5 ms·
My question is: why does the FDA need to (get domestic pharma companies to) conduct its own studies here? If the drug has been used in Europe for 30 years, pres
by derefr 4y ago
My question is: why does the FDA need to (get domestic pharma companies to) conduct its own studies here? If the drug has been used in Europe for 30 years, presumably there are 30 years of evidence in European clinical practice that can be used as evidence. Maybe even existing meta-analyses of said evidence in European medical journals. Why isn't that sufficient?
- Aeolos 4y agoThe FDA does not accept any studies conducted overseas as clinical evidence. They request studies to contain at least 50% US citizens and be analyzed by US certified physicians. Now whether that leads to better outcomes or is just a protectionist measure for the local industry is anyone’s guess. A bit of both, I would imagine.
- quickthrower2 4y agoWhy not? They could, and at least have strict criteria for how good the studies must be.
- junofan 4y agoThis is completely untrue. Foreign data may be used as the sole basis for marketing approval [1]. [1]: https://www.govinfo.gov/content/pkg/CFR-2006-title21-vol5/pdf/CFR-2006-title21-vol5-sec314-106.pdf https://www.govinfo.gov/content/pkg/CFR-2006-title21-vol5/pd...
- boppo1 4y agoI'd trust European data more than , say chinese or pakistani data. However, that kind of exclusivity is politically untenable.
- sokoloff 4y agoI would imagine you could create a shared medicine treaty group and structure it with explicit membership qualifications and then a voting on membership and long enough delay to make the membership politically tenable.
- s1artibartfast 4y agoIt would be a very tough job to align the health and testing requirements for even the US and European countries
- mhb 4y agoFortunately, realpolitik can still prevail over wokeism in international affairs in which there are obvious life and death consequences.
- marmadukester39 4y agoWhat does this have to do with wokeism?
- mhb 4y agoTreating different countries differently, even for completely objective and common sensical reasons violates the woke desire for equality of outcome.
- deleted 4y ago[deleted]
- rosnd 4y agoHow would that be politically untenable? There are tons of similar situations. Similar rules are applied to passports and driving licenses too, some countries are trusted more than others.
- yonaguska 4y agoThe cynic in me says that the FDA wants the company that makes the drug to put up the money for the studies, they won't do it for free and without any possibilities of kickbacks.
- ohbleek 4y agoWell the FDA doesn’t conduct clinical trials. So they also can’t get kickbacks for doing them.