FDA Has Many Measures to Avoid Conflict of Interest  

This week Dr. Scott Gottlieb was nominated to head the FDA. Dr. Gottlieb has a very interesting resume. He was the Deputy Commissioner at FDA, followed by working at political think-tanks and a very active investor in FDA regulated companies, so obvious questions about conflict of interest may arise at his confirmation. The confirmation of the last FDA commissioner, Dr. Robert Califf, was delayed extensively due to his work as a consultant for pharmaceutical companies. That pales in comparison to Dr. Gottlieb’s connections to the investment community. That said, such concerns of conflict of interest, while relevant and valid, are reduced, if not completely eliminated, by the existing checks and balances at place at the FDA for all its employees. There are numerous laws that govern any financial gains made by government officials based on decisions they make. Political appointees have additional restrictions imposed on them. On top political appointees are also always under a microscope with regards to their statements, decisions and any actions that may directly or indirectly benefit them financially. It can be argued that people can craft ingenious ways to game the system and go around the laws. It can also be argued that many gains are not necessarily immediately obvious or may not be overtly financial. For that reason, surely his political opponents will be constantly looking for mistakes, intentional or not. The next few days will see a robust hearing in the Congress for his confirmation where questions like this will be raised. His confirmation is guaranteed due to the political numbers. Among the various candidates being considered for the job, he is the most qualified and least objectionable. For non-US companies seeing this political drama unfold, it may seem to give a wrong perception of the American system but perceptions and facts are not always on the same plane. Most of FDA’s decisions are not based on who its Commissioner is. Decisions such as product approvals, project management, the inspection findings, operational policies, and almost all the legal decisions are unaffected by the change in the leadership. But FDA Commissioners influence new policies, and the overall direction of the Agency. Dr. Gottlieb has strongly advocated faster approval of products among other major policy changes at the FDA, which have broad support. So, let’s not get too swayed by the political discussions about financial conflict of interest, and look towards what policies will affect everyone.