Call it creative problem solving. Johnson & Johnson ($JNJ) is considering a new strategy for easing the Doxil shortage, Bloomberg reports, aiming to boost supplies by September. The idea is to allow its former contract manufacturer, Ben Venue Laboratories, to formulate the cancer drug, and then send it elsewhere for filling and packaging.
J&J still plans to move Doxil production to another supplier. But to boost supplies in the meantime, it would allow Ben Venue to make the injectable treatment. The subsidiary of Boehringer Ingelheim had to halt production at an Ohio plant--where Doxil was made--last fall after FDA inspectors said it fell short of manufacturing standards. Several products produced at that plant have since been recalled. Ben Venue says it's working to fix the problems and aims to get the plant back online by the end of this year.
Splitting bulk production from fill-and-finish operations would allow J&J to get a small amount of Doxil back on the market beginning in September, with bigger supplies to follow, a spokeswoman told Bloomberg. "We anticipate health authority approval would be in the September time frame, with limited amount of Doxil available shortly thereafter," J&J's Lisa Vaga said. "This is a method for us to try to get Doxil back before the late 2012 time frame, when the whole facility would be back up and running."
Because of the Doxil shortage, the FDA allowed J&J to distribute Ben Venue-made batches that had been held back at the Ohio plant. These batches are the sole remaining supplies now on the market, and they're being rationed to patients who were already undergoing Doxil treatment, InPharm says.
- read the Bloomberg piece
- get more from InPharm
Related Articles:
FDA calls on contractors, India to counter Ben Venue drug shortages
FDA brings Sun's Doxil copy online to fix shortage
Ben Venue's idled plant triggers 'dire' leukemia-drug shortage
J&J to release new Doxil batches