Despite the agency’s leading role in the country’s coronavirus response, it has been without a permanent chief since Biden took office in January. Califf would replace acting commissioner Janet Woodcock, the agency’s longtime chief drugs officer, who led the agency for nine months.
Califf returned to cardiology after his tenure at the FDA and currently works for the Duke Clinical Research Institute, but also took on a position as head of health policy at Google’s parent company, Alphabet in 2019.
While he garnered the support of many Senators in his 2016 confirmation process, Sen. Bernie Sanders (I-Vt.) Raised concerns about his ties to the industry and said he could s ‘oppose the vote. At the time, Califf wrote articles with executives in the pharmaceutical industry and consulted with manufacturers of drugs and devices.
“Rob Califf would be a strong, experienced and efficient commissioner,” former FDA commissioner Mark McClellan told POLITICO.
The Washington Post first reported the move.
The next FDA commissioner will be tasked with guiding the country towards a possible end of the Covid-19 pandemic, overseeing scientists who monitor vaccines, therapies and tests. Califf will also have to deal with a workforce depleted by the sheer workload and, before that, by attempts by some Trump administration officials to bypass the agency’s regulatory process to allow these interventions. .
This fall and winter, the agency is set to make major decisions on Covid-19 vaccines for children and booster shots for adults, as well as treatments for the disease – such as the antiviral drug. from Merck, molnupiravir.
The FDA is also leading sweeping new e-cigarette policies, establishing a framework to regulate cannabidiol and dramatically expanding its oversight of over-the-counter products.
“It will be valuable to have a permanent commissioner, as the agency is facing so many changes, which Covid-19 has exacerbated,” said Carl Tobias, former FDA consultant and current President Williams of Richmond University Law. “Woodcock was an effective interim commissioner. But Biden and the agency need a permanent leader.
Woodcock, who joined the FDA in 1986, was reportedly vying for the post of permanent commissioner. But although she has many supporters in the Senate, a handful of Democrats, including Sen. Joe Manchin (DW.Va.) opposed her appointment because of his role in the agency’s handling of the crisis. opioids.
Califf previously worked closely with Biden on the Cancer Moonshot initiative launched by the Obama administration. Califf also has a long history with North Carolina, noted Alston & Bird attorney Marc Scheineson, who previously served as FDA associate commissioner for legislative affairs under former FDA commissioner David Kessler.
“California should have an internal track for a lot of different reasons,” Scheineson. “Senator Richard Burr (RN.C.) can help iron out a confirmation… having the Senator from North Carolina as a senior member of the committee confirming this is very important.”
Lauren Gardner contributed to this report.