Posted 09 October 2012
By Alexander Gaffney
A long-running drug shortage involving Johnson & Johnson's anti-cancer drug Doxil (doxorubicin) may be on the verge of easing after the company applied to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new, shared manufacturing method.
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."
The drug, used in a variety of cancer treatments, is among the most prominent ones to experience a shortage situation in the US this year, and FDA has been aggressive in working to ease supply problem. In February 2012, for instance, 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.
"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.
But rather than rely on Lipodox, which FDA conceded at the time had not undergone bioequivalence testing, J&J is attempting to bring its domestic manufacturing up to capacity by getting a new manufacturing process approved, reports The Wall Street Journal.
Under the proposed plan, the Ben Venue site, which is still under restrictions, would produce Doxil. A second facility would then be charged with ensuring the sterility of the drug and other quality concerns.
A long-term plan to get the Ben Venue facility up to full operating capacity is still in the works, a spokeswoman told the WSJ.