II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Patient Access to Med5 ical Innovation Act’’. 

6 SEC. 2. HUMANITARIAN USE DEVICE EXEMPTIONS. 

7 (a) IN GENERAL.—Section 520(m) of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is 

9 amended— 

10 (1) in paragraph (6)— 

11 (A) in subparagraph (A)— 


jbell on DSK7SPTVN1PROD with BILLS
2 

•S 1865 IS

1 (i) in the matter preceding clause (i), 

2 by striking ‘‘subparagraph (D)’’ and in3 serting ‘‘subparagraph (C)’’; 

4 (ii) by striking clause (i) and inserting 

5 the following: 

6 ‘‘(i) The device with respect to which the ex7 emption is granted was approved under this sub8 section before, on, or after the date of enactment of 

9 the Patient Access to Medical Innovation Act.’’; 

10 (iii) by striking clause (ii) and insert11 ing the following: 

12 ‘‘(ii) During any calendar year, the number of 

13 such devices distributed during that year under each 

14 exemption granted under this subsection does not 

15 exceed the number of such devices needed to treat, 

16 diagnose, or cure a population of 4,000 individuals 

17 in the United States (referred to in this paragraph 

18 as the ‘annual distribution number’).’’; and 

19 (iv) in clause (iv), by striking ‘‘2012’’ 

20 and inserting ‘‘2017’’; 

21 (B) by striking subparagraph (C); 

22 (C) by redesignating subparagraphs (D) 

23 and (E) as subparagraphs (C) and (D), respec24 tively; 


jbell on DSK7SPTVN1PROD with BILLS
3 

•S 1865 IS

1 (D) in subparagraph (C), as so redesig2 nated, by striking ‘‘and modified under sub3 paragraph (C), if applicable,’’; and 

4 (E) in subparagraph (D), as so redesig5 nated, by adding at the end the following: 

6 ‘‘(iii) In this subsection, the term ‘pediatric device’ 

7 means a device with respect to which the exemption is 

8 granted that is intended for the treatment or diagnosis 

9 of a disease or condition that occurs in pediatric patients 

10 or in a pediatric subpopulation, and such device is labeled 

11 for use in pediatric patients or in a pediatric subpopula12 tion in which the disease or condition occurs.’’; 

13 (2) in paragraph (7), by striking ‘‘regarding a 

14 device’’ and inserting ‘‘regarding a pediatric device’’; 

15 and 

16 (3) in paragraph (8), by striking ‘‘of all devices 

17 described in paragraph (6)’’ and inserting ‘‘of all pe18 diatric devices granted an exemption under para19 graph (2)’’. 

20 (b) REPORT.—Not later than 5 years after the date 

21 of enactment of this Act, the Comptroller General of the 

22 United States shall submit to Congress a report that eval23 uates and describes— 


jbell on DSK7SPTVN1PROD with BILLS
4 

•S 1865 IS

1 (1) the effectiveness of the amendments made 

2 by subsection (a)(1) in stimulating innovation with 

3 respect to medical devices; and 

4 (2) the effect of such amendments on patients 

5 described in such section 520(m) of the Federal 

6 Food, Drug, and Cosmetic Act (as amended by sub7 section (a)). 

8 SEC. 3. CONFLICTS OF INTEREST. 

9 Section 712 of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 379d–1) is amended— 

11 (1) by striking subsection (b); 

12 (2) by redesignating subsection (c) as sub13 section (b); 

14 (3) in subsection (b), as so redesignated, by 

15 striking paragraph (2)(C) and inserting the fol16 lowing: 

17 ‘‘(C) CONSIDERATION BY SECRETARY.— 

18 The Secretary shall ensure that each determina19 tion under subparagraph (B) considers the 

20 scope and magnitude of the financial interest at 

21 issue with the public health need for the exper22 tise of the member on the advisory committee.’’; 

23 and 

24 (4) by redesignating subsection (d) as sub25 section (c); 


jbell on DSK7SPTVN1PROD with BILLS
5 

•S 1865 IS

1 (5) in subsection (c), as so redesignated, by 

2 striking ‘‘subsection (c)(3)’’ and inserting ‘‘sub3 section (b)(3)’’; and 

4 (6) by striking subsections (e) and (f). 

Æ 


jbell on DSK7SPTVN1PROD with BILLS