Gupta is also expected to take a lead role in guiding the FDA’s communications strategy, serving as the public face on high-profile issues and trying to build trust in the agency’s health recommendations.
Currently chief medical officer for new products at Amazon, Gupta has raised her national profile over the past two years as a medical analyst and frequent TV commentator on the Covid pandemic. He was also part of a panel of health experts advising President Joe Biden’s presidential campaign and transition on the pandemic response.
An FDA spokesperson declined to comment. Gupta also declined to comment.
The search for a high-level adviser comes as the FDA has played a pivotal role in simultaneous efforts to fight the pandemic, ease the shortage of infant formula and protect access to abortion. But the agency has repeatedly stumbled in its messaging on these issues to the public and to lawmakers on Capitol Hill. Those difficulties have reinforced a belief within the Biden administration that FDA Commissioner Robert Califf needs higher-level support, people with knowledge of the matter said.
In recent months, Califf has struggled to explain the FDA’s slow response to the formula supply crisis, frustrating Democratic lawmakers and tarnishing the agency’s reputation.
“There were a lot of warning signs of this crisis,” the senator said. Patty Murray (D-Wash.) said during a hearing in May where several lawmakers pressed Califf over the agency’s actions. “And it looks like the people responsible for security and supply here have just blown every one of them.”
The FDA has also been criticized for its lengthy assessment of Covid vaccines for the nation’s youngest children. He offered mixed messages for the delay which has fueled confusion and angst among parents trying to protect their children as the nation increasingly lets go of Covid restrictions.
And after the Supreme Court overturned Roe vs. Wade, it took several hours for the FDA to issue an official response. In it, the agency said, “Patients should have access to safe and effective drugs for their FDA-approved use.” The FDA did not provide further details, despite Biden’s assurances the agency will play a lead role in protecting and improving access to abortion pills.
In addition to managing the post-deer fallout, the agency is preparing to roll out another round of Covid vaccinations this fall intended to help protect against Omicron subvariants. The FDA also moved to ban e-cigarettes made by vaping giant Juul and to drastically reduce nicotine levels in cigarettes — major policy decisions that have sparked a political and industry backlash and have already been blocked by the courts.
Gupta’s planned hire would be one of a series of high-profile additions to the FDA in recent weeks. Hilary Marston, a former member of the White House Covid Response Team, joins the FDA this month as Califf’s chief medical officer. Namandjé Bumpus, a pharmacologist at Johns Hopkins University, will start in August as the agency’s chief scientist.
Gupta would be primarily responsible for improving the FDA’s image and building public confidence in the agency as a public health authority, as well as serving as a senior adviser to Califf on various policy issues.
Califf has expressed concerns about public trust in government on health, recently declaring misinformation to be the nation’s “leading killer” and calling for more aggressive action to combat it.
The role of senior medical adviser could continue to evolve after the planned retirement of Senior Deputy Commissioner Janet Woodcock, a longtime health official whom Biden once considered leading the FDA. Woodcock recently told colleagues she would likely leave the agency by the end of the year.
Califf is also considering hiring a senior adviser to oversee FDA food policy operations in the wake of formula shortages, a person with knowledge of the matter said but has yet to find a final candidate to lead the overhaul. .