Significant changes are underway at OIVD, and perhaps FDA more broadly. A new era of enforcement has begun.
One bit of evidence for this is the rapid crackdown we have seen on H1N1 claims. It's wasn't just the obvious Internet scams that got letters -- even reputable companies with real products got warned for coloring outside the lines on H1N1 performance claims.
That's not all that's going on, but that's about all I can discuss at this point. I have seen "untitled" letters I can't comment on. I have also heard rumors and discussion suggesting other actions that may be underway. When these letters and actions become public, I may have more specific comments to offer.
The bottom line is this: the "grey area" activity you may have gotten away with the last few years may soon become a target for stricter enforcement. FDA has stated numerous times that they have broad authority over areas of the diagnostic market that they have so far chosen not to enforce. If what I've seen this last week is any indication of broader trends, they are beginning the process of enforcing that authority.
I'm sorry I can't offer any more specific information at the moment. Suffice it to say if you have a business plan that is predicated on a low risk of enforcement, it is time to update your risk calculations.
Tags: Advertising & Promotion, Best Practices, Enforcement, FDA, FDA 101, IVDMIA, LDTs, Policy
