FDA warning letter requires early exec presence, artful response

That the FDA is flexing its enforcement muscle these days is indisputable--big name companies like the venerable Johnson & Johnson's McNeil felt the regulator's might in the recent Tylenol recall, as did biotech giant Genzyme in last week's announcement of a likely consent decree at its Boston facility. They are joined by lesser recognized generics makers Ranbaxy and Caraco, in recent examples.

And by halving the time for manufacturers to respond to warning letters, the FDA has compounded the operations impact.

"You have to get the executive team involved at the beginning, at the same time you launch the core response teams," says Mike Mynhier, a partner at consultancy PRTM, in an interview. Mynhier has been involved in helping drugmakers back from the GMP-violation brink.

"Industry has to remember the FDA's job regarding safety for the population," he says. When inspectors report violations, the FDA wants to know whether it needs to advise the public of the risks, via alerts or product recalls.

He adds that there is "a certain art" to responding to warning letters in the new 15-day timeframe versus the previous 30-day period. "It's less about any change in the steps to be taken, and more about gaining insights from what the inspectors report on the Form 483."

For example, when the FDA cites "failure of your quality unit to...," the regulator expects the company to fix that problem at all sites, not just the one that is the subject of the Form 483. "They're saying, ‘don't make us go to all your sites,'" says Mynhier.

In responding to warning letters--which Mynhier notes is not a mandate, though manufacturers will probably want to reply so they can avoid re-inspection before they are prepared--drugmakers need to be aware of the FDA's current notion: "That's enough second chances." The history of multiple warning letters sent to the same company for the same issues--"that's less and less the way FDA wants to go," says Mynhier. "They want it to get done right, and right the first time." - George Miller

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