FDA rebukes CMO plant at center of J&J shortage

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Sad stories are piling up from cancer patients unable to get treatment because of drug shortages. Regulatory chatter about what to do is increasing, too. But the shortage of Johnson & Johnson's ($JNJ) Doxil illustrates just how difficult it might be to not only keep tabs on potentially scarce drugs, but also to fix the problems that cause shortages in the first place.

A Boehringer Ingelheim unit, Ben Venue Laboratories, is at the center of J&J's Doxil supply problem. It's been struggling with manufacturing problems for some time. Company officials have cited "capacity constraints" for their production shortfalls, which affect a variety of drugs made for pharma clients.

Ben Venue has also recalled some drug batches, and it admitted some quality-control difficulties at a Cleveland-area plant. HealthCanada went so far as to bar several Ben Venue products from the country. Most recently, the company said it would be winding down its contract manufacturing business, working with clients such as J&J as it transitioned away from the field.

A report from FDA inspectors shows the extent of Ben Venue's lapses--and they're significant. Obtained by Dow Jones through a Freedom of Information Act request, the report shows inspectors found a host of problems at the plant where Doxil is made. Inspectors found metal particles in medicines, something that might have been caused by damaged metal doors at the plant. Certain batches of products were contaminated by bacteria. Mold was found in some manufacturing areas. Equipment was rusty. A ceiling leaked.

Ben Venue tells Dow Jones it's working on fixing the problems. Meanwhile, J&J is on the hunt for a new Doxil supplier. But that's no easy task, a spokeswoman said, because "it's a very complex drug to manufacture." Its backup inventory of the drug ran out because of the Ben Venue problems, and although J&J recently released a limited supply, a waiting list of patients remains. And thanks to Dow Jones' FOIA request, the FDA released its redacted inspection report, available at the link below.

- see the FDA inspection report
- read the Dow Jones piece

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