The FDA and Congress share the blame for outrageous EpiPen prices—commentary

The FDA and Congress share the blame for outrageous EpiPen prices—commentary: "Let's take a little journey down memory lane so that Iowa Senator Chuck Grassley, Presidential Candidate Hillary Clinton and Mylan's contemplable board can get on the same page!

When George Calkins and Stanley Sarnoff invented the EpiPen forbearer in 1973, they acknowledged that their ideas were improvements upon work commissioned for the U.S. and U.K. military emergency medicine needs in the 1960s! That the U.S. Patent Office granted their patent in 1973 was, at the time, a bit of a stretch as it was more about a mechanical design improvement – not a real invention. This technology, used in the military and in EMS kits around the world was the basis for their company.

As the U.S. government was a principal buyer of anaphylaxis injector pens and funded a considerable amount of the technical improvements thereto, the U.S. government has march-in rights to use the technology at a reasonable commercial royalty rate it can set!

The U.S. government's EpiPens don't cost $608 per unit. Meridian Medical Technologies – the Department of Defense's supplier of the actual EpiPen (owned by Pfizer) – sell the same technology dispensing numerous anaphylaxis drugs to the U.S. government for under $50 a unit.

Epinephrine, the drug in the EpiPen has been off patent for decades. It's the dispenser — the actual injection pen — that's covered by a patent (U.S. Patent 7,794,432) that Meridian received and then licensed to Mylan (and others).

And let's face it, Congress knows about this. The FDA knows this. And the reason why Mylan gets away with this – just like they get away with incorporating out of the U.S. using the dubious inversion strategy for tax efficiency – is because powers that be love to provide liquidity to their benefactors!

The U.S. Patent Office and the U.S. Food and Drug Administration have given Mylan license to extract excessive benefit from public that needs treatment options. Pfizer's Meridian Medical is cruising along under the radar with a very clear statement on their website stating that their technology is "Available only for use by United States military personnel." And Sarah Jessica Parker is keeping the Hollywood face on the whole racket unaware that what she's encouraging parents and school districts to do is really to enrich a dubious corporation while preying on real public fear."



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