We'll see more shortages of diagnostic tests if the FDA has its way

[SheltieLover]

https://www.statnews.com/2020/04/15/diagnostic-tests-shortages-fda-decision/

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.

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.

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.

Much more at link.

[Midnightwalk]

1. Good article

I think it’s saying that medical tests were approved by labs using a process called the Clinical Laboratory Improvement Amendments (CLIA). Faster process that allowed improvements to tests to be adopted rapidly.

The new process, VALID, makes the FDA the approver of medical tests which involves more lawyers and paperwork.

The article claims this advantages large pharmaceutical companies over smaller medical labs. It also cites some cases where the CLIA process ran parallel to a VALID process. The FDA test became obsolete because it couldn’t be improved as rapidly.

The author discloses he works for a lab.

I have no knowledge one way or the other if there were some problematic CLIA approves tests, but I find the articles argument persuasive. Particularly with regulatory capture by pharmaceutical companies. This move gives tham an unfair advantage.

Sorry for a long and maybe wrong summary sprinkled with some opinions. If you read this far, definitely read the article and correct anything I got wrong.