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Source: https://nypost.com/2020/03/07/overre...ore-dangerous/
Overregulation is making the coronavirus outbreak even more dangerous
By Roger D. Klein
March 7, 2020 | 1:08pm
...It’s troubling that community spread in Washington state and other parts of the United States — possibly affecting hundreds to thousands of individuals — wasn’t detected sooner.
Overregulation of diagnostic testing has played a major role in this delay. For weeks, the CDC operated the nation’s sole diagnostic laboratory for coronavirus, while testing in the rest of the world proceeded apace...
...In theory, doctors could have tested any individuals in whom they suspected coronavirus, and Vice President Mike Pence on March 3rd encouraged this; however, the unavailability of testing has been a major obstacle in practice.
see also
Chinese workers head back to work as coronavirus death toll climbs
On Feb. 4, following Health and Human Services Secretary Alex Azar’s declaration of a public-health emergency, the Food and Drug Administration issued an Emergency Use Authorization (EUA) to the CDC, allowing it to distribute test kits to designated public-health laboratories.
The CDC began shipping the kits on Feb. 5, but laboratories could not validate them because they contained a defective reagent.
Laboratory tests typically contain what is termed a “negative control” — material expected to yield a negative result when tested, and which protects against false-positive results stemming from contamination or other issues. Many labs obtained positive results with the negative controls, invalidating test runs and precluding use of the kits. Affected labs were required to send their specimens to the overburdened CDC.
The FDA has not allowed the experienced and highly skilled professionals at public-health, academic and commercial laboratories to set up their own laboratory developed tests (LDTs), and no manufactured test kits have been authorized for sale in the US. In Europe, several companies, at least one US-based, have regulatory approval to sell test kits there.
The FDA’s regulation of laboratory tests has been a longstanding concern. This includes moves to regulate LDTs, despite the existence of stringent alternative-regulatory and oversight mechanisms. In general, the FDA has exercised “enforcement discretion” with respect to LDTs. With coronavirus testing, the FDA’s abandonment of enforcement discretion may have proved deadly...
Overregulation is making the coronavirus outbreak even more dangerous
By Roger D. Klein
March 7, 2020 | 1:08pm
...It’s troubling that community spread in Washington state and other parts of the United States — possibly affecting hundreds to thousands of individuals — wasn’t detected sooner.
Overregulation of diagnostic testing has played a major role in this delay. For weeks, the CDC operated the nation’s sole diagnostic laboratory for coronavirus, while testing in the rest of the world proceeded apace...
...In theory, doctors could have tested any individuals in whom they suspected coronavirus, and Vice President Mike Pence on March 3rd encouraged this; however, the unavailability of testing has been a major obstacle in practice.
see also
Chinese workers head back to work as coronavirus death toll climbs
On Feb. 4, following Health and Human Services Secretary Alex Azar’s declaration of a public-health emergency, the Food and Drug Administration issued an Emergency Use Authorization (EUA) to the CDC, allowing it to distribute test kits to designated public-health laboratories.
The CDC began shipping the kits on Feb. 5, but laboratories could not validate them because they contained a defective reagent.
Laboratory tests typically contain what is termed a “negative control” — material expected to yield a negative result when tested, and which protects against false-positive results stemming from contamination or other issues. Many labs obtained positive results with the negative controls, invalidating test runs and precluding use of the kits. Affected labs were required to send their specimens to the overburdened CDC.
The FDA has not allowed the experienced and highly skilled professionals at public-health, academic and commercial laboratories to set up their own laboratory developed tests (LDTs), and no manufactured test kits have been authorized for sale in the US. In Europe, several companies, at least one US-based, have regulatory approval to sell test kits there.
The FDA’s regulation of laboratory tests has been a longstanding concern. This includes moves to regulate LDTs, despite the existence of stringent alternative-regulatory and oversight mechanisms. In general, the FDA has exercised “enforcement discretion” with respect to LDTs. With coronavirus testing, the FDA’s abandonment of enforcement discretion may have proved deadly...
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