Ligand was told to improve the manufacturing process and up the purity in 1999, when they got accelerated approval. They tried and failed. So they essentially blew off the FDA commitment. Eisai bought the drug without appropriate input on how tough this problem would be to fix. In the last couple of years, Eisai Discovery people fixed the purity problem and retooled the purification process, but Manufacturing acted too slowly to fix the other outdated parts of the commercial process. FDA finally lost patience and pulled the drug from the market. CMO Lonza also reacted at snail's pace to everything. The article is wrong, however - patients previously on ONTAK can get the drug (under its generic name) with special follow-up from their oncologists. I'm also pretty sure we can't charge them for it. Dr. Dang should know this - he's a long-term ONTAK prescriber.
