In this day and age of a WORLD economy, WHY cant the FDA agency work with European countries to enable a worldwide approval process for devices such as the HG1-c (GCM)! I know most of us donate a lot of money that seems to get wasted on all this red tape not to mention the major risk of hypoglycemia.
Because Europe doesn't have the litigious US Legal system. You aren't just paying the guy in the lab, you are paying his lawyer ***and*** putting money into insurance vs. the potential for lawsuits. I don't think they have the same issues in Europe, although I'd be intrigued to hear some of our European members correct me if I'm off base? Although it's the middle of the night there now!
Because the FDA is beholden to others.
The FDA may have its red tape and problems, but this just screams problems to me for any sovereign nation. The next step could easily be foreign countries dictating to the US what can/can't be used, how long, when, etc.
For instance in Mexico (from what I have heard) most every drug is over the counter. It may be very difficult for the US and Mexico to agree on what the risks and restrictions on new drugs are. And then how is worldwide approval done? If its a simple majority vote, then I would have issue with small countries like Lithuania and Sudan having equal voting power as the US.
This is a difficult situation with murky waters.
In the EU , companies normally apply for a central licence. However , they then have to apply for market authorisation in each individual country. The reports from the .the European Medicines Evaluation Agency are electronic and will obviously be available to member countries, there's an agreement on the criteria for authorisation, but that doesn't mean a country has to to rubber stamp a licence,so no loss in sovereignity. There are drugs licensed in some countries that are not available in others. .
Each country also has it's own review and alert system , this feeds into a European wide alert system but each country makes individual decisions. Recently for example the French authorities conducted a study on oral diabetes drugs, they found an increased rate of bladder cancer in patients who used pioglitazone. France and Germany suspended it's use. Other countries decided to wait for the results of a European review . This resulted in the UK allowing it's continued prescription but with a warning about who it should and who it shouldn't be prescribed to.
The expertise is shared, for example the UK has with other countries, recently helped Latvia, Malta and the Czech republic set up their own regulatory bodies.
Could it work internationally, I don't know, the system is very much integrated into EU stuctures.
( I would also have my own doubts about US influence rather than the other way round)
It is an interesting topic, I'm sure this has been raised multiple times with the FDA. I have not done my homework in the full FDA process yet, do they take clinical trial data that is performed in Europe in consideration for approval in US?
I must admit I'm just really excited about the thought of having a non invasive CGM and it seems time moves so slow.
Interesting points. Thanks
I have been wondering the same thing for quite some time!
Sadly, I think the reason for the lack of collaboration DOES have a lot to do with the reason you mention, acidrock23... :(
What kind of malpractice awards are there in European courts? I have been corresponding here w/ somebody from Denmark who seems to be from Prague (I don't want to guess Czech/ Slovak/ ?? or anything, I think the diversity is cool though!) but if she were to get sick, go to the doc who removed her pancreas incorrectly, would she be able to take the doctor to the cleaners in Denmark where she is or would she have to file in Prague or could she, at her option, file in Monaco if the courts there throw money around like drunken sailors?
I work with some of these "venue" issues at work but it must be more complicated in Europe. Perhaps the extra complexity holds down costs by serving as a barrier to damages awards? It may also be that an improved system to take care of injured/ disabled people serves to help victims. I am not ure that people in the US are as well served by a system which gives them a large, lump sum damage award (with a chunk, maybe 1/3 going to their attorney...) but then leaves them fending for Medicare benefits through the tortuous SSDI process