A new regulatory report gives us a peek at the recall of Roche's HIV remedy Viracept--and it's not a pretty picture. You'll remember that Viracept was withdrawn from the European market in June because impurities were found in the pills; it's now back on the market. Just how the drug was tainted hadn't been publicly acknowledged
According to European regulators, Roche employees didn't clean out a holding tank used to store the starting compounds for Viracept. And when they finally did, they allowed an ethanol cleaning solution to mix with the drug ingredients. Result: a toxic compound that ended up in patients' pills.
Roche has since corrected the problem. But the root cause, the EMEA report concluded, was that employees simply didn't understand the drug's manufacturing process, perhaps because it was purchased from another company. Is this a taste of things to come, given all the drug-buying that's going on in pharma these days? Let's hope not.
- see the report from the EMEA
- read the Financial Times article
Related Articles:
Viracept snafu costing Roche millions. Report
EU puts Viracept on hold. Report