J&J releases Doxil batch; Ben Venue troubles detailed in FDA report

An in-process batch of cancer drug Doxil, halted at Ben Venue Labs when the contract manufacturer suspended operations due to QA concerns, has cleared the scrutiny of Johnson & Johnson ($JNJ) and is on its way to patients. It's just a minor reprieve, though. There's about enough of the short-supply drug for 1,000 patients, so it will go only to those already on a regimen; about 2,700 remain wait-listed.

The Doxil release comes just after an FDA inspection that provided disturbing details of the Ben Venue quality system breakdown.

J&J vouches for the quality of the Doxil batch, saying it conducted its own inspection, reports Dow Jones. In a Dec. 12, letter from J&J unit Janssen Products, VP Peter Callegari tells healthcare providers, "We have performed thorough quality reviews ... which included a review of production procedures and extensive sample testing." He writes also that the release "does not foreshadow the potential for any additional supply of DOXIL in the immediate future." The drugmaker continues to seek a new contractor for production.

The product release, though limited, is a bright spot in a dark story. Since Ben Venue, a unit of Boehringer Ingelheim, halted operations in Bedford, OH, in November, most recent consequences include multiple precautionary drug recalls in Europe plus an additional whack to cancer drugs already in short supply in the U.S.

A recent FDA inspection turned up more disturbing news, pushing the situation from bad to worse. Among findings reported in a Form 483 report from Nov. 7-Dec. 2 visits to the Bedford facilities, investigators observed that more than 100 preventative maintenance activities required by good manufacturing practices are at least 30 days past due. In addition, the QA unit failed to run a risk assessment for a past-due investigation of an "unknown liquid" in a 10-gallon can that tests indicate is urine.

PharmaPro cites a Ben Venue spokesman who said the company reported the urine to police, who are investigating.

- here's the Janssen letter to healthcare providers
- see the Dow Jones story
- here's the recent FDA inspection report
- and the PharmaPro story