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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 1865 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                S. 1865

            To improve patient access to medical innovation.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           November 15, 2011

  Mr. Franken (for himself, Mr. Alexander, Mr. Kerry, and Mrs. Hagan) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
            To improve patient access to medical innovation.

    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 Access to Medical Innovation 
Act''.

SEC. 2. HUMANITARIAN USE DEVICE EXEMPTIONS.

    (a) In General.--Section 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (6)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i), by 
                        striking ``subparagraph (D)'' and inserting 
                        ``subparagraph (C)'';
                            (ii) by striking clause (i) and inserting 
                        the following:
            ``(i) The device with respect to which the exemption is 
        granted was approved under this subsection before, on, or after 
        the date of enactment of the Patient Access to Medical 
        Innovation Act.'';
                            (iii) by striking clause (ii) and inserting 
                        the following:
            ``(ii) During any calendar year, the number of such devices 
        distributed during that year under each exemption granted under 
        this subsection does not exceed the number of such devices 
        needed to treat, diagnose, or cure a population of 4,000 
        individuals in the United States (referred to in this paragraph 
        as the `annual distribution number').''; and
                            (iv) in clause (iv), by striking ``2012'' 
                        and inserting ``2017'';
                    (B) by striking subparagraph (C);
                    (C) by redesignating subparagraphs (D) and (E) as 
                subparagraphs (C) and (D), respectively;
                    (D) in subparagraph (C), as so redesignated, by 
                striking ``and modified under subparagraph (C), if 
                applicable,''; and
                    (E) in subparagraph (D), as so redesignated, by 
                adding at the end the following:
    ``(iii) In this subsection, the term `pediatric device' means a 
device with respect to which the exemption is granted that is intended 
for the treatment or diagnosis of a disease or condition that occurs in 
pediatric patients or in a pediatric subpopulation, and such device is 
labeled for use in pediatric patients or in a pediatric subpopulation 
in which the disease or condition occurs.'';
            (2) in paragraph (7), by striking ``regarding a device'' 
        and inserting ``regarding a pediatric device''; and
            (3) in paragraph (8), by striking ``of all devices 
        described in paragraph (6)'' and inserting ``of all pediatric 
        devices granted an exemption under paragraph (2)''.
    (b) Report.--Not later than 5 years after the date of enactment of 
this Act, the Comptroller General of the United States shall submit to 
Congress a report that evaluates and describes--
            (1) the effectiveness of the amendments made by subsection 
        (a)(1) in stimulating innovation with respect to medical 
        devices; and
            (2) the effect of such amendments on patients described in 
        such section 520(m) of the Federal Food, Drug, and Cosmetic Act 
        (as amended by subsection (a)).

SEC. 3. CONFLICTS OF INTEREST.

    Section 712 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379d-1) is amended--
            (1) by striking subsection (b);
            (2) by redesignating subsection (c) as subsection (b);
            (3) in subsection (b), as so redesignated, by striking 
        paragraph (2)(C) and inserting the following:
                    ``(C) Consideration by secretary.--The Secretary 
                shall ensure that each determination under subparagraph 
                (B) considers the scope and magnitude of the financial 
                interest at issue with the public health need for the 
                expertise of the member on the advisory committee.''; 
                and
            (4) by redesignating subsection (d) as subsection (c);
            (5) in subsection (c), as so redesignated, by striking 
        ``subsection (c)(3)'' and inserting ``subsection (b)(3)''; and
            (6) by striking subsections (e) and (f).
                                 <all>
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