Fumble Delay Abet

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.”
-Ayn Rand.

Making the obvious virtuous

Businesses controlled by “any major figure in government” will be prohibited from receiving loans or investments from Treasury Department programs included in a $2 trillion CCP virus relief plan.

Senate Minority Leader Charles E. Schumer (D-N.Y.) proudly stressed to CNN that the provision applies to “[A]ny major figure in government. That makes sense,” he said, “Those of us who write the law shouldn’t benefit from the law.”

Well, yes. That’s so obvious you might think it needn’t be said. But, if it makes sense for these benefits for this law, why doesn’t it make sense for all laws?

So, let me fix that for you, Chuck: “Those of us who tried to stuff it full of social justice, climate hysteria, and payoffs to our friends wrote this law shouldn’t benefit from this law.” Since you all benefit from THE law – all the other legislation you pass – you’ve merely made an exception this time. There apparently are limits to how obvious special treatment for major figures in government can be.

Do I hear a protest? Sorry, but you routinely exempt yourselves from the laws you make the the rest of us follow, like the Obamacare mandates, FOIA, OSHA, and transparency on insider trading.

No other “profession” manages to produce so many multi-millionaires on comparable salaries. And didn’t you and Nancy just prove “benefit” includes the opportunity to purchase votes with other people’s money?

In which SCOTUS agrees with FDR

Today the Supreme Court ruled on compulsory government sector union fees, recognizing such fees as a First Amendment issue about compelled political speech. To summarize:

JANUS v. AMERICAN FEDERATION OF STATE, COUNTY, AND MUNICIPAL EMPLOYEES

States and public-sector unions may no longer extract agency fees from nonconsenting employees. The First Amendment is violated when money is taken from nonconsenting employees for a public-sector union; employees must choose to sup- port the union before anything is taken from them. Accordingly, nei- ther an agency fee nor any other form of payment to a public-sector union may be deducted from an employee, nor may any other attempt be made to collect such a payment, unless the employee affirmatively consents to pay.

This opinion essentially agrees with that of famous Progressive Franklin Roosevelt:

All Government employees should realize that the process of collective bargaining, as usually understood, cannot be transplanted into the public service. It has its distinct and insurmountable limitations when applied to public personnel management. The very nature and purposes of Government make it impossible for administrative officials to represent fully or to bind the employer in mutual discussions with Government employee organizations. The employer is the whole people, who speak by means of laws enacted by their representatives in Congress. Accordingly, administrative officials and employees alike are governed and guided, and in many instances restricted, by laws which establish policies, procedures, or rules in personnel matters.

There is no such thing as a “public-sector” union. There are government unions, of which the public is the employer, where bureaucrats “negotiate” among themselves, and a third party payer is stuck with the results.

When you name such unions “government unions”, it’s much easier to understand that government “management” and government “labor” have common goals and the employer doesn’t even have a seat at the table.

Public/Pirate partnerships

Friday, I noted Michigan’s private marketing bureau rip-off. It just gets worse.

Michigan Senate Bill 97. Emphasis mine:

To give state and local government agencies the power to enter into joint operating arrangements with a particular business for purposes of building a hospital or transportation facilities. The private operator would benefit from tax exemptions and its governmental partner’s power to impose property taxes, borrow, take private property using eminent domain and more. The government agency involved could choose the private sector actor without necessarily having to accept the lowest bid. The projects could be proposals from a private developer.

This is just a corporate version of the SEIU dues scam and is no less reprehensible simply because there’s a different set of government approved thieves. The Granholm Democrats licensed a union to steal Medicaid dollars from taxpayers. The Snyder Republicans are getting ready to legalize similar looting by Blue Cross Blue Shield, the Michigan Infrastructure & Transportation Association, and Matty Maroun (owner of the Ambassador Bridge). Of course, it’s endorsed by the Chamber of Cronyism.

H/T Right Michigan where you can find out who to call to kill this assault on Michigan taxpayers.

Rent Seekers

Bills Make It Easier For Private Marketing Bureaus To Force Dues on Businesses

This regulatory statist, public/pirate partnership should cease. The parallels (rent-seeking and arbitrary, bureaucratic consumer punishment) to Trump’s trade war impulses are educational opportunities for the economically ignorant.

Update 01/13/17:
It occurs to me to ask how this is different from the SEIU dues-skimming travesty?