Shame on you, Congress

[Digit]

This was modified Oct. 3, 2011, so I don't suppose a whole lot of the facts have changed. Nutshell summary for non-link followers: synthetic (man-made) insulin is expensive, because it's valuable, seeing as it keeps diabetics alive. Some type-2 diabetics and all type-1 diabetics must have it. The patents for Novo Nordisk's Novolin line are still in effect, so my gripe is moot with respect to that, but the patents for the Humulin line, which there's nothing wrong with and is still to this day used by many people, expired in 2001 and 2002.

But do you think that means that generic companies are making Humulin insulins at low cost? No. Yes, it costs less than the Novolin insulins, but it's still only brand-name companies making it. No generic companies. Apparently, Congress has been dragging its feet since 2001 regarding the codifying of manufacturing quality standards for biologics (insulin is not categorized as a drug, enter the legal labyrinth of semantics).

So Congress refuses to figure out what the bar is for generic insulin makers to measure up to. A little like you wanting to enter a race, and I say "In order to enter the race, you have to pass the XYZ qualification." You say "What's the XYZ qualification?" I say "I haven't made it yet." Nice way of keeping you out, huh?

I have to ask myself, didn't Eli Lilly Co. have to certify its manufacturing process? Why not use that as a measuring stick?

Shame on you, Congress.

[Marduk]

I have little to add on the specifics of this, other than to say that our good friend Newt worked as a "historian" for Novo Nordisk.