As we enter the second week of the Sequester, our experience has led us to send this warning to our clients, allies and friends.
When a power vacuum exists in Washington or the Food and Drug Administration (FDA) faces extreme budget cuts, the compliance arms of FDA have historically flexed their muscles to show Congress and the citizenry that the only thing that stands between the public and catastrophe is a well-funded FDA compliance machine. Whether the increase in compliance activity is an intentional activity to demonstrate the worth of FDA, merely an automatic default position of compliance officers without any leadership, or simply a historic coincidence, we cannot offer any definitive conclusions. Nevertheless, the reality of the situation is that companies, manufacturing facilities, clinical trials sites, clinical investigators and everyone that is subject to “current good practices” of one type or another should be ready for increased scrutiny from FDA investigators.
As industries have become more virtual, the ability to control every facet that is not directly performed by a company has become more difficult. Further, the contracts between virtual companies and the companies they rely upon for their myriad of services are often sparse, cryptic or may not even exist . For these reasons, we urge everyone to review their current agreements with outside companies. Additionally, everyone should monitor their vendors’ and their own paperwork and processes because these are the easiest things for investigators to review and cite as violations.
We hope that our insights on these issues will help you avoid future tragedies. As Julius Caesar once said, “Experience is the teacher of all things.”