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Politics : PRESIDENT GEORGE W. BUSH
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To: Red Heeler who wrote (456772)9/11/2003 12:57:22 AM
From: Doug R  Read Replies (1) of 769670
 
"In the absence of FDA approval of a product for a specific countermeasure use, the BioShield bill permits the HHS Secretary to issue an emergency authorization that would provide Americans with access to certain unlicensed countermeasures. "

"FDA regulations are stringent when it comes to informed consent for investigational products. Because urgent situations may require mass inoculations and/or drug treatments, such informed consent requirements may prove impossible to implement within the necessary time frame when trying to achieve the public health goal of protecting Americans from the imminent danger. The legislation would provide for the Secretary to impose conditions on the authorization, either by regulation or on a case-by-case basis, where appropriate to protect public health. Specifically, the bill provides that such conditions shall include labeling and other requirements to ensure that health care professionals are informed of the special emergency nature of the authorization; of the benefits and risks (and the extent to which such benefits and risks are unknown)"

"the conditions of authorization may include the following:

requirements, or waiver of otherwise-applicable requirements, regarding good manufacturing practice; and

requirements for monitoring and reporting adverse events."

hhs.gov

a million to one that an attack somewhere in the US would adversely affect my health.
probably 50 to one that ingesting unapproved, experimental, poorly manufactured drugs WILL adversely affect my health.
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