Why haven't competitors entered the market with cheaper products?
[1] http://www.windgapmedical.com/ [2] https://www.auvi-q.com/ [3] http://www.fiercepharma.com/sales-and-marketing/fda-swats-do...
http://www.adrenaclick.com/how_to_use_adrenaclick_epinephrin...
Some people apparently decide to buy vials of epinephrine and manually fill a syringe.
http://www.consumerreports.org/drugs/can-you-get-a-cheaper-e...
It sounds like it's harder than we might think to make this work.
Given that, and the low volumes, it might not be that profitable even at $600 per sale.
Consider the typical failure rate of ball-point pens. That's consumer-grade injection molding.
[1] http://www.advancedmt.com/wp-content/uploads/2012/10/amt_med... [2] http://www.vision-systems.com/articles/print/volume-9/issue-...
I have a child with a peanut allergy. I am worried every damn day of my life. I see articles about people who die every year because they didn't have an Epipen handy. The numbers of people who die will increase. I want to see FDA bureaucrats hauled to those funerals so they can see what they've done.
I also find your comment pretty uninformed considering that the FDA just paved the way for generic drug makers to basically "knock-off" super expensive biologic drugs like Humira and Enbrel which were previously covered by similar patents.
The FDA has it's problems - but to say that it is an agency staffed by people who don't care ("bureaucrats") who typically have both Ph.D and M.D.s and have dedicated their careers to ensure patients have safe and effective medicine is unfair.
edit: grammar.
Yes, if the process is so rigorous and expensive that it drives the cost of drugs beyond the reach of people who need them, and it hampers the effective functioning of the free market. And I think it's widely accepted that's far more expensive to bring a drug to market here than it is elsewhere in the world.
The FDA believes its mission should be to ensure that drugs are safe and effective. That is wrongheaded. Instead, it should undertake a rational risk/benefit approach. Rather than saying that no drug gets through the filter unless it's safe (as demonstrated through reams of evidence), it should ask, how much risk should we tolerate in exchange for how much benefit?
In the case of Epipens, there's little risk, because epinephrine is an old, widely-used drug. There is some risk that it will be mis-administered by a less-than-perfect device, but the fact is that a $10 bottle of epinephrine and a $1 syringe can save a life. It is offensive that the FDA thinks it should get in the way of the distribution of such things.
I was in Colorado last summer and took my son horseback riding. Our tour guide was allergic to bee stings, but she was just scraping by financially, and couldn't afford an Epipen. She'd been stung before, and her throat had tightened, but fortunately she happened to have an old, expired pen from before the price went up and so she survived. But now she was going out bare. We gave her one my son's pens. It won't last long. It's possible that she won't last long either.
You want evidence this is an evil system? There it is.
IMO, I also don't see how your solution would solve any real problems. People shouldn't have to ask themselves "Do I buy the one that is 600$ with a 100% success rate, or the one that's 100$ with a 95% success rate?". That sounds like a pretty bleak state of affairs, and could easily encourage cutting corners to cut costs. "How much does a death cost us?"
You're not prevented from using that method and some people and a lot of emergency services (that have relevant training) do. There are problems with that too though, epinephrine isn't completely stable and properly injecting when you or someone you know needs the shot isn't an easy task.
What the FDA is and should prevent are devices like the Auvi-Q that couldn't inject the proper amount reliably.
Well one risk is that you'll jam the thing into your thigh and get no epinephrine, because the injection mechanism failed. If this happened to your son, and he died, would you take that outcome serenely? This is what the FDA is trying to prevent.
> There is some risk that it will be mis-administered by a less-than-perfect device, but the fact is that a $10 bottle of epinephrine and a $1 syringe can save a life.
Then buy the bottle and syringe. The FDA is not, to my knowledge, preventing people from doing so. It's not as easy or reliable as an auto-injector, but it's also a lot cheaper, so it seems the system is already providing an alternative. There is also at least one other auto-injector on the market besides EpiPen. Again--not as easy to use, but cheaper.
Do you really believe the FDA isn't doing this? The price of these drugs is directly linked with the risk*cost of being sued. In order to reduce the cost of the drugs, we need to reduce the benefits of suing, but this will undoubtably upset libertarians. Can't please everyone.
Generally, prices are set to whatever will maximize profit. In the 'free market', nobody with any sophistication prices things based on cost. It's a fundamental of microeconomics.
This isn't to say the leadership of the FDA is compromised by or somehow beholden to "Big Pharma" or some such. I certainly wouldn't disagree that we need rigorous demonstrations of efficacy and safety for medicines and devices, but I question in what manner and capacity the FDA is actually structured to pursue that end.
Clearly the epipen thing is a huge problem, and if the FDA can fix it, they need to do so ASAP or be ordered to do so by Congress. But I'm hesitant to say that their only motivation is petty bureaucracy.
They can't win!
If no one purchases the non-evaluated product then the market will have spoken and the non-evaluated products will disappear. On the other hand if the non-evaluated products are successful then the market will have provided a better product.
what I see is an unholy alliance between the regulators and industry to extract max profits.
if you don't have an approving authority for e.g. Epipens, it seems to be that you get something like the supplements industry which is mostly marketing and exploiting the ignorant. you need some IP protection for the crazy amount of incredibly skilled R&D and massive testing that goes into an Epipen but this is ridiculous.
drug and medical device companies merge for maximum market power vs. insurers, who try to merge for maximum market power against drug companies and doctors/hospitals.
eventually you'll have just one insurer and one drug company and one hospital company and you can nationalize the whole thing.
just kidding, but I see Obamacare failing if it can't evolve, prices continuing to go up, and eventually everyone demanding a single-payer solution.
As drug innovation has slowed, single payer US healthcare will be the solution to these problems. Nationalize some/all of the provider networks and drugs like this become built to spec government bids where buying power drives cost down.
They actually had a very innovative product. It was much smaller than the EpiPen and used voice prompts to tell you how to administer the drug (people in the heat of the moment sometimes don't remember to leave the EpiPen in long enough for a proper dose to be fully administered). I'm frankly mystified how they botched things so badly that they had to pull the product.
Either way, I have trained and informed myself on the proper use of the generic Adrenaclick auto-injector. From what I gather, the main differences are that there are two safety covers on both sides of the injector (instead of a cover on just the non-needle side) and the method of determining whether a dose was supposedly administered correctly (mainly, the EpiPen's needle cover is extended vs just observing an extended needle on the Adrenaclick). I am left to presume that their therapeutic effectiveness is the same, even though the FDA may not explicitly declare it as so. I will consult my physician and current pharmacist (local, non-chain pharmacy with excellent focus on patient care) to determine if I have any misunderstandings.
I have also trained the people most likely to administer epinephrine to myself (family, friends, coworkers) the particular procedures of Adrenaclick administration, so I am not too worried about procedural differences between EpiPens and my generic auto-injector.
Still, I am left wondering what the therapeutic difference between an EpiPen and a generic Adrenaclick alternative really is. I do understand that different administration procedures are a problem for training, but I would expect the actual therapeutic effects of both auto-injectors to be similar --- if used administered according to directions.