Enforcement on Steroids: FDA Delivers Twice the Drug GMP Warning Letters
This article was originally published in The Gold Sheet
Executive Summary
Enforcement on steroids: As expected, FDA enforcement went into overdrive last year. The warning letter rate doubled and punishments were swift and harsh. But that was just the beginning. The agency expanded its field force, and after a few years of training, its new investigators will bring it on. No more dithering about Form 483 findings. Import alert hits Apotex 10 days after inspection. KV gets consent decree just four weeks after inspectors find it failed to file field alerts. Ranbaxy ANDA reviews halted by FDA's GMP concerns, even though EU and WHO saw nothing wrong. FDA's criminal investigators will coordinate more with the rest of the agency and others. Last year's 34 warning letters harped on the same issues as before, but with a new focus on foreign API makers. FDA's new foreign offices focus on data integrity in India and GMPs in China. Congress showers FDA with money but further constrains its regulatory discretion. Expect Dingell's Globalization Act to decorate 2012 PDUFA Christmas tree