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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9938 Introduced in House (IH)]

<DOC>

118th CONGRESS
  2d Session
                                H. R. 9938

 To amend the Federal Food, Drug, and Cosmetic Act to establish a time-
limited conditional approval pathway, subject to specific obligations, 
   for certain drugs and biological products, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            October 4, 2024

     Mr. Westerman (for himself and Mr. Mike Garcia of California) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
 To amend the Federal Food, Drug, and Cosmetic Act to establish a time-
limited conditional approval pathway, subject to specific obligations, 
   for certain drugs and biological products, 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 ``Promising Pathway Act 2.0''.

SEC. 2. CONDITIONAL APPROVAL OF NEW HUMAN DRUGS FOR INDIVIDUALS WITH 
              RARE, PROGRESSIVE, AND SERIOUS DISEASES.

    (a) In General.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 
the end of the following:

``SEC. 524C. CONDITIONAL APPROVAL OF HUMAN DRUGS FOR INDIVIDUALS WITH 
              RARE, PROGRESSIVE, AND SERIOUS DISEASES.

    ``(a) Conditional Approval; Priority Review; Other Designations.--
            ``(1) In general.--The sponsor of a drug may file with the 
        Secretary an application for conditional approval of an 
        eligible drug described in subsection (b). The Secretary shall 
        approve or deny such application in accordance with subsection 
        (c).
            ``(2) Priority review.--The Secretary shall give priority 
        review to an application for conditional approval of an 
        eligible drug described in subsection (b).
            ``(3) Other designations.--If a drug that is granted 
        conditional approval under this section is eligible for a 
        special designation by the Secretary under this Act, including 
        as a drug for a rare disease or condition under section 526, 
        all applicable benefits of such other designation shall be 
        available for use under such conditional approval, including 
        any tax credits and waiving of fees under chapter VII.
            ``(4) Other programs.--A sponsor of a drug seeking 
        conditional approval of such drug under this section may also 
        seek designation, exclusivity, or approval, as applicable, of 
        such drug under other applicable provisions of this Act or the 
        Public Health Service Act, subject to the requirements of such 
        provisions.
    ``(b) Eligibility.--
            ``(1) In general.--A drug may be eligible for conditional 
        approval under this section if such drug is intended to treat a 
        disease or condition that is--
                    ``(A) rapidly progressive, terminal, and has 
                substantial unmet medical need, as determined by the 
                Secretary; or
                    ``(B) a rare disease or condition (as defined in 
                section 526(a)(2)) that results in a substantially 
                shortened lifespan, substantial reduction in quality of 
                life, or other substantial adverse health effects, as 
                determined by the Secretary.
            ``(2) Exclusion from eligibility.--A drug that is intended 
        to treat or respond to a material threat identified by the 
        Secretary of Homeland Security under section 319F-
        2(c)(2)(A)(ii) shall not be eligible for conditional approval 
        under this section.
    ``(c) Standard of Review for Conditional Approval.--
            ``(1) Requirements.--The Secretary shall only approve an 
        application for conditional approval of a drug under this 
        section if--
                    ``(A) the Secretary determines that--
                            ``(i)(I) evidence of safety for the drug 
                        has been established by--
                                    ``(aa) the completion of a phase 1 
                                clinical investigation of the drug (as 
                                described in section 312.21 of title 
                                21, Code of Federal Regulations (or 
                                successor regulations)); or
                                    ``(bb) another demonstration of 
                                safety, as determined appropriate by 
                                the Secretary; and
                            ``(II) evidence of effectiveness in 
                        treating a given indication (which indication 
                        is congruent with the eligibility requirements 
                        of subsection (b)), as established by an 
                        ongoing or completed phase 2 clinical 
                        investigation of the drug (as described in 
                        section 312.21 of title 21, Code of Federal 
                        Regulations (or successor regulations)); or
                            ``(ii) in the case of a drug that is 
                        intended to treat a terminal pediatric rare 
                        disease or condition (as defined in section 
                        526(a)(2)) that does not predominately affect 
                        adults--
                                    ``(I) evidence of safety for the 
                                drug has been established in accordance 
                                with clause (i)(I); and
                                    ``(II) the drug shows preliminary 
                                evidence of clinical effectiveness 
                                based upon studies in animal models; 
                                and
                    ``(B) the sponsor has provided a written 
                affirmation of the sponsor's intent to pursue under 
                section 505 of this Act or section 351 of the Public 
                Health Service Act approval of the drug, which 
                affirmation shall include a justification and a plan 
                for pursuing such approval.
            ``(2) Rolling, real-time review.--
                    ``(A) In general.--If the Secretary determines, 
                after preliminary evaluation of data submitted by the 
                sponsor, that a drug may meet the standard for 
                conditional approval, the sponsor may submit portions 
                of an application for conditional approval of a drug 
                under this section for evaluation by the Secretary 
                before the sponsor submits a complete application, 
                which submission shall include--
                            ``(i) a schedule for submission of 
                        information necessary to make the application 
                        complete; and
                            ``(ii) a payment of any fee that may be 
                        required under section 736.
                    ``(B) Review.--The Secretary--
                            ``(i) shall evaluate each application 
                        submitted under subparagraph (A) to assess 
                        whether such application is complete or ready 
                        to be filed; and
                            ``(ii) may commence review of portions of 
                        such application for approval.
            ``(3) Use of real-world evidence.--
                    ``(A) In general.--The Secretary shall allow the 
                use of real world evidence (as defined in section 
                505F(b)), including real world data used to generate 
                real world evidence, and of external sources of data, 
                including prospective or retrospective natural history 
                data, to support an application for conditional 
                approval under this section.
                    ``(B) Data integrity requirements.--In using 
                evidence described in subparagraph (A) to support an 
                application for conditional approval under this 
                section, the sponsor shall consider the guidance of the 
                Food and Drug Administration entitled `Data Standards 
                for Drug and Biological Product Submissions Containing 
                Real-World Data' and dated December 2023 (or successor 
                guidance).
    ``(d) FDA Authority To Withdraw Conditional Approval.--
            ``(1) In general.--The Secretary may withdraw the 
        conditional approval of a drug under this section if--
                    ``(A) after adequate review of appropriate safety 
                data, including data from an observational registry 
                established under subsection (g), the Secretary 
                determines that such data no longer supports 
                conditional approval;
                    ``(B) the Secretary determines that the application 
                for conditional approval submitted under subsection 
                (a)(1) contained an untrue statement of material fact; 
                or
                    ``(C) the Secretary determines that the drug is no 
                longer eligible under subsection (b).
            ``(2) FDA examination authority.--
                    ``(A) In general.--For purposes determining whether 
                to withdraw the conditional approval of a drug under 
                paragraph (1), the Secretary may--
                            ``(i) review any available clinical data 
                        made available through clinical trials or an 
                        observational registry under subsection (g), 
                        applicable to such drug; and
                            ``(ii) determine whether the sponsor of 
                        such drug is in violation of a requirement 
                        established under paragraph (3) or (4) of 
                        section 505(o) or section 505-1 with respect to 
                        the drug.
                    ``(B) Transparency.--
                            ``(i) In general.--The Secretary may 
                        require drug sponsors and observational 
                        registries under subsection (g) to submit the 
                        data described in subparagraph (A) for the 
                        purposes of the review under that subparagraph.
                            ``(ii) Fines.--The Secretary may levy fines 
                        on sponsors and observational registries that 
                        do not comply with a request for data under 
                        clause (i) within such reasonable timeframe as 
                        is established by the Secretary.
            ``(3) Effect of withdrawal.--
                    ``(A) Availability to new patients.--
                            ``(i) In general.--If a conditional 
                        approval is withdrawn under this subsection, 
                        the sponsor may not make the drug available to 
                        any new patients, but may continue to make such 
                        drug available to patients who started taking 
                        the drug prior to the date of withdrawal.
                            ``(ii) Effect.--Nothing in this 
                        subparagraph shall be construed to require--
                                    ``(I) a patient to continue taking 
                                a conditionally approved drug if such 
                                patient decides to stop taking such 
                                drug; or
                                    ``(II) the sponsor to ensure such 
                                drug continues to be manufactured after 
                                the date of withdrawal.
                    ``(B) Civil monetary penalty.--Any sponsor who 
                makes available to new patients a drug for which 
                conditional approval has been withdrawn under this 
                subsection shall be subject to such civil monetary 
                penalty as is determined by the Secretary.
            ``(4) Withdrawal notice.--Upon determining to withdraw the 
        conditional approval of a drug under paragraph (1), the 
        Secretary shall submit written notice to the sponsor of such 
        drug and such withdrawal shall be effective on the date that is 
        14 days after the date of such submission of notice.
            ``(5) Appeals.--Not later than 180 days after the date of 
        enactment of the Promising Pathway Act 2.0, the Secretary, by 
        rule, shall establish a process by which a sponsor of a drug 
        for which conditional approval was withdrawn under paragraph 
        (1) may appeal such withdrawal.
            ``(6) Automatic withdrawal.--
                    ``(A) In general.--If the sponsor of a drug that 
                receives conditional approval under this section does 
                not submit an application for renewal of such 
                conditional approval under subsection (f)(2) by the 
                deadline under that subsection, such conditional 
                approval shall automatically be withdrawn in accordance 
                with paragraph (3) on the date on which such 
                conditional approval expires.
                    ``(B) Marketing requirement.--If any drug that 
                receives conditional approval under this section is not 
                brought to market within 1 year of the date on which 
                the conditional approval is granted, such conditional 
                approval, along with any benefits described in 
                subsection (a)(3), shall automatically be withdrawn in 
                accordance with paragraph (3) on such date.
                    ``(C) No right to appeal; effect of automatic 
                withdrawal.--
                            ``(i) In general.--A sponsor shall not have 
                        the right to appeal an automatic withdrawal 
                        under this paragraph.
                            ``(ii) Effect.--The Secretary shall have no 
                        means or power to prevent an automatic 
                        withdrawal under this paragraph from occurring.
    ``(e) Labeling; Review of Materials.--
            ``(1) In general.--Sponsors may not make available to 
        patients a drug conditionally approved under this section, 
        unless--
                    ``(A) all labeling and advertising of such drug 
                contains the statement `conditionally approved for a 
                limited population' in a prominent manner and adjacent 
                to, and not more prominent than--
                            ``(i) the proprietary name of such drug, if 
                        any; or
                            ``(ii) if there is no proprietary name, the 
                        established name of such drug, if any, as 
                        defined in section 502(e)(3), or, in the case 
                        of a drug that is a biological product, the 
                        proper name, as defined by regulation; and
                    ``(B) the prescribing information for the drug 
                required by section 201.57 of title 21, Code of Federal 
                Regulations (or any successor regulation) includes the 
                following statement: `This drug is conditionally 
                approved for use in a limited and specific population. 
                This drug has not received full approval by the Food 
                and Drug Administration. Conditional approval of this 
                drug may be withdrawn at short notice.'.
            ``(2) Submission.--Not later than 45 days before such 
        materials are distributed, all promotional, educational, and 
        marketing materials for such drug shall be submitted to the 
        Secretary for review.
            ``(3) Public list.--The Secretary shall maintain a list of 
        all drugs conditionally approved under this section on a 
        publicly accessible website. Such website shall briefly 
        describe what each conditionally approved drugs is and list the 
        1 or more diseases or conditions for which the drug is 
        indicated.
    ``(f) Renewal of Conditional Approval; Requirement To Bring Drug to 
Market.--
            ``(1) Duration; renewals.--The conditional approval for a 
        drug under this section is effective for a 2-year period. The 
        sponsor may request renewal of such conditional approval for up 
        to 3 subsequent 2-year periods. Conditional approval with 
        respect to a drug shall not exceed a total of 8 years from the 
        initial date the drug was granted conditional approval.
            ``(2) Applications for renewal of conditional approval.--
                    ``(A) In general.--Except as provided in 
                subparagraph (C), the sponsor of a drug seeking a 
                renewal of conditional approval for such drug under 
                this subsection shall submit to the Secretary, not 
                later than 180 days before the date on which such 
                conditional approval expires, an application that 
                contains the applicable information described in 
                paragraph (3) in a standardized format determined by 
                the Secretary.
                    ``(B) Process for granting renewals.--Not later 
                than 180 days after the date of enactment of the 
                Promising Pathway Act 2.0, the Secretary, by rule, 
                shall establish the process for granting a renewal 
                under this subsection.
                    ``(C) Exemption for small population diseases.--
                            ``(i) In general.--The Secretary shall 
                        exempt from the requirements of subparagraph 
                        (A) and paragraph (3) an application for a 
                        renewal of conditional approval for a drug 
                        under this subsection if the Secretary 
                        determines that the population affected by the 
                        disease or condition that the drug is intended 
                        to treat does not support additional 
                        preliminary evidence of effectiveness (as 
                        defined in paragraph (3)(D)).
                            ``(ii) Application for exemption.--Sponsors 
                        may submit an application for exemption under 
                        this subparagraph not later than 180 days 
                        before the date on which the conditional 
                        approval expires.
                            ``(iii) Application process.--Not later 
                        than 180 days after the date of enactment of 
                        the Promising Pathway Act 2.0, the Secretary 
                        shall establish a standardized application 
                        process for purposes of this subparagraph.
                            ``(iv) Deadline.--The Secretary shall 
                        approve or deny an application under this 
                        subparagraph before the date on which the 
                        conditional approval expires.
                            ``(v) Appeals.--Not later than 180 days 
                        after the date of enactment of the Promising 
                        Pathway Act 2.0, the Secretary shall establish 
                        a process under which a sponsor my appeal a 
                        denial of an application under this 
                        subparagraph.
            ``(3) Additional preliminary evidence of effectiveness.--
        The information described in this paragraph is the following:
                    ``(A) For the first approval renewal.--With respect 
                to an application under paragraph (2) for the first 
                renewal of conditional approval for a drug under this 
                subsection, additional preliminary evidence of 
                effectiveness of the drug, as compared to the evidence 
                provided in the initial application for conditional 
                approval for the drug under subsection (c).
                    ``(B) For the second approval renewal.--With 
                respect to an application under paragraph (2) for the 
                second renewal of conditional approval for a drug under 
                this subsection, additional preliminary evidence of 
                effectiveness of the drug, as compared to the evidence 
                provided in the renewal application described in 
                subparagraph (A).
                    ``(C) For the final approval renewal.--With respect 
                to an application under paragraph (2) for the third 
                renewal of conditional approval for a drug under this 
                subsection, a written affirmation from the head of the 
                drug's review division of the Office of New Drugs or 
                the Office of Therapeutic Products asserting that a 
                third renewal is necessary--
                            ``(i) for patients who have benefitted from 
                        such drug to retain access to such drug; and
                            ``(ii) to generate additional preliminary 
                        evidence of effectiveness for the purposes of 
                        attaining approval under section 505 of this 
                        Act or section 351 of the Public Health Service 
                        Act.
                    ``(D) Definition.--In this paragraph, the term 
                `preliminary evidence of effectiveness' means--
                            ``(i) clinical evidence generated by an 
                        ongoing or completed clinical trial conducted 
                        in accordance with section 11.22 of title 42, 
                        Code of Federal Regulations (or successor 
                        regulations);
                            ``(ii) real-world evidence (as defined in 
                        section 505F(b)); or
                            ``(iii) evidence from an observational 
                        registry under subsection (g).
            ``(4) Denial of renewal on the basis of data fraud.--The 
        Secretary may deny the application for renewal of conditional 
        approval for a drug under this subsection if the Secretary, in 
        conducting a review under subsection (d)(2), finds that the 
        evidence provided in such application under subparagraph (A) or 
        (B) of paragraph (3) was fraudulently manipulated by the 
        applicable observational registry and that such application 
        substantially relies on such data.
    ``(g) Observational Registries.--
            ``(1) Establishment.--
                    ``(A) In general.--Subject to subparagraph (C), the 
                sponsor of a drug conditionally approved under this 
                section shall establish an observational registry, for 
                patients who are or will be treated with such drug, 
                that pertains to the disease or condition that the drug 
                is intended to treat.
                    ``(B) Registries.--In establishing an observational 
                registry for a drug under subparagraph (A), the sponsor 
                may--
                            ``(i) establish a new observational 
                        registry;
                            ``(ii) use an existing observational 
                        registry that pertains to the disease or 
                        condition such drug is intended to treat;
                            ``(iii) combine 1 or more existing 
                        observational registries that pertain to the 
                        disease or condition such drug is intended to 
                        treat with a new observational registry; or
                            ``(iv) combine 2 or more existing 
                        observational registries that pertain to the 
                        disease or condition such drug is intended to 
                        treat.
                    ``(C) Approval of registry and right to appeal.--
                Not later than 180 days after the date of enactment of 
                the Promising Pathway Act 2.0, the Secretary shall 
                establish--
                            ``(i) a process to approve or deny the 
                        establishment of an observational registry 
                        under subparagraph (A); and
                            ``(ii) a process for sponsors that received 
                        such a denial to appeal the denial.
            ``(2) Requirement for patients to enroll in observational 
        registry.--
                    ``(A) In general.--A drug conditionally approved 
                under this section shall not be made available to a 
                patient unless such patient is enrolled in the 
                applicable observational registry described in 
                paragraph (1).
                    ``(B) Informed consent.--
                            ``(i) In general.--Prior to enrolling in an 
                        observational registry under subparagraph (A), 
                        a patient shall provide informed consent in 
                        accordance with clause (ii).
                            ``(ii) Application of certain 
                        requirements.--The requirements for informed 
                        consent under part 50 of subchapter A of 
                        chapter I of title 21, Code of Federal 
                        Regulations (or successor regulations), shall 
                        apply to enrollment an observational registry 
                        under this paragraph.
            ``(3) Submission of patient data.--
                    ``(A) In general.--The sponsor of a drug 
                conditionally approved under this section shall be 
                responsible for obtaining and submitting patient data 
                to the applicable observational registry described in 
                paragraph (1).
                    ``(B) Submission standards.--Not later than 180 
                days after date of enactment of the Promising Pathway 
                Act 2.0, the Secretary shall establish data submission 
                standards for sponsors to comply with for purposes of 
                subparagraph (A) to ensure that registry data is 
                consistent and clinically informed.
            ``(4) Requirements for registries.--An observational 
        registry described in paragraph (1) for a drug conditionally 
        approved under this section may be operated by the sponsor of 
        such drug or, at the sponsor's discretion, a third party, for-
        profit organization, or nonprofit organization.
            ``(5) Risk and benefit data.--
                    ``(A) In general.--The sponsor of a drug 
                conditionally approved under this section shall submit 
                relevant risk and benefit data to the applicable 
                observational registry described in paragraph (1).
                    ``(B) Online portal.--The Secretary shall operate 
                an online portal on an existing website of the 
                Secretary for sponsors to submit data described in 
                subparagraph (A).
            ``(6) Accessibility.--
                    ``(A) In general.--An observational registry 
                described in paragraph (1) shall--
                            ``(i) not later than 30 days after receipt 
                        of a request, provide patients (or their 
                        designated representatives) with access to such 
                        patient's personal registry information; and
                            ``(ii) provide approved researchers and 
                        medical professionals access to de-identified 
                        and aggregated data from the registry for the 
                        purposes of indication- and disease-specific 
                        and translational research into conditions and 
                        diseases relating to the disease or condition 
                        that the drug tracked by the observational 
                        registry is intended to treat.
                    ``(B) Approved researchers and medical 
                professionals.--Not later than 180 days after the date 
                of enactment of the Promising Pathway Act 2.0, the 
                Secretary, by rule, shall establish a process for 
                approving researchers and medical professionals for 
                purposes of subparagraph (A)(ii).
            ``(7) Effect.--Nothing in this section shall be construed 
        to modify or limit the Secretary's authority to require for a 
        drug conditionally approved under this section any type of 
        postapproval study under any other provision of law, including 
        sections 505(o)(3), 505B, and 506.
    ``(h) Pursuit of a Different Indication.--
            ``(1) In general.--In the case of a drug conditionally 
        approved under this section for which such approval was 
        withdrawn under subsection (d), expired under subsection 
        (f)(1), or was denied for renewal under subsection (f)(4), not 
        later than 2 years after the date of withdrawal, expiration, or 
        denial, as applicable, the sponsor of such drug shall have the 
        opportunity to petition the Secretary to receive conditional 
        approval of such drug, in accordance with this section, for a 
        different indication.
            ``(2) Process.--Not later than 180 days after the date of 
        enactment of the Promising Pathway Act 2.0, the Secretary shall 
        establish a process for petitions under paragraph (1).
    ``(i) Transition to Other Forms of Approval.--
            ``(1) In general.--A drug that receives conditional 
        approval under this section may be granted approval under 
        section 505 of this Act or section 351 of the Public Health 
        Service Act during the period in which such conditional 
        approval is in effect. Effective on the date on which approval 
        for such drug is granted under section 505 of this Act or 
        section 351 of the Public Health Service Act, such conditional 
        approval shall be automatically withdrawn in accordance with 
        subsection (d)(3).
            ``(2) Consideration of certain evidence.--In determining 
        whether to approve under section 505 of this Act or section 351 
        of the Public Health Service Act a drug that has received 
        conditional approval under this section, the Secretary may 
        consider evidence from the observational registry for the drug 
        under subsection (g).
    ``(j) Informed Consent.--
            ``(1) In general.--Prior to being prescribed a drug 
        conditionally approved under this section, a patient shall 
        provide informed consent in accordance with paragraph (2).
            ``(2) Application of certain requirements.--The 
        requirements for informed consent under part 50 of subchapter A 
        of chapter I of title 21, Code of Federal Regulations (or 
        successor regulations), shall apply to drugs conditionally 
        approved under this section.
            ``(3) Observational registries.--An observational registry 
        established for a drug in accordance with subsection (g) may 
        obtain, and maintain records of, informed consent of a patient 
        on behalf of the drug sponsor, in accordance with paragraph 
        (2).
            ``(4) Common rule.--Drugs conditionally approved under this 
        section shall comply with subpart A of part 46 of title 45, 
        Code of Federal Regulations (commonly known as the `Common 
        Rule') (or successor regulations), if applicable.
    ``(k) Limitation on Liability.--With respect to any claim under 
State law relating to a drug made available pursuant to a grant of 
conditional approval under this section, no liability shall lie against 
a sponsor or manufacturer of the drug, or any health care provider who 
prescribes or administers the drug, absent intentional wrongdoing.
    ``(l) Report to Congress.--
            ``(1) In general.--Not later than 2 years after the date of 
        enactment of the Promising Pathway Act 2.0, and once every 2 
        years thereafter, the Secretary, in collaboration with drug 
        sponsors, shall submit a report to Congress on all drugs 
        granted conditional approval under this section. Such report 
        shall include--
                    ``(A) an estimated number of patients treated with 
                each such drug, and the number of patients tracked in 
                an observational registry under subsection (g) with 
                respect to each such drug, if applicable;
                    ``(B) a discussion, at an aggregate level , of the 
                types and amounts of data obtained through 
                observational registries under subsection (g), such as 
                patient treatments and uses, length of use, side 
                effects encountered, relevant biomarkers, scan results, 
                cause of death and how long the patient lived, and 
                adverse drug effects;
                    ``(C) a list of all such drugs for which an 
                application for approval under this section, or an 
                application for an extension of conditional approval 
                under this section, has been submitted; and
                    ``(D) the number of all applications granted and 
                denied conditional approval under this section.
            ``(2) Sponsor participation.--Not later than 180 days 
        before the date on which the Secretary submits a report under 
        paragraph (1), the sponsor of a drug conditionally approved 
        under this section shall provide to the Secretary the 
        information described in subparagraphs (A) and (B) of paragraph 
        (1), as applicable.
            ``(3) Notice authority.--The Secretary may notify sponsors 
        of drugs conditionally approved under this section and 
        observational registries under subsection (g) as necessary to 
        complete a report under paragraph (1).''.
    (b) Conforming Amendment.--Section 505(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(a)) is amended by inserting ``, 
or there is in effect a conditional approval under section 524C with 
respect to such drug'' before the period.
    (c) Reimbursement.--
            (1) Private health insurers.--Section 2719A of the Public 
        Health Service Act (42 U.S.C. 300gg-19a) is amended by adding 
        at the end the following:
    ``(f) Coverage of Certain Drugs.--A group health plan or health 
insurance issuer offering group or individual health insurance coverage 
shall provide coverage for, and shall not impose any cost sharing 
requirements for, drugs conditionally approved under section 524C of 
the Federal Food, Drug, and Cosmetic Act for patients who have the 
disease or condition the drug is intended to treat.''.
            (2) Federal health care programs.--The requirement under 
        subsection (f) of section 2719A of the Public Health Service 
        Act (as added by paragraph (1)) shall apply with respect to 
        coverage determinations under a Federal health care program (as 
        defined in section 1128B(f) of the Social Security Act (42 
        U.S.C. 1320a-7b(f))) in the same manner such requirement 
        applies under such subsection (f).
            (3) Conforming amendment.--Section 1927(k)(2)(A)(i) of the 
        Social Security Act (42 U.S.C. 1396r-8(k)(2)(A)(i)) is 
        amended--
                    (A) by striking ``or which'' and inserting ``, 
                which''; and
                    (B) by inserting ``, or which is conditionally 
                approved under section 524C of such Act'' before the 
                semicolon.
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