Johnson & Johnson ($JNJ) and the FDA sprang into action in 2011 when J&J's popular chemo drug Doxil became hard to get because of problems with the contract manufacturer. While the FDA looked for alternatives suppliers, J&J initially had to ration the drug. But it also figured out a process by which it could have it manufactured at one plant and finished at another. For 6 months now, the FDA has allowed J&J to use the novel process to bring one lot at a time to market, even though it has yet to give its final approval to the workaround.
In a "Dear Health Professional" letter last week, Janssen, the J&J subsidiary that makes the drug, said, "Although this manufacturing approach has not been approved by the FDA, the additional lot of newly manufactured Doxil has undergone 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, OH, 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 process vessels, other specialized equipment and takes 5 days for each batch. After that, there is additional testing. Ben Venue in January signed a consent decree with the FDA over its Bedford Laboratories plant. Because the contract manufacturer was producing so many essential drugs, the agency took the unusual step of allowing it to continue to keep manufacturing open and make up to 100 drugs while it works on 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.
- here's the Janssen letter (PDF)
- here's its explanation of manufacturing