Tuesday, September 22, 2015

Go to Canada

Greed, in the person of Martin Shkreli and Turing Pharmaceutical, has handed Hillary Clinton and Bernie Sanders a wonderful club to whack the pharma industry with.  Shkreli, candidate for worst person in the world, purchased Turing and Turing bought the exclusive US marketing rights to a drug called Daraprim, which has a number of uses, but not much of a market and upped the price from $13.50 to $750 a tablet.  This is the but the end of the chain.

Daraprim, which is also used to treat malaria, was approved by the F.D.A. in 1953 and has long been made by GlaxoSmithKline. Glaxo sold United States marketing rights to CorePharma in 2010. Last year, Impax Laboratories agreed to buy Core and affiliated companies for $700 million. In August, Impax sold Daraprim to Turing for $55 million, a deal announced the same day Turing said it had raised $90 million from Mr. Shkreli and other investors in its first round of financing.
Since this broke Shkreli has been bragging about what a clever bunny he is and how everybunny else can, well, think of what David Cameron asked his local pig's head to do.

Daraprim is a small molecule that is used for treating toxoplasmosis and other parasitical infections. It is given to people with HIV and to pregnant women in areas subject to malaria.  To understand what happened a good place to start is Derek Lowe's blog at Science Translational Medicine.  For certain drugs where the supply is thin, pharma companies can get an exclusive marketing right for a few years
By various means, old generic compounds have ended up as protected species, and several companies have made it their business to take advantage of these situations to the maximum extent possible. The FDA grants market exclusivity to companies that are willing to take “grandfathered” compounds into compliance with their current regulatory framework, and that’s led to some ridiculous situations with drugs like colchicine and progesterone . (Perhaps the worst example is a company that’s using this technique to get ahold of a drug that’s currently being provided at no charge whatsoever. There are also loopholes that companies are trying to exploit when competitors try to prove generic equivalence: whatever it takes to keep competition away and get unlimited pricing power.
Shkreli is just the latest to push the envelope, but this has popped into the political arena and he is going to have an interesting time.

Daraprim remains available worldwide, both from Glaxo Smith Kline and generic source.  The FDA policy towards drug importation is, well yes, not allowed, but we have enough to do and if you want to go to Canada and pick up a 90 day supply FDA will not hassle you.  However, not everybunny can go to Canada or where ever.

A friend of Eli's had an interesting idea.  FDA could send a letter to the manufacturing pharmacists in the US saying that if they want to source Daraprim FDA won't bother them.


Barton Paul Levenson said...

This kind of thing simply should not be allowed.

Everett F Sargent said...

All I need is a street address and ...

The FDA did something of the sort when AstraZeneca (AZ) fought the FDA 'tooth and nail' over the expiration of the exclusive patent on Seroquel (they still hold the patent for the SR version into 2017, I believe).

Seroquel was, by AZ's own admissions a 'blockbuster' drug, meaning it provided a significant fraction of it's total global revenue stream.

In the runup to the deadline FDA remained silent (lots of federal court documents filed by AZ against FDA though) and not too surprisingly AZ Seroquel quickly rose in price in the months before the deadline.

About one-two days after the deadline FDA had approved almost a dozen generic quetiapine manufacturers.

A somewhat similar situation occurred somewhat earlier in the UK (and Canada), it's been awhile, can't recall all those details.

I don't know the current law, but if the FDA and/or USPTO sort of 'tied their own hands' on generics, this idiot will tie it up in court for as long as possible. In other words, the FDA just needs to approve another generic manufacturer ASAP without giving this idiot first dibs on a DC court date (which is what an FDA letter would do).

Unknown said...

You have to wonder how it's possible that a drug with a patent life of 20 years is still protected after more than 60 years.

EliRabett said...

Nigel, they don't have patent protection, what they have is an exclusive marketing agreement from the FDA based on agreeing to do certain things such as bringing the qualification of the drug up to modern standards. If you go over to the Science Transitional Medicine site you will see that this has become a game that small pharma companies play to raise prices and eliminate competition.


The relative ease of organic synthesis these days brings bulk production costs below a thousand dollars a kilogram, which translates into pennies per pill for most drugs, .

The very idea of &750 a pop invites a new kind of drug war, in which the dark net purveys real lifesavers from white market chemists at prices no higher than heroin or cocaine

the internet is hard on IP across the board

John said...
This comment has been removed by the author.
John said...

Important takehome lesson:

in capitalism today, monopoly (or oligopoly) is just as normal, and just as natural, as competition.

jrkrideau said...