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This sounds like it will be an absolute disaster: "This act would also create a new, faster approval process for “breakthrough technologies” that are believed

This sounds like it will be an absolute disaster: "This act would also create a new, faster approval process for “breakthrough technologies” that are believed — but not necessarily proved — to offer significant advantages over existing alternatives. This would allow a device to be approved based on even lower standards of evidence than are currently used, on the theory that the need outweighs the risk. The legislation defines “breakthrough” loosely, creating a perverse incentive for manufacturers to use this term both to take advantage of the faster approval process and as a marketing gimmick."

digitalneal 11y ago
Right. Then the FTC/BCP will swoop in with massive $$$ lawsuits over unsubstantiated claims.
refurb 11y ago
Sounds like a relatively biased article. "Breakthrough therapy" designation already exists for drugs. The FDA identifies those drugs that have shown promising results in early trials for diseases where there are few treatments. The reason this is being done is because the choice isn't between an untested treatment and a tested treatment, it's a choice between an untested treatment and death. Why shouldn't physicians/patients be given an opportunity to try out a therapy when no alternatives exist? Obviously (and the FDA already does this), the risk/benefit should be carefully analyzed. It makes no sense at all to allow a device on the market with little data if it doesn't provide a substantial benefit where none currently exists. Concerning the follow-up trial that the FDA requires of manufacturers: I'd have no problem at all if the FDA provided "temporary approvals". You're device/drug looks promising, so we'll approve it now, but you need to run a full trial to provide the needed data. That trial will take 2 years to conduct and readout? Great, you now have a 2-year temporary approval and if the data doesn't show up, we pull your device/drug off the market.
- navait 11y ago
  > Sounds like a relatively biased article. It's an op-ed. The entire point is that it's biased.
HeyLaughingBoy 11y ago
Having been in the Medical Device industry for the past 20 years, I read the article thinking I was going to disagree with you completely. Now I'm not so sure. This is farther than I would have expected the FDA to go. I can see releasing a device without full clinical trials, because those can be extremely difficult to set up and can create very long delays. Imagine having to find a large enough number of people with just the right disease state and who consent to be part of the group, then getting the right control groups, building relationships with labs and hospitals in the right places, etc. But shifting reponsibility from the FDA to a third party is something I'm not sure I'm comfortable with. There's lots of precedence: nobody ships their devices off to the FCC for emissions testing, there are independent labs that sign off on that. Likewise companies such as UL that set safety requirements, have been around for decades. But as much as we bitch about the hoops we have to jump through to keep the FDA happy, I think deep down we're all glad they are there to do the job and keep us honest. The moderating influence is that device manufacturers as a group are generally extremely, repeat extremely, conservative. The Quality Assurance engineers are generally a brick wall that have to be completely appeased before they will allow anything to be released.
- seehafer 11y ago
  "But shifting reponsibility from the FDA to a third party is something I'm not sure I'm comfortable with." This is exactly what happens in Europe, though. And it's one of the reasons we generally release products there first.
fnordfnordfnord 11y ago
>This sounds like it will be an absolute disaster: It does; but isn't the status quo also an absolute disaster?
- AnimalMuppet 11y ago
  No, IMHO. The status quo is an attempt to walk a knife-edge ridge with cliffs on both sides. There are failures on both sides, and different people getting burned by the failures on each side. Both groups decide that the status quo is an absolute disaster, but disagree on which direction the disaster is.
  - fnordfnordfnord 11y ago
    Your statement seems to be a bit self-contradictory, or else I've read it wrong. So you agree that the status-quo is bad, but you think that almost anything else would be worse? I notice in another reply ITT you stated that you were once employed in engineering medical devices and left that line of work because of the "horrible environment". That's another anecdote I'd use to support my opinion.
    - AnimalMuppet 11y ago
      > So you agree that the status-quo is bad, but you think that almost anything else would be worse? I think the status quo is a trade-off between too easy and too restrictive. Too easy kills people; too restrictive kills different people. Saving more of one set of people almost automatically means killing more of the other. Re the horrible environment: It was horrible in that we didn't (at the time I was there) have much automation to handle the FDA documentation requirements. (Don't think the standard "document your code" here; FDA requirements are much more than that.) The result was a mass of manual paperwork for the software engineers, which (at least for this one) is a horrible environment to work in. It got better after I left, as they got more tools to help them. > That's another anecdote I'd use to support my opinion. But I don't see it as supporting your opinion, and I'm the guy it happened to.

digitalneal 11y ago

Right. Then the FTC/BCP will swoop in with massive $$$ lawsuits over unsubstantiated claims.

refurb 11y ago

Sounds like a relatively biased article. "Breakthrough therapy" designation already exists for drugs. The FDA identifies those drugs that have shown promising results in early trials for diseases where there are few treatments. The reason this is being done is because the choice isn't between an untested treatment and a tested treatment, it's a choice between an untested treatment and death. Why shouldn't physicians/patients be given an opportunity to try out a therapy when no alternatives exist? Obviously (and the FDA already does this), the risk/benefit should be carefully analyzed. It makes no sense at all to allow a device on the market with little data if it doesn't provide a substantial benefit where none currently exists. Concerning the follow-up trial that the FDA requires of manufacturers: I'd have no problem at all if the FDA provided "temporary approvals". You're device/drug looks promising, so we'll approve it now, but you need to run a full trial to provide the needed data. That trial will take 2 years to conduct and readout? Great, you now have a 2-year temporary approval and if the data doesn't show up, we pull your device/drug off the market.

navait 11y ago
> Sounds like a relatively biased article. It's an op-ed. The entire point is that it's biased.

HeyLaughingBoy 11y ago

Having been in the Medical Device industry for the past 20 years, I read the article thinking I was going to disagree with you completely. Now I'm not so sure. This is farther than I would have expected the FDA to go. I can see releasing a device without full clinical trials, because those can be extremely difficult to set up and can create very long delays. Imagine having to find a large enough number of people with just the right disease state and who consent to be part of the group, then getting the right control groups, building relationships with labs and hospitals in the right places, etc. But shifting reponsibility from the FDA to a third party is something I'm not sure I'm comfortable with. There's lots of precedence: nobody ships their devices off to the FCC for emissions testing, there are independent labs that sign off on that. Likewise companies such as UL that set safety requirements, have been around for decades. But as much as we bitch about the hoops we have to jump through to keep the FDA happy, I think deep down we're all glad they are there to do the job and keep us honest. The moderating influence is that device manufacturers as a group are generally extremely, repeat extremely, conservative. The Quality Assurance engineers are generally a brick wall that have to be completely appeased before they will allow anything to be released.

seehafer 11y ago
"But shifting reponsibility from the FDA to a third party is something I'm not sure I'm comfortable with." This is exactly what happens in Europe, though. And it's one of the reasons we generally release products there first.

fnordfnordfnord 11y ago

>This sounds like it will be an absolute disaster: It does; but isn't the status quo also an absolute disaster?

AnimalMuppet 11y ago
No, IMHO. The status quo is an attempt to walk a knife-edge ridge with cliffs on both sides. There are failures on both sides, and different people getting burned by the failures on each side. Both groups decide that the status quo is an absolute disaster, but disagree on which direction the disaster is.
- fnordfnordfnord 11y ago
  Your statement seems to be a bit self-contradictory, or else I've read it wrong. So you agree that the status-quo is bad, but you think that almost anything else would be worse? I notice in another reply ITT you stated that you were once employed in engineering medical devices and left that line of work because of the "horrible environment". That's another anecdote I'd use to support my opinion.
  - AnimalMuppet 11y ago
    > So you agree that the status-quo is bad, but you think that almost anything else would be worse? I think the status quo is a trade-off between too easy and too restrictive. Too easy kills people; too restrictive kills different people. Saving more of one set of people almost automatically means killing more of the other. Re the horrible environment: It was horrible in that we didn't (at the time I was there) have much automation to handle the FDA documentation requirements. (Don't think the standard "document your code" here; FDA requirements are much more than that.) The result was a mass of manual paperwork for the software engineers, which (at least for this one) is a horrible environment to work in. It got better after I left, as they got more tools to help them. > That's another anecdote I'd use to support my opinion. But I don't see it as supporting your opinion, and I'm the guy it happened to.