"So, what will the FDA enforce?"

I must get asked the question in the title three or four times a week. I don't blame people for wanting to know - clearly, it would make life much easier for just about everyone if we knew and could concentrate on what FDA perceives to be the potential critical points of failure in the industry's work. But I don't know beyond what FDA states in guidance, and I can't read minds, so, due to budget cuts and an attendant lack of a crystal ball, I turn to the next best thing for my answer: FDA Warning Letters.

After reading these letters every day, I've come up with a pat response which, though probably more flippant than it should be, contains a grain of truth:

FDA seems to care most about food products and promotional material. So as long as you don't make something people are going to eat, and you don't claim that your product cures anything, you're pretty much good to go.

Like I said, flippant. But also not without its truth. If you read all of the warning letters sent to companies in recent months, you'll find that the vast majority of them pertain to either food products that were manufactured in environments that were not in compliance with regulations or promotional materials that don't accurately reflect the benefits, risks, and side effects associated with a drug (or device or biologic).

I'm not sure whether I feel that this will change at all as the environment in the industry changes. It feels like now more than ever, the public is demanding "safer" drugs. ("Safer" in quotes because if you're reading this, chances are you know as well as I do that safety is all relative after a certain point.) I'm not sure whether that will translate over time to more stringent regulations (and therefore enforcement) for safety data for new compounds (and what that could potentially mean to the industry), or whether the hue and cry over DTC ads will continue instead. Perhaps both will happen to some extent.