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Avian flu testing begins too late

by xyonent
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Remember my warning about the FDA taking over lab-developed tests?

…Lab-developed tests have never been regulated by the FDA, except for the brief period of the pandemic emergency. Such regulation would have had disastrous consequences. Dire consequences were predicted in advance by Paul Clement and Laurence Tribe. Nevertheless, for reasons I cannot understand, the FDA’s plan is moving forward while many others are beginning to warn of dire consequences.

The plan went smoothly and we have arrived at this point.

KFF NewsClinical laboratories are also starting to develop their own tests from scratch. FDA Regulations The move will allow the FDA to exercise greater oversight over lab-developed tests and increase the time it takes for them to be approved. FDA spokesperson Janelle Goodwin said in an email to KFF Health News that the rule will be implemented in stages.

But Susan Van Meter, president of the American Clinical Laboratory Association, a trade group that includes the nation’s largest private diagnostic labs, said companies need more clarity. “The growing confusion about what’s permissible is slowing things down,” she said.

One of the motivations for efforts like Operation Warp Speed ​​and the advance market commitments I made during the pandemic was that companies would not invest enough in tests because diseases might go away. But given the enormous costs of shutting down an economy, it may well be worth paying some money to test for a disease that will go away, so long as the tests are ready when the disease doesn’t go away.

Making test kits for avian flu is already a risky gamble because demand is uncertain. It’s unclear whether this cattle outbreak will cause an epidemic or subside. In addition to the problems with the CDC and FDA, clinical labs are reporting health problems. Insurance companies and governments We will cover the cost of bird flu testing.

We have Pandemic Trust Fund Strengthen ex-ante market commitments where necessary.

On the positive side, I New program pays farmers and farm workers for testing. for example:

Friday’s incentive announcement included paying $75 to farmworkers who agree to provide blood and nasal swab samples to the CDC.

“Bird flu” currently infects over 50 species of mammals. To be clear, bird flu may yet pass, but any pathogen with the potential to cause a pandemic is a test of preparedness, and we’re still getting a C+ at best.

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