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-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Lowering Prescription 
Drug Costs and Extending Community Health Centers 
and Other Public Health Priorities Act’’. 
SEC. 2. TABLE OF CONTENTS. 
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 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. 
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TITLE I—LOWERING 
PRESCRIPTION DRUG COSTS 
Subtitle A—Bringing Low-Cost Op-
tions and Competition While 
Keeping 
Incentives 
for 
New 
Generics 
SEC. 101. CHANGE CONDITIONS OF FIRST GENERIC EXCLU-
SIVITY TO SPUR ACCESS AND COMPETITION. 
Section 505(j)(5)(B)(iv) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amend-
ed— 
(1) in subclause (I), by striking ‘‘180 days 
after’’ and all that follows through the period at the 
end and inserting the following: ‘‘180 days after the 
earlier of— 
‘‘(aa) the date of the first com-
mercial marketing of the drug (includ-
ing the commercial marketing of the 
listed drug) by any first applicant; or 
‘‘(bb) the applicable date speci-
fied in subclause (III).’’; and 
(2) by adding at the end the following new sub-
clause: 
‘‘(III) APPLICABLE DATE.—The appli-
cable date specified in this subclause, with 
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Subtitle B—Protecting Consumer 
Access to Generic Drugs 
SEC. 111. UNLAWFUL AGREEMENTS. 
(a) AGREEMENTS PROHIBITED.—Subject to sub-
sections (b) and (c), it shall be unlawful for an NDA or 
BLA holder and a subsequent filer (or for two subsequent 
filers) to enter into, or carry out, an agreement resolving 
or settling a covered patent infringement claim on a final 
or interim basis if under such agreement— 
(1) a subsequent filer directly or indirectly re-
ceives from such holder (or in the case of such an 
agreement between two subsequent filers, the other 
subsequent filer) anything of value, including a li-
cense; and 
(2) the subsequent filer agrees to limit or fore-
go research on, or development, manufacturing, 
marketing, or sales, for any period of time, of the 
covered product that is the subject of the application 
described in subparagraph (A) or (B) of subsection 
(g)(8). 
(b) EXCLUSION.—It shall not be unlawful under sub-
section (a) if a party to an agreement described in such 
subsection demonstrates by clear and convincing evidence 
that the value described in subsection (a)(1) is compensa-
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tion solely for other goods or services that the subsequent 
filer has promised to provide. 
(c) LIMITATION.—Nothing in this section shall pro-
hibit an agreement resolving or settling a covered patent 
infringement claim in which the consideration granted by 
the NDA or BLA holder to the subsequent filer (or from 
one subsequent filer to another) as part of the resolution 
or settlement includes only one or more of the following: 
(1) The right to market the covered product 
that is the subject of the application described in 
subparagraph (A) or (B) of subsection (g)(8) in the 
United States before the expiration of— 
(A) any patent that is the basis of the cov-
ered patent infringement claim; or 
(B) any patent right or other statutory ex-
clusivity that would prevent the marketing of 
such covered product. 
(2) A payment for reasonable litigation ex-
penses not to exceed $7,500,000 in the aggregate. 
(3) A covenant not to sue on any claim that 
such covered product infringes a patent. 
(d) ENFORCEMENT BY FEDERAL TRADE COMMIS-
SION.— 
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(1) GENERAL APPLICATION.—The requirements 
of this section apply, according to their terms, to an 
NDA or BLA holder or subsequent filer that is— 
(A) a person, partnership, or corporation 
over which the Commission has authority pur-
suant to section 5(a)(2) of the Federal Trade 
Commission Act (15 U.S.C. 45(a)(2)); or 
(B) a person, partnership, or corporation 
over which the Commission would have author-
ity pursuant to such section but for the fact 
that such person, partnership, or corporation is 
not organized to carry on business for its own 
profit or that of its members. 
(2) UNFAIR OR DECEPTIVE ACTS OR PRACTICES 
ENFORCEMENT AUTHORITY.— 
(A) IN GENERAL.—A violation of this sec-
tion shall be treated as an unfair or deceptive 
act or practice in violation of section 5(a)(1) of 
the Federal Trade Commission Act (15 U.S.C. 
45(a)(1)). 
(B) POWERS OF COMMISSION.—Except as 
provided in subparagraph (C) and paragraphs 
(1)(B) and (3)— 
(i) the Commission shall enforce this 
section in the same manner, by the same 
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means, and with the same jurisdiction, 
powers, and duties as though all applicable 
terms and provisions of the Federal Trade 
Commission Act (15 U.S.C. 41 et seq.) 
were incorporated into and made a part of 
this section; and 
(ii) any NDA or BLA holder or subse-
quent filer that violates this section shall 
be subject to the penalties and entitled to 
the privileges and immunities provided in 
the Federal Trade Commission Act. 
(C) JUDICIAL REVIEW.—In the case of a 
cease and desist order issued by the Commis-
sion under section 5 of the Federal Trade Com-
mission Act (15 U.S.C. 45) for violation of this 
section, a party to such order may obtain judi-
cial review of such order as provided in such 
section 5, except that— 
(i) such review may only be obtained 
in— 
(I) the United States Court of 
Appeals for the District of Columbia 
Circuit; 
(II) the United States Court of 
Appeals for the circuit in which the 
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ultimate parent entity, as defined in 
section 801.1(a)(3) of title 16, Code 
of Federal Regulations, or any suc-
cessor thereto, of the NDA or BLA 
holder (if any such holder is a party 
to such order) is incorporated as of 
the date that the application described 
in subparagraph (A) or (B) of sub-
section (g)(8) or an approved applica-
tion that is deemed to be a license for 
a biological product under section 
351(k) of the Public Health Service 
Act (42 U.S.C. 262(k)) pursuant to 
section 7002(e)(4) of the Biologics 
Price Competition and Innovation Act 
of 2009 (Public Law 111–148; 124 
Stat. 817) is submitted to the Com-
missioner of Food and Drugs; or 
(III) the United States Court of 
Appeals for the circuit in which the 
ultimate parent entity, as so defined, 
of any subsequent filer that is a party 
to such order is incorporated as of the 
date that the application described in 
subparagraph (A) or (B) of subsection 
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(g)(8) is submitted to the Commis-
sioner of Food and Drugs; and 
(ii) the petition for review shall be 
filed in the court not later than 30 days 
after such order is served on the party 
seeking review. 
(3) ADDITIONAL ENFORCEMENT AUTHORITY.— 
(A) CIVIL
PENALTY.—The Commission 
may commence a civil action to recover a civil 
penalty in a district court of the United States 
against any NDA or BLA holder or subsequent 
filer that violates this section. 
(B) SPECIAL
RULE
FOR
RECOVERY
OF 
PENALTY
IF
CEASE
AND
DESIST
ORDER 
ISSUED.— 
(i) IN GENERAL.—If the Commission 
has issued a cease and desist order in a 
proceeding under section 5 of the Federal 
Trade Commission Act (15 U.S.C. 45) for 
violation of this section— 
(I) the Commission may com-
mence a civil action under subpara-
graph (A) to recover a civil penalty 
against any party to such order at 
any time before the expiration of the 
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1-year period beginning on the date 
on which such order becomes final 
under section 5(g) of such Act (15 
U.S.C. 45(g)); and 
(II) in such civil action, the find-
ings of the Commission as to the ma-
terial facts in such proceeding shall be 
conclusive, unless— 
(aa) the terms of such order 
expressly provide that the Com-
mission’s findings shall not be 
conclusive; or 
(bb) such order became final 
by reason of section 5(g)(1) of 
such Act (15 U.S.C. 45(g)(1)), in 
which case such findings shall be 
conclusive if supported by evi-
dence. 
(ii) RELATIONSHIP TO PENALTY FOR 
VIOLATION
OF
AN
ORDER.—The penalty 
provided in clause (i) for violation of this 
section is separate from and in addition to 
any penalty that may be incurred for viola-
tion of an order of the Commission under 
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section 5(l) of the Federal Trade Commis-
sion Act (15 U.S.C. 45(l)). 
(C) AMOUNT OF PENALTY.— 
(i) IN GENERAL.—The amount of a 
civil penalty imposed in a civil action under 
subparagraph (A) on a party to an agree-
ment described in subsection (a) shall be 
sufficient to deter violations of this section, 
but in no event greater than— 
(I) if such party is the NDA or 
BLA holder (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who gave the 
value described in subsection (a)(1)), 
the greater of— 
(aa) 3 times the value re-
ceived by such NDA or BLA 
holder (or by such subsequent 
filer) that is reasonably attrib-
utable to the violation of this sec-
tion; or 
(bb) 3 times the value given 
to the subsequent filer (or to the 
other subsequent filer) reason-
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ably attributable to the violation 
of this section; and 
(II) if such party is the subse-
quent filer (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who received 
the value described in subsection 
(a)(1)), 3 times the value received by 
such subsequent filer that is reason-
ably attributable to the violation of 
this section. 
(ii) FACTORS FOR CONSIDERATION.— 
In determining such amount, the court 
shall take into account— 
(I) the nature, circumstances, ex-
tent, and gravity of the violation; 
(II) with respect to the violator, 
the degree of culpability, any history 
of violations, the ability to pay, any 
effect on the ability to continue doing 
business, profits earned by the NDA 
or BLA holder (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who gave the 
value described in subsection (a)(1)), 
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compensation received by the subse-
quent filer (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who received 
the value described in subsection 
(a)(1)), and the amount of commerce 
affected; and 
(III) other matters that justice 
requires. 
(D) INJUNCTIONS AND OTHER EQUITABLE 
RELIEF.—In a civil action under subparagraph 
(A), the United States district courts are em-
powered to grant mandatory injunctions and 
such other and further equitable relief as they 
deem appropriate. 
(4) REMEDIES
IN
ADDITION.—Remedies pro-
vided in this subsection are in addition to, and not 
in lieu of, any other remedy provided by Federal 
law. 
(5) PRESERVATION OF AUTHORITY OF COMMIS-
SION.—Nothing in this section shall be construed to 
affect any authority of the Commission under any 
other provision of law. 
(e) FEDERAL TRADE COMMISSION RULEMAKING.— 
The Commission may, in its discretion, by rule promul-
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gated under section 553 of title 5, United States Code, 
exempt from this section certain agreements described in 
subsection (a) if the Commission finds such agreements 
to be in furtherance of market competition and for the 
benefit of consumers. 
(f) ANTITRUST LAWS.—Nothing in this section shall 
modify, impair, limit, or supersede the applicability of the 
antitrust laws as defined in subsection (a) of the first sec-
tion of the Clayton Act (15 U.S.C. 12(a)), and of section 
5 of the Federal Trade Commission Act (15 U.S.C. 45) 
to the extent that such section 5 applies to unfair methods 
of competition. Nothing in this section shall modify, im-
pair, limit, or supersede the right of a subsequent filer 
to assert claims or counterclaims against any person, 
under the antitrust laws or other laws relating to unfair 
competition. 
(g) DEFINITIONS.—In this section: 
(1) AGREEMENT
RESOLVING
OR
SETTLING
A 
COVERED
PATENT
INFRINGEMENT
CLAIM.—The 
term ‘‘agreement resolving or settling a covered pat-
ent infringement claim’’ means any agreement 
that— 
(A) resolves or settles a covered patent in-
fringement claim; or 
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(B) is contingent upon, provides for a con-
tingent condition for, or is otherwise related to 
the resolution or settlement of a covered patent 
infringement claim. 
(2) COMMISSION.—The term ‘‘Commission’’ 
means the Federal Trade Commission. 
(3) COVERED PATENT INFRINGEMENT CLAIM.— 
The term ‘‘covered patent infringement claim’’ 
means an allegation made by the NDA or BLA hold-
er to a subsequent filer (or, in the case of an agree-
ment between two subsequent filers, by one subse-
quent filer to another), whether or not included in 
a complaint filed with a court of law, that— 
(A) the submission of the application de-
scribed in subparagraph (A) or (B) of para-
graph (9), or the manufacture, use, offering for 
sale, sale, or importation into the United States 
of a covered product that is the subject of such 
an application— 
(i) in the case of an agreement be-
tween an NDA or BLA holder and a sub-
sequent filer, infringes any patent owned 
by, or exclusively licensed to, the NDA or 
BLA holder of the covered product; or 
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(ii) in the case of an agreement be-
tween two subsequent filers, infringes any 
patent owned by the subsequent filer; or 
(B) in the case of an agreement between 
an NDA or BLA holder and a subsequent filer, 
the covered product to be manufactured under 
such application uses a covered product as 
claimed in a published patent application. 
(4) COVERED
PRODUCT.—The term ‘‘covered 
product’’ means a drug (as defined in section 201(g) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(g))), including a biological product (as 
defined in section 351(i) of the Public Health Serv-
ice Act (42 U.S.C. 262(i)). 
(5) NDA OR BLA HOLDER.—The term ‘‘NDA 
or BLA holder’’ means— 
(A) the holder of— 
(i) an approved new drug application 
filed under section 505(b)(1) of the Fed-
eral Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)(1)) for a covered product; 
or 
(ii) a biologics license application filed 
under section 351(a) of the Public Health 
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Service Act (42 U.S.C. 262(a)) with re-
spect to a biological product; 
(B) a person owning or controlling enforce-
ment of the patent on— 
(i) the list published under section 
505(j)(7) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(7)) in con-
nection with the application described in 
subparagraph (A)(i); or 
(ii) any list published under section 
351 of the Public Health Service Act (42 
U.S.C. 262) comprised of patents associ-
ated with biologics license applications filed 
under section 351(a) of such Act (42 
U.S.C. 262(a)); or 
(C) the predecessors, subsidiaries, divi-
sions, groups, and affiliates controlled by, con-
trolling, or under common control with any en-
tity described in subparagraph (A) or (B) (such 
control to be presumed by direct or indirect 
share ownership of 50 percent or greater), as 
well as the licensees, licensors, successors, and 
assigns of each of the entities. 
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(6) PATENT.—The term ‘‘patent’’ means a pat-
ent issued by the United States Patent and Trade-
mark Office. 
(7) 
STATUTORY
EXCLUSIVITY.—The 
term 
‘‘statutory exclusivity’’ means those prohibitions on 
the submission or approval of drug applications 
under 
clauses 
(ii) 
through 
(iv) 
of 
section 
505(c)(3)(E) (5- and 3-year exclusivity), clauses (ii) 
through (iv) of section 505(j)(5)(F) (5-year and 3- 
year exclusivity), section 505(j)(5)(B)(iv) (180-day 
exclusivity), section 527 (orphan drug exclusivity), 
section 505A (pediatric exclusivity), or section 505E 
(qualified infectious disease product exclusivity) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(c)(3)(E), 355(j)(5)(B)(iv), 355(j)(5)(F), 
360cc, 355a, 355f), or prohibitions on the submis-
sion or licensing of biologics license applications 
under section 351(k)(6) (interchangeable biological 
product exclusivity) or section 351(k)(7) (biological 
product reference product exclusivity) of the Public 
Health Service Act (42 U.S.C. 262(k)(6), (7)). 
(8) SUBSEQUENT
FILER.—The term ‘‘subse-
quent filer’’ means— 
(A) in the case of a drug, a party that 
owns or controls an abbreviated new drug appli-
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cation submitted pursuant to section 505(j) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) or a new drug application sub-
mitted pursuant to section 505(b)(2) of the 
Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21U.S.C. 355(b)(2)) and filed under section 
505(b)(1) of such Act (21 U.S.C. 355(b)(1)) or 
has the exclusive rights to distribute the cov-
ered product that is the subject of such applica-
tion; or 
(B) in the case of a biological product, a 
party that owns or controls an application filed 
with the Food and Drug Administration under 
section 351(k) of the Public Health Service Act 
(42 U.S.C. 262(k)) or has the exclusive rights 
to distribute the biological product that is the 
subject of such application. 
(h) EFFECTIVE DATE.—This section applies with re-
spect to agreements described in subsection (a) entered 
into on or after the date of the enactment of this Act. 
SEC. 112. NOTICE AND CERTIFICATION OF AGREEMENTS. 
(a) NOTICE OF ALL AGREEMENTS.—Section 1111(7) 
of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (21 U.S.C. 355 note) is 
amended by inserting ‘‘or the owner of a patent for which 
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a claim of infringement could reasonably be asserted 
against any person for making, using, offering to sell, sell-
ing, or importing into the United States a biological prod-
uct that is the subject of a biosimilar biological product 
application’’ before the period at the end. 
(b) CERTIFICATION OF AGREEMENTS.—Section 1112 
of such Act (21 U.S.C. 355 note) is amended by adding 
at the end the following: 
‘‘(d) CERTIFICATION.—The Chief Executive Officer 
or the company official responsible for negotiating any 
agreement under subsection (a) or (b) that is required to 
be filed under subsection (c) shall, within 30 days of such 
filing, execute and file with the Assistant Attorney General 
and the Commission a certification as follows: ‘I declare 
that the following is true, correct, and complete to the best 
of my knowledge: The materials filed with the Federal 
Trade Commission and the Department of Justice under 
section 1112 of the Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003, with respect to the 
agreement referenced in this certification— 
‘‘ ‘(1) represent the complete, final, and exclu-
sive agreement between the parties; 
‘‘ ‘(2) include any ancillary agreements that are 
contingent upon, provide a contingent condition for, 
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were entered into within 30 days of, or are otherwise 
related to, the referenced agreement; and 
‘‘ ‘(3) include written descriptions of any oral 
agreements, representations, commitments, or prom-
ises between the parties that are responsive to sub-
section (a) or (b) of such section 1112 and have not 
been reduced to writing.’.’’. 
SEC. 113. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 
Section 505(j)(5)(D)(i)(V) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) 
is amended by inserting ‘‘section 111 of the Lowering Pre-
scription Drug Costs and Extending Community Health 
Centers and Other Public Health Priorities Act or’’ after 
‘‘that the agreement has violated’’. 
SEC. 114. COMMISSION LITIGATION AUTHORITY. 
Section 16(a)(2) of the Federal Trade Commission 
Act (15 U.S.C. 56(a)(2)) is amended— 
(1) in subparagraph (D), by striking ‘‘or’’ after 
the semicolon; 
(2) in subparagraph (E), by inserting ‘‘or’’ 
after the semicolon; and 
(3) by inserting after subparagraph (E) the fol-
lowing: 
‘‘(F) under section 111(d)(3)(A) of the 
Lowering Prescription Drug Costs and Extend-
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ing Community Health Centers and Other Pub-
lic Health Priorities Act;’’. 
SEC. 115. STATUTE OF LIMITATIONS. 
(a) IN GENERAL.—Except as provided in subsection 
(b), the Commission shall commence any administrative 
proceeding or civil action to enforce section 111 of this 
Act not later than 6 years after the date on which the 
parties to the agreement file the Notice of Agreement as 
provided by section 1112(c)(2) and (d) of the Medicare 
Prescription Drug, Improvement, and Modernization Act 
of 2003 (21 U.S.C. 355 note). 
(b) CIVIL ACTION AFTER ISSUANCE OF CEASE AND 
DESIST ORDER.—If the Commission has issued a cease 
and desist order under section 5 of the Federal Trade 
Commission Act (15 U.S.C. 45) for violation of section 
111 of this Act and the proceeding for the issuance of 
such order was commenced within the period required by 
subsection (a) of this section, such subsection does not 
prohibit the commencement, after such period, of a civil 
action under section 111(d)(3)(A) against a party to such 
order or a civil action under subsection (l) of such section 
5 for violation of such order. 
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Subtitle C—Creating and Restoring 
Equal 
Access 
to 
Equivalent 
Samples 
SEC. 121. ACTIONS FOR DELAYS OF GENERIC DRUGS AND 
BIOSIMILAR BIOLOGICAL PRODUCTS. 
(a) DEFINITIONS.—In this section— 
(1) the term ‘‘commercially reasonable, market- 
based terms’’ means— 
(A) a nondiscriminatory price for the sale 
of the covered product at or below, but not 
greater than, the most recent wholesale acquisi-
tion cost for the drug, as defined in section 
1847A(c)(6)(B) of the Social Security Act (42 
U.S.C. 1395w–3a(c)(6)(B)); 
(B) a schedule for delivery that results in 
the transfer of the covered product to the eligi-
ble product developer consistent with the timing 
under subsection (b)(2)(A)(iv); and 
(C) no additional conditions are imposed 
on the sale of the covered product; 
(2) the term ‘‘covered product’’— 
(A) means— 
(i) any drug approved under sub-
section (c) or (j) of section 505 of the Fed-
eral Food, Drug, and Cosmetic Act (21 
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U.S.C. 355) or biological product licensed 
under subsection (a) or (k) of section 351 
of the Public Health Service Act (42 
U.S.C. 262); 
(ii) any combination of a drug or bio-
logical product described in clause (i); or 
(iii) when reasonably necessary to 
support approval of an application under 
section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355), or sec-
tion 351 of the Public Health Service Act 
(42 U.S.C. 262), as applicable, or other-
wise meet the requirements for approval 
under either such section, any product, in-
cluding any device, that is marketed or in-
tended for use with such a drug or biologi-
cal product; and 
(B) does not include any drug or biological 
product that appears on the drug shortage list 
in effect under section 506E of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
356e), unless— 
(i) the drug or biological product has 
been on the drug shortage list in effect 
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under such section 506E continuously for 
more than 6 months; or 
(ii) the Secretary determines that in-
clusion of the drug or biological product as 
a covered product is likely to contribute to 
alleviating or preventing a shortage. 
(3) the term ‘‘device’’ has the meaning given 
the term in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321); 
(4) the term ‘‘eligible product developer’’ means 
a person that seeks to develop a product for ap-
proval pursuant to an application for approval under 
subsection (b)(2) or (j) of section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
for licensing pursuant to an application under sec-
tion 351(k) of the Public Health Service Act (42 
U.S.C. 262(k)); 
(5) the term ‘‘license holder’’ means the holder 
of an application approved under subsection (c) or 
(j) of section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) or the holder of a li-
cense under subsection (a) or (k) of section 351 of 
the Public Health Service Act (42 U.S.C. 262) for 
a covered product; 
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(6) the term ‘‘REMS’’ means a risk evaluation 
and mitigation strategy under section 505–1 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355–1); 
(7) the term ‘‘REMS with ETASU’’ means a 
REMS that contains elements to assure safe use 
under section 505–1(f) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355–1(f)); 
(8) the term ‘‘Secretary’’ means the Secretary 
of Health and Human Services; 
(9) the term ‘‘single, shared system of elements 
to assure safe use’’ means a single, shared system 
of elements to assure safe use under section 505– 
1(f) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355–1(f)); and 
(10) the term ‘‘sufficient quantities’’ means an 
amount of a covered product that the eligible prod-
uct developer determines allows it to— 
(A) conduct testing to support an applica-
tion under— 
(i) subsection (b)(2) or (j) of section 
505 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355); or 
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(ii) section 351(k) of the Public 
Health Service Act (42 U.S.C. 262(k)); 
and 
(B) fulfill any regulatory requirements re-
lating to approval of such an application. 
(b) CIVIL ACTION FOR FAILURE TO PROVIDE SUFFI-
CIENT QUANTITIES OF A COVERED PRODUCT.— 
(1) IN GENERAL.—An eligible product developer 
may bring a civil action against the license holder 
for a covered product seeking relief under this sub-
section in an appropriate district court of the United 
States alleging that the license holder has declined 
to provide sufficient quantities of the covered prod-
uct to the eligible product developer on commercially 
reasonable, market-based terms. 
(2) ELEMENTS.— 
(A) IN GENERAL.—To prevail in a civil ac-
tion brought under paragraph (1), an eligible 
product developer shall prove, by a preponder-
ance of the evidence— 
(i) that— 
(I) the covered product is not 
subject to a REMS with ETASU; or 
(II) if the covered product is sub-
ject to a REMS with ETASU— 
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(aa) the eligible product de-
veloper has obtained a covered 
product authorization from the 
Secretary in accordance with sub-
paragraph (B); and 
(bb) the eligible product de-
veloper has provided a copy of 
the covered product authorization 
to the license holder; 
(ii) that, as of the date on which the 
civil action is filed, the product developer 
has not obtained sufficient quantities of 
the covered product on commercially rea-
sonable, market-based terms; 
(iii) that the eligible product developer 
has submitted a written request to pur-
chase sufficient quantities of the covered 
product to the license holder and such re-
quest— 
(I) was sent to a named cor-
porate officer of the license holder; 
(II) was made by certified or reg-
istered mail with return receipt re-
quested; 
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(III) specified an individual as 
the point of contact for the license 
holder to direct communications re-
lated to the sale of the covered prod-
uct to the eligible product developer 
and a means for electronic and writ-
ten communications with that indi-
vidual; and 
(IV) specified an address to 
which the covered product was to be 
shipped upon reaching an agreement 
to transfer the covered product; and 
(iv) that the license holder has not de-
livered to the eligible product developer 
sufficient quantities of the covered product 
on commercially reasonable, market-based 
terms— 
(I) for a covered product that is 
not subject to a REMS with ETASU, 
by the date that is 31 days after the 
date on which the license holder re-
ceived the request for the covered 
product; and 
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subject to a REMS with ETASU for pur-
poses of— 
(I) development and testing that 
does not involve human clinical trials, 
if the eligible product developer has 
agreed to comply with any conditions 
the Secretary determines necessary; or 
(II) development and testing that 
involves human clinical trials, if the 
eligible product developer has— 
(aa)(AA) submitted proto-
cols, 
informed 
consent 
docu-
ments, and informational mate-
rials for testing that include pro-
tections that provide safety pro-
tections comparable to those pro-
vided by the REMS for the cov-
ered product; or 
(BB) otherwise satisfied the 
Secretary that such protections 
will be provided; and 
(bb) met any other require-
ments the Secretary may estab-
lish. 
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(iii) NOTICE.—A covered product au-
thorization issued under this subparagraph 
shall state that the provision of the covered 
product by the license holder under the 
terms of the authorization will not be a 
violation of the REMS for the covered 
product. 
(3) AFFIRMATIVE DEFENSE.—In a civil action 
brought under paragraph (1), it shall be an affirma-
tive defense, on which the defendant has the burden 
of persuasion by a preponderance of the evidence— 
(A) that, on the date on which the eligible 
product developer requested to purchase suffi-
cient quantities of the covered product from the 
license holder— 
(i) neither the license holder nor any 
of its agents, wholesalers, or distributors 
was engaged in the manufacturing or com-
mercial marketing of the covered product; 
and 
(ii) neither the license holder nor any 
of its agents, wholesalers, or distributors 
otherwise had access to inventory of the 
covered product to supply to the eligible 
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product developer on commercially reason-
able, market-based terms; 
(B) that— 
(i) the license holder sells the covered 
product through agents, distributors, or 
wholesalers; 
(ii) the license holder has placed no 
restrictions, explicit or implicit, on its 
agents, distributors, or wholesalers to sell 
covered products to eligible product devel-
opers; and 
(iii) the covered product can be pur-
chased by the eligible product developer in 
sufficient quantities on commercially rea-
sonable, market-based terms from the 
agents, distributors, or wholesalers of the 
license holder; or 
(C) that the license holder made an offer 
to the individual specified pursuant to para-
graph (2)(A)(iii)(III), by a means of commu-
nication (electronic, written, or both) specified 
pursuant to such paragraph, to sell sufficient 
quantities of the covered product to the eligible 
product developer at commercially reasonable 
market-based terms— 
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(i) for a covered product that is not 
subject to a REMS with ETASU, by the 
date that is 14 days after the date on 
which the license holder received the re-
quest for the covered product, and the eli-
gible product developer did not accept such 
offer by the date that is 7 days after the 
date on which the eligible product devel-
oper received such offer from the license 
holder; or 
(ii) for a covered product that is sub-
ject to a REMS with ETASU, by the date 
that is 20 days after the date on which the 
license holder received the request for the 
covered product, and the eligible product 
developer did not accept such offer by the 
date that is 10 days after the date on 
which the eligible product developer re-
ceived such offer from the license holder. 
(4) REMEDIES.— 
(A) IN GENERAL.—If an eligible product 
developer prevails in a civil action brought 
under paragraph (1), the court shall— 
(i) order the license holder to provide 
to the eligible product developer without 
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delay sufficient quantities of the covered 
product on commercially reasonable, mar-
ket-based terms; 
(ii) award to the eligible product de-
veloper reasonable attorney’s fees and costs 
of the civil action; and 
(iii) award to the eligible product de-
veloper a monetary amount sufficient to 
deter the license holder from failing to pro-
vide eligible product developers with suffi-
cient quantities of a covered product on 
commercially 
reasonable, 
market-based 
terms, if the court finds, by a preponder-
ance of the evidence— 
(I) that the license holder delayed 
providing sufficient quantities of the 
covered product to the eligible product 
developer without a legitimate busi-
ness justification; or 
(II) that the license holder failed 
to comply with an order issued under 
clause (i). 
(B) MAXIMUM
MONETARY
AMOUNT.—A 
monetary amount awarded under subparagraph 
(A)(iii) shall not be greater than the revenue 
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that the license holder earned on the covered 
product during the period— 
(i) beginning on— 
(I) for a covered product that is 
not subject to a REMS with ETASU, 
the date that is 31 days after the date 
on which the license holder received 
the request; or 
(II) for a covered product that is 
subject to a REMS with ETASU, the 
date that is 31 days after the later 
of— 
(aa) the date on which the 
license holder received the re-
quest; or 
(bb) the date on which the 
license holder received a copy of 
the covered product authorization 
issued by the Secretary in ac-
cordance with paragraph (2)(B); 
and 
(ii) ending on the date on which the 
eligible product developer received suffi-
cient quantities of the covered product. 
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(C) AVOIDANCE
OF
DELAY.—The court 
may issue an order under subparagraph (A)(i) 
before conducting further proceedings that may 
be necessary to determine whether the eligible 
product developer is entitled to an award under 
clause (ii) or (iii) of subparagraph (A), or the 
amount of any such award. 
(c) LIMITATION OF LIABILITY.—A license holder for 
a covered product shall not be liable for any claim under 
Federal, State, or local law arising out of the failure of 
an eligible product developer to follow adequate safeguards 
to assure safe use of the covered product during develop-
ment or testing activities described in this section, includ-
ing transportation, handling, use, or disposal of the cov-
ered product by the eligible product developer. 
(d) NO VIOLATION OF REMS.—Section 505–1 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355– 
1) is amended by adding at the end the following new sub-
section: 
‘‘(l) PROVISION OF SAMPLES NOT A VIOLATION OF 
STRATEGY.—The provision of samples of a covered prod-
uct to an eligible product developer (as those terms are 
defined in section 121(a) of the Lowering Prescription 
Drug Costs and Extending Community Health Centers 
and Other Public Health Priorities Act) shall not be con-
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sidered a violation of the requirements of any risk evalua-
tion and mitigation strategy that may be in place under 
this section for such drug.’’. 
(e) RULE OF CONSTRUCTION.— 
(1) DEFINITION.—In this subsection, the term 
‘‘antitrust laws’’— 
(A) has the meaning given the term in 
subsection (a) of the first section of the Clayton 
Act (15 U.S.C. 12); and 
(B) includes section 5 of the Federal 
Trade Commission Act (15 U.S.C. 45) to the 
extent that such section applies to unfair meth-
ods of competition. 
(2) ANTITRUST LAWS.—Nothing in this section 
shall be construed to limit the operation of any pro-
vision of the antitrust laws. 
SEC. 122. REMS APPROVAL PROCESS FOR SUBSEQUENT 
FILERS. 
Section 505–1 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355–1), as amended by section 121, 
is further amended— 
(1) in subsection (g)(4)(B)— 
(A) in clause (i) by striking ‘‘or’’ after the 
semicolon; 
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(B) in clause (ii) by striking the period at 
the end and inserting ‘‘; or’’; and 
(C) by adding at the end the following: 
‘‘(iii) accommodate different, com-
parable aspects of the elements to assure 
safe use for a drug that is the subject of 
an application under section 505(j), and 
the applicable listed drug.’’; 
(2) in subsection (i)(1), by striking subpara-
graph (C) and inserting the following: 
‘‘(C)(i) Elements to assure safe use, if re-
quired under subsection (f) for the listed drug, 
which, subject to clause (ii), for a drug that is 
the subject of an application under section 
505(j) may use— 
‘‘(I) a single, shared system with the 
listed drug under subsection (f); or 
‘‘(II) a different, comparable aspect of 
the elements to assure safe use under sub-
section (f). 
‘‘(ii) The Secretary may require a drug 
that is the subject of an application under sec-
tion 505(j) and the listed drug to use a single, 
shared system under subsection (f), if the Sec-
retary determines that no different, comparable 
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aspect of the elements to assure safe use could 
satisfy the requirements of subsection (f).’’; 
(3) in subsection (i), by adding at the end the 
following: 
‘‘(3) SHARED
REMS.—If the Secretary ap-
proves, in accordance with paragraph (1)(C)(i)(II), a 
different, comparable aspect of the elements to as-
sure safe use under subsection (f) for a drug that 
is the subject of an abbreviated new drug application 
under section 505(j), the Secretary may require that 
such different comparable aspect of the elements to 
assure safe use can be used with respect to any 
other drug that is the subject of an application 
under section 505(j) or 505(b) that references the 
same listed drug.’’; and 
(4) by adding at the end the following: 
‘‘(m) SEPARATE REMS.—When used in this section, 
the terms ‘different, comparable aspect of the elements to 
assure safe use’ or ‘different, comparable approved risk 
evaluation and mitigation strategies’ means a risk evalua-
tion and mitigation strategy for a drug that is the subject 
of an application under section 505(j) that uses different 
methods or operational means than the strategy required 
under subsection (a) for the applicable listed drug, or 
other application under section 505(j) with the same such 
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listed drug, but achieves the same level of safety as such 
strategy.’’. 
SEC. 123. RULE OF CONSTRUCTION. 
(a) IN GENERAL.—Nothing in this subtitle, the 
amendments made by this subtitle, or in section 505–1 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355–1), shall be construed as— 
(1) prohibiting a license holder from providing 
an eligible product developer access to a covered 
product in the absence of an authorization under 
this subtitle; or 
(2) in any way negating the applicability of a 
REMS with ETASU, as otherwise required under 
such section 505–1, with respect to such covered 
product. 
(b) DEFINITIONS.—In this section, the terms ‘‘cov-
ered product’’, ‘‘eligible product developer’’, ‘‘license hold-
er’’, and ‘‘REMS with ETASU’’ have the meanings given 
such terms in section 121(a). 
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TITLE II—EXTENSION OF 
PUBLIC HEALTH PROGRAMS 
SEC. 201. EXTENSION FOR COMMUNITY HEALTH CENTERS, 
THE NATIONAL HEALTH SERVICE CORPS, 
AND TEACHING HEALTH CENTERS THAT OP-
ERATE GME PROGRAMS. 
(a) COMMUNITY HEALTH CENTERS FUNDING.—Sec-
tion 10503(b)(1)(F) of the Patient Protection and Afford-
able Care Act (42 U.S.C. 254b–2(b)(1)(F)) is amended 
by striking ‘‘fiscal year 2019’’ and inserting ‘‘each of fiscal 
years 2019 and 2020’’. 
(b) NATIONAL HEALTH SERVICE CORPS.—Section 
10503(b)(2)(F) of the Patient Protection and Affordable 
Care Act (42 U.S.C. 254b–2(b)(2)(F)) is amended by 
striking ‘‘2018 and 2019’’ and inserting ‘‘2018, 2019, and 
2020’’. 
(c) TEACHING HEALTH CENTERS THAT OPERATE 
GRADUATE MEDICAL EDUCATION PROGRAMS.—Section 
340H(g)(1) of the Public Health Service Act (42 U.S.C. 
256h(g)(1)) is amended by striking ‘‘2018 and 2019’’ and 
inserting ‘‘2018, 2019, and 2020’’. 
(d) APPLICATION.—Amounts appropriated pursuant 
to this section for fiscal year 2020 are subject to the re-
quirements contained in Public Law 115–245 for funds 
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for programs authorized under sections 330 through 340 
of the Public Health Service Act (42 U.S.C. 254b–256). 
(e) CONFORMING AMENDMENT.—Section 3014(h)(4) 
of title 18, United States Code, is amended by striking 
‘‘and section 50901(e) of the Advancing Chronic Care, Ex-
tenders, and Social Services Act’’ and inserting ‘‘, section 
50901(e) of the Advancing Chronic Care, Extenders, and 
Social Services Act, and section 201(d) of the Lowering 
Prescription Drug Costs and Extending Community 
Health Centers and Other Public Health Priorities Act’’. 
SEC. 202. EXTENSION FOR SPECIAL DIABETES PROGRAMS. 
(a) SPECIAL DIABETES PROGRAM FOR TYPE I DIA-
BETES.—Section 330B(b)(2)(D) of the Public Health 
Service Act (42 U.S.C. 254c–2(b)(2)(D)) is amended by 
striking ‘‘2018 and 2019’’ and inserting ‘‘2018, 2019, and 
2020’’. 
(b) SPECIAL DIABETES PROGRAM FOR INDIANS.— 
Section 330C(c)(2)(D) of the Public Health Service Act 
(42 U.S.C. 254c–3(c)(2)(D)) is amended by striking 
‘‘2018 and 2019’’ and inserting ‘‘2018, 2019, and 2020’’. 
SEC. 203. EXTENSION FOR FAMILY-TO-FAMILY HEALTH IN-
FORMATION CENTERS. 
(a) IN GENERAL.—Section 501(c) of the Social Secu-
rity Act (42 U.S.C. 701(c)(1)(A)(vii)) is amended by strik-
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ing ‘‘2018 and 2019’’ and inserting ‘‘2018, 2019, and 
2020’’. 
(b) CONFORMING CHANGE.—Section 501(c)(3)(C) of 
the Social Security Act (42 U.S.C. 701(c)(3)(C)) is 
amended by striking ‘‘2018 and 2019’’ and inserting 
‘‘2018, 2019, and 2020’’. 
SEC. 204. EXTENSION FOR SEXUAL RISK AVOIDANCE EDU-
CATION 
AND 
PERSONAL 
RESPONSIBILITY 
EDUCATION. 
(a) SEXUAL RISK AVOIDANCE EDUCATION.—Sub-
sections (a) and (f) of section 510 of the Social Security 
Act (42 U.S.C. 710) are amended by striking ‘‘2018 and 
2019’’ each place it appears and inserting ‘‘2018, 2019, 
and 2020’’. 
(b) PERSONAL RESPONSIBILITY EDUCATION.—Sec-
tion 513 of the Social Security Act (42 U.S.C. 713) is 
amended— 
(1) in subsection (a)(1)(A), by striking ‘‘2019’’ 
and inserting ‘‘2020’’; and 
(2) in subsection (a)(4), by striking ‘‘2019’’ 
each place it appears and inserting ‘‘2020’’; and 
(3) in subsection (f), by striking ‘‘2019’’ and 
inserting ‘‘2020’’. 
Æ 
VerDate Sep 11 2014 
04:40 May 29, 2019
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