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Tick. Tick. Tick.

Thursday, June 8, 2006  |  posted by Hugh Hewitt
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From the WSJ.com Avian Flu News Tracker:

9:10 a.m.: A new U.S. rule published Wednesday means that, in the event of a public health emergency, suspected victims will no longer have to grant permission before experimental tests can be run to determine why they’re sick. Privacy experts called the exception unnecessary, ripe for abuse and an override of state informed-consent laws.

Here’s a link to yesterday’s Federal Register, but I haven’t found the actual rule yet.

UPDATE: Here it is. The rule’s summary:

SUMMARY: The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational.

Clearly the FDA has avian flu on its mind:

FDA is proceeding without notice and comment rulemaking because the
Nation needs to have this regulation in place immediately to be
prepared to deal effectively with a terrorism event or other potential public health emergency. Under the provisions of the Administrative Procedure Act at 5 U.S.C. 553(b)(B), FDA finds for good cause that prior notice and comment on this rule are impracticable and contrary to the public interest. The absence of this exception was an impediment to the most efficient and effective public health response to the SARS outbreak. We do not want the absence of such an exception to be an impediment to our response to an outbreak of Avian flu or some other public health emergency. It is critical that FDA act quickly now to ensure that, in the future, individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent have the benefit of the timely use of the most appropriate diagnostic devices, including those that are investigational. For the same reasons, the agency is making this interim final rule effective as of the date of publication.

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