The FDA is under a lot of pressure lately...

and rightly so…based on some of the news I've been reading lately...

Not only on the “Big D” side, drug safety, and efficacy, imports, but also on the “Big F” side of the house…, food imports, food safety…it goes on and on.

I really can’t comment on the food inspection functions as I have limited experience with those processes, and I will leave safety and efficacy to the experts…assuming there are any experts anyway…but that’s another whole issue.

It is my experience that overall the GMP manufacturing side of FDA regulation works pretty much as advertised…companies are supposed to manufacture products in a “state of control”…the FDA periodically inspects the process to spot check conformance with requirements…deviations are noted and addressed…it all sounds pretty much like that’s what should happen, and that’s a good thing…

When companies do not maintain control of the manufacturing process, they face an escalating series of comments and sanctions from the FDA…minor comments are addressed on an on-going basis, more serious issued are cited, companies find them selves facing consent decrees, serious fines, or even orders to cease and desist for serious violations.

I have two basic comments on the whole situation…

One, the process works, if you are out of control, the FDA will catch you…a glimpse at their websites will give you a listing of latest citations and descriptions of the situation…Companies respect, or more likely, fear FDA inspections and it keeps them on their toes…of course there are some horror stories to be told…most people working on the manufacturing side have their favorite “let me tell you how unreasonable the FDA is…” story…

Two, it is scary how out of control you have to be before the FDA catches you…

Follow-up: why don’t drug companies learn from big fines?