FDA Chides House Republican’s “Body Count” Amendment
by Matthew Madia, 6/7/2011
An amendment introduced by Rep. Denny Rehberg (R-MT) would hogtie the Food and Drug Administration (FDA) by forcing the agency to wait for public health crises to happen before it could act. "This amendment would require that consumers actually be harmed before FDA can take certain actions to protect the public health,” the agency said.
Rehberg’s amendment, attached to a spending bill that moved out of the House appropriations committee last week, would prohibit the FDA from taking regulatory action on food, medical products, or tobacco unless it has “hard science” showing that a product or substance will harm consumers. The amendment makes a clumsy attempt to define “hard science,” but the intent is clearly to prevent the FDA from taking proactive measures to protect vulnerable people unless and until it can conclusively solve a health or safety mystery – no matter how many bodies pile up or hospital beds fill up in the process. Here is the text:
Sec. 740. None of the funds made available by this Act may be used by the Food and Drug Administration to write, prepare, develop or publish a proposed, interim, or final rule, regulation, or guidance that is intended to restrict the use of a substance or a compound unless the Secretary bases such rule, regulation or guidance on hard science (and not on such factors as cost and consumer behavior), and determines that the weight of toxicological evidence, epidemiological evidence, and risk assessments clearly justifies such action, including a demonstration that a product containing such substance or compound is more harmful to users than a product that does not contain such substance or compound, or in the case of pharmaceuticals, has been demonstrated by scientific study to have none of the purported benefits.
Michael Taylor, FDA’s Deputy Commissioner for Foods, spoke in opposition to the amendment today. “I think if we waited until the last science was in, I think the public would find that unacceptable because you'd be waiting until people are hurt," Taylor said, according to The Hill. “He gave the example of efforts to prevent contaminated irrigation water that is known to be a hazard even though regulators lack data on how each individual type of produce can affect the public health,” The Hill reports.
“Legislation that would require us to wait until people are hurt in order to take action is counter, in our view, to what public health is all about.”