3 ms·

I think the Europeans Medicine Agency is a model for making sensible tradeoffs here, at least compared to the FDA. I sort of with the US could just outsource d

I think the Europeans Medicine Agency is a model for making sensible tradeoffs here, at least compared to the FDA. I sort of with the US could just outsource drug approval to them.

seehafer 6y ago
EMA and FDA make different tradeoffs. They’re not necessarily easier. But I agree with you in part, I wish we had more harmonization or at least regulatory overlap — approved in EU you can sell in US, and vice versa, for instance.
refurb 6y ago
The EMA is? The EMA typically takes longer on average to approve a drug than the FDA.[1] And if you want to look up an EU scandal, check out the Servier and Mediator. Hundreds of deaths reports and it took France almost 20 years to pull it off the market.[2] [1]https://news.yale.edu/2017/04/05/fda-approves-drugs-more-quickly-peer-agency-europe https://news.yale.edu/2017/04/05/fda-approves-drugs-more-qui... [2]https://www.fiercepharma.com/pharma/servier-faces-courtroom-long-running-mediator-death-investigation#:~:text=Servier%20is%20among%2011%20institutions,other%20countries%20stopped%20selling%20it https://www.fiercepharma.com/pharma/servier-faces-courtroom-....
- Symmetry 6y ago
  Sure but I'm thinking of different metrics here.Europe has a variety of competing EpiPen equivalents so no price gouging. They had beta-blockers approved a decade before they were available in the US, with a small risk of liver failure for that first drug true, but many, many more lives were saved than lost. They had sunscreen that stopped UV A a decade before the US because the FDA's test only looked at skin burning so it took a long time to get the framework in place to examine sunscreens that block both. And yes you do have failures like Mediator or Thalidomide but on net I'd rather have their system.
  - refurb 6y ago
    Valid point for EpiPen, but a part of the reason for the US price gouging was physician prescribing - there were/are non-equivalent EpiPens available in the US (different, but still effective). Doctor choose or don’t know to prescribe it. The beta-blockers is also valid, but back then (mid-20th century) the EMA (or constituent countries) were consistently approving faster than the FDA. It wasn’t until the 80’a when the FDA was revamped to be more like the EMA. Regardless, even though some may prefer failures like Mediator or Thalidomide, I just don’t think there is the political appetite to tell folks “yeah, the drug turned out to hurt people, but that’s the price we pay for having faster approvals”. Logically it makes sense, but when it’s your child who is hurt by a drug, people get very risk adverse very quickly.
- BurningFrog 6y ago
  There are two types of risks in this field: 1. Approve something too soon. This kills/hurts patients using it. 2. Wait too long approving something. This kills/hurts sick people who are deprived of good treatment. The classic big FDA flaw is to heavily lean towards type 2 errors, because type 1 deaths lead to bad PR, while no one notices type 2 errors. So that EMA apparently made a type 1 error here is possibly a good sign!
  - JediWing 6y ago
    It's worth noting that in medical culture, knowingly implementing a process that does not aim to eliminate all type #1 errors as much as possible would violate the spirit of the Hippocratic oath, whereas #2 would not.

I think the Europeans Medicine Agency is a model for making sensible tradeoffs here, at least compared to the FDA. I sort of with the US could just outsource drug approval to them.

seehafer 6y ago

EMA and FDA make different tradeoffs. They’re not necessarily easier. But I agree with you in part, I wish we had more harmonization or at least regulatory overlap — approved in EU you can sell in US, and vice versa, for instance.

refurb 6y ago

The EMA is? The EMA typically takes longer on average to approve a drug than the FDA.[1] And if you want to look up an EU scandal, check out the Servier and Mediator. Hundreds of deaths reports and it took France almost 20 years to pull it off the market.[2] [1]https://news.yale.edu/2017/04/05/fda-approves-drugs-more-quickly-peer-agency-europe https://news.yale.edu/2017/04/05/fda-approves-drugs-more-qui... [2]https://www.fiercepharma.com/pharma/servier-faces-courtroom-long-running-mediator-death-investigation#:~:text=Servier%20is%20among%2011%20institutions,other%20countries%20stopped%20selling%20it https://www.fiercepharma.com/pharma/servier-faces-courtroom-....

Symmetry 6y ago
Sure but I'm thinking of different metrics here.Europe has a variety of competing EpiPen equivalents so no price gouging. They had beta-blockers approved a decade before they were available in the US, with a small risk of liver failure for that first drug true, but many, many more lives were saved than lost. They had sunscreen that stopped UV A a decade before the US because the FDA's test only looked at skin burning so it took a long time to get the framework in place to examine sunscreens that block both. And yes you do have failures like Mediator or Thalidomide but on net I'd rather have their system.
- refurb 6y ago
  Valid point for EpiPen, but a part of the reason for the US price gouging was physician prescribing - there were/are non-equivalent EpiPens available in the US (different, but still effective). Doctor choose or don’t know to prescribe it. The beta-blockers is also valid, but back then (mid-20th century) the EMA (or constituent countries) were consistently approving faster than the FDA. It wasn’t until the 80’a when the FDA was revamped to be more like the EMA. Regardless, even though some may prefer failures like Mediator or Thalidomide, I just don’t think there is the political appetite to tell folks “yeah, the drug turned out to hurt people, but that’s the price we pay for having faster approvals”. Logically it makes sense, but when it’s your child who is hurt by a drug, people get very risk adverse very quickly.
BurningFrog 6y ago
There are two types of risks in this field: 1. Approve something too soon. This kills/hurts patients using it. 2. Wait too long approving something. This kills/hurts sick people who are deprived of good treatment. The classic big FDA flaw is to heavily lean towards type 2 errors, because type 1 deaths lead to bad PR, while no one notices type 2 errors. So that EMA apparently made a type 1 error here is possibly a good sign!
- JediWing 6y ago
  It's worth noting that in medical culture, knowingly implementing a process that does not aim to eliminate all type #1 errors as much as possible would violate the spirit of the Hippocratic oath, whereas #2 would not.