Over the past year, we have written several stories about the troubling drug shortages that have been occurring. This summer, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA), which gave FDA new authorities to help fight drug shortages. Additionally, FDA recently announced that it had seen fewer drug shortages.
Moving forward with positive news, Johnson & Johnson recently applied for U.S. and European regulatory approval of a new manufacturing process that would provide a short-term fix to the supply shortage of the cancer drug Doxil, reported the Wall Street Journal.
Doxil is used in a variety of cancer treatments, and is among the most prominent drugs to experience a shortage situation in the US this year. FDA has been aggressive in working to ease supply problem. For example, in February 2012, FDA said it would allow select foreign manufacturers to import unapproved supplies of Doxil—the foreign version of which is called Lipodox—to ease shortages.
The root of Doxil’s shortages is a “voluntary shutdown” of an Ohio facility run by Ben Venue Laboratories, a contract manufacturer working for J&J, after a November 2011 inspection by FDA and EMA found “ongoing quality and manufacturing issues,” reported RAPS. The Doxil shortageleft as many as 2,700 patients on a waiting list for the drug last year, though J&J has since squeezed out enough supply to clear the waiting list.
The plan includes J&J's existing contract manufacturer, Ben Venue Laboratories, whose factory troubles led to a suspension in the manufacturing and distribution of Doxil last year. The supply crunch for the drug—used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi's sarcoma—caused sales to plunge 87% to $37 million for the first half of 2012.
Under J&J’s plan, Ben Venue would produce Doxil while a second supplier would handle other tasks such as ensuring the injectable drug is sterile, said J&J spokeswoman Lisa Vaga. She declined to identify the other supplier, citing “confidentiality obligations.” FDA and EMA are reviewing J&J’s applications to use the new manufacturing process, Ms. Vaga said. “It isn't clear when the agencies will make a decision, but J&J and Ben Venue have said they expected Doxil production to resume by the end of 2012. Ms. Vaga said J&J is in discussions with the regulators.”
“If regulators approve J&J's plan, Doxil would be made in areas of the Ben Venue facility that are available for production, Ms. Vaga said.” Sterile filtration and aseptic filling—which are designed to ensure the drug remains free of contamination—would be performed elsewhere by the other supplier.
FDA spokeswoman Erica Jefferson said the agency can't comment on any pending applications. “We are confident using regulatory discretion to ensure the safety and utility of this product,” said FDA Associate Director Valerie Jensen, who heads the drug shortage program, at the time of the announcement. An EMA spokesman couldn't be reached. Doxil is sold in Europe as Caelyx.
Ben Venue spokeswoman Marjorie Moeling said the company is making progress toward upgrading the Bedford plant. "We will provide updates on our progress to resume manufacturing once we are more fully confident that our restart plans are being realized," she said.
In May, an EMA advisory body recommended J&J pursue a plan to transfer sterile filtration and aseptic filling for Doxil from the Ben Venue plant to an alternative site. The EMA committee recommended J&J apply for such approval by September.
“Longer term, the New Brunswick, N.J., company is planning to move all Doxil production processes to multiple suppliers and away from Ben Venue, which plans to exit the contract-manufacturing business. That process could take about two years because of the complexity of the Doxil manufacturing process, according to the EMA.
Ms. Vaga said J&J's long-term plan is ongoing and on track.”