Doxil supplier's woes shine spotlight on CMO activity

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Thanks to an ongoing shortage of Johnson & Johnson's ($JNJ) cancer drug Doxil, the unfolding drama at Ben Venue Laboratories has been on center stage. The FDA has repeatedly jumped on the contract manufacturer for violations at an Ohio plant, and each time, the citations have made news. As well they should. But if such a high-profile drug-supply problem wasn't involved, would the spotlight on Ben Venue's lapses be so strong?

As The Wall Street Journal suggests today, outsourced manufacturing isn't the best-known segment of the drug industry. So its potential pitfalls aren't exactly conversation-starters. Unbeknown to most of the public, drugmakers continue to step up their outsourcing activities--and with the increase in CMO activity comes an uptick in manufacturing problems.

It should be noted that many drugs are produced by outside suppliers with no shortfall in quality. As Purdue University's Stephen Byrn tells the WSJ, "The quantities made safely are in large numbers." Companies that outsource production do keep a watchful eye on their CMOs. But they're not always successful at bringing outside manufacturing up to standard, another expert tells the Journal.

Ben Venue may be an extreme example of that: The company has recalled drugs. Canada has barred some of its products on quality concerns. And FDA inspectors have found a raft of violations, including a particularly unsavory one mentioned in a new report obtained by the WSJ: The tardy investigation of a mysterious liquid found in a 10-gallon can. When officials did check it out, they found the can apparently contained urine.

Ben Venue has said it's working with the FDA to correct the problems at the Ohio plant and get scarce products back onto the market. It shut down production at the Ohio plant three weeks ago for maintenance and testing, the Associated Press reports. Meanwhile, J&J is working to transfer Doxil production to a new supplier.

- read the WSJ story
- get more from the AP

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