FDA Investigators Will Focus on Simple GMP Lapses when Inspecting Complex Biotech Systems, Former Compliance Official Cosgrove is Advising

Former FDA Center for Drug Evaluation and Research (CDER) senior compliance official Tom Cosgrove, now a partner at the law firm Covington & Burling, is cautioning biotech companies to make sure they are in compliance with the more mundane GMP details, on which investigators will be focused, to keep the regulatory pathway clear for their new technologies and avoid manufacturing pitfalls.

Cosgrove directed the CDER compliance office’s Office of Manufacturing Quality (OMQ), where he had key responsibility for drug warning letters and import alerts, before joining the food, drug and device law practice at Covington in late 2017.

In addressing the final session of the 2018 ISPE Europe Biotechnology Conference held in Lyon, France in September, Cosgrove began by offering some valuable observations based on his experience “as a compliance official who had the humbling responsibility of making some hard decisions on drug compliance at the FDA.”

He cautioned the biotech audience that the concept of risk takes on different meanings across the regulatory spectrum depending on who is using it, and that if the outcome is a quality failure, regulators apply a “strict liability standard” and do not give credit for the risk-based approach the firm may have taken in setting its compliance priorities.

Among his learnings from looking at the global compliance landscape is that “on the high end of the biotech manufacturing world, it is really the little things that get one in trouble. It is the little things that pile up and oftentimes cause there to be a significant quality or compliance issue.”

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