There are really two villains here, Mylan, of course, but more importantly, the FDA. FDA regulations make the cost of bringing a new medical device to the market absurd. There are no competitors because the time and effort to bring a competing device is so ridiculously high that it doesn't pay to do so.
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.
So, The FDA, because they require drug and device makers to demonstrate efficacy and safety by going through a rigorous clinical trial process, are evil? Really?
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.
> So, The FDA, because they require drug and device makers to demonstrate efficacy and safety by going through a rigorous clinical trial process, are evil? Really?
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 $1 syringe can save a life. It is offensive that the FDA thinks it should get in the way of the distribution of such things.
I was in Colorado last summer and took my son horseback riding. Our tour guide was allergic to bee stings, but she was just scraping by financially, and couldn't afford an Epipen. She'd been stung before, and her throat had tightened, but fortunately she happened to have an old, expired pen from before the price went up and so she survived. But now she was going out bare. We gave her one my son's pens. It won't last long. It's possible that she won't last long either.
You want evidence this is an evil system? There it is.
I don't really think you know all the history here. There are other companies who have/are attempting to create competitors to EpiPen. A few of them weren't able to get passed by the FDA, and one of them passed the FDA in 2012 but was recalled because of the product misfiring. The EpiPen problem seems to be much less an FDA problem then it is a problem with manufacturing, other companies don't seem to be able to make products that work nearly as well as EpiPen. If the FDA wasn't in the picture, you would still have the problem that there aren't any other reliable replacements for EpiPen even though companies have tried.
IMO, I also don't see how your solution would solve any real problems. People shouldn't have to ask themselves "Do I buy the one that is 600$ 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?"
What about buying 5 of them that are $20 bucks a piece? Maybe they can be made in a stackable format, so it would be easy to carry 5 of them. If one misfires, snap it off and use the next one in the stack.
That only works if you can actually tell if it misfired or not - if you're administering it to someone else, you may simply not be able to. With that, part of the problem was that the misfires would deliver some of the drug but not all, and only sometimes would completely fail to deliver any of the drug. Telling if you got 50% vs. 100% would probably be tough - and even if you could, if you took two because the first gave you 50%, you might end-up getting a big overdose or still get an underdose. So having multiple of those pens really just doesn't solve the problem if the pens themselves are unreliable.
> a $10 bottle of epinephrine and a $1 syringe can save a life
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.
> In the case of Epipens, there's little risk, because epinephrine is an old, widely-used drug.
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.
> 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?
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.
> The price of these drugs is directly linked with the risk*cost of being sued
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.
The workers ("staffed") in the FDA are (mostly, probably) people who want to help but the bureaucrats in charge are part of the political system (e.g. lobbyists, political insiders, etc.). I think you're conflating the workers of the FDA with the people who, ultimately, guide it and make decisions.
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.
Approval and other decisions in the lifecycle of a drug (it's entire fate basically) are made by committees and panels of physicians primarily. The FDA does it's job well in my opinion and they use a panel system to make sure that no single pipeline / process ensnares a treatment:
http://www.fda.gov/AdvisoryCommittees/
It's a really difficult balance to strike with the FDA. Too strict and you get situations like this, too lenient and you get thalidomide. It's hard to come up with a single set of rules that will rush forward all good, effective medication, block all dangerous medication, and continue to do so despite constantly changing technology and understanding.
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.
Exactly! I wouldn't want to be working at the FDA to be honest. On one hand you get blamed when an unsafe drug hits the market and the next day get blamed because you're holding up innovative.
I'm sure the FDA could be more efficient, but isn't a large part of the difficulty intrinsic to bringing a safe and effective device to the market? The flip side of people dying from not having an Epipen is people dying because their generic Epipen didn't work.
So allow devices to be labeled as "FDA approved" or "not evaluated by the FDA". Customers who value the FDA approved status can purchase those products. Customers who are comfortable determining the efficacy of a product via other means can purchase the non-evaluated products.
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.
Obamacare is driving regional healthcare provider consolidation as well as insurer consolidation.
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.
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.