5 ms·

I spent time at a large medical device company. I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous. We were encouraged to

I spent time at a large medical device company. I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous. We were encouraged to keep the information light or the FDA would be easily confused and reject. Rejection had more to do with giving the FDA simple warm fuzzies rather than rigorous data analysis. The FDA process is more an exercise in paperwork, not in rigorous drug/device performance. As you say, doctors and pharma have done unsafe, harmful, and fraudulent things to patients. How much was the FDA complacent in this? All of these drugs were approved by the FDA's "process". https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls https://www.fda.gov/drugs/drug-safety-and-availability/drug-...

sterlind 6y ago
Drugs are much more rigorously evaluated than medical devices. It's just a quirk of the FDA that medical devices aren't nearly as well regulated or tested.
jonathankoren 6y ago
I suggest you read up on the history of medicine prior to creation of the FDA, and similar agencies world wide.
- abfan1127 6y ago
  I'm sufficiently versed on the days of snake oil. I'm also familiar with the modern follies of the FDA, including artificial spinal disk treatments, "standard of care" balks, etc.
mmmrtl 6y ago
Do you realize the irony in providing a list of FDA recalls while bemoaning their lack of rigor? Lots of these "drugs" were unapproved dietary supplements that the FDA found to actually contain drugs, or drugs that failed QC while on the market, not the pristine batches and data that would have gotten the drug approved in the first place. To me, it's similar to having more trust for media outlets that post corrections rather than pretending that nothing ever goes wrong. It's a point in their favor that a stamp of approval can be rescinded. You might have an argument that the companies need to be taken out of the drug approval process entirely, due to issues of hiding data to avoid giving the FDA a hint of anything wrong (or making them "confused" as you say), or maybe we need much stricter rules on data withholding. I'm with you there.
- abfan1127 6y ago
  The irony is specifically why I posted it. FDA approval is treated as a "gold standard" yet we have lots of evidence that it isn't. Companies lie, make non-intentional mistakes not caught by the FDA, there's all sorts of issues with it. The FDA review process is more like an editor checking spelling than actual rigorous analysis. I don't think your media analogy is accurate. It would be like the government censoring media companies, but having a poor biased criteria which then changes later, but is also subject to lies, etc. I don't think its a good analogy. I think drug companies should be rated on their data openness, with enough information to reproduce results. I think approval processes should be replaced with levels of confidence certifications. For example: Gold is independent labs find similar results to internal labs (verified) Silver is only internal labs produced results, not reproduced elsewhere etc.
jpeloquin 6y ago
> I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous. Is this referring to all of the submission pathways, or one in particular? That is, I wouldn't expect the 510(k) process to be particularly rigorous, but the PMA process should ratchet up the scrutiny.
- abfan1127 6y ago
  Its been 10 years since that employment so I don't recall the details. We would get annual "FDA training" on how to report, document, etc. my particular employer always stressed on being accurate and doing what was right for the patient. But "over-reporting" was discouraged... I always related it to a police investigation. Don't give them any more information than asked, you never know what rabbit hole they will go down, risking rejection.

sterlind 6y ago

Drugs are much more rigorously evaluated than medical devices. It's just a quirk of the FDA that medical devices aren't nearly as well regulated or tested.

jonathankoren 6y ago

I suggest you read up on the history of medicine prior to creation of the FDA, and similar agencies world wide.

abfan1127 6y ago
I'm sufficiently versed on the days of snake oil. I'm also familiar with the modern follies of the FDA, including artificial spinal disk treatments, "standard of care" balks, etc.

mmmrtl 6y ago

Do you realize the irony in providing a list of FDA recalls while bemoaning their lack of rigor? Lots of these "drugs" were unapproved dietary supplements that the FDA found to actually contain drugs, or drugs that failed QC while on the market, not the pristine batches and data that would have gotten the drug approved in the first place. To me, it's similar to having more trust for media outlets that post corrections rather than pretending that nothing ever goes wrong. It's a point in their favor that a stamp of approval can be rescinded. You might have an argument that the companies need to be taken out of the drug approval process entirely, due to issues of hiding data to avoid giving the FDA a hint of anything wrong (or making them "confused" as you say), or maybe we need much stricter rules on data withholding. I'm with you there.

abfan1127 6y ago
The irony is specifically why I posted it. FDA approval is treated as a "gold standard" yet we have lots of evidence that it isn't. Companies lie, make non-intentional mistakes not caught by the FDA, there's all sorts of issues with it. The FDA review process is more like an editor checking spelling than actual rigorous analysis. I don't think your media analogy is accurate. It would be like the government censoring media companies, but having a poor biased criteria which then changes later, but is also subject to lies, etc. I don't think its a good analogy. I think drug companies should be rated on their data openness, with enough information to reproduce results. I think approval processes should be replaced with levels of confidence certifications. For example: Gold is independent labs find similar results to internal labs (verified) Silver is only internal labs produced results, not reproduced elsewhere etc.

jpeloquin 6y ago

> I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous. Is this referring to all of the submission pathways, or one in particular? That is, I wouldn't expect the 510(k) process to be particularly rigorous, but the PMA process should ratchet up the scrutiny.

abfan1127 6y ago
Its been 10 years since that employment so I don't recall the details. We would get annual "FDA training" on how to report, document, etc. my particular employer always stressed on being accurate and doing what was right for the patient. But "over-reporting" was discouraged... I always related it to a police investigation. Don't give them any more information than asked, you never know what rabbit hole they will go down, risking rejection.