BioPharm Executive: Clean Up Your Act

Published: Jun 30, 2010

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Clean Up Your Act

It's a little late for Spring cleaning, but that's exactly what pharma needs right now, at least according to FDA. A remarkable number of companies have been under fire over the past year for manufacturing and quality control issues, and it's becoming clear that FDA has no intention of stopping its steady flow of warning letters anytime soon.

If you don't think cleanliness is next to godliness, you're in the wrong industry. Genzyme's well-publicized issues with its facility in Allston Landing, Massachusetts, caught activist investor Carl Icahn's attention and threatened the very independence of the company (although, for the moment, Icahn has agreed to a compromise in his proxy battle with the company). Cadence Pharmaceuticals was delayed once again on its lengthy effort to win FDA approval for Ofirmev, an injectable acetaminophen. Not because there's anything wrong with the drug or the application, apparently, but because of deficiencies at a third-party plant in Mississippi operated by Baxter. For a company with no other products and limited resources, delays can be life or death.

Then there was the April shutdown of a McNeil Consumer Healthcare manufacturing facility for numerous cGMP violations, resulting in a massive recall of Johnson & Johnson's Children's Tylenol. The fallout of that episode may still result in criminal prosecution by the government. And more recently, FDA has turned its attention to Perrigo, a major generic manufacturer, which also has some significant manufacturing issues, according to FDA.

FDA staffers have been remarkably frank about the pattern of problems at J&J /McNeil, and to hear their side of the story, it really sounds as if management at key manufacturing facilities simply shrugged off warning after warning. FDA describes a corporate culture that had drifted away from a focus on compliance at best, and had maybe even abandoned a commitment to quality and safety. It's not easy to repair that kind of damage to your reputation.

There is perhaps the impression in some quarters of the industry that FDA, with its limited resources, will choose its battles carefully, and that some corners can be safely cut. That may be the case, but it should be clear at this point that this FDA is serious about cleaning up manufacturing.

Moreover, the agency is getting canny about how it gets the message out. For one thing, it now wants to make complete response (aka "approvable") letters public. That's a cheap way of telling everyone exactly why a given product wasn't approved, and to draw other companies' attention to where they, too, may need to improve. While few companies want to see their own complete response letters made public, it seems likely that this is coming eventually. With such a cheap and simple means of driving its point home, FDA will have money left over for more inspections. Time to clean house. - Karl Thiel

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