Monday, 26 October 2015

Generic drugs and barriers to entry

From Fiercepharma:

... a compounding pharmacy has stepped up with its own alternative to the med--at about $1 per pill, a tiny fraction of the cost of Turing Pharmaceuticals' brand, which runs $750 per tablet after a widely publicized 5000%-plus price increase.

Imprimis will have its work cut out for it to market the compounded meds, however. After the meningitis outbreak linked to the New England Compounding Center, new regulations tightened up on distribution of compounded drugs, which aren't specifically approved by the FDA. Compounded meds can only be dispensed on specific prescriptions for specific patients, rather than distributed in bulk as FDA-approved products are.

The company's pyrimethamine-plus-leucovorin combination can be ordered directly, an Imprimis spokesman said, with a physicians' prescription. Imprimis Cares is designed to streamline that process.

There's the hook - without FDA approval you are still on the back foot.

As we know, the corporatist EU loves licensing stuff, "in the interests of consumer safety and to ensure high uniform high standards" no doubt, because it is so expensive getting approval it shuts the little guys out of the market.


Bayard said...

I am sure the EU pharma companies are green with envy when they see how the US ones have the US market stitched up. Of course they would want the EU to go the same way and they know just how to do that.

Random said...
Please do a parody of this mark.

Mark Wadsworth said...

B, yes.

R, the daily mash has already done it.

A K Haart said...

The link seems to be broken.

Mark Wadsworth said...

Akh, oops, I have fixed.

A K Haart said...

I see the active ingredient (pyrimethamine) has been available since 1953 and is not subject to any unexpired patent. Not exactly a cutting edge pharmaceutical but as you say, it's all about barriers to entry.

paul said...

I think in terms of sales its not worth any generic company licencing that product on the USA so compounding pharmacies are the only alternative but are subject to much lower quality standards and recently have been some fatal errors. In the UK under EU law we have a similar structure but are specifically forbidden from producing products or importing unlicensed products solely for the reason of cost. If there is an unaffordable licenced version we must use it.