3 ms·

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 marke

by ccleve 10y ago

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.

RockyMcNuts 10y ago
hmmh... what's the reg, specifically? 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.
- Spooky23 10y ago
  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.
dfsegoat 10y ago
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. edit: grammar.
- baddox 10y ago
  There's a big difference between "rigorous" and "prohibitively expensive."
- ccleve 10y ago
  > 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.
  - bottled_poe 10y ago
    > 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.
PhasmaFelis 10y ago
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.
- refurb 10y ago
  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. They can't win!
alecdbrooks 10y ago
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.
- gwright 10y ago
  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.

by ccleve 10y ago

RockyMcNuts 10y ago

hmmh... what's the reg, specifically? 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.

Spooky23 10y ago
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.

dfsegoat 10y ago

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. edit: grammar.

baddox 10y ago
There's a big difference between "rigorous" and "prohibitively expensive."
ccleve 10y ago
> 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.
- bottled_poe 10y ago
  > 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.

PhasmaFelis 10y ago

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.

refurb 10y ago
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. They can't win!

alecdbrooks 10y ago

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.

gwright 10y ago
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.