In its letter to health professionals regarding the expected shortage, Janssen said that it “currently cannot estimate when Doxil will be available again.”
Janssen spokeswoman Lisa Vaga told Outsourcing-pharma.com “We’re disappointed that an issue was identified at Ben Venue Laboratories, and has resulted in a production delay. We’re working closely with Ben Venue to resolve this matter.”
According to both the American Society of Health-System Pharmacists (ASHP) and Vaga, Janssen is working to transition Doxil manufacturing to additional suppliers for the long-term. ASHP says that the current solution of using areas of the Ben Venue facility in Ohio is under review by the US FDA. The FDA approved several lots of 2 mg/mL 10 mL vials “but no more lots using this process will be released,” ASHP said.
“We have offered various alternative solutions to Ben Venue and its parent company, Boehringer Ingelheim, to maintain production and are taking action to ensure Ben Venue meets its contractual obligations to manufacture,” Janssen said in its letter.
Earlier this month Johnson & Johnson filed a lawsuit against Ben Venue for failing to meet those contractual obligations.
The company also advised doctors to not begin new patients on Doxil and to contact Sun Pharma on the availability of a generic doxorubicin hydrochloride liposome injection. In February 2012, the FDA began allowing the Sun Pharma imports of Doxil generics.
Sun Pharma stock in India hit an all-time high last Thursday when news of the shortage surfaced.
Background
This latest announcement follows a string of issues that ultimately led Ben Venue to voluntarily enter a consent decree with the FDA in January. But under that decree, Ben Venue was allowed to continue to manufacture more than 100 drugs as long as they were compliant with FDA terms.
The FDA is now working to ensure those drugs are being produced under cGMP (current good manufacturing practice) requirements, according to the ASHP.
Shortage Concerns
This latest Doxil shortage announcement coincides with Rep. C.W. Bill Young’s (R-Fla.) recent letter to FDA Commissioner Margaret Hamburg questioning what the FDA is doing to solve the larger problem of drug shortages in the US, which has increased over the past five years.
He says he recognizes that solutions for shortages have been detailed in the recently passed Food and Drug Administration Safety and Innovation Act of 2012.
But still he questions whether the FDA might be able to link new drug patents with a commitment to new or continued production of generics, real-time monitoring of manufacturing production volume vs. utilization, possible stockpiles for drugs that might face shortages, and the removal other barriers to allow more drug imports.
“From my understanding, there were 299 active drug shortages in the last quarter of 2012 alone, the highest quarterly number to date…This is absolutely unacceptable given our advancements made to modern medicine and I hope to start a dialogue with the FDA in an effort to find real solutions to this growing problem,” Rep. Young wrote.