The newest service to be ‘outsourced’ is about to make taking drugs even riskier
If someone were trying to deliberately make taking drugs even more dangerous, this would be it.
It revolves around what the FDA considers its cornerstone of drug safety – its FAERS database (or the FDA Adverse Events Reporting System).
The agency relies on FAERS to monitor side effects and deaths from a drug.
And as if it wasn’t a bad enough system before, it’s just become a hundred times worse.
Because Big Pharma is washing its hands of the whole thing, packing it up and outsourcing it to India.
Yes, India.
That means any side effects that are reported to a drug company aren’t even looked at when they come in, but shipped halfway around the world. There, workers are charged with analyzing it, getting it into a database, and sending it back to the drug maker, which in turn forwards it to the FDA.
And this isn’t just about entering information into a computer. It’s a job that requires not only medical knowledge but a lot of “detective work.” If not done correctly, experts warn, it can lead to the risk of deadly side effects “going unnoticed.”
So knowing how great all that outsourced customer service has been, I can only imagine what happens next.
Source:
“New outsourcing frontier in India: Monitoring drug safety” Sean McLain, February 1, 2015, The Wall Street Journal, wsj.com
