Regurgitated Rhetoric

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The teleconference was sloppily scripted, and the players were as awkward as kids in a school play.

Key Food and Drug Administration officials, however, sat there and touted “initial objectives,” as if targeting shoddy manufacturers, bettering inspection methods and clarifying regulatory verbiage were novel ideas.

Even more obtuse was the notion that the information divulged during the late-February puppetry differed from an announcement six months earlier, when Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach was unveiled.

And with the same rhetoric that federal agencies are infamous for, such words, as “clarifying,” “enhancing” and “facilitating” categorized accomplishments the FDA so gallantly believes it has achieved.

Tangent-laden treatises were also used defensively, especially when the FDA was asked when timely biannual inspections will resume as it moves forward with its mission to protect the public.

The inconsistencies are clear, and it is that much more demoralizing if the contamination control community, let alone the public, allows itself to be pushed by an agency known for its browbeating.

It's not just time to question authority. It's a matter of who's going to bloody the bully's nose first.

Mark A. DeSorbo
Associate Editor


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