Slashdot Mirror
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 $4.3 million this year alone.
Make your own EpiPen clone, the EpiPencil.
The company claimed on official government forms for multiple years that the drug is a generic.
The drug, epinephrine, is generic. It is adrenaline, which your body produces naturally. There is no patent stopping generic injectors, but so far none have been approved by the FDA. Teva submitted an injector, but the FDA denied approval for reasons that are not clear.
Or, it could be not malice, but mere stupidity.
It seems there's been a series of unfortunate events affecting Mylan's competitors:
Will anyone ever give Mylan’s ($MYL) blockbuster epinephrine injection, EpiPen, a run for its money?
That’s the question now that another potential competitor is out of the running. The FDA stiff-armed Adamis' ($ADMP) prefilled epinephrine syringe, asking for more data. Regulators want the San Diego-based company to expand a patient usability study and product stress testing studies included in the original application.
The way Evercore ISI analyst Umer Raffat sees it, Adamis’ product wouldn’t have been “a large competitor” for EpiPen, given the difference between its prefilled syringe and Mylan’s more convenient injection pen device. But “Adamis could have added to managed care pressures,” through its stated strategy of acting as a discounted product.
Instead, Mylan is home free--a status it must be getting used to, given the failures that have repeatedly befallen its competitors. Back in November, Sanofi's ($SNY) Auvi-Q hit a wall, when an injector fault triggered a hefty recall. Ultimately, the pharma giant yanked Auvi-Q from the market, and then bailed on its marketing partnership with developer PDL BioPharma ($PDLI), putting the med’s future up in the air. It was EpiPen's first real challenger in years.
More recently, the FDA handed generics giant Teva ($TEVA) a rejection for its generic version of EpiPen, flagging “certain major deficiencies” in its letter to the Israeli pharma. With serious issues to work through, Teva said earlier this year that it expects its product to be "significantly delayed"--meaning it doesn’t expect a rollout before 2017.
The FDA wouldn't have anything to do with the recall, and a request for more information isn't really a particularly effective use of corrupt power. Requests for more data happen all the time, so they're usually turned around pretty quickly. My money's on a perfect storm of chance events, and Mylan's taking the opportunity to capitalize on it.
You do not have a moral or legal right to do absolutely anything you want.
The drug, epinephrine, is generic. It is adrenaline, which your body produces naturally. There is no patent stopping generic injectors, but so far none have been approved by the FDA.
Yes, they have. Adrenaclick's been on the market (with FDA approval) for 5+ years, and costs like 1/4 what Epipen does.
http://www.consumerreports.org...
rage, rage against the dying of the light
That CEO was basically given a degree because of her father's political ties. https://en.wikipedia.org/wiki/...
Only the State obtains its revenue by coercion. - Murray Rothbard
The company claimed on official government forms for multiple years that the drug is a generic.
The drug, epinephrine, is generic. It is adrenaline, which your body produces naturally. There is no patent stopping generic injectors, but so far none have been approved by the FDA. Teva submitted an injector, but the FDA denied approval for reasons that are not clear.
The patent on epinephrine expired Sep 11, 2005. Basically, the Epipen is a mechanism for delivery of the drug which could easily be likened to a simple auto-injection procedure or as it was known during the Second World War a Syrette .
Yes, why don't we patent a device known for over 60 years, put a new coat of paint on it and (this is the most important part) wrap it up in legalese so that professional people who are supposedly peers have no idea what the new patent is about and get rich. It does help if a few palms are greased as well.
There ain't no such thing as proprietary standards only proprietary formats. Standards are by definition open.
That list of problems with competitors fails to mention Impax's Adrenaclick, which has been FDA approved and sold in the US market freely since 2010; it's widely available (it's sold at Rite Aid, Walgreens, CVS, Walmart, Target, etc) and much cheaper than EpiPen.
rage, rage against the dying of the light
The UK NHS net prices for the 3 alternatives approved in the UK are:
Emerald (iMed) £26.94
EpiPen (Meda) £26.45
Jext (ALK-Abelló) £23.99
(aproximately US $30 to $35)
https://www.evidence.nhs.uk/formulary/bnf/current/3-respiratory-system/34-antihistamines-hyposensitisation-and-allergic-emergencies/343-allergic-emergencies/anaphylaxis/adrenalineepinephrine
Meanwhile, in the civilised world, our govenments negotiate huge bulk discounts, and prescrition drugs are subsidised to a fixed maximum.
The best part, we spend less per capita than the US on healthcare. Go figure.
Nope it depends on the state you live in and its Board of Pharmacy rules. In this state the written prescription must match the drug issued. Period. For example if a Dr writes a script for Diovan for high blood pressure. Most insurance will not pay for the brand name drug. The pharmacist will talk to the patient then call the Dr and ask for a new script to be issued for the generic Valsartan. If the Dr says the Brand must be used. The Dr will do all of the "medically necessary" paperwork for the insurance co. The pharmacy just waits for the insurance co. to OK the charges online. 95% of the pain and time working in a pharmacy is dealing with the insurance companies.
Good friend owns a pharmacy and at one time I had a pharmacy technician license.