Yesterday, the Senate confirmed Dr. Scott Gottlieb as Commissioner of the U.S. Food & Drug Administration. I believe this is very good news for patients anxiously awaiting more answers to their pressing health needs. I worked with Scott early in his career, and am confident that he has the experience, the intellect and the temperament to focus the agency on its core responsibilities, while addressing many of the challenges we face healthcare today. I believe he will make a difference.
Challenges? There are a lot of them, from the speed of getting life-saving and life-changing medicines to market, to access to drugs, to the huge amounts of information readily available to patients and other consumers that barely existed just 10 years ago. The FDA can’t fix everything that’s problematic with the healthcare system today, but it can have a big impact on many issues.
Opportunities? One thing I believe about Scott is that at the root of his beliefs is that what matters to patients is what matters most. I don’t have a crystal ball, but I do think we’ll begin to see a much greater focus at the Agency on patient-centered activities that are authentic and will have impact now and in the future.
Having worked at the FDA, Scott understands the organization – both what it does well and where it needs work. He understands that the Agency’s risk assessment skills are unparalleled, and need to be focused. As he said in a speech before the International Society for Stem Cell Research: “The FDA need to focus on those areas that create the most potential for risk, and channel its resource behind those efforts. Right now, FDA is often too easily distracted by attractive areas like iPhone apps that nonetheless pose relatively low risks and could be ably addressed by other regulatory agencies.”
The search for absolute statistical certainty for the risks and benefits of new drugs has stalled much progress in new drug development. I think we should expect more use of readily available new tools – related to trial design and statistical analysis – to tighten up the approval process for potentially life-saving drugs.
The FDA plays a critical role in assessing the safety and granting approval of potentially life-saving (or at least life-changing) drugs. Under Dr. Gottlieb’s leadership, I believe patients will see the Agency become a welcome partner in the efficient and effective pursuit of safe and valuable treatments. I respect, admire and trust Scott, and he has my “vote” to do many needed and different actions for the American healthcare system and, most particularly, for the patients anxiously awaiting these innovative drugs and devices to become available.