[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1597 Reported in Senate (RS)]

<DOC>





                                                       Calendar No. 413
114th CONGRESS
  2d Session
                                S. 1597

   To enhance patient engagement in the medical product development 
                    process, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 17, 2015

 Mr. Wicker (for himself, Ms. Klobuchar, Ms. Collins, Mr. Franken, Mr. 
   Isakson, Mr. Bennet, Mr. Donnelly, Mr. Cotton, and Ms. Murkowski) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

                             April 5, 2016

              Reported by Mr. Alexander, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
   To enhance patient engagement in the medical product development 
                    process, and for other purposes.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Patient-Focused Impact 
Assessment Act of 2015''.</DELETED>

<DELETED>SEC. 2. PUBLIC DISCLOSURE OF SAFETY AND EFFECTIVENESS DATA IN 
              ACTION PACKAGE.</DELETED>

<DELETED>    Paragraph (2) of section 505(l) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(l)) is amended--</DELETED>
        <DELETED>    (1) in subparagraph (C), by adding at the end the 
        following:</DELETED>
                <DELETED>    ``(vii) Documentation of the patient 
                engagement assessment efforts made as part of the 
                review, including identification of the patient-focused 
                drug development tools and data reviewed in informing 
                the decision to approve the application, and including 
                an explanation of whether the following were reviewed 
                or examined:</DELETED>
                        <DELETED>    ``(I) Patient population benefit 
                        and risk data.</DELETED>
                        <DELETED>    ``(II) Draft or final guidances 
                        issued by the Food and Drug 
                        Administration.</DELETED>
                        <DELETED>    ``(III) Patient-reported or 
                        caregiver-reported outcomes data.</DELETED>
                        <DELETED>    ``(IV) Patient preference 
                        data.</DELETED>
                        <DELETED>    ``(V) Perspectives of patients 
                        serving on advisory committees or participating 
                        in medical product development 
                        proceedings.</DELETED>
                        <DELETED>    ``(VI) Perspectives of medical and 
                        scientific professionals with relevant 
                        expertise.</DELETED>
                        <DELETED>    ``(VII) Other measures to assess 
                        the impact of patient-focused drug development 
                        tools, as determined by the Secretary.''; 
                        and</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
        <DELETED>    ``(F) Annual reports.--The Secretary shall prepare 
        and submit to the Committee on Health, Education, Labor, and 
        Pensions of the Senate and the Committee on Energy and Commerce 
        of the House of Representatives an annual report summarizing 
        the data collected from the action packages under subparagraph 
        (C)(vii). Such report shall include an assessment by the Food 
        and Drug Administration of the trends of such agency with 
        respect to the use of patient-focused drug development tools in 
        reviewing applications under subsection (b) and section 351 of 
        the Public Health Service Act.''.</DELETED>

<DELETED>SEC. 3. GUIDANCE TO PATIENTS AND INDUSTRY ON PATIENT-FOCUSED 
              DRUG DEVELOPMENT.</DELETED>

<DELETED>    (a) Publication of Guidance; Contents.--The Secretary of 
Health and Human Services (referred to in this section as the 
``Secretary''), acting through the Commissioner of Food and Drugs, 
shall publish guidance that--</DELETED>
        <DELETED>    (1) specifies how the Food and Drug Administration 
        views collaboration between patients or patient advocacy 
        organizations and industry sponsors for the purposes of--
        </DELETED>
                <DELETED>    (A) developing patient-focused drug 
                development tools; and</DELETED>
                <DELETED>    (B) obtaining patient perspectives on 
                medical products under development;</DELETED>
        <DELETED>    (2) specifies the position of the Food and Drug 
        Administration with respect to advocacy and industry 
        collaborations that would be permitted to develop such tools 
        and obtain such perspectives; and</DELETED>
        <DELETED>    (3) specifies the position of the Food and Drug 
        Administration with respect to activities that would not be 
        permitted for such purposes.</DELETED>
<DELETED>    (b) Timing.--The Secretary shall--</DELETED>
        <DELETED>    (1) not later than 6 months after the date of 
        enactment of this Act, publish proposed guidance under this 
        section; and</DELETED>
        <DELETED>    (2) not later than 6 months after the date of 
        publication of such proposed guidance, and after providing an 
        opportunity for the public to comment on such proposed 
        guidance, publish final guidance under this section.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Patient-Focused Impact Assessment 
Act of 2016''.

SEC. 2. PATIENT EXPERIENCE DATA.

    Section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-8c) is amended--
            (1) in subsection (a)--
                    (A) in the subsection heading, by striking ``In 
                General'' and inserting ``Patient Engagement in Drugs 
                and Devices'';
                    (B) by redesignating paragraphs (1) and (2) as 
                subparagraphs (A) and (B), respectively, and adjusting 
                the margins accordingly; and
                    (C) by striking ``The Secretary'' and inserting the 
                following:
            ``(1) In general.--The Secretary'';
            (2) by redesignating subsections (b) through (e) as 
        paragraphs (2) through (5), respectively, and adjusting the 
        margins accordingly; and
            (3) by adding at the end the following:
    ``(b) Statement of Patient Experience.--
            ``(1) In general.--Following the approval of an application 
        that was submitted under section 505(b) of this Act or section 
        351(a) of the Public Health Service Act (42 U.S.C. 262(a)) at 
        least 6 months after the date of enactment of the Patient-
        Focused Impact Assessment Act of 2016, the Secretary shall make 
        public a brief statement regarding the patient experience data 
        and related information, if any, submitted and reviewed as part 
        of such application. The Secretary shall include in the 
        statement information on whether the data and information 
        described in paragraph (2) were submitted and reviewed as part 
        of such application.
            ``(2) Data and information.--The data and information 
        referred to in paragraph (1) are--
                    ``(A) patient experience data;
                    ``(B) information on patient-focused drug 
                development tools; and
                    ``(C) other relevant information, as determined by 
                the Secretary.
    ``(c) Patient Experience Data.--For purposes of this section, the 
term `patient experience data' includes data that--
            ``(1) are collected by any persons (including patients, 
        family members and caregivers of patients, patient advocacy 
        organizations, disease research foundations, researchers, and 
        drug manufacturers); and
            ``(2) are intended to provide information about patients' 
        experiences with a disease or condition, including--
                    ``(A) the impact of such disease or condition, or a 
                related therapy, on patients' lives; and
                    ``(B) patient preferences with respect to treatment 
                of such disease or condition.''.

SEC. 3. GUIDANCE TO PATIENTS AND INDUSTRY ON PATIENT-FOCUSED DRUG 
              DEVELOPMENT.

    (a) Publication of Guidance Documents.--Not later than 6 months 
after the date of enactment of this Act, the Secretary of Health and 
Human Services (referred to in this section as the ``Secretary''), 
acting through the Commissioner of Food and Drugs, shall develop a plan 
to issue draft and final versions of one or more guidance documents, 
over a period of 5 years, regarding the collection of patient 
experience data, and the use of such data and related information in 
drug development. Not later than 18 months after that date of 
enactment, the Secretary shall issue a draft version of at least one 
such guidance document. Not later than 1 year after the public comment 
period on the draft document ends, the Secretary shall issue a final 
version of that document.
    (b) Patient Experience Data.--For purposes of this section, the 
term ``patient experience data'' includes data that--
            (1) are collected by any persons (including patients, 
        family members and caregivers of patients, patient advocacy 
        organizations, disease research foundations, researchers, and 
        drug manufacturers); and
            (2) are intended to provide information about patients' 
        experiences with a disease or condition, including--
                    (A) the impact of such disease or condition, or a 
                related therapy, on patients' lives; and
                    (B) patient preferences with respect to treatment 
                of such disease or condition.
    (c) Contents.--The guidance documents described in subsection (a) 
shall address--
            (1) how a person seeking to collect patient experience data 
        for submission to and proposed use by the Food and Drug 
        Administration in regulatory decisionmaking may--
                    (A) submit initial concepts about how such person 
                plans to gather patient experience data;
                    (B) develop and collect patient experience data 
                using methodologies that--
                            (i) ensure data are accurate;
                            (ii) ensure data are representative of the 
                        intended population; and
                            (iii) are relevant and objective; and
                    (C) submit patient experience data, analysis, or 
                other applicable related information, including through 
                a regulatory application, a public docket, or other 
                means;
            (2) how a person seeking to develop and submit proposed 
        draft guidance relating to patient experience data for 
        consideration by the Food and Drug Administration may submit 
        such proposed draft guidance to the Food and Drug 
        Administration;
            (3) the format and content required for submissions under 
        this section to the Food and Drug Administration, including 
        with respect to the information described in paragraph (1);
            (4) how the Secretary intends to respond to submissions 
        under paragraph (1), if appropriate given the manner in which a 
        submission is made, including any timeframe for response when 
        such submission is not part of a regulatory application or 
        other submission that has an associated timeframe for response; 
        and
            (5) how, when the Commissioner of Food and Drugs determines 
        appropriate, such Commissioner anticipates using relevant 
        patient experience data and related information, including with 
        respect to the structured risk-benefit assessment framework 
        described in section 505(d) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(d)).

SEC. 4. PATIENT INPUT EXEMPT FROM PAPERWORK REDUCTION ACT.

    Chapter 35 of title 44, United States Code, shall not apply to 
collections of information to which a response is voluntary, that are 
initiated by the Secretary under section 3 of the Patient-Focused 
Impact Assessment Act of 2016.

SEC. 5. REPORT TO CONGRESS ON PATIENT EXPERIENCE DRUG DEVELOPMENT.

    Not later than June 1 of 2021, 2026, and 2031, the Secretary of 
Health and Human Services, acting through the Commissioner of Food and 
Drugs, shall prepare and publish on the website of the Food and Drug 
Administration a report assessing the trends of the Food and Drug 
Administration with respect to the review of patient experience data 
and information on patient-focused drug development tools as part of 
approved applications submitted under section 505(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and section 351(a) of 
the Public Health Service Act (42 U.S.C. 262(a)).
                                                       Calendar No. 413

114th CONGRESS

  2d Session

                                S. 1597

_______________________________________________________________________

                                 A BILL

   To enhance patient engagement in the medical product development 
                    process, and for other purposes.

_______________________________________________________________________

                             April 5, 2016

                       Reported with an amendment