Gupta is also expected to take a lead role in guiding the FDA’s communications strategy, serving as its public face on high-profile issues and trying to bolster trust in the agency’s health recommendations.
Currently the chief medical officer for new products at Amazon, Gupta raised his national profile over the last two years as a medical analyst and frequent TV commentator on the Covid pandemic. He was also part of a group 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 top adviser comes as the FDA has taken a central role in simultaneous efforts to battle the pandemic, ease a shortage of infant formula and protect abortion access. But the agency has stumbled repeatedly in its messaging on those issues to the public and lawmakers on Capitol Hill. Those difficulties have heightened the belief within the Biden administration that FDA Commissioner Robert Califf needs more high-level support, the people with knowledge of the matter said.
In recent months, Califf has struggled to explain the FDA’s sluggish response to the baby formula supply crisis, frustrating Democratic lawmakers and denting the agency’s reputation.
“There were plenty of warning signs about this crisis,” Sen. Patty Murray (D-Wash.) said during a May hearing where several lawmakers pressed Califf over the agency’s actions. “And it seems like the people responsible for safety and supply here just blew through each and every one of them.”
The FDA also faced criticism over its lengthy evaluation of Covid vaccines for the nation’s youngest children. It offered mixed messages for the delay that fed confusion and angst among parents trying to protect their kids as the nation increasingly dropped Covid restrictions.
And after the Supreme Court overturned Roe v. Wade, it took several hours for the FDA to issue an official response. In it, the agency said “patients should have access to medications that are safe and effective for their FDA-approved use.” The FDA has not offered any more detail, despite Biden’s assurances the agency will play a lead role in protecting and boosting access to abortion pills.
In addition to managing the post-Roe fallout, the agency is preparing to roll out another round of Covid vaccinations this fall intended to help protect against Omicron subvariants. The FDA has also moved to ban e-cigarettes made by vaping giant Juul and drastically cut cigarettes’ nicotine levels — major policy decisions that have sparked political and industry pushback and already been held up by the courts.
Gupta’s planned hiring would be one in a series of high-level additions to the FDA in the last few weeks. Hilary Marston, a former member of the White House’s Covid response team, is joining FDA this month as Califf’s chief medical officer. Johns Hopkins University pharmacologist Namandjé Bumpus will start in August as the agency’s chief scientist.
Gupta would be charged primarily with improving the FDA’s image and boosting public trust in the agency as a public health authority, as well as serving as a top adviser to Califf on various policy issues.
Califf has expressed concerns about the public’s faith in government on health matters, recently declaring misinformation the nation’s “leading cause of death” and calling for more aggressive action to combat it.
The principal medical adviser role could continue to evolve following the expected retirement of Principal Deputy Commissioner Janet Woodcock, a longtime health official who Biden once considered to run the FDA. Woodcock has told colleagues recently that she will likely leave the agency by the end of the year.
Califf also eventually plans to hire a senior adviser to oversee the FDA’s food policy operations in the wake of the formula shortage, a person with knowledge of the matter said, but has yet to land on a final candidate to lead the revamp.