IV 112th CONGRESS 1st Session H. RES. 98 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 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— (A)faces data constraints in making postmarket drug safety decisions, with weaknesses in the different types of data available to the FDA; and (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

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.