This is scandalous.
Brian H. Shirts, M.D., is a molecular pathologist at the University of Washington. He writes: We’ll see more shortages of diagnostic tests if the FDA has its way
“February was a frustrating month for my laboratory. We wanted to make tests to detect the virus that causes Covid-19. My virology colleagues had great ideas and solid testing platforms. The Food and Drug Administration told us to stop. [That link is worth reading!]
Why? Because of a quirk in FDA regulations. Diagnostic tests are currently regulated in one of two ways, and there’s no clear rule to determine which one applies to coronavirus tests. This uncertainty is a big part of why test shortages have caused a national crisis.
This uncertainty is no accident. James Bovard, at Mises Institute:
“Dr. David Kessler, who became FDA commissioner in 1990, quickly sought to intimidate the companies that his agency regulates. A laudatory Washington Post article concluded, “What he cannot accomplish with ordinary regulation, Kessler hopes to accomplish with fear.” Kenneth Feather of the FDA’s drug advertising surveillance branch boasted: “We want to say to these companies that you don’t know when or how we’ll strike. We want to eliminate predictability.”
See the notes at the end of this post.
Now, back to Dr. Shirts:
“The VALID Act, introduced in Congress in early March, aims to address the confusion about who regulates diagnostic testing, but it would make the situation worse. If the VALID Act passes, we would see shortages in diagnostic tests for even more diseases than Covid-19, including cancers.
Under one system of regulation, laboratory directors are licensed by their states to develop tests through a set of rules called the Clinical Laboratory Improvement Amendments (CLIA). When a CLIA-licensed lab creates a test and documents that it works, doctors can order that test.
Diagnostic testing, and interpreting those tests, is considered the practice of medicine. The FDA is not allowed to regulate the practice of medicine. Yet it is responsible for regulating medical devices. Diagnostic tests use machines, sample tubes, and other tools that are clearly medical devices.
Here’s where the second system comes in: The FDA approves devices — not the lab that produces it — on a case-by-case basis. So which diagnostic tests are devices regulated by the FDA and which are laboratory-developed tests regulated through CLIA?
The FDA gets to choose…
The VALID Act will give the FDA power to create more monopolies on diagnostic tests. CLIA-licensed labs will be shut out of producing new tests that perform as well as FDA-approved versions — or better than them. The result will be higher costs and periodic shortages…
The VALID Act was created because large pharmaceutical companies wanted to have monopolies on cancer tests…”
If you recall, the FDA granted a monopoly to the CDC for CCP virus test kits. The kits were quite late, few, and didn’t work.
With the VALID Act, the FDA is going to be able to create a public/pirate partnership – making private industry more like the CDC.
Notes. Thoughts on complex and uncertain ‘law’ in the hands of unaccountable bureaucrats.
“After having thus successively taken each member of the community in its powerful grasp and fashioned him at will, the supreme power then extends its arm over the whole community. It covers the surface of society with a network of small, complicated rules, minute and uniform, through which the most original minds and the most energetic characters cannot penetrate, to rise above the crowd. The will of man is not shattered, but softened, bent, and guided; men seldom forced by it to act, but they are constantly restrained from acting. Such a power does not destroy, but it prevents existence; it does not tyrannize, but it compresses, enervates, extinguishes, and stupefies a people, till each nation is reduced to nothing better than a flock of timid and industrious animals, of which the government is the shepherd.”
-Alexis de Tocqueville
“We’re after power and we mean it… There’s no way to rule innocent men. The only power any government has is the power to crack down on criminals. Well, when there aren’t enough criminals one makes them. One declares so many things to be a crime that it becomes impossible for men to live without breaking laws. Who wants a nation of law-abiding citizens? What’s there in that for anyone? But just pass the kind of laws that can neither be observed nor enforced or objectively interpreted – and you create a nation of law-breakers – and then you cash in on guilt. Now that’s the system, Mr. Reardon, that’s the game, and once you understand it, you’ll be much easier to deal with.”