Posted on 08/25/2016 11:26:30 AM PDT by amorphous
Once again, the government creates a problem that only they can provide a solution to.
How many EPI-PENS could have been given to poor people for the $250,000.00 that she gave to the Clinton Crime Family Slush Fund????
Anyone that pays anything for insurance pays for it.
So why can't someone manufacture an auto-injector using the old design with the expired patent? That should only cost about $50 out-of-pocket.
The corporation is the one raising the price not the FDA. The problem is not the lack of competition but the disparity in negotiating power. Let every libertarian go to the corporation and say I want to negotiate the contract of sale for your product. The B*stards running the drug companies are screaming “Regulate my Prices, I can’t control myself!”
There is a similar article on today’s WSJ opinion page.
Instead of government discouraging monopolies by enforcing Anti-Trust laws, they now openly embrace monopolies.
The CEO of the company that owns EpiPen is the daughter of a US Senator! Surprise! And FedGov just mandated that schools MUST have these on hand.
So we have FedGov killing competition, mandating sale, and allowing price hikes.
And we STILL won’t vote these people out.
Corruption is out of control. Follow it and one always finds a path to the Clinton Foundation.
The conductor of this symphony is Obamacare.
I could smell this back-of-the-story from miles away. No one could introduce these kinds of increases unless they were an approved monopoly. The old concept of the “Peter Principal” also applies as the price kept increasing until the screams were no longer able to be kept quiet.
That was my thought as well. (the old design thing.)
I declare a fatwa on Joe Manchin and his daughter and indeed anyone on the board of that company.
The “old” design of the epi pen is obsolete.
These injectors are driven by springs and plastic parts.
Older designs had springs that did not always deliver the required force to make the plunger move inside the syringe cartridge inside the injector.
Auto-injectors function because the spring energy expels the contents of the syringe into the body.
The FDA has imposed tighter and tighter regulations on “combination” products that combine an injectable product with a device that allows delivery of the drug.
These combination rules require the creation and maintenance of “Device Design and History Controls” that provide documented evidence of validation for the product.
I have been in Pharma for almost 40 years and regulations just get harder and harder to achieve. The amount of $$$ that we in Pharma spend to meet FDA and other world regulatory rules is often prohibitive. If a company cannot absorb the cost, the pass it on in the piece price of the unit.
Finally, the reimbursement schedules for devices is another regulatory maze that prohibits competition as most companies will stop making the product instead of putting millions of $ into an old product.
END
G
“I have been in Pharma for almost 40 years and regulations just get harder and harder to achieve.”
I know nothing about pharma :-). Absolutely nothing :-).
Is there some kind of minimum velocity a medication must enter the body (i.e. mL/seconds)?
If not, I can’t see why a micro-electromechanical delivery system can’t do the job (I’m an EE). There are lots of different technologies out there (check out MEMS if you are curious) where, under a simple microprocessor’s control, deliver the medication. It’d probably be cheap enough to put redundant MEMS systems in the pen given the task of the pen and it’s life saving properties.
The only drawback is that it might not deliver the medication at a fast enough rate into the body (though that can be addressed).
What’s slick about MEMS is that you can integrate the digital control onto the same die as the mechanical system. This translates into a huge cost savings manufacturing the control system. Moreover, they’re a heck of a lot more reliable.
I’d have to dig into the problem more, but I can’t see, offhand anyway, why this medication can’t be delivered electromechanically in a simple pen form.
The military has been using auto-injectors for decades for things like atropine. If it’s good enough for them it should be good enough for civilians.
I think the Israelis make an auto-injector that was submitted to the FDA for approval. I wonder what’s happening with that?
I don’t have time to read the article, but the design of this epipen has not changed in a long time. They used to be available for $75 no insurance. The last time I went to refill one, it was going to be $230 out of pocket after the insurance discount for a pair of them.
I purchased empty syringes, needles, and epinephrine in sterile vials for around $25 per setup, and these babies pack around 2ml of medicine, enough for spills, and multiple 0.3ml rounds of injections as needed.
Who needs a spring?
And 2-Pam Chloride auto injectors. :)
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