section 5 applies to unfair methods 

12 of competition. Nothing in this section shall modify, im13 pair, limit, or supersede the right of a subsequent filer 

14 to assert claims or counterclaims against any person, 

15 under the antitrust laws or other laws relating to unfair 

16 competition. 

17 (g) DEFINITIONS.—In this section: 

18 (1) AGREEMENT RESOLVING OR SETTLING A

19 COVERED PATENT INFRINGEMENT CLAIM.—The 

20 term ‘‘agreement resolving or settling a covered pat21 ent infringement claim’’ means any agreement 

22 that— 

23 (A) resolves or settles a covered patent in24 fringement claim; or 


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1 (B) is contingent upon, provides for a con2 tingent condition for, or is otherwise related to 

3 the resolution or settlement of a covered patent 

4 infringement claim. 

5 (2) COMMISSION.—The term ‘‘Commission’’ 

6 means the Federal Trade Commission. 

7 (3) COVERED PATENT INFRINGEMENT CLAIM.— 

8 The term ‘‘covered patent infringement claim’’ 

9 means an allegation made by the NDA or BLA hold10 er to a subsequent filer (or, in the case of an agree11 ment between two subsequent filers, by one subse12 quent filer to another), whether or not included in 

13 a complaint filed with a court of law, that— 

14 (A) the submission of the application de15 scribed in subparagraph (A) or (B) of para16 graph (9), or the manufacture, use, offering for 

17 sale, sale, or importation into the United States 

18 of a covered product that is the subject of such 

19 an application— 

20 (i) in the case of an agreement be21 tween an NDA or BLA holder and a sub22 sequent filer, infringes any patent owned 

23 by, or exclusively licensed to, the NDA or 

24 BLA holder of the covered product; or 


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1 (ii) in the case of an agreement be2 tween two subsequent filers, infringes any 

3 patent owned by the subsequent filer; or 

4 (B) in the case of an agreement between 

5 an NDA or BLA holder and a subsequent filer, 

6 the covered product to be manufactured under 

7 such application uses a covered product as 

8 claimed in a published patent application. 

9 (4) COVERED PRODUCT.—The term ‘‘covered 

10 product’’ means a drug (as defined in section 201(g) 

11 of the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 321(g))), including a biological product (as 

13 defined in section 351(i) of the Public Health Serv14 ice Act (42 U.S.C. 262(i)). 

15 (5) NDA OR BLA HOLDER.—The term ‘‘NDA 

16 or BLA holder’’ means— 

17 (A) the holder of— 

18 (i) an approved new drug application 

19 filed under section 505(b)(1) of the Fed20 eral Food, Drug, and Cosmetic Act (21 

21 U.S.C. 355(b)(1)) for a covered product; 

22 or 

23 (ii) a biologics license application filed 

24 under section 351(a) of the Public Health 


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1 Service Act (42 U.S.C. 262(a)) with re2 spect to a biological product; 

3 (B) a person owning or controlling enforce4 ment of the patent on— 

5 (i) the list published under section 

6 505(j)(7) of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 355(j)(7)) in con8 nection with the application described in 

9 subparagraph (A)(i); or 

10 (ii) any list published under section 

11 351 of the Public Health Service Act (42 

12 U.S.C. 262) comprised of patents associ13 ated with biologics license applications filed 

14 under section 351(a) of such Act (42 

15 U.S.C. 262(a)); or 

16 (C) the predecessors, subsidiaries, divi17 sions, groups, and affiliates controlled by, con18 trolling, or under common control with any en19 tity described in subparagraph (A) or (B) (such 

20 control to be presumed by direct or indirect 

21 share ownership of 50 percent or greater), as 

22 well as the licensees, licensors, successors, and 

23 assigns of each of the entities. 


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1 (6) PATENT.—The term ‘‘patent’’ means a pat2 ent issued by the United States Patent and Trade3 mark Office. 

4 (7) STATUTORY EXCLUSIVITY.—The term 

5 ‘‘statutory exclusivity’’ means those prohibitions on 

6 the submission or approval of drug applications 

7 under clauses (ii) through (iv) of section 

8 505(c)(3)(E) (5- and 3-year exclusivity), clauses (ii) 

9 through (iv) of section 505(j)(5)(F) (5-year and 3- 

10 year exclusivity), section 505(j)(5)(B)(iv) (180-day 

11 exclusivity), section 527 (orphan drug exclusivity), 

12 section 505A (pediatric exclusivity), or section 505E 

13 (qualified infectious disease product exclusivity) of 

14 the Federal Food, Drug, and Cosmetic Act (21 

15 U.S.C. 355(c)(3)(E), 355(j)(5)(B)(iv), 355(j)(5)(F), 

16 360cc, 355a, 355f), or prohibitions on the submis17 sion or licensing of biologics license applications 

18 under section 351(k)(6) (interchangeable biological 

19 product exclusivity) or section 351(k)(7) (biological 

20 product reference product exclusivity) of the Public 

21 Health Service Act (42 U.S.C. 262(k)(6), (7)). 

22 (8) SUBSEQUENT FILER.—The term ‘‘subse23 quent filer’’ means— 

24 (A) in the case of a drug, a party that 

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1 cation submitted pursuant to section 505(j) of 

2 the Federal Food, Drug, and Cosmetic Act (21 

3 U.S.C. 355(j)) or a new drug application sub4 mitted pursuant to section 505(b)(2) of the 

5 Federal Food, Drug, and Cosmetic Act 

6 (21U.S.C. 355(b)(2)) and filed under section 

7 505(b)(1) of such Act (21 U.S.C. 355(b)(1)) or 

8 has the exclusive rights to distribute the cov9 ered product that is the subject of such applica10 tion; or 

11 (B) in the case of a biological product, a 

12 party that owns or controls an application filed 

13 with the Food and Drug Administration under 

14 section 351(k) of the Public Health Service Act 

15 (42 U.S.C. 262(k)) or has the exclusive rights 

16 to distribute the biological product that is the 

17 subject of such application. 

18 (h) EFFECTIVE DATE.—This section applies with re19 spect to agreements described in subsection (a) entered 

20 into on or after the date of the enactment of this Act. 

21 SEC. 112. NOTICE AND CERTIFICATION OF AGREEMENTS. 

22 (a) NOTICE OF ALL AGREEMENTS.—Section 1111(7) 

23 of the Medicare Prescription Drug, Improvement, and 

24 Modernization Act of 2003 (21 U.S.C. 355 note) is 

25 amended by inserting ‘‘or the owner of a patent for which 


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1 a claim of infringement could reasonably be asserted 

2 against any person for making, using, offering to sell, sell3 ing, or importing into the United States a biological prod4 uct that is the subject of a biosimilar biological product 

5 application’’ before the period at the end. 

6 (b) CERTIFICATION OF AGREEMENTS.—Section 1112 

7 of such Act (21 U.S.C. 355 note) is amended by adding 

8 at the end the following: 

9 ‘‘(d) CERTIFICATION.—The Chief Executive Officer 

10 or the company official responsible for negotiating any 

11 agreement under subsection (a) or (b) that is required to 

12 be filed under subsection (c) shall, within 30 days of such 

13 filing, execute and file with the Assistant Attorney General 

14 and the Commission a certification as follows: ‘I declare 

15 that the following is true, correct, and complete to the best 

16 of my knowledge: The materials filed with the Federal 

17 Trade Commission and the Department of Justice under 

18 section 1112 of the Medicare Prescription Drug, Improve19 ment, and Modernization Act of 2003, with respect to the 

20 agreement referenced in this certification— 

21 ‘‘ ‘(1) represent the complete, final, and exclu22 sive agreement between the parties; 

23 ‘‘ ‘(2) include any ancillary agreements that are 

24 contingent upon, provide a contingent condition for, 


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1 were entered into within 30 days of, or are otherwise 

2 related to, the referenced agreement; and 

3 ‘‘ ‘(3) include written descriptions of any oral 

4 agreements, representations, commitments, or prom5 ises between the parties that are responsive to sub6 section (a) or (b) of such section 1112 and have not 

7 been reduced to writing.’.’’. 

8 SEC. 113. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 

9 Section 505(j)(5)(D)(i)(V) of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) 

11 is amended by inserting ‘‘section 111 of the Lowering Pre12 scription Drug Costs and Extending Community Health 

13 Centers and Other Public Health Priorities Act or’’ after 

14 ‘‘that the agreement has violated’’. 

15 SEC. 114. COMMISSION LITIGATION AUTHORITY. 

16 Section 16(a)(2) of the Federal Trade Commission 

17 Act (15 U.S.C. 56(a)(2)) is amended— 

18 (1) in subparagraph (D), by striking ‘‘or’’ after 

19 the semicolon; 

20 (2) in subparagraph (E), by inserting ‘‘or’’ 

21 after the semicolon; and 

22 (3) by inserting after subparagraph (E) the fol23 lowing: 

24 ‘‘(F) under section 111(d)(3)(A) of the 

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1 ing Community Health Centers and Other Pub2 lic Health Priorities Act;’’. 

3 SEC. 115. STATUTE OF LIMITATIONS. 

4 (a) IN GENERAL.—Except as provided in subsection 

5 (b), the Commission shall commence any administrative 

6 proceeding or civil action to enforce section 111 of this 

7 Act not later than 6 years after the date on which the 

8 parties to the agreement file the Notice of Agreement as 

9 provided by section 1112(c)(2) and (d) of the Medicare 

10 Prescription Drug, Improvement, and Modernization Act 

11 of 2003 (21 U.S.C. 355 note). 

12 (b) CIVIL ACTION AFTER ISSUANCE OF CEASE AND

13 DESIST ORDER.—If the Commission has issued a cease 

14 and desist order under section 5 of the Federal Trade 

15 Commission Act (15 U.S.C. 45) for violation of section 

16 111 of this Act and the proceeding for the issuance of 

17 such order was commenced within the period required by 

18 subsection (a) of this section, such subsection does not 

19 prohibit the commencement, after such period, of a civil 

20 action under section 111(d)(3)(A) against a party to such 

21 order or a civil action under subsection (l) of such section 

22 5 for violation of such order. 


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1 Subtitle C—Creating and Restoring 

2 Equal Access to Equivalent 

3 Samples 

4 SEC. 121. ACTIONS FOR DELAYS OF GENERIC DRUGS AND 

5 BIOSIMILAR BIOLOGICAL PRODUCTS. 

6 (a) DEFINITIONS.—In this section— 

7 (1) the term ‘‘commercially reasonable, market8 based terms’’ means— 

9 (A) a nondiscriminatory price for the sale 

10 of the covered product at or below, but not 

11 greater than, the most recent wholesale acquisi12 tion cost for the drug, as defined in section 

13 1847A(c)(6)(B) of the Social Security Act (42 

14 U.S.C. 1395w–3a(c)(6)(B)); 

15 (B) a schedule for delivery that results in 

16 the transfer of the covered product to the eligi17 ble product developer consistent with the timing 

18 under subsection (b)(2)(A)(iv); and 

19 (C) no additional conditions are imposed 

20 on the sale of the covered product; 

21 (2) the term ‘‘covered product’’— 

22 (A) means— 

23 (i) any drug approved under sub24 section (c) or (j) of section 505 of the Fed25 eral Food, Drug, and Cosmetic Act (21 


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1 U.S.C. 355) or biological product licensed 

2 under subsection (a) or (k) of section 351 

3 of the Public Health Service Act (42 

4 U.S.C. 262); 

5 (ii) any combination of a drug or bio6 logical product described in clause (i); or 

7 (iii) when reasonably necessary to 

8 support approval of an application under 

9 section 505 of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 355), or sec11 tion 351 of the Public Health Service Act 

12 (42 U.S.C. 262), as applicable, or other13 wise meet the requirements for approval 

14 under either such section, any product, in15 cluding any device, that is marketed or in16 tended for use with such a drug or biologi17 cal product; and 

18 (B) does not include any drug or biological 

19 product that appears on the drug shortage list 

20 in effect under section 506E of the Federal 

21 Food, Drug, and Cosmetic Act (21 U.S.C. 

22 356e), unless— 

23 (i) the drug or biological product has 

24 been on the drug shortage list in effect 


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1 under such section 506E continuously for 

2 more than 6 months; or 

3 (ii) the Secretary determines that in4 clusion of the drug or biological product as 

5 a covered product is likely to contribute to 

6 alleviating or preventing a shortage. 

7 (3) the term ‘‘device’’ has the meaning given 

8 the term in section 201 of the Federal Food, Drug, 

9 and Cosmetic Act (21 U.S.C. 321); 

10 (4) the term ‘‘eligible product developer’’ means 

11 a person that seeks to develop a product for ap12 proval pursuant to an application for approval under 

13 subsection (b)(2) or (j) of section 505 of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 

15 for licensing pursuant to an application under sec16 tion 351(k) of the Public Health Service Act (42 

17 U.S.C. 262(k)); 

18 (5) the term ‘‘license holder’’ means the holder 

19 of an application approved under subsection (c) or 

20 (j) of section 505 of the Federal Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 355) or the holder of a li22 cense under subsection (a) or (k) of section 351 of 

23 the Public Health Service Act (42 U.S.C. 262) for 

24 a covered product; 


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1 (6) the term ‘‘REMS’’ means a risk evaluation 

2 and mitigation strategy under section 505–1 of the 

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

4 355–1); 

5 (7) the term ‘‘REMS with ETASU’’ means a 

6 REMS that contains elements to assure safe use 

7 under section 505–1(f) of the Federal Food, Drug, 

8 and Cosmetic Act (21 U.S.C. 355–1(f)); 

9 (8) the term ‘‘Secretary’’ means the Secretary 

10 of Health and Human Services; 

11 (9) the term ‘‘single, shared system of elements 

12 to assure safe use’’ means a single, shared system 

13 of elements to assure safe use under section 505– 

14 1(f) of the Federal Food, Drug, and Cosmetic Act 

15 (21 U.S.C. 355–1(f)); and 

16 (10) the term ‘‘sufficient quantities’’ means an 

17 amount of a covered product that the eligible prod18 uct developer determines allows it to— 

19 (A) conduct testing to support an applica20 tion under— 

21 (i) subsection (b)(2) or (j) of section 

22 505 of the Federal Food, Drug, and Cos23 metic Act (21 U.S.C. 355); or 


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1 (ii) section 351(k) of the Public 

2 Health Service Act (42 U.S.C. 262(k)); 

3 and 

4 (B) fulfill any regulatory requirements re5 lating to approval of such an application. 

6 (b) CIVIL ACTION FOR FAILURE TO PROVIDE SUFFI7 CIENT QUANTITIES OF A COVERED PRODUCT.— 

8 (1) IN GENERAL.—An eligible product developer 

9 may bring a civil action against the license holder 

10 for a covered product seeking relief under this sub11 section in an appropriate district court of the United 

12 States alleging that the license holder has declined 

13 to provide sufficient quantities of the covered prod14 uct to the eligible product developer on commercially 

15 reasonable, market-based terms. 

16 (2) ELEMENTS.— 

17 (A) IN GENERAL.—To prevail in a civil ac18 tion brought under paragraph (1), an eligible 

19 product developer shall prove, by a preponder20 ance of the evidence— 

21 (i) that— 

22 (I) the covered product is not 

23 subject to a REMS with ETASU; or 

24 (II) if the covered product is sub25 ject to a REMS with ETASU— 


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1 (aa) the eligible product de2 veloper has obtained a covered 

3 product authorization from the 

4 Secretary in accordance with sub5 paragraph (B); and 

6 (bb) the eligible product de7 veloper has provided a copy of 

8 the covered product authorization 

9 to the license holder; 

10 (ii) that, as of the date on which the 

11 civil action is filed, the product developer 

12 has not obtained sufficient quantities of 

13 the covered product on commercially rea14 sonable, market-based terms; 

15 (iii) that the eligible product developer 

16 has submitted a written request to pur17 chase sufficient quantities of the covered 

18 product to the license holder and such re19 quest— 

20 (I) was sent to a named cor21 porate officer of the license holder; 

22 (II) was made by certified or reg23 istered mail with return receipt re24 quested; 


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1 (III) specified an individual as 

2 the point of contact for the license 

3 holder to direct communications re4 lated to the sale of the covered prod5 uct to the eligible product developer 

6 and a means for electronic and writ7 ten communications with that indi8 vidual; and 

9 (IV) specified an address to 

10 which the covered product was to be 

11 shipped upon reaching an agreement 

12 to transfer the covered product; and 

13 (iv) that the license holder has not de14 livered to the eligible product developer 

15 sufficient quantities of the covered product 

16 on commercially reasonable, market-based 

17 terms— 

18 (I) for a covered product that is 

19 not subject to a REMS with ETASU, 

20 by the date that is 31 days after the 

21 date on which the license holder re22 ceived the request for the covered 

23 product; and 


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1 (II) for a covered product that is 

2 subject to a REMS with ETASU, by 

3 31 days after the later of— 

4 (aa) the date on which the 

5 license holder received the re6 quest for the covered product; or 

7 (bb) the date on which the 

8 license holder received a copy of 

9 the covered product authorization 

10 issued by the Secretary in ac11 cordance with subparagraph (B). 

12 (B) AUTHORIZATION FOR COVERED PROD13 UCT SUBJECT TO A REMS WITH ETASU.— 

14 (i) REQUEST.—An eligible product de15 veloper may submit to the Secretary a 

16 written request for the eligible product de17 veloper to be authorized to obtain suffi18 cient quantities of an individual covered 

19 product subject to a REMS with ETASU. 

20 (ii) AUTHORIZATION.—Not later than 

21 120 days after the date on which a request 

22 under clause (i) is received, the Secretary 

23 shall, by written notice, authorize the eligi24 ble product developer to obtain sufficient 

25 quantities of an individual covered product 


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1 subject to a REMS with ETASU for pur2 poses of— 

3 (I) development and testing that 

4 does not involve human clinical trials, 

5 if the eligible product developer has 

6 agreed to comply with any conditions 

7 the Secretary determines necessary; or 

8 (II) development and testing that 

9 involves human clinical trials, if the 

10 eligible product developer has— 

11 (aa)(AA) submitted proto12 cols, informed consent docu13 ments, and informational mate14 rials for testing that include pro15 tections that provide safety pro16 tections comparable to those pro17 vided by the REMS for the cov18 ered product; or 

19 (BB) otherwise satisfied the 

20 Secretary that such protections 

21 will be provided; and 

22 (bb) met any other require23 ments the Secretary may estab24 lish. 


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1 (iii) NOTICE.—A covered product au2 thorization issued under this subparagraph 

3 shall state that the provision of the covered 

4 product by the license holder under the 

5 terms of the authorization will not be a 

6 violation of the REMS for the covered 

7 product. 

8 (3) AFFIRMATIVE DEFENSE.—In a civil action 

9 brought under paragraph (1), it shall be an affirma10 tive defense, on which the defendant has the burden 

11 of persuasion by a preponderance of the evidence— 

12 (A) that, on the date on which the eligible 

13 product developer requested to purchase suffi14 cient quantities of the covered product from the 

15 license holder— 

16 (i) neither the license holder nor any 

17 of its agents, wholesalers, or distributors 

18 was engaged in the manufacturing or com19 mercial marketing of the covered product; 

20 and 

21 (ii) neither the license holder nor any 

22 of its agents, wholesalers, or distributors 

23 otherwise had access to inventory of the 

24 covered product to supply to the eligible 


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1 product developer on commercially reason2 able, market-based terms; 

3 (B) that— 

4 (i) the license holder sells the covered 

5 product through agents, distributors, or 

6 wholesalers; 

7 (ii) the license holder has placed no 

8 restrictions, explicit or implicit, on its 

9 agents, distributors, or wholesalers to sell 

10 covered products to eligible product devel11 opers; and 

12 (iii) the covered product can be pur13 chased by the eligible product developer in 

14 sufficient quantities on commercially rea15 sonable, market-based terms from the 

16 agents, distributors, or wholesalers of the 

17 license holder; or 

18 (C) that the license holder made an offer 

19 to the individual specified pursuant to para20 graph (2)(A)(iii)(III), by a means of commu21 nication (electronic, written, or both) specified 

22 pursuant to such paragraph, to sell sufficient 

23 quantities of the covered product to the eligible 

24 product developer at commercially reasonable 

25 market-based terms— 


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1 (i) for a covered product that is not 

2 subject to a REMS with ETASU, by the 

3 date that is 14 days after the date on 

4 which the license holder received the re5 quest for the covered product, and the eli6 gible product developer did not accept such 

7 offer by the date that is 7 days after the 

8 date on which the eligible product devel9 oper received such offer from the license 

10 holder; or 

11 (ii) for a covered product that is sub12 ject to a REMS with ETASU, by the date 

13 that is 20 days after the date on which the 

14 license holder received the request for the 

15 covered product, and the eligible product 

16 developer did not accept such offer by the 

17 date that is 10 days after the date on 

18 which the eligible product developer re19 ceived such offer from the license holder. 

20 (4) REMEDIES.— 

21 (A) IN GENERAL.—If an eligible product 

22 developer prevails in a civil action brought 

23 under paragraph (1), the court shall— 

24 (i) order the license holder to provide 

25 to the eligible product developer without 


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1 delay sufficient quantities of the covered 

2 product on commercially reasonable, mar3 ket-based terms; 

4 (ii) award to the eligible product de5 veloper reasonable attorney’s fees and costs 

6 of the civil action; and 

7 (iii) award to the eligible product de8 veloper a monetary amount sufficient to 

9 deter the license holder from failing to pro10 vide eligible product developers with suffi11 cient quantities of a covered product on 

12 commercially reasonable, market-based 

13 terms, if the court finds, by a preponder14 ance of the evidence— 

15 (I) that the license holder delayed 

16 providing sufficient quantities of the 

17 covered product to the eligible product 

18 developer without a legitimate busi19 ness justification; or 

20 (II) that the license holder failed 

21 to comply with an order issued under 

22 clause (i). 

23 (B) MAXIMUM MONETARY AMOUNT.—A 

24 monetary amount awarded under subparagraph 

25 (A)(iii) shall not be greater than the revenue 


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1 that the license holder earned on the covered 

2 product during the period— 

3 (i) beginning on— 

4 (I) for a covered product that is 

5 not subject to a REMS with ETASU, 

6 the date that is 31 days after the date 

7 on which the license holder received 

8 the request; or 

9 (II) for a covered product that is 

10 subject to a REMS with ETASU, the 

11 date that is 31 days after the later 

12 of— 

13 (aa) the date on which the 

14 license holder received the re15 quest; or 

16 (bb) the date on which the 

17 license holder received a copy of 

18 the covered product authorization 

19 issued by the Secretary in ac20 cordance with paragraph (2)(B); 

21 and 

22 (ii) ending on the date on which the 

23 eligible product developer received suffi24 cient quantities of the covered product. 


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1 (C) AVOIDANCE OF DELAY.—The court 

2 may issue an order under subparagraph (A)(i) 

3 before conducting further proceedings that may 

4 be necessary to determine whether the eligible 

5 product developer is entitled to an award under 

6 clause (ii) or (iii) of subparagraph (A), or the 

7 amount of any such award. 

8 (c) LIMITATION OF LIABILITY.—A license holder for 

9 a covered product shall not be liable for any claim under 

10 Federal, State, or local law arising out of the failure of 

11 an eligible product developer to follow adequate safeguards 

12 to assure safe use of the covered product during develop13 ment or testing activities described in this section, includ14 ing transportation, handling, use, or disposal of the cov15 ered product by the eligible product developer. 

16 (d) NO VIOLATION OF REMS.—Section 505–1 of the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355– 

18 1) is amended by adding at the end the following new sub19 section: 

20 ‘‘(l) PROVISION OF SAMPLES NOT A VIOLATION OF

21 STRATEGY.—The provision of samples of a covered prod22 uct to an eligible product developer (as those terms are 

23 defined in section 121(a) of the Lowering Prescription 

24 Drug Costs and Extending Community Health Centers 

25 and Other Public Health Priorities Act) shall not be conVerDate Sep 11 2014 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00038 Fmt 6652 Sfmt 6201 E:\BILLS\H2700.IH H2700

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1 sidered a violation of the requirements of any risk evalua2 tion and mitigation strategy that may be in place under 

3 this section for such drug.’’. 

4 (e) RULE OF CONSTRUCTION.— 

5 (1) DEFINITION.—In this subsection, the term 

6 ‘‘antitrust laws’’— 

7 (A) has the meaning given the term in 

8 subsection (a) of the first section of the Clayton 

9 Act (15 U.S.C. 12); and 

10 (B) includes section 5 of the Federal 

11 Trade Commission Act (15 U.S.C. 45) to the 

12 extent that such section applies to unfair meth13 ods of competition. 

14 (2) ANTITRUST LAWS.—Nothing in this section 

15 shall be construed to limit the operation of any pro16 vision of the antitrust laws. 

17 SEC. 122. REMS APPROVAL PROCESS FOR SUBSEQUENT 

18 FILERS. 

19 Section 505–1 of the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 355–1), as amended by section 121, 

21 is further amended— 

22 (1) in subsection (g)(4)(B)— 

23 (A) in clause (i) by striking ‘‘or’’ after the 

24 semicolon; 


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1 (B) in clause (ii) by striking the period at 

2 the end and inserting ‘‘; or’’; and 

3 (C) by adding at the end the following: 

4 ‘‘(iii) accommodate different, com5 parable aspects of the elements to assure 

6 safe use for a drug that is the subject of 

7 an application under section 505(j), and 

8 the applicable listed drug.’’; 

9 (2) in subsection (i)(1), by striking subpara10 graph (C) and inserting the following: 

11 ‘‘(C)(i) Elements to assure safe use, if re12 quired under subsection (f) for the listed drug, 

13 which, subject to clause (ii), for a drug that is 

14 the subject of an application under section 

15 505(j) may use— 

16 ‘‘(I) a single, shared system with the 

17 listed drug under subsection (f); or 

18 ‘‘(II) a different, comparable aspect of 

19 the elements to assure safe use under sub20 section (f). 

21 ‘‘(ii) The Secretary may require a drug 

22 that is the subject of an application under sec23 tion 505(j) and the listed drug to use a single, 

24 shared system under subsection (f), if the Sec25 retary determines that no different, comparable 


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1 aspect of the elements to assure safe use could 

2 satisfy the requirements of subsection (f).’’; 

3 (3) in subsection (i), by adding at the end the 

4 following: 

5 ‘‘(3) SHARED REMS.—If the Secretary ap6 proves, in accordance with paragraph (1)(C)(i)(II), a 

7 different, comparable aspect of the elements to as8 sure safe use under subsection (f) for a drug that 

9 is the subject of an abbreviated new drug application 

10 under section 505(j), the Secretary may require that 

11 such different comparable aspect of the elements to 

12 assure safe use can be used with respect to any 

13 other drug that is the subject of an application 

14 under section 505(j) or 505(b) that references the 

15 same listed drug.’’; and 

16 (4) by adding at the end the following: 

17 ‘‘(m) SEPARATE REMS.—When used in this section, 

18 the terms ‘different, comparable aspect of the elements to 

19 assure safe use’ or ‘different, comparable approved risk 

20 evaluation and mitigation strategies’ means a risk evalua21 tion and mitigation strategy for a drug that is the subject 

22 of an application under section 505(j) that uses different 

23 methods or operational means than the strategy required 

24 under subsection (a) for the applicable listed drug, or 

25 other application under section 505(j) with the same such 


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1 listed drug, but achieves the same level of safety as such 

2 strategy.’’. 

3 SEC. 123. RULE OF CONSTRUCTION. 

4 (a) IN GENERAL.—Nothing in this subtitle, the 

5 amendments made by this subtitle, or in section 505–1 

6 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

7 355–1), shall be construed as— 

8 (1) prohibiting a license holder from providing 

9 an eligible product developer access to a covered 

10 product in the absence of an authorization under 

11 this subtitle; or 

12 (2) in any way negating the applicability of a 

13 REMS with ETASU, as otherwise required under 

14 such section 505–1, with respect to such covered 

15 product. 

16 (b) DEFINITIONS.—In this section, the terms ‘‘cov17 ered product’’, ‘‘eligible product developer’’, ‘‘license hold18 er’’, and ‘‘REMS with ETASU’’ have the meanings given 

19 such terms in section 121(a). 


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1 TITLE II—EXTENSION OF 

2 PUBLIC HEALTH PROGRAMS 

3 SEC. 201. EXTENSION FOR COMMUNITY HEALTH CENTERS, 

4 THE NATIONAL HEALTH SERVICE CORPS, 

5 AND TEACHING HEALTH CENTERS THAT OP6 ERATE GME PROGRAMS. 

7 (a) COMMUNITY HEALTH CENTERS FUNDING.—Sec8 tion 10503(b)(1)(F) of the Patient Protection and Afford9 able Care Act (42 U.S.C. 254b–2(b)(1)(F)) is amended 

10 by striking ‘‘fiscal year 2019’’ and inserting ‘‘each of fiscal 

11 years 2019 and 2020’’. 

12 (b) NATIONAL HEALTH SERVICE CORPS.—Section 

13 10503(b)(2)(F) of the Patient Protection and Affordable 

14 Care Act (42 U.S.C. 254b–2(b)(2)(F)) is amended by 

15 striking ‘‘2018 and 2019’’ and inserting ‘‘2018, 2019, and 

16 2020’’. 

17 (c) TEACHING HEALTH CENTERS THAT OPERATE

18 GRADUATE MEDICAL EDUCATION PROGRAMS.—Section 

19 340H(g)(1) of the Public Health Service Act (42 U.S.C. 

20 256h(g)(1)) is amended by striking ‘‘2018 and 2019’’ and 

21 inserting ‘‘2018, 2019, and 2020’’. 

22 (d) APPLICATION.—Amounts appropriated pursuant 

23 to this section for fiscal year 2020 are subject to the re24 quirements contained in Public Law 115–245 for funds 


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1 for programs authorized under sections 330 through 340 

2 of the Public Health Service Act (42 U.S.C. 254b–256). 

3 (e) CONFORMING AMENDMENT.—Section 3014(h)(4) 

4 of title 18, United States Code, is amended by striking 

5 ‘‘and section 50901(e) of the Advancing Chronic Care, Ex6 tenders, and Social Services Act’’ and inserting ‘‘, section 

7 50901(e) of the Advancing Chronic Care, Extenders, and 

8 Social Services Act, and section 201(d) of the Lowering 

9 Prescription Drug Costs and Extending Community 

10 Health Centers and Other Public Health Priorities Act’’. 

11 SEC. 202. EXTENSION FOR SPECIAL DIABETES PROGRAMS. 

12 (a) SPECIAL DIABETES PROGRAM FOR TYPE I DIA13 BETES.—Section 330B(b)(2)(D) of the Public Health 

14 Service Act (42 U.S.C. 254c–2(b)(2)(D)) is amended by 

15 striking ‘‘2018 and 2019’’ and inserting ‘‘2018, 2019, and 

16 2020’’. 

17 (b) SPECIAL DIABETES PROGRAM FOR INDIANS.— 

18 Section 330C(c)(2)(D) of the Public Health Service Act 

19 (42 U.S.C. 254c–3(c)(2)(D)) is amended by striking 

20 ‘‘2018 and 2019’’ and inserting ‘‘2018, 2019, and 2020’’. 

21 SEC. 203. EXTENSION FOR FAMILY-TO-FAMILY HEALTH IN22 FORMATION CENTERS. 

23 (a) IN GENERAL.—Section 501(c) of the Social Secu24 rity Act (42 U.S.C. 701(c)(1)(A)(vii)) is amended by strikVerDate Sep 11 2014 04:40 May 29, 2019 Jkt 089200 PO 00000 Frm 00044 Fmt 6652 Sfmt 6201 E:\BILLS\H2700.IH H2700

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1 ing ‘‘2018 and 2019’’ and inserting ‘‘2018, 2019, and 

2 2020’’. 

3 (b) CONFORMING CHANGE.—Section 501(c)(3)(C) of 

4 the Social Security Act (42 U.S.C. 701(c)(3)(C)) is 

5 amended by striking ‘‘2018 and 2019’’ and inserting 

6 ‘‘2018, 2019, and 2020’’. 

7 SEC. 204. EXTENSION FOR SEXUAL RISK AVOIDANCE EDU8 CATION AND PERSONAL RESPONSIBILITY 

9 EDUCATION. 

10 (a) SEXUAL RISK AVOIDANCE EDUCATION.—Sub11 sections (a) and (f) of section 510 of the Social Security 

12 Act (42 U.S.C. 710) are amended by striking ‘‘2018 and 

13 2019’’ each place it appears and inserting ‘‘2018, 2019, 

14 and 2020’’. 

15 (b) PERSONAL RESPONSIBILITY EDUCATION.—Sec16 tion 513 of the Social Security Act (42 U.S.C. 713) is 

17 amended— 

18 (1) in subsection (a)(1)(A), by striking ‘‘2019’’ 

19 and inserting ‘‘2020’’; and 

20 (2) in subsection (a)(4), by striking ‘‘2019’’ 

21 each place it appears and inserting ‘‘2020’’; and 

22 (3) in subsection (f), by striking ‘‘2019’’ and 

23 inserting ‘‘2020’’. 

Æ 


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