YES, You Are a Target

Once upon a time, long before FDA use the MAPP (Manual of Policies and Procedures) to tell us where they are going, a young investigator believed in transparency in government. Shocking, I know. In fact, this young investigator was speaking on behalf of the FDA at an industry conference when she made a comment about how FDA's Office of Regulatory Affairs (ORA) was being assigned drug surveillance inspections based on an algorithm used by CDER.

I remember the day so vividly. A high(ish) ranking leader in ORA interrupted my presentation to try to back pedal the fact that indeed, even in the early 2000's (pre-2005), CDER was applying a new and still rudimentary algorithm to help identify firms for inspection. I will not mention his/her name, but I hope he/she is reading this...

You would have thought that I released the nuclear codes on social media. Not only was I cutoff in my presentation but what ensued was the usual overreaction of the ORA leadership. A stern talking to! And an inquisition into who in the world reviewed and approved my presentation (I am still protecting that innocent). To be clear, the algorithm and the specific contributors were never mentioned, although hypothetically the audience kicked around what they thought might contribute.

Now let's have a reality check. CDER's first "MAPP" came out in 2005 on this topic. It was not deep on detail and the algorithm itself has never been exposed. You have no way of knowing the relative weight of the contributing factors leading to your risk score. For sure, the 2005 release was not well publicized and there were not long pontifications on LinkedIn or any other platform. The MAPP has evolved, 2012 and now 2023.

It became clear as we strolled through the '00s and '10s that the foreign inspection program continued to be a hot topic as evidenced by FDA returning to standing up operations in key, foreign locations. And, as the number of inspections began to increase in specific countries, say China or India, for instance, people began to wonder if they were being targeted. During several presentations, yes, they kept letting me talk out loud, industry audience members would ask very directly, "Am I being targeted just because I have facilities in India and China?".

Ok, come on, like FDA would ever let me say, "Yes, yes you are." Everyone thought it, everyone "kinda" knew it, but in perfect political spin, the honest answer was "no". The algorithm at that time did not take into account the compliance history of any specific geographic region or country. So, truly, no, there was no target on firms in India, China or anywhere else for that matter. It was really based on a site or site(s) performance. Even in my post-FDA life, I continued to support this as fact.

Then, in June 2023, FDA updated the MAPP for the Site Selection Model (SSM). And what do you know, there it was, the addition of the country or regional compliance to the magic that makes the risk score. Now if we ask the question, "Am I being targeted...", why YES, YES YOU ARE!

We can debate the fairness of this inclusionary factor for sure. In reality, it is, in my opinion, a most powerful tool to allow in country industry to pressure their own regulatory bodies to step up the accountability of the bad actors. Who wants to suffer more inspections because your regional or country neighbor down the road in the industrial park can't seem to get it together?

Will the pressure from industry drive local, state, regional and federal watch dogs to develop stringent requirements aligned with industry standards or will the industry just decide it may not be cheaper, but it may be easier to just keep the business in the US or EU? Not sure I could possibly know the answer, but it will be fun to watch and see how this plays out.

As for me, I'm feeling like I was just ahead of the game.

If you ever wondered what regional or geographical compliance might look like, here is a quick infographic for your consideration.