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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.

5 of 136 comments (clear)

  1. Re:Yahoo! Epi For all! by jeff4747 · · Score: 4, Insightful

    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)

  2. Re:Yahoo! Epi For all! by sjames · · Score: 4, Insightful

    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.

  3. Win the battle, lose the war by psychic_bacon · · Score: 3, Insightful

    This is just another example of the absurdity of prescription drugs. Obviously there's no reason for Epi Pens to be that expensive, since they weren't that expensive long ago. The real reason for the expense was because a lot of places were required to buy them. Kids are allergic to everything these days (seriously), and so schools need to have epi pens. Would you send your toddler to a preschool without an epi pen? Think of the children! So that cost could be hidden in the budget of "safety" for schools. If you were a consumer, you could avoid them. I had allergy shots and my provider gave me an epi pen prescription. I didn't really need it, but it was in the 1 in a 1000 chance I had a reaction when I wasn't around. But she also gave me a coupon to make it go down to a reasonable cost. But now there's an outcry about this absurdity, and so we get another option. This fixes the tiny problem, allows the drug companies to still make handfuls of money, and no one talks about what is really needed in the US: the government as the only buyer of drugs. If drugs are such that there is only one supplier, with patent protections that give a monopoly on production, there should be a single buyer, that would negotiate an acceptable price, and then this buyer sells to all pharmacies at cost, which leads to an equitable distribution.

  4. "Popular" by MoralCharacter · · Score: 4, Insightful

    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)

  5. Now do Insulin by SuperKendall · · Score: 3, Insightful

    Apparently Insulin has shot up in recent years. It seems crazy it should cost much at all, it's been made forever...

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