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FDA Opposes Proposed ‘Hard Science’ Amendment

By Zachary Brousseau posted 09-Jun-2011 17:10

  

The US Food and Drug Administration (FDA) has taken a strong public stance against an amendment to proposed legislation that would limit the type of information the agency may use in making regulatory decisions. The amendment to an agriculture appropriations bill was offered by Rep. Denny Rehberg (R-MT) in what Rehberg said is an effort to block FDA from relying on “soft science.” If passed, the amendment would hinder FDA efforts to protect the public from unsafe drugs, tobacco, lead-filled candy and tainted blood, according to FDA documents. “FDA must sometimes act when there are credible risks, but before the weight of scientific evidence has been established,” agency officials wrote in an analysis of the amendment. “This amendment would require that consumers actually be harmed before FDA can take certain actions to protect the public health.”

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