Title: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
Policy area: Health

Summary:
Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
This bill addresses prescription drugs and extends several health care, research, and workforce programs.
Currently, a generic drug manufacturer is awarded 180 days of exclusivity on the market if it is the first applicant to file an application with the Food and Drug Administration (FDA), and the exclusivity period begins upon the first applicant's commercial marketing. The bill authorizes the FDA	to approve a subsequent generic drug application prior to the first applicant's first date of commercial marketing if certain conditions are met.
The bill prohibits a brand-name, generic, or biosimilar drug manufacturer from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement, with specified exclusions, is a violation of the bill if the filer of the subsequent generic application receives something of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biological product.
The developer of a drug or biological product, such as a generic or biosimilar version of a drug, may bring a civil action against the license holder of an approved drug if the holder has declined to make available sufficient quantities of the approved drug for the developer's testing.
The bill also extends several health care, research, and workforce programs, including the National Health Service Corps, through FY2020.


[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2700 Introduced in House (IH)]

<DOC>






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.

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

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 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.

               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.

    Section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(5)(B)(iv)) is amended--
            (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 
                                commercial marketing of the drug 
                                (including the commercial marketing of 
                                the listed drug) by any first 
                                applicant; or
                                    ``(bb) the applicable date 
                                specified in subclause (III).''; and
            (2) by adding at the end the following new subclause:
                            ``(III) Applicable date.--The applicable 
                        date specified in this subclause, with respect 
                        to an application for a drug described in 
                        subclause (I), is the date on which each of the 
                        following conditions is first met:
                                    ``(aa) The approval of such an 
                                application could be made effective, 
                                but for the eligibility of a first 
                                applicant for 180-day exclusivity under 
                                this clause.
                                    ``(bb) At least 30 months have 
                                passed since the date of submission of 
                                an application for the drug by at least 
                                one first applicant.
                                    ``(cc) Approval of an application 
                                for the drug submitted by at least one 
                                first applicant is not precluded under 
                                clause (iii).
                                    ``(dd) No application for the drug 
                                submitted by any first applicant is 
                                approved at the time the conditions 
                                under items (aa), (bb), and (cc) are 
                                all met, regardless of whether such an 
                                application is subsequently 
                                approved.''.

        Subtitle B--Protecting Consumer Access to Generic Drugs

SEC. 111. UNLAWFUL AGREEMENTS.

    (a) Agreements Prohibited.--Subject to subsections (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 receives from 
        such holder (or in the case of such an agreement between two 
        subsequent filers, the other subsequent filer) anything of 
        value, including a license; and
            (2) the subsequent filer agrees to limit or forego 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 subsection (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 compensation solely for other goods or services that the 
subsequent filer has promised to provide.
    (c) Limitation.--Nothing in this section shall prohibit 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 covered 
                patent infringement claim; or
                    (B) any patent right or other statutory exclusivity 
                that would prevent the marketing of such covered 
                product.
            (2) A payment for reasonable litigation expenses 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 Commission.--
            (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 pursuant 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 authority 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 section 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 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 subsequent 
                        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 Commission under section 5 
                of the Federal Trade Commission Act (15 U.S.C. 45) for 
                violation of this section, a party to such order may 
                obtain judicial 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 
                                ultimate parent entity, as defined in 
                                section 801.1(a)(3) of title 16, Code 
                                of Federal Regulations, or any 
                                successor 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 
                                subsection (g)(8) or an approved 
                                application 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 Commissioner 
                                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 
                                (g)(8) is submitted to the Commissioner 
                                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 commence a 
                                civil action under subparagraph (A) to 
                                recover a civil penalty against any 
                                party to such order at any time before 
                                the expiration of the 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 
                                findings of the Commission as to the 
                                material facts in such proceeding shall 
                                be conclusive, unless--
                                            (aa) the terms of such 
                                        order expressly provide that 
                                        the Commission'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 evidence.
                            (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 violation of an order of the 
                        Commission under section 5(l) of the Federal 
                        Trade Commission 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 agreement 
                        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 filers, the 
                                subsequent filer who gave the value 
                                described in subsection (a)(1)), the 
                                greater of--
                                            (aa) 3 times the value 
                                        received by such NDA or BLA 
                                        holder (or by such subsequent 
                                        filer) that is reasonably 
                                        attributable to the violation 
                                        of this section; or
                                            (bb) 3 times the value 
                                        given to the subsequent filer 
                                        (or to the other subsequent 
                                        filer) reasonably attributable 
                                        to the violation of this 
                                        section; and
                                    (II) if such party is the 
                                subsequent filer (or, in the case of an 
                                agreement between two subsequent 
                                filers, the subsequent filer who 
                                received the value described in 
                                subsection (a)(1)), 3 times the value 
                                received by such subsequent filer that 
                                is reasonably 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, 
                                extent, 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 
                                filers, the subsequent filer who gave 
                                the value described in subsection 
                                (a)(1)), compensation received by the 
                                subsequent filer (or, in the case of an 
                                agreement between two subsequent 
                                filers, 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 empowered to grant mandatory 
                injunctions and such other and further equitable relief 
                as they deem appropriate.
            (4) Remedies in addition.--Remedies provided in this 
        subsection are in addition to, and not in lieu of, any other 
        remedy provided by Federal law.
            (5) Preservation of authority of commission.--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 promulgated 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 section 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, impair, 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 patent infringement claim'' means any agreement 
        that--
                    (A) resolves or settles a covered patent 
                infringement claim; or
                    (B) is contingent upon, provides for a contingent 
                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 holder to a subsequent filer (or, in the case of an 
        agreement between two subsequent filers, by one subsequent 
        filer to another), whether or not included in a complaint filed 
        with a court of law, that--
                    (A) the submission of the application described in 
                subparagraph (A) or (B) of paragraph (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 between an 
                        NDA or BLA holder and a subsequent filer, 
                        infringes any patent owned by, or exclusively 
                        licensed to, the NDA or BLA holder of the 
                        covered product; or
                            (ii) in the case of an agreement between 
                        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 
        Service 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 Federal 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 
                        Service Act (42 U.S.C. 262(a)) with respect to 
                        a biological product;
                    (B) a person owning or controlling enforcement 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 
                        connection 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 associated with 
                        biologics license applications filed under 
                        section 351(a) of such Act (42 U.S.C. 262(a)); 
                        or
                    (C) the predecessors, subsidiaries, divisions, 
                groups, and affiliates controlled by, controlling, or 
                under common control with any entity 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.
            (6) Patent.--The term ``patent'' means a patent issued by 
        the United States Patent and Trademark 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 submission 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 ``subsequent filer'' 
        means--
                    (A) in the case of a drug, a party that owns or 
                controls an abbreviated new drug application 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 submitted 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 covered product that is the subject 
                of such application; 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 respect 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 a claim of infringement could reasonably be asserted against any 
person for making, using, offering to sell, selling, or importing into 
the United States a biological product 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, Improvement, and Modernization Act of 2003, with 
respect to the agreement referenced in this certification--
            ```(1) represent the complete, final, and exclusive 
        agreement between the parties;
            ```(2) include any ancillary agreements that are contingent 
        upon, provide a contingent condition for, 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 promises between the parties 
        that are responsive to subsection (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 Prescription 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 following:
                    ``(F) under section 111(d)(3)(A) of the Lowering 
                Prescription Drug Costs and Extending Community Health 
                Centers and Other Public 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.

 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 acquisition 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 eligible 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 subsection (c) 
                        or (j) of section 505 of the Federal Food, 
                        Drug, and Cosmetic Act (21 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 
                        biological 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 section 351 of the Public 
                        Health Service Act (42 U.S.C. 262), as 
                        applicable, or otherwise meet the requirements 
                        for approval under either such section, any 
                        product, including any device, that is marketed 
                        or intended for use with such a drug or 
                        biological 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 under such 
                        section 506E continuously for more than 6 
                        months; or
                            (ii) the Secretary determines that 
                        inclusion 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 approval 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 
        section 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 license under subsection (a) or (k) of section 
        351 of the Public Health Service Act (42 U.S.C. 262) for a 
        covered product;
            (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 product developer 
        determines allows it to--
                    (A) conduct testing to support an application 
                under--
                            (i) subsection (b)(2) or (j) of section 505 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 355); or
                            (ii) section 351(k) of the Public Health 
                        Service Act (42 U.S.C. 262(k)); and
                    (B) fulfill any regulatory requirements relating to 
                approval of such an application.
    (b) Civil Action for Failure To Provide Sufficient 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 subsection in an appropriate district 
        court of the United States alleging that the license holder has 
        declined to provide sufficient quantities of the covered 
        product to the eligible product developer on commercially 
        reasonable, market-based terms.
            (2) Elements.--
                    (A) In general.--To prevail in a civil action 
                brought under paragraph (1), an eligible product 
                developer shall prove, by a preponderance of the 
                evidence--
                            (i) that--
                                    (I) the covered product is not 
                                subject to a REMS with ETASU; or
                                    (II) if the covered product is 
                                subject to a REMS with ETASU--
                                            (aa) the eligible product 
                                        developer has obtained a 
                                        covered product authorization 
                                        from the Secretary in 
                                        accordance with subparagraph 
                                        (B); and
                                            (bb) the eligible product 
                                        developer 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 reasonable, 
                        market-based terms;
                            (iii) that the eligible product developer 
                        has submitted a written request to purchase 
                        sufficient quantities of the covered product to 
                        the license holder and such request--
                                    (I) was sent to a named corporate 
                                officer of the license holder;
                                    (II) was made by certified or 
                                registered mail with return receipt 
                                requested;
                                    (III) specified an individual as 
                                the point of contact for the license 
                                holder to direct communications related 
                                to the sale of the covered product to 
                                the eligible product developer and a 
                                means for electronic and written 
                                communications with that individual; 
                                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 
                        delivered 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 received 
                                the request for the covered product; 
                                and
                                    (II) for a covered product that is 
                                subject to a REMS with ETASU, by 31 
                                days after the later of--
                                            (aa) the date on which the 
                                        license holder received the 
                                        request for the covered 
                                        product; or
                                            (bb) the date on which the 
                                        license holder received a copy 
                                        of the covered product 
                                        authorization issued by the 
                                        Secretary in accordance with 
                                        subparagraph (B).
                    (B) Authorization for covered product subject to a 
                rems with etasu.--
                            (i) Request.--An eligible product developer 
                        may submit to the Secretary a written request 
                        for the eligible product developer to be 
                        authorized to obtain sufficient quantities of 
                        an individual covered product subject to a REMS 
                        with ETASU.
                            (ii) Authorization.--Not later than 120 
                        days after the date on which a request under 
                        clause (i) is received, the Secretary shall, by 
                        written notice, authorize the eligible product 
                        developer to obtain sufficient quantities of an 
                        individual covered product subject to a REMS 
                        with ETASU for purposes 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 
                                        protocols, informed consent 
                                        documents, and informational 
                                        materials for testing that 
                                        include protections that 
                                        provide safety protections 
                                        comparable to those provided by 
                                        the REMS for the covered 
                                        product; or
                                            (BB) otherwise satisfied 
                                        the Secretary that such 
                                        protections will be provided; 
                                        and
                                            (bb) met any other 
                                        requirements the Secretary may 
                                        establish.
                            (iii) Notice.--A covered product 
                        authorization 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 affirmative 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 sufficient 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 commercial 
                        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 
                        product developer on commercially reasonable, 
                        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 
                        developers; and
                            (iii) the covered product can be purchased 
                        by the eligible product developer in sufficient 
                        quantities on commercially reasonable, 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 paragraph 
                (2)(A)(iii)(III), by a means of communication 
                (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--
                            (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 request for the covered 
                        product, and the eligible product developer did 
                        not accept such offer by the date that is 7 
                        days after the date on which the eligible 
                        product developer received such offer from the 
                        license holder; or
                            (ii) for a covered product that is subject 
                        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 received 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 delay 
                        sufficient quantities of the covered product on 
                        commercially reasonable, market-based terms;
                            (ii) award to the eligible product 
                        developer reasonable attorney's fees and costs 
                        of the civil action; and
                            (iii) award to the eligible product 
                        developer a monetary amount sufficient to deter 
                        the license holder from failing to provide 
                        eligible product developers with sufficient 
                        quantities of a covered product on commercially 
                        reasonable, market-based terms, if the court 
                        finds, by a preponderance of the evidence--
                                    (I) that the license holder delayed 
                                providing sufficient quantities of the 
                                covered product to the eligible product 
                                developer without a legitimate business 
                                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 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 
                                        request; or
                                            (bb) the date on which the 
                                        license holder received a copy 
                                        of the covered product 
                                        authorization issued by the 
                                        Secretary in accordance with 
                                        paragraph (2)(B); and
                            (ii) ending on the date on which the 
                        eligible product developer received sufficient 
                        quantities of the covered product.
                    (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 development or testing activities described in this section, 
including transportation, handling, use, or disposal of the covered 
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 subsection:
    ``(l) Provision of Samples Not a Violation of Strategy.--The 
provision of samples of a covered product 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 considered a violation 
of the requirements of any risk evaluation 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 methods of competition.
            (2) Antitrust laws.--Nothing in this section shall be 
        construed to limit the operation of any provision of the 
        antitrust laws.

SEC. 122. REMS APPROVAL PROCESS FOR SUBSEQUENT FILERS.

    Section 505-1 of the Federal Food, Drug, and Cosmetic 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;
                    (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, comparable 
                        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 subparagraph (C) and 
        inserting the following:
                    ``(C)(i) Elements to assure safe use, if required 
                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 
                        subsection (f).
                    ``(ii) The Secretary may require a drug that is the 
                subject of an application under section 505(j) and the 
                listed drug to use a single, shared system under 
                subsection (f), if the Secretary determines that no 
                different, comparable 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 approves, in 
        accordance with paragraph (1)(C)(i)(II), a different, 
        comparable aspect of the elements to assure 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 evaluation 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 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 ``covered product'', 
``eligible product developer'', ``license holder'', and ``REMS with 
ETASU'' have the meanings given such terms in section 121(a).

             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.

    (a) Community Health Centers Funding.--Section 10503(b)(1)(F) of 
the Patient Protection and Affordable 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 requirements contained in Public 
Law 115-245 for funds 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, Extenders, 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 Diabetes.--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 INFORMATION CENTERS.

    (a) In General.--Section 501(c) of the Social Security Act (42 
U.S.C. 701(c)(1)(A)(vii)) is amended by striking ``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 EDUCATION AND PERSONAL 
              RESPONSIBILITY EDUCATION.

    (a) Sexual Risk Avoidance Education.--Subsections (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.--Section 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''.
                                 <all>