3 ms·
This is an almost comically evil regulatory failure. "W-we're going to shut down a foreign facility that produces life-saving drugs for Americans because... we
by A_D_E_P_T 3y ago
This is an almost comically evil regulatory failure.
"W-we're going to shut down a foreign facility that produces life-saving drugs for Americans because... we don't like the way they keep records. And they evaded our authority! Sorry American cancer patients, gg, better luck next time."
Making generic drugs is a low-margin business and many if not most manufacturing facilities are as bad as that one. See, e.g., https://archive.is/ImWtW https://archive.is/ImWtW
It would be infinitely more rational to simply run batch tests on the chemicals or drugs upon import, when they're introduced into the US drug supply chain. If they're good, they're good. Simple as.
- nradov 3y agoIt's not that simple. Beyond checking for the active ingredient, there are a huge amount of different toxins and contaminants that could potentially be introduced by a defective manufacturing process. Just like with software, you can't test quality into pharmaceutical products. Quality assurance has to be built into the process from the start.