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

114th CONGRESS
  1st 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, and Mr. Bennet) introduced the following bill; which was read 
 twice and referred to the Committee on Health, Education, Labor, and 
                                Pensions

_______________________________________________________________________

                                 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,

SECTION 1. SHORT TITLE.

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

SEC. 2. PUBLIC DISCLOSURE OF SAFETY AND EFFECTIVENESS DATA IN ACTION 
              PACKAGE.

    Paragraph (2) of section 505(l) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(l)) is amended--
            (1) in subparagraph (C), by adding at the end the 
        following:
                    ``(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:
                            ``(I) Patient population benefit and risk 
                        data.
                            ``(II) Draft or final guidances issued by 
                        the Food and Drug Administration.
                            ``(III) Patient-reported or caregiver-
                        reported outcomes data.
                            ``(IV) Patient preference data.
                            ``(V) Perspectives of patients serving on 
                        advisory committees or participating in medical 
                        product development proceedings.
                            ``(VI) Perspectives of medical and 
                        scientific professionals with relevant 
                        expertise.
                            ``(VII) Other measures to assess the impact 
                        of patient-focused drug development tools, as 
                        determined by the Secretary.''; and
            (2) by adding at the end the following:
            ``(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.''.

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

    (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--
            (1) specifies how the Food and Drug Administration views 
        collaboration between patients or patient advocacy 
        organizations and industry sponsors for the purposes of--
                    (A) developing patient-focused drug development 
                tools; and
                    (B) obtaining patient perspectives on medical 
                products under development;
            (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
            (3) specifies the position of the Food and Drug 
        Administration with respect to activities that would not be 
        permitted for such purposes.
    (b) Timing.--The Secretary shall--
            (1) not later than 6 months after the date of enactment of 
        this Act, publish proposed guidance under this section; and
            (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.
                                 <all>
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