- FDA Commissioner Scott Gottlieb, MD, has announced his resignation from the top post at the Food and Drug Administration.
Gottlieb, who has taken a strong stance on public health issues such as opioid abuse, drug pricing, and e-cigarette use, has also overseen the FDA’s strategic planning for artificial intelligence and the continued development of precision medicine.
“I’m immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public health goals we advanced together, and the strong support of [HHS Secretary Alex Azar] and [President Trump],” Gottlieb wrote on Twitter. “This has been a wonderful journey and parting is very hard.”
The reason for his resignation has not been made public, according to multiple news reports, but it does not appear that the White House requested the change. Instead, Gottlieb leaves with fond farewells from his colleagues, including Azar.
“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” Azar said in a statement also posted to Twitter. “He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation. I will personally miss working with Scott on the important goals we share, and I know that is true for so many other members of the HHS family.”
“Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important polices to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more. The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”
Gottlieb took over FDA leadership at a pivotal time, just after the passage of the 21st Century Cures Act and in the middle of the nation’s opioid crisis.
He has aggressively pursued FDA policies to curb inappropriate access to opioids while preserving the ability of chronic pain patients to remain on necessary treatment.
He has also sought to prepare the healthcare industry for an influx of innovative approaches to precision therapies and medical devices infused with machine learning, balancing the need for extensive safety testing with the urgency of bringing breakthrough approaches into the care environment.
“Software is increasingly used in healthcare to treat and diagnose conditions and diseases, aid clinical decision making, and manage patient care,” the agency said in January when introducing its software review plan aimed at the new generation of AI-enabled tools.
“Historically, healthcare has been slow to implement technology tools that have transformed other areas of commerce and daily life.”
“It is important for public health to address these distinctive aspects of digital health technology – its clinical promise, unique user interface, ability to facilitate patient engagement with the developer, and compressed commercial cycle of new product introductions – while ensuring that existing standards of safety and effectiveness are met or exceeded.”
During Gottlieb’s tenure, the FDA gave the go-ahead to some of the first clinical decision support tools based on artificial intelligence, such as a system that uses AI to detect wrist fractures in x-ray images and an algorithm that can scan CT images for chronic thromboembolic pulmonary hypertension patterns.
“AI holds enormous promise for the future of medicine,” Gottlieb said in 2018, stressing the importance of integrating real-world evidence into the safety review process for AI tools, clinical trials, and other activities that fall under the agency’s purview.
“Our longstanding goal for medical care is to ensure that the right drug or device is delivered to the right patient at the right time. This vision is increasingly possible with the innovative products that are becoming available.”
Hopefully, the FDA will continue along the path set by Gottlieb when a new top executive takes over. Gottlieb plans to remain in his post until early April, giving federal officials time to select a new Commissioner.