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FDA: Tougher or more lenient?

The figures on their enforcement are interesting, but it’s not always clear what message they send.

Last column, we reviewed some of the basic concepts relating to FDA enforcement, and offered some advice on making effective responses. This month, we look at FDA enforcement from a different angle, by asking, “Is FDA getting tougher or more lenient?”

It’s a deceptively complex question, and it’s not fair or valid to answer on one’s own behalf the moment FDA walks in your door to inspect your facility. We’re trying to get a handle on larger trends.

Statistics about FDA’s enforcement activities are always a logical place to start. FDA’s enforcement actions—such as seizure, injunction, prosecution, pressure to recall, import alerts, civil money penalties, even Warning Letters—most commonly begin with an inspection, so one could make a good case that FDA’s getting tougher in terms of enforcement when its number of inspections goes up. More inspections means more opportunities for regulators to discover and take action against problems, therefore more actions, therefore, they’re being tougher.

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