Since last year, the FDA has been evaluating an "alternative manufacturing approach" for Janssen's Doxil. The essential chemo drug hit the shortage list after the agency brought the hammer down on its contract manufacturer Ben Venue Laboratories in 2011. While the FDA has yet to give its final sign-off to this creative work-around, it has permitted the Johnson & Johnson ($JNJ) subsidiary to release a lot at a time, the latest last week.
In a "Dear Health Professional" letter, Janssen said, while the new system has yet to get an FDA sign-off, the drug went through "a full Janssen internal review to ensure that it meets quality and safety standards. Janssen will continue to seek FDA approval for this manufacturing approach."
While Janssen has not fully explained the process, it has said it involves Ben Venue's Bedford, Ohio plant starting the process and another supplier finishing it. On a website devoted to the drug shortage, Janssen explained that a "typical sterile, intravenous chemotherapy formulation" requires a few process vessels and a couple of manufacturing steps and may take hours to complete. Doxil, it says, requires 17 vessels, other specialized equipment and takes 5 days for each batch. After that, there is additional testing, and of course fill and finish.
Ben Venue in January signed a consent decree with the FDA over the Bedford Laboratories plant that the FDA had savaged in Form 483 reports back in 2011. Because the contract manufacturer was producing so many essential drugs, the agency took the unusual step of allowing it to continue keep manufacturing up to 100 drugs while it works on its plant upgrades.
The agency also has looked for other creative ways to keep some of the chemo drug available. In February it approved a generic from India's Sun Pharma that it had put through a fast-track approval. Before that, it had temporarily allowed Sun to import an unapproved version of that drug while it worked to get the U.S. generic through the approval process.