[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 613 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                 S. 613

   To prohibit the use of Federal funds to approve certain biologics 
       license applications by the Food and Drug Administration.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 17, 2009

 Mr. Brownback introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To prohibit the use of Federal funds to approve certain biologics 
       license applications by the Food and Drug Administration.

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

SECTION 1. PROHIBITION ON USE OF FEDERAL FUNDS TO APPROVAL CERTAIN 
              BIOLOGICS LICENSE APPLICATIONS.

    Notwithstanding any other provision of law, no funds provided by 
any Appropriations Act enacted before the date of enactment of this Act 
that remain unobligated as of such date of enactment shall be used by 
the Food and Drug Administration to process a biologics license 
application under section 351 of the Public Health Service Act (42 
U.S.C. 262) for any such product for which--
            (1) information submitted in such application, or any other 
        information available to the Secretary of Health and Human 
        Services, shows that the biologic product is, bears, or 
        contains a listed select agent or toxin within the meaning of 
        part 331 of title 7, Code of Federal Regulations, part 121 of 
        title 9, Code of Federal Regulations, and part 73 of title 42, 
        Code of Federal Regulations; and
            (2) the entity filing such application has, during the 2-
        year period before the date of submission of such application 
        to the Secretary--
                    (A) marketed, sold, or distributed that product in 
                the Islamic Republic of Iran;
                    (B) provided select agents or toxins to 
                institutions in the Islamic Republic of Iran, including 
                to the Pasteur Institute in Tehran and Tehran 
                University;
                    (C) submitted patient safety or efficacy data 
                produced through experiments or trials that would 
                violate the laws of the United States governing the 
                proper handling of select agents or toxins; or
                    (D) been the subject of an investigation by the 
                Office of Foreign Assets Control of the Department of 
                Treasury, the Bureau of Industry and Security of the 
                Department of Commerce, or the Department of Justice 
                for potential violations of the Iran Sanctions Act of 
                1996 (Public Law 104-172; 50 U.S.C. 1701 note).
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