[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 1972 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                S. 1972

          To amend the Food and Drug Administration's mission.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            December 8, 2011

 Mr. Coats (for himself and Ms. Ayotte) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
          To amend the Food and Drug Administration's mission.

    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 ``Food and Drug Administration Mission 
Reform Act of 2011''.

SEC. 2. FDA'S MISSION.

    Section 1003(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 393(b)) is amended--
            (1) in paragraph (2), by striking ``with respect to such 
        products'' and inserting ``with respect to regulated 
        products'';
            (2) in paragraph (4), by striking ``(1) through (3)'' and 
        inserting ``(1) through (4)'';
            (3) by redesignating paragraphs (2) through (4) as 
        paragraphs (3) through (5); and
            (4) by inserting after paragraph (1) the following:
            ``(2) establish a regulatory system that--
                    ``(A) advances medical innovation by incorporating 
                modern scientific tools, standards, and approaches to 
                ensure the predictable, consistent, and efficient 
                review, clearance, approval, and licensing (as 
                appropriate) of innovative products, including drugs, 
                devices, and biological products;
                    ``(B) protects the public health and enables 
                patients to access novel products while promoting 
                economic growth, innovation, competitiveness, and job 
                creation among the industries regulated by this Act;
                    ``(C) is based on the best available science;
                    ``(D) allows for public participation and an open 
                exchange of ideas;
                    ``(E) promotes predictability, allows flexibility, 
                and reduces uncertainty;
                    ``(F) identifies and uses the most innovative and 
                least burdensome tools for achieving regulatory ends;
                    ``(G) ensures that regulations are accessible, 
                consistent, transparent, written in plain language, and 
                easy to understand;
                    ``(H) measures, and seeks to improve, the actual 
                results of regulatory requirements; and
                    ``(I) incorporates a patient-focused benefit-risk 
                framework that accounts for varying degrees of risk 
                tolerance, including for people living with a life-
                impacting chronic disease or disability;''.
                                 <all>