Who IS Going to Be the New Boss at FDA?

Well, not naming any names- I really won’t come out and say who my pick would be, but, depending on the administration’s pick, this is a pretty crucial decision for the Agency.  Here are some of the attributes I think would be important for the position:

  1. A knowledge of the FDA review and approval process
  2. A strong medical background
  3. A person that believes that science should rule the day
  4. Someone who is above the political fray
  5. A person that has both compassion and common sense
  6. Someone with an understanding of how the drug industry operated

Which of these attributes do I think is most important?  Without a doubt- #4!  I have reported up to several commissioners when I was at FDA and have observed a number of commissioners from the industry perspective in my close to 42-year career as a pharmacist and consultant.  In my entire career, I do not believe that I have ever seen the Agency as politicized as it is today. I heartily believe that the last time I felt the FDA was truly the most independent and the least politicized was during Dr. David Kessler’s tenure.  In my opinion, he did not seem to buckle to political pressure and always made his decision based on the science behind the issue.

And that is how the FDA should make its decisions – science-based, health-driven decisions that have nothing more than a positive impact on public health.  The FDA does not (in my opinion) need a total makeover, as some have suggested. Nor does it need to be “blown up” as some of the headlines have read.  The FDA does what it is supposed to do by protecting the health of the nation.  Could there be some tweaks?  Sure – like assessing with greater certainty what needs to be known versus what is nice to know, by assuring the Agency is not burying firms in Ph.D. thesis questions and focusing more directly to what the industry and public need to be assessed of, in order to assure safety and efficacy of the products that it is charged with regulating.

Some have touted moving away from an efficacy standard and just approved products as safe and let the marketplace do the rest.  This sounds like a step back to 1938, and would, in my opinion, be a “big league” mistake, especially for conditions for which there are other proven effective treatments.  Patients clinging for hope need to have some assurance that the rock they grab on to is not going to break off the face of the slope they are attempting to climb.  There must be a solid basis for approval and the best assurance of efficacy, so patients do not delay treatments that are proven to be effective.  Now for life-threatening disease states for which there are no known treatments, perhaps the efficacy barrier may need to be lowered somewhat, but certainly not eliminated.

Would I like to see drugs approved faster for both generic and brand name products – sure, who would not?  But at what expense?  There needs to be a balance that is struck between risk and benefit, quality and availability, and the standards must be high.  We must have confidence in both our approval process and the quality of the products to which we trust out lives.  But there does need to be a balance.  Hopefully, whomever is selected to be the next commissioner will be able to work with the Congress and the industry to make certain that balance is appropriately struck and maintained, so the American people are best served by any new direction the Agency takes.