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FDA Approves First Generic Version of EpiPen (go.com)
An anonymous reader quotes a report from ABC News: The U.S. Food and Drug Administration has approved the first generic version of the EpiPen and EpiPen Jr auto injector for the emergency treatment of allergic reactions. The approval is part of the FDA's "longstanding commitment" to providing access to low-cost generic alternatives, FDA Commissioner Scott Gottlieb said in a statement. It is unclear how much the generic product -- manufactured by Teva Pharmaceuticals -- will cost. In August 2016, Mylan Pharmaceuticals was criticized for raising the price of a two-pack of EpiPens to $600. The price of two EpiPens was about $100 in 2009. The brand name version is by far the most popular epinephrine auto-injector on the market. "This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," said FDA Commissioner Scott Gottlieb in a statement.
Natural monopoly by the incumbent.
Generic: "Hey, we could make generic Epipens for about $100 each. The brand name costs $600. Let's sell them for $200 and undercut"
Incumbent: (Cuts price to $100. Eats small loss per unit)
Generic: (Goes bankrupt)
Incumbent: (Raises price back to $600, recoups losses)
In part because the FDA requires each producer to re-test the proven design so much to prove it really is exactly like the already approved one that it's almost as expensive as introducing something new, but with a lot less potential for profit.
Then you get overly specific legislation like when schools are required to have $600 epi-pens on hand rather than $10 pre-filled with epinephrine syringes.
I'm not so sure it'd be appropriate to call a medical product 'popular' when the only reason it makes its sales is because up until now they were the only ones legally allowed to produce this life saving device in the US.
It's not like Mylan raised the price of their epipens to 600 bucks because they're the Apple of EpiPens here. People either had to cough up the cash or die. Consider that an EpiPen costs $30 to manufacture. (yeah yeah sure, there's shipping costs and the like. But I'm pretty sure they weren't using SpaceX to ship their EpiPens from Pensylvannia, to the rest of the US)
I think you're forgetting the part where the government forbids the sale of the generic completely. As has been the case up until now.
Also, if this were a common and accurate portrayal of events, why am I able to buy generic versions of many other types of drugs and medications? Shouldn't this have happened in ever other instance as well?
Jeebus, I can understand not knowing how the process works, but really you can't make it past the damn headline without incorporating the relevant information ?
FDA Approves First Generic Version of EpiPen
That is why there was no generic on the market, none were improved. Now if you want to go poking fingers about how horrible the system is, the CEO of Meylan (Heather Bresch) is Joe Manchin's daughter and oddly enough the FDA has been curiously well disposed towards his little girl's company
http://fortune.com/2016/09/07/...
Oh and he's a Democrat by the way, something to remember the next time they promise free healthcare.
part because the FDA requires each producer to re-test the proven design so much to prove it really is exactly like the already approved one that it's almost as expensive as introducing something new, but with a lot less potential for profit.
As someone who has done this repeatedly, I can tell you that proving equivalency is an order of magnitude cheaper than proving a new design.