[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H. Res. 98 Introduced in House (IH)]

112th CONGRESS
  1st Session
H. RES. 98

     Expressing the sense of the House of Representatives that the 
   Commissioner of the Food and Drug Administration should give the 
    greatest weight in making critical policy decisions to readily 
   available hard science data, including evidence from the natural 
          sciences, physical sciences, and computing sciences.


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                    IN THE HOUSE OF REPRESENTATIVES

                           February 17, 2011

Mr. Fincher (for himself, Mr. McIntyre, Mrs. Blackburn, and Mr. Coble) 
submitted the following resolution; which was referred to the Committee 
                         on Energy and Commerce

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                               RESOLUTION


 
     Expressing the sense of the House of Representatives that the 
   Commissioner of the Food and Drug Administration should give the 
    greatest weight in making critical policy decisions to readily 
   available hard science data, including evidence from the natural 
          sciences, physical sciences, and computing sciences.

Whereas the Food and Drug Administration (referred to as the FDA), within the 
        Department of Health and Human Services, is responsible for protecting 
        the public health by assuring safety and effectiveness of the food 
        supply, and of human and veterinary drugs, vaccines and other biological 
        products, medical devices, cosmetics, dietary supplements, radiation 
        emitting products, and tobacco products in our Nation;
Whereas the Government Accountability Office, in reviewing the activities of the 
        FDA during the past several months, has found numerous instances of the 
        FDA failing to follow its core mission with respect to the oversight of 
        products within its jurisdiction;
Whereas the Government Accountability Office has also raised significant 
        concerns regarding the ability of the FDA to keep pace with scientific 
        progress, including--

    (1) a survey of FDA managers, where GAO found that 67 percent reported 
that updated scientific technologies would greatly help them to meet FDA's 
goals and responsibilities, but only 36 percent of managers believed that 
FDA was making great progress in keeping pace with scientific progress;

    (2) a report finding that FDA officials acknowledged that there are 
challenges in the ability of the FDA to fulfill and manage its growing 
medical product oversight responsibilities that can be attributed to 
resource constraints, but the FDA could not provide the information 
necessary to develop reliable estimates of its resource needs; and

    (3) a report indicating that the FDA--

    G    (A) faces data constraints in making postmarket drug safety 
decisions, with weaknesses in the different types of data available to the 
FDA; and

    G    (B) lacks the authority to require certain studies and has 
resource limitations for obtaining data;

Whereas the FDA has a number of pending decisions affecting various industries 
        in which it is being urged to base its decisions on findings made in 
        social sciences, while there is inadequate data from the natural 
        sciences, physical sciences, or computing sciences to support such 
        decisions; and
Whereas any efforts by the FDA to impose new mandates, standards, or other 
        requirements should not be made final if supported substantially only by 
        social sciences and speculative conclusions as to cause and effect: Now, 
        therefore, be it
    Resolved, That it is the sense of the House of Representatives that 
the Commissioner of the Food and Drug Administration should--
            (1) give the greatest weight in making critical policy 
        decisions to readily available hard science data, including 
        evidence from the natural sciences, physical sciences, and 
        computing sciences; and
            (2) avoid paternalistic policy decisions that are not 
        grounded in hard science.
                                 <all>