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by ciguy 995 days ago
There is a note saying the tests may be expired, but it's ok because the FDA extended the expiry date. I wonder who lobbied to have that date extended, in my experience it is incredibly difficult to get the FDA to revisit things like this. Someone (Maybe USPS?) must have over ordered and didn't want to throw the extras away.
3 comments

No this is normal. When you introduce a new diagnostic test, part of the approval process is that you have to run an aging study on the reagents/test cartridge.

The normal procedure is to set some of the tests aside when they first come off the production line. Typically every six months, you run a new study to validate that the tests you set aside still work. If they do, you can file an amendment to your approval to extend the expiration date. If this weren't allowed, you'd have to wait to bring your test on the market for two years or however long you wanted the shelf life to be.

The US military has a program to grade the efficacy of "expired" medication.

The generous version is that it's only feasible for a company to make a guarantee of efficacy to a point and the cynical version is that people will buy more as long as the expiration is some economically tolerable length. The .MIL has enough to make the efficacy tests worthwhile.

https://www.fda.gov/emergency-preparedness-and-response/mcm-...

> I wonder who lobbied to have that date extended

According to the FDA, the manufacturers are doing ongoing stability testing, and as they find the tests are still effective after the date they initially estimated, they can contact the FDA to share their results and request that the FDA authorize a longer shelf life. This actually costs the manufacturer money since they'd be paid when people replaced the "expired" product they threw away, but they're doing it anyway because not everything is a weird conspiracy (and maybe also because the most shelf stable products have an advantage when it comes to what people order for their stockpiles)