Older prescription drugs see huge price increase

[drauz]

http://blogs.sciencemag.org/pipeline...-its-a-bad-one

Daraprim, which is also used to treat malaria, was approved by the FDA in 1953 and has long been made by GlaxoSmithKline. Glaxo sold US marketing rights in 2010 to CorePharma. 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 Shkreli and other investors in its first round of financing.

Daraprim cost only about $1 per tablet several years ago, but it went up sharply after CorePharma acquired it. According to IMS Health, which tracks prescriptions, sales of the drug jumped to $6.3 million in 2011 from $667,000 in 2010, even as prescriptions held steady at about 12,700. In 2014, after further price increases, sales were $9.9 million, as the number of prescriptions shrank to 8,821. The figures do not include inpatient use in hospitals.

[Whirlin]

I was under the impression that after about 5, 10 (or some other amount of time) years, some forms of patents elapsed, and allowed competitor companies typically reverse engineered the medications to offer generic forms of the same medicine. I'd imagine something that was invented back in 1953 would have a variety of generic forms available, and would basically be commodities at this point.

I dunno, definitely worth learning more, since my understanding of pharma industry appears erroneous.

[drauz]

With the price now high, other companies could conceivably make generic copies, since patents have long expired. One factor that could discourage that option is that Daraprim’s distribution is now tightly controlled, making it harder for generic companies to get the samples they need for the required testing.

[crb]

I was under the impression that after about 5, 10 (or some other amount of time) years, some forms of patents elapsed, and allowed competitor companies typically reverse engineered the medications to offer generic forms of the same medicine. I'd imagine something that was invented back in 1953 would have a variety of generic forms available, and would basically be commodities at this point.

I dunno, definitely worth learning more, since my understanding of pharma industry appears erroneous.

14 years.

But you can still sell the name brand of the drug.

Also, in same cases (rarely) the drug simply costs a lot to make so even if generic it is pricey.

Read the whole post:

So here’s the conflict: companies do (and should) have the right to charge what they think their market will bear. But ordinarily, you’d think that most markets wouldn’t have enough slack in them for a price increase like that one. What we’re seeing is a peculiar part of a generally peculiar market, though. Drug companies are granted a temporary monopoly by the patent system, in recognition of the value of new therapies. Arguing about this tradeoff does not cease, but overall, I think it’s a reasonable system (although one can imagine others, which would involve tradeoffs of their own). But one feature of the existing order is that patents expire (and you’d be surprised how many loud anti-pharma activists don’t seem to realize that). And once they expire, the price comes down as the generic manufacturers get into the market.

That’s how it’s supposed to work, anyway. But in recent years, another strategy has emerged, and Retrophin/Turing are just the most dramatic examples of it. Entire companies have sprung up to take advantage of this sort of leverage – not by discovering their own drugs (too expensive, too risky!) but by buying up existing ones. And the most egregious examples have come in the generic sector. 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.

Your government at work.

It isn't the USPTO it is the FDA causing the problem. Regulations, not Patents.

[time4fun]

The FDA was never created for the benefit of "the people". It is fully equipped to protect the profits of companies, but it has virtually no ability to protect citizens. (Case and point- it is virtually impossible for the FDA to force a food recall)

More to the point though, this is what happens when you don't have a single payer system AND when you have a legal ban on Federal government negotiations with drug companies on prices. Unlike more reasonable countries, our government can't actually step in and fight these kinds of increases. Though I imagine that's not going to be the case much longer. The jackass who pulled this bullshit has likely just enabled some changes that Democrats have been arguing for, for years.

[Whirlin]

Thanks for the clarification viril.

In your opinion, does that make it easier or more difficult to resolve?

[crb]

The FDA was never created for the benefit of "the people". It is fully equipped to protect the profits of companies, but it has virtually no ability to protect citizens. (Case and point- it is virtually impossible for the FDA to force a food recall)

More to the point though, this is what happens when you don't have a single payer system AND when you have a legal ban on Federal government negotiations with drug companies on prices. Unlike more reasonable countries, our government can't actually step in and fight these kinds of increases. Though I imagine that's not going to be the case much longer. The jackass who pulled this bullshit has likely just enabled some changes that Democrats have been arguing for, for years.

I always wonder why people who would seem to hate monopolies always seem to argue FOR one when it comes to healthcare. "If only there was absolutely no competition we'd have a good system!" What wonderful logic. Tell me more about how lack of competition and consumer choice helps quality, service, and affordability?

In your opinion, does that make it easier or more difficult to resolve?

Easier, as a regulation Obama could change it with an XO.

The issue though is that goes against his motivation of more regulation. The FDA has stricter regulations than it used to, they're telling people if they take these old drugs that were approved under a more lax regulatory framework (and have been used safely since) and get them reapproved under the new harder more expensive framework they can get some exclusivity to them. So the company incurs the cost (not insignificant) of doing this, to get the profits of the exclusivity. This is all done under the assumption that there is some value to reanalyzing a drug in use for the last 50 years, that our new more complex regulatory process has value to it. To do away with this would in a way be inferring that there isn't much value in the new framework vs the old framework, which is antithetical to people who believe more regulation is the answer to most things - and also to anyone who works in regulatory compliance (the FDA itself). It is more or less them saying "Our job is not that important."

I'm not sure Obama could wave his wand and reneg on exclusivity already granted, but he could wave it and stop future deals. Of course then no one will bother retesting old drugs to make sure they're still safe under the new rules... as if it were the rules and not the underlying biochemical facts, that make something safe or not.

He also has a political motivation NOT to do this, the same way he has one not to try to fix immigration.

[Androidpk]

Fuck this guy, I hope he gets ass cancer.

[drauz]

I think this is the guy from the other thread in this forum Vanmar from DR.

[Taernath]

Saw this the other day and wanted to believe it was an Onion headline.