With Scott Gottlieb, M.D., winning confirmation to head the FDA yesterday, the Agency is ready to move forward to the beat of a different drummer. It will be an interesting ride and we will watch it along the way. It also looks like the User Fee legislation may make its way to law, as it looks like the last hurdles have been cleared.
Now it looks like Dr. Gottlieb will have the funds needed to keep the FDA moving in the right direction, as he steers the giant ship along its lumbering course. How much adjustment he will make in the various Centers may be crucial to containing drug prices, remaking the approval process, ensuring the safety of our food supply and medical device system, and even how regulation of tobacco evolves.
One thing is for certain, if you read Gottlieb’s resume, he has plenty of energy to effectuate positive change. At least now, we won’t need to worry about the efficacy standard!
A big challenge will be hiring and retention of highly qualified staff. With close to 1000 vacancies at the FDA, this may be the biggest issue facing his initial months as Commissioner. As noted in previous posts, getting people on board is only the beginning of the process. It is the training of those folks to be efficient and productive in their new government positions that takes the real time and effort. One must remember that the training is done by experienced FDA reviewers and, thus, each new hire will eat up a chunk of the trainer’s review productivity, and thus, slow down the system. If you can imagine the diversity of the work the FDA is engaged in, you can get a sense of magnitude of the transfer of knowledge and experience that must be accomplished for each new hire to be a successful contributor to the Agency’s mission.
So prepare yourself for a slow transition or a real shake-up. We don’t know how this will play out, but knowing Dr. Gottlieb, my bet is on success.
