BioCentury
ARTICLE | Politics & Policy

House GOP seeks 'hard science' test for FDA actions

June 3, 2011 12:12 AM UTC

The House Appropriations Committee passed an FY12 budget with an amendment that committee Democrats say could hamper FDA's ability to regulate the use of drugs. The amendment, introduced by Rep. Denny Rehberg (R-Mont.), would prohibit funding to restrict the use of a substance or compound unless the decision is based on "hard science" and not on "factors of cost and consumer behavior." The amendment adds that FDA should determine that the weight of toxicological evidence, epidemiological evidence, and risk assessments "clearly justifies" such action. The committee approved the amendment in a 29-20 vote. In a statement, Rep. Henry Waxman (D-Calif.) said the Rehberg amendment could "weaken FDA's ability to assure the safety of our drug and food supply." Waxman is ranking member of the Energy and Commerce Committee, which has jurisdiction over FDA. ...