Remember my warnings about the FDAs takeover of lab developed tests?
…Lab developed tests have never been FDA regulated except briefly during the pandemic emergency when such regulation led to catastrophic consequences. Catastrophic consequences that had been predicted in advanced by Paul Clement and Lawrence Tribe. Despite this, for reasons I do not understand, the FDA plan is marching forward but many other people are starting to warn of dire consequences.
Well the plan marched forward and here we are. Regarding tests for bird flu:
KFFNews: Clinical laboratories have also begun to develop their own tests from scratch. But researchers said they’re moving cautiously because of a recent FDA rule that gives the agency more oversight of lab-developed tests, lengthening the pathway to approval. In an email to KFF Health News, FDA press officer Janell Goodwin said the rule’s enforcement will occur 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’s slowing things down because it’s adding to the confusion about what is allowable.”
One the motivations for Operation Warp Speed and my work during the pandemic on things like advance market commitments was that firms wouldn’t invest enough in tests because diseases might fizzle out. The extreme costs of shutting down the economy, however, mean that it’s well worth paying for some tests for diseases that fizzle out if tests are ready when a disease doesn’t fizzle out.
Creating tests for the bird flu is already a risky bet, because demand is uncertain. It’s not clear whether this outbreak in cattle will trigger an epidemic or fizzle out. In addition to issues with the CDC and FDA, clinical laboratories are trying to figure out whether health insurers or the government will pay for bird flu tests.
We need a pandemic trust fund to ramp up advance market commitments when necessary.
On the plus side, I do approve of the new program to pay farmers and farm workers for testing. For example:
Friday’s incentives announcement included a $75 payment to any farm worker who agrees to give blood and nasal swab samples to the CDC.
“Bird flu” has now infected more than 50 mammals. To be clear, bird flu may yet fade but every potential pandemic pathogen is a test of readiness and we still are getting a C+ at best.
