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The rule lays out a scenario where a laboratory discovers what appears to be an unusual bug in a sample taken from a patient before a public health emergency was even suspected. With the apparent bug in the lab but the patient gone, going back for permission to use a confirmatory but experimental test - often the only type of test available - would introduce "unacceptable delays," the FDA said.
"They're basically overriding state informed-consent laws," said Sue Blevins, president of the Institute for Health Freedom. Blevins said her group advocates for informed consent but that in emergencies it could be sought after the fact.
"If they don't have the time to get it, at least inform them retroactively what's been done, so people can keep track of what information has been collected from them," Blevins said.