5 ms·

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

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.
  - hackuser 10y ago
    > 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.
- DSMan195276 10y ago
  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?"
  - derekp7 10y ago
    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.
sidlls 10y ago
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.
- dfsegoat 10y ago
  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/ http://www.fda.gov/AdvisoryCommittees/

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.
- hackuser 10y ago
  > 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.
DSMan195276 10y ago
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?"
- derekp7 10y ago
  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.

sidlls 10y ago

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.

dfsegoat 10y ago
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/ http://www.fda.gov/AdvisoryCommittees/