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.
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.