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Feds Go After Mylan For Scamming Medicaid Out of Millions On EpiPen Pricing (arstechnica.com)
An anonymous reader quotes a report from Ars Technica: Over the nine or so years that Mylan, Inc. has been selling -- and hiking the price -- of EpiPens, the drug company has been misclassifying the life-saving device and stiffing Medicaid out of full rebate payments, federal regulators told Ars. Under the Medicaid Drug Rebate Program, drug manufacturers, such as Mylan, can get their products covered by Medicaid if they agree to offer rebates to the government to offset costs. With a brand-name drug such as the EpiPen, which currently has no generic versions and has patent protection, Mylan was supposed to classify the drug as a "single source," or brand name drug. That would mean Mylan is required to offer Medicaid a rebate of 23.1 percent of the costs, plus an "inflation rebate" any time Mylan raises the price of the brand-name drug at a rate higher than inflation. Mylan has opted for such price increases -- a lot. Since Mylan bought the rights to EpiPen in 2007, it has raised the price on 15 separate occasions, bringing the current list price to $608 for a two-pack up from about $50 a pen in 2007. That's an increase of more than 500 percent, which easily beats inflation. But instead of classifying EpiPen as a "single source" drug, Mylan told regulators that it's a "non-innovator multiple source," or generic drug. Under that classification, Mylan is only required to offer a rebate of 13 percent and no inflation rebates. It's unclear how much money Mylan has skipped out on paying in total to state and federal governments. But according to the state health department of Minnesota, as reported by CNBC, the misclassification cost that state $4.3 million this year alone.
The company claimed on official government forms for multiple years that the drug is a generic. Make it so. Job done. The government can do that.
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ban drug ad's on tv!
Cynicism makes you feel powerful eh? You're pitiful.
Your math is off "$608 for a two pack" means $304 per pen. Compared to $50 per pen that is a 6-fold change equal to a 500% increase (500% + 100%).
If the pharmacist can't substitute the Adrenaclick for an EpiPen, then EpiPen isn't generic.
The real "Libtards" are the Libertarians!
Epinephrine is old and is or should be generic. The auto injector is a drug delivery system, and should I think be treated separately.
It could deliver any injectable drug no?
That there are no effective competitors to Mylans EpiPen reeks of impropriety.
This is capitalism at its finest. Every capitalist wants government mandates and protection for its monopoly. More money that way. When poor people get money from the government it is socialism, and when big business gets money from the government it is capitalism?
With the patent system as it is, where genetic codes and proteins can be patented, and where protection for drug profits is long and deep, there are situations like this that come up that allow unscrupulous companies to hike drug costs ridiculously like these clowns at Mylan.
Yes, many drug research efforts don't pan out. But Epinephrine has been out for a long time. Is anyone seriously going to try to tell me that $50 in 2007 became $304 in 2017? Even given the bogusly low inflation rates that are officially reported, that's insane.
This is profiteering. If the company didn't need to profiteer in 2007, why do they in 2017? No good reason methinks.
How about the definition of sole source is 'no equivalent product available at present'?
And how about you cap the rates at which drug costs can increase unless the providers can show material evidence that their costs have escalated so much?
I don't have $608 to shell out (US) for something I have to replace every 1-2 years. I'm carrying an old epi-pen that's probably not as efficacious now, but it's likely still better than no pen. I just can't afford the money to get a new one (let alone two, since protocol says you hit yourself with the first and about 30 minutes later the second if you haven't reached emergency medical care).
This should be a true generic. There should be equipment whose patents have an earlier mandatory expiry because they exist in the space called 'in the interest of public health'. I'm not suggesting these guys shouldn't have got their money back, but seems to me they are well beyond that point now.
On the other hand, this is exactly why the government or NGOs should be investing in some sorts of medical research in the public interest and making the product patents entirely open and available.
Epinephrine isn't patented. Its the injector. This seems like the kind of thing a Gates Foundation or even the Government could underwrite the development of (and may have already for Atropine and the like in prior days, if we call those syrettes an early version). Make the injector patent available and then it truly is generic because epinephrine is not patented.
The reality is that big Pharma has great lobbyists, political connections, and lawyers and the whole US patent system around biomedical issues defies any sort of common sense or rational thinking.
I hear rumours of alternatives, but I'm not sure they are available beyond the US borders. The Epipen fiasco and the price rise has hit many of us living in other countries too, but I'm not sure any alternatives exist where I live. I am going to look into that now though.
Patents should help protect innovation, but not form monopolies artificially (well, that may be other legislation that does that but that also needs looked at), should not have extensive duration, and should have clauses surrounding medical equipment that if the equipment price rises too quickly or if the provider becomes sole source, that the patent becomes licenseable by other companies for a very modest fee. At some point, the public interest has merit at least as great as profits for corporations.
-- Mal: "Well they tell you: never hit a man with a closed fist. But it is, on occasion, hilarious."