Remember my warnings about the FDA’s takeover of lab tests?
…Laboratory testing has never been regulated by the FDA except briefly during a violent emergency when this regulation led to disastrous results. The disastrous results were predicted earlier by Paul Clement and Lawrence Tribe. Despite this, for reasons I don’t understand, the FDA plan is moving forward but many other people are starting to warn of the side effects.
Well, the plan went ahead and here we are. About bird flu testing:
KFFNews: Clinical laboratories have also started doing their own tests from scratch. But researchers say they are treading carefully because of a recent FDA rule that gives the agency more oversight of lab-developed tests, extending the path to approval. In an email to KFF Health News, FDA press officer Janell Goodwin said implementation of the rule will happen gradually.
However, Susan Van Meter, president of the American Clinical Laboratory Association, a trade group whose members include the nation’s largest commercial diagnostic labs, said companies need more clarity: “It narrows things down because it adds confusion about what’s allowed.”
One of the motivations for Operation Warp Speed and my work during the crisis on things like pre-market commitment is that firms can’t invest enough in testing because diseases can break out. The severe economic costs of closure, however, mean that it is worth paying for additional tests for outbreaks if the tests are ready when the disease is not present.
Creating bird flu tests is already a risky bet, because demand is uncertain. It is not clear whether this cattle outbreak will cause an epidemic or end. In addition to the CDC and FDA’s problems, clinical laboratories are trying to find out whether health insurers or the government will pay for bird flu testing.
We need a dynamic trust fund to strengthen market bonds in advance if necessary.
On a positive note, I approve of the new payment system for farmers and farm workers to be tested. For example:
Friday’s incentive announcement includes a $75 payment to any farm worker who agrees to provide the CDC with blood samples and nasal swabs.
“Bird flu” has now infected more than 50 mammals. To be clear, bird flu may be gone but every pandemic pathogen is a preparedness test and we still get a C+ at best.
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