FDA is focusing more on import compliance and is leveraging DOJ resources
After FDA re-inspected Ranbaxy for cGMP violations, DOJ subpoenaed Parexel & Co., a consulting firm that Ranbaxy’s attorneys hired, and moved to compel, over attorney’s privilege claims
FDA told Ranbaxy that it would not act on Ranbaxy’s applications unless it received the consultant’s audit reports
Demonstrates greater leveraging of DOJ resources in traditional FDA cGMP matter
Demonstrates more aggressive position regarding attorney-client and work product privileges
Reflects greater concern about API manufactured abroad
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