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Swine Flu 'Emergency Use Authorizations' fail to meet the legal standard

Posted Nov 19 2009 10:03pm
The swine flu pandemic triggered a variety of government responses throughout the world. In the United States, plans to deal with the disease required that a variety of emergency procedures be used. Both the HHS Secretary and President had to declare emergencies. CDC advised FDA, which issued Emergency Use Authorizations. To invoke the Public Readiness and Emergency Preparedness Act (PREPA) the HHS secretary had to confer with the Homeland Security Secretary.

The laws require multiple consultations in order to prevent our leaders from frivolously invoking emergency powers.

However, in the present instance, the use of "Emergency Use Authorizations" did not conform with US law, in my opinion.

What does the law require in order to allow the use of unlicensed and potentially untested drugs, vaccines, masks and medical tests? Here is the actual language:

§ 360bbb–3. Authorization for medical products for use in emergencies

(b)Declaration of emergency
(1)In general
The Secretary may declare an emergency justifying the authorization under this subsection for a product on the basis of—
(A)a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agents;

(B)a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a specified biological, chemical, radiological, or nuclear agent or agents; or

(C)a determination by the Secretary of a public healthemergencyunder section247dof title42that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents.
Back in April, when we knew little about the potential impact of the swine flu virus on society, it was probably reasonable to assume that it could affect national security. However, we now know the swine flu has not overwhelmed the US medical system, let alone national security. Despite DHHS Secretary Sibelius saying that the government had built in "on ramps and off ramps" for its emergency response, especially in terms of its vaccines, neither the law nor the government have demanded a pause in our emergency preparations and a reassessment.

Almost everyone would agree at this point that the Swine Flu lacks "a significant potential to affect national security." Shouldn't that result in an acknowledgment that invoking a law requiring a national security threat is wrong, and we either need a new law for using untested products in purely medical emergencies, or we need to revoke the new Emergency Use Authorizations and rethink our preparedness strategies?
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