Book Review: Former FDA Inspector Calls for Revitalized Agency, Focus
In a book he says is neither a “toasting or a roasting,” former inspector Patrick Stone clearly loves the FDA he worked at from August 1998 until March 2011, but hates some of what he’s seen happen at the agency.
“Bubble Gum Badge” is invaluable for regulated companies because, among other things, it shows the importance of gauging the human side of FDA inspectors. As Stone notes, they have different approaches and interpretations to how they do their work, including what they look for on inspections and what they consider problems. It’s incumbent on regulated companies to have best practices in place, but also to be prepared to explain their rationale to inspectors.
“FDA investigators, the good ones, at least, can read individuals like a book; and your lack of experience is on the front page. Good leaders listen to the experts in the field and are willing to learn from a subordinate,” Stone advises higher-ups at regulated companies. His book is full of such practical, nuts and bolts advice.
Stone also calls for both industry and the FDA to do a better job with electronic data integrity and electronic record keeping. There’s lots of room for improvement on both sides. He lays out several areas where each needs to raise the bar, but for industry it boils down to taking it seriously, using common sense, and not trying to hide violations. For the FDA, it’s about practicing what it preaches, and issuing some vastly overdue new guidances for 21 CFR Part 11, among other electronic record areas. Fuzzy FDA directives aren’t helping anyone, Stone maintains.
This isn’t a rough hatchet job, but more of a carefully considered critique of an agency Stone loves, but wishes could be better. “I am not a disgruntled employee… I have nothing but respect for the field investigators, laboratory staff, support staff, and frontline workers as well as the center reviewers.”
I hope some current senior FDA staff read this book and take it to heart.
Click here to purchase his book.