Initial FDA thoughts..

December 25, 2017

A few thoughts about working at the FDA

I promised I would write about my experiences at the FDA.   While I am waiting on my gluten free rolls that seem to have a potential to be a failure, I figured now is a good time to write about it. 

The FDA is a large organization so I am sure others have different views and experiences.  It reminds me of when I was a co-op at Eastman Kodak in Rochester, NY and people would ask if I knew someone who worked there.  Well, there were 50,000 people who were employed at Kodak in 1989 so the chances that I knew that person were low.  Plus, there are many different divisions at the FDA and they all have very different management and internal missions. 

Everyone I directly worked with at FDA was a dedicated/career government employee.  They worked hard.  My supervisor/sponsor, Steve Wood was on site usually 10-11 hrs a day and on weekends.  I worry about him sometimes.  He was encyclopedic with his knowledge of FDA and decisions.  He truly cares about the health and well-being of the American people. 

Having said this, there was no doubt that stereotypical government ‘waste’ and dysfunction occurs at the FDA.  It started with getting my i.d. card.  We had all the forms filled out twice and Steve walked me to the card office.  They claimed he needed to call someone else and he was ready to walk all the way back to his office to talk to them on the phone.  The FDA is a big campus and I finally asked if there was a phone nearby that he could use.  They pointed him to one on the wall.  He was on hold for a long time and then the person he was actually told to call came out from a side office. 

Any organization can be improved or destroyed by different types of leadership.  Having spent 21 years in academia and having seen different types of leadership, I am pretty good at identifying what constitutes good and bad leadership.  An example was that at RPI when Shirley Ann Jackson was originally named President, many things changed very positively at first due to her emphasis on research.  Of course, later other problems showed up, but the faculty were very engaged with this dynamic new leader and worked hard to move the organization forward out of the stagnation that occurred with the previous administration. 

I don’t know all the details about what happened at FDA, but there was a large change or merging of divisions that really affected the people around me.  I saw local leadership that seemed more worried about nit-picky little problems rather than focused on the true mission of the FDA to serve the American people.  That bothered me a lot.  The hard working scientists at the FDA deserve much better leadership.  I truly believe that having a strong sense of mission to serve would really drive incredible research findings among the FDA scientists that would greatly serve many. 

To continue about the use of funding, I was always interested to read the email news that popped into my in-box every day.  I learned a lot of different things.  I was intrigued by perhaps the lack of accounting or other analyses that seemed to occur over the years.  One thing Scott Gottleib did early on was look at the costs of inspecting different pharmaceutical sites around the world including the US.  They found that across the board in the US, Canada and Western Europe, the average infraction rate for rules was roughly 6% (or maybe less).  Yet, in India and China it approached 20%.  Meanwhile, the resources being used in India and China for inspections was far, far less than in the US and Europe where low incidences of violations occur.  They actually decided to shift funds to the places that need it to review these higher violating places. 

While I try to remain open-minded and perhaps independent, I believe seriously looking at aspects of mission and how to fund things from the government is important.  It is a hard thing to do and people don’t like doing it. 

Anyway, there will be more thoughts and reflections, but it is Christmas and I best get on to my next task this morning. 

However, I’ll leave a parting shot because it is funny.  People still cannot figure out why there are not pictures of the President and VP at the FDA.  There are 3 sites where you come in that pictures hang.  As you can see, the slots for the President and VP are not hanging.  No one knows why when the (then) HHS secretary and FDA director are posted and not the President and VP.  Every other President and VP including Bush 1, Bush 2, Clinton and Obama were all posted.