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Mending A Poor Reputation With FDA An Uphill Battle For Firms – But It Can Be Done

This article was originally published in The Silver Sheet

Executive Summary

Manufacturers can develop a bad reputation with FDA for a variety of reasons, including failing to systemically fix problems or follow through on commitments. “It’s tiresome, frankly, as a regulator, to have firms come in and pay lip service to the steps that they’re going to take, and then not follow up to demonstrate that they’ve taken those steps,” said CDRH Office of Compliance Director Steven Silverman. In addition, two former agency officials explain why FDA doesn’t trust some companies. “As promises that are made to the agency are broken, or when there is a failure to seriously strive to correct violations, this leads to FDA mistrust, no question about it,” said Larry Spears, now a director for consulting firm Deloitte. A Gambro Renal Products official, who now works at Medtronic, tells how Gambro staff worked to change FDA’s perception of the company after it imposed an import ban on the firm in 2006.

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