A lot can be said of Washington in 2019. Talk of government dysfunction and party politics clouds even the simplest conversations and policies. Working in government, once held up as a way to serve our country, has turned into a partisan attack line. But there are some exceptions.

Scott Gottlieb, through his deep respect for the agency he was entrusted to run, set himself apart from this political wrangling and did what was right for Americans. As he steps away from the Food and Drug Administration, he will be sorely missed.

During the 22 months that Gottlieb led the FDA, it achieved extraordinary accomplishments during a tumultuous period for the United States.

As an advocate for cancer research, I have watched and worked with FDA commissioners for more than 25 years. By any standards, Gottlieb joins the ranks of some of our country’s best. I understand this may seem like a bit of a love letter to the commissioner, but it is not. It is simply an acknowledgement of a public servant’s accomplishment, but also a warning: An agency this important cannot be put in the hands of anyone less accomplished. In the current political environment, Gottlieb’s example matters more than ever.

When President Trump nominated Gottlieb to head the FDA in March 2017 — after having served in the agency a decade before — he arrived with significant knowledge of and experience with the interworking of an institution that oversees one quarter of the U.S. economy. Even more important, he came with a genuine respect for the public servants working there.

Through this respect — and the acknowledgment of decades of leadership from people heading vital areas of the agency like Janet Woodcock, Rick Pazdur, Peter Marks, and Jeff Shuren — as well as gratitude for the entire staff working to protect the public’s health, food supply, and everyday life — he was sworn into office in May 2017 with internal support for an ambitious agenda.

If you look at Gottlieb’s tenure as commissioner without knowing which administration he served, it would be difficult to identify partisan politics on his part or gauge the party of the president who nominated him. From issues ranging from vaccination, food safety, drug pricing, and tobacco and vaping, Gottlieb kept one audience in mind: patients and consumers, also known as the American people.

Among his accomplishments, he helped change how we evaluate the choices we make in restaurants; implemented the 21st Century Cures Act and established the FDA’s Oncology Center for Excellence, which suggests how the future FDA may be structured; and helped create an ecosystem that makes it possible for clinical trials to adapt to the speed of science. All the while he made sure that regulations enhanced scientific innovation and didn’t impede it.

Without a leader like Gottlieb, I worry that the progress of the FDA over the past years — including tackling a growing public health threat in children vaping, the dire front we face with opioid abuse, and further positioning the agency to be able to readily adapt to changing scientific advancements like cell therapies — could be stifled.

While the full impact of Gottlieb’s accomplishments and programs may not be fully realized for years to come, one thing is certain: He set the bar for what leadership of any government agency looks like.

While Gottlieb’s resignation is sad news to those of us in the patient advocacy and scientific communities, his work there should offer President Trump and future presidents a blueprint for who to nominate for the FDA or any other agency: candidates who not only have the credentials, political savvy, and skills to be confirmed, but those who have the respect of their peers and who in turn respect those who serve the health and well-being of our country.

https://www.statnews.com/2019/03/06/scott-gottlieb-fda-leadership-publi…