Remember my warnings about the FDA’s resumption of laboratory-developed tests?
…Laboratory-developed tests have never been regulated by the FDA, except briefly during the pandemic emergency, when such regulation led to catastrophic consequences. Catastrophic consequences which had been predicted in advance by Paul Clement and Lawrence Tribe. Despite this, for reasons I don’t understand, the FDA’s plan is moving forward but many others are beginning to warn of dire consequences.
Well, the plan progressed and here we are. Regarding avian flu tests:
KFFNews: Clinical laboratories have also started developing their own tests from scratch. But the researchers said they were moving cautiously because of a recent FDA rule This gives the agency greater oversight of laboratory-developed tests, thereby lengthening the path to approval. In an email to KFF Health News, FDA press secretary Janell Goodwin said enforcement 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 slows things down because that this adds to the confusion about what is allowed. »
One of the motivations for Operation Warp Speed and my work during the pandemic on things like pre-market commitments was that companies wouldn’t invest enough in testing because diseases might disappear. However, the extreme costs of shutting down the economy mean it is worth paying for some tests for diseases that go away if the tests are ready while a disease does not go away.
Creating tests for avian flu is already a risky bet, because demand is uncertain. It is unclear whether this outbreak in cattle will spark an epidemic or stop. In addition to issues with the CDC and FDA, clinical laboratories are trying to determine whether healthcare insurers or the government will pay for avian flu tests.
We need a pandemic trust fund to scale up anticipated market commitments where necessary.
On the positive side, I approve of the new program to pay farmers and farm workers for testing. For example:
Friday’s incentive announcement included a $75 payment to any farm worker who agrees to give blood and nasal swab samples to the CDC.
The “bird flu” has now infected more than 50 mammals. To be clear, avian flu might still disappear, but every potential pandemic pathogen is a readiness test and we always get a C+ at best.
