The FDA & the World Series: Reality Happens

Regular readers of the Blog should understand that I hate the New York Yankees. I live in the Puget Sound area and our local ball club, the Mariners, will Never be able to match the Yankees’ Payroll. They will never be able to fork over a multi-million dollar contract for A-Rod the way the Yankees can. A-Rod started with the Mariners, as did Junior and the Big Unit. They went off to more lucrative regions.. and I can’t afford a ticket to the big leagues any more. At least Junior made an attempt at redemption which is more than I can say for others. However, the Yankees are a fact of life. Reality happens.

Recently I spoke at a quality assurance workshop. During the break, an attendee came up and asked about the training of FDA field inspectors. Her company had recently had an FDA inspection and she was shocked at how little the field investigator understood about the clinical trial and the therapeutic area. I explained that FDA didn’t have the necessary training available to their staff and that there was abysmal management by the field organization, the Office of Regulatory Affairs (ORA). In fact, most ORA managers don’t know how clinical trials are run. I’m a big supporter of the mission of FDA. Read the Blog and that’s pretty clear. However, there are simple facts of life. ORA’s poor management of the Bioresearch Monitoring program is reality. It happens. Just like the Yankees winning the World Series.

However, I’m an optimist. I think FDA and ORA can change. I take the same attitude with the Yankees. Wait ‘Till Next Year!