Senate confirms Scott Gottlieb as FDA commissioner; health IT organizations rejoice

The U.S. Senate voted 57-42 to confirm President Donald Trump’s nomination to lead the FDA, ushering in a new era of drug and device regulation under Scott Gottlieb.

Gottlieb’s confirmation was widely expected, although he faced criticism from Democratic senators over his close ties to the pharmaceutical and digital health industry. Gottlieb previously served as deputy commissioner at the FDA during the Bush administration, but spent his subsequent years as a partner at the venture capital firm New Enterprise Associates and as a fellow at the conservative-leaning American Enterprise Institute

Gottlieb has written extensively about his thoughts on how the FDA should regulate drugs and devices, and advocated for a more hands-off approach to mHealth.

Related: Gottlieb defends digital health connections as senators raise concerns about industry ties

During his hearing, Gottlieb defended his investments in digital health companies like Glytec, an app-based technology that provides personalized diabetes therapy management. He vowed to divest in Glytec and several other companies, including Medavante, a data collection platform designed to improve clinical trials.

Prior to the vote, Sen. Patty Murray (D-Wash.) a ranking member of the Health, Education, Labor and Pensions Committee once again urged the Senate not to vote for Gottlieb given his industry connections and questioned whether he could “withstand political pressure” from the Trump administration.

“I’ve grown increasingly concerned about whether he can lead the FDA in an unbiased way given his unprecedented industry ties,” Murray said.

But health IT organizations were generally pleased with Gottlieb’s confirmation. Digital health CEOs and investors previously told FierceHealthcare that they see Gottlieb’s experience as both a regulator and an investor as a benefit for the industry.

Related: 3 ways Trump’s FDA nominee could reshape digital health

“Dr. Gottlieb brings a wealth of public- and private-sector experience to the position at a critical time,” Douglas Fridsma, M.D., president and CEO of the American Medical Informatics Association (AMIA) said in a statement. “Strong leadership, supported by full Congressional funding, is critical for the FDA to implement provisions in the 21st Century Cures Act and deliver on the commitments outlined during the user fee negotiations.”

Related: Trump’s proposal to increase FDA user fees could impact small digital health innovators

Health IT Now Executive Director Joel White added his congratulations, noting that he looks forward to working with the new FDA chief on interoperability, information blocking and building “a more modernized healthcare experience for patients and providers alike.”

“Throughout this process, he has demonstrated a willingness to embrace new technologies and ease barriers that stand in the way of innovation, all while protecting patient safety,” White said.