To amend the Federal Food, Drug, and Cosmetic Act to provide for the development and use of patient experience data to enhance the structured risk-benefit assessment framework, and for other purposes.

SECTION 1. DEVELOPMENT AND USE OF PATIENT EXPERIENCE DATA TO ENHANCE 
              STRUCTURED RISK-BENEFIT ASSESSMENT FRAMEWORK.

    (a) In General.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (d), by striking ``The Secretary shall 
        implement'' and all that follows through ``premarket approval 
        of a drug.''; and
            (2) by adding at the end the following new subsections:
    ``(x) Structured Risk-Benefit Assessment Framework.--
            ``(1) In general.--The Secretary shall implement a 
        structured risk-benefit assessment framework in the new drug 
        approval process--
                    ``(A) to facilitate the balanced consideration of 
                benefits and risks; and
                    ``(B) to develop and implement a consistent and 
                systematic approach to the discussion of, regulatory 
                decisionmaking with respect to, and the communication 
                of, the benefits and risks of new drugs.
            ``(2) Rule of construction.--Nothing in paragraph (1) shall 
        alter the criteria for evaluating an application for premarket 
        approval of a drug.
    ``(y) Development and Use of Patient Experience Data To Enhance 
Structured Risk-Benefit Assessment Framework.--
            ``(1) In general.--Not later than two years after the date 
        of the enactment of this subsection, the Secretary shall 
        establish and implement processes under which--
                    ``(A) an entity seeking to develop patient 
                experience data may submit to the Secretary--
                            ``(i) initial research concepts for 
                        feedback from the Secretary; and
                            ``(ii) with respect to patient experience 
                        data collected by the entity, draft guidance 
                        documents, completed data, and summaries and 
                        analyses of such data;
                    ``(B) the Secretary may request such an entity to 
                submit such documents, data, and summaries and 
                analyses; and
                    ``(C) patient experience data may be developed and 
                used to enhance the structured risk-benefit assessment 
                framework under subsection (x).
            ``(2) Patient experience data.--In this subsection, the 
        term `patient experience data' means data collected by 
        patients, parents, caregivers, patient advocacy organizations, 
        disease research foundations, medical researchers, research 
        sponsors or other parties determined appropriate by the 
        Secretary that is intended to facilitate or enhance the 
        Secretary's risk-benefit assessments, including information 
        about the impact of a disease or a therapy on patients' 
        lives.''.
    (b) Guidance.--
            (1) In general.--The Secretary of Health and Human Services 
        shall publish guidance on the implementation of subsection (y) 
        of section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355), as added by subsection (a). Such guidance shall 
        include--
                    (A) with respect to draft guidance documents, data, 
                or summaries and analyses submitted to the Secretary 
                under paragraph (1)(A) of such subsection, guidance--
                            (i) specifying the timelines for the review 
                        of such documents, data, or summaries and 
                        analyses by the Secretary; and
                            (ii) on how the Secretary will use such 
                        documents, data, or summaries and analyses to 
                        update any guidance documents published under 
                        this subsection or publish new guidance;
                    (B) with respect to the collection and analysis of 
                patient experience data (as defined in paragraph (2) of 
                such subsection (y)), guidance on--
                            (i) methodological considerations for the 
                        collection of patient experience data, which 
                        may include structured approaches to gathering 
                        information on--
                                    (I) the experience of a patient 
                                living with a particular disease;
                                    (II) the burden of living with or 
                                managing the disease;
                                    (III) the impact of the disease on 
                                daily life and long-term functioning; 
                                and
                                    (IV) the effect of current 
                                therapeutic options on different 
                                aspects of the disease; and
                            (ii) the establishment and maintenance of 
                        registries designed to increase understanding 
                        of the natural history of a disease;
                    (C) methodological approaches that may be used to 
                assess patients' beliefs with respect to the benefits 
                and risks in the management of the patient's disease; 
                and
                    (D) methodologies, standards, and potential 
                experimental designs for patient-reported outcomes.
            (2) Timing.--Not later than three years after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services shall issue draft guidance on the implementation of 
        subsection (y) of section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355), as added by subsection (a). The 
        Secretary shall issue final guidance on the implementation of 
        such subsection not later than one year after the date on which 
        the comment period for the draft guidance closes.
            (3) Workshops.--
                    (A) In general.--Not later than 6 months after the 
                date of the enactment of this Act and once every 6 
                months during the following 12-month period, the 
                Secretary of Health and Human Services shall convene a 
                workshop to obtain input regarding methodologies for 
                developing the guidance under paragraph (1), including 
                the collection of patient experience data.
                    (B) Attendees.--A workshop convened under this 
                paragraph shall include--
                            (i) patients;
                            (ii) representatives from patient advocacy 
                        organizations, biopharmaceutical companies, and 
                        disease research foundations;
                            (iii) representatives of the reviewing 
                        divisions of the Food and Drug Administration; 
                        and
                            (iv) methodological experts with 
                        significant expertise in patient experience 
                        data.
            (4) Public meeting.--Not later than 90 days after the date 
        on which the draft guidance is published under this subsection, 
        the Secretary of Health and Human Services shall convene a 
        public meeting to solicit input on the guidance.

Summary: This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish processes under which: (1) an entity seeking to develop patient experience data may submit initial research concepts for feedback. (2) the FDA may request or receive from such an entity draft guidance documents, data, and summaries and analyses of data. And (3) patient experience data may be considered in the risk-benefit assessment of a new drug. ldquo, Patient experience datardquo. Is data collected by patients or others that is intended to facilitate the FDA's risk-benefit assessments, including information about the impact of a disease or a therapy on patients' lives. The FDA must convene workshops and publish guidance on the patient experience data processes described above.