Johnson & Johnson ($JNJ) has been struggling with Doxil supplies for months. As one of the standard treatments for ovarian cancer, the drug has been sorely missed as supplies ran short. Now, the company is asking regulators to approve a new plan to boost supplies, at least in the short term.
You'll recall that the Doxil shortage began after contract manufacturer Ben Venue Laboratories ran afoul of FDA inspectors. A plant in Bedford, OH, had to suspend Doxil manufacturing and distribution because of quality control shortfalls, including contamination and sterility problems.
The shortage attracted plenty of press--besides ovarian cancer, Doxil is used to fight multiple myelmoa and Kaposi's sarcoma--and, because it seemed to embody the growing drug-shortage problem, spawned plenty of demands from patient groups and politicians. Like so many other scarce drugs, Doxil was made by a contract manufacturer idled because of failed FDA inspections.
Since then, J&J has been looking for a new supplier, and Ben Venue has been working to fix its problems at the Bedford plant. And J&J was able to release some Doxil supplies earlier this year, after backstock held at Ben Venue was tested.
Now, J&J wants to enlist Ben Venue's help again. As The Wall Street Journal reports, J&J's new Doxil plan would rely on Ben Venue to produce the drug, in areas of its Bedford plant that are now available and approved for use. Another supplier would handle sterile filtration and aseptic filling, to make sure the drug isn't contaminated.
J&J has asked FDA and its counterparts in the EU to approve the new process, the WSJ says. That would amp up Doxil supplies in the short term, giving J&J time to find a long-term manufacturer for Doxil.
- see the WSJ article (sub. req.)
Special Report: Think about what could go wrong -- 10 keys to supplying global clinical trials