It's not as cheap as the stockholders want it to be in the US.

Probably true.

Better to keep profit margins up than actually make revenue.

To make a completely uneducated guess, probably recertifications from a change in bill of materials? These are medical drugs we're talking about.

A change like that shouldn't be a big deal. A meeting to decide whether or not it constitutes a Design Change (it doesn't!) and if the new insert needs to be Validated again (likely not) and you're pretty much done from a Compliance standpoint and on to Vendor Qualification.

My guess is that the problem is more likely to be finding a vendor that can print/cut to your specification at the scale you need and, critically, who can produce it on your schedule. Any capable printer is likely already booked solid for months.

If it was a real problem I dare say they could ship with loose leaf pages detailing everything nobody reads.

Assuming they fit into the existing manufacturing process, sure. But that still doesn't solve the problem of finding a printer to print those millions of pages.

It sounds like it should be easy? Do you remember the TP shortage of 2020? That also sounded easy.

The scale makes it hard.

What makes you think toilet paper manufacture is equivalent to printing?

It involves a supply of specialty paper.

Ding ding ding! Got it in one

You're assuming that there are high-quality, high-volume print suppliers with slack time / idle machinery. I wouldn't be so sure. And even then, existing literally everywhere in the world now becomes a problem of finding them.

There has actually be a pretty significant general paper shortage over the last two years due to difficulties sourcing the raw materials. Not sure if that's the root cause for the issue mentioned here but I'd bet it contributed to it.