text: 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                          data collected by the entity, draft guidance 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.
target: 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 data&rdquo; 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.
feat_title: 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.