Dr. Robert Califf was chosen by President Joe Biden on Friday to lead the powerful regulatory agency again. He used to be an FDA commissioner and prominent medical researcher.
After months of concern that the agency has lacked a permanent leader, Califf was nominated. The agency is at the center of the government’s Covid response.
Robert Califf Picked To Lead FDA Again
Before the White House decided on Califf, over half a dozen of names were floated for the job.
Califf, a cardiologist, and clinical trial specialist served as an FDA commissioner for the end of President Barack Obama’s second term. He is now 70 years old.
Before this, he spent a year as the agency’s #2 official after over 35 years as a researcher at Duke University. Here, he helped design studies for a lot of the world’s biggest drugmakers. Some concerns regarding his connections to the drug industry were voiced in 2016, but with an overwhelming 89-4 Senate vote, he was confirmed as the head.
He worked as a policy adviser for Google ever since he left the government. He did this in addition to his ongoing academic work at Duke.
Biden said that it is of the utmost importance that the FDA had a steady, independent head to guide it as they consider many consequential decisions around the approval of vaccines. Along with the regulation of e-cigarettes and the effectiveness standards of prescription drugs, Califf, it was confirmed by the Senate, would oversee decisions on Covid vaccines as well.
Califf, since the 1940s, would be the first commissioner to return for a second stint.
Wayne Pines said that Rob since he is known in Washington and is widely respected is a relatively safe choice. He is a former FDA associate commissioner who, during their confirmation process, has helped multiple commissioners.
He said that Rob will have broad support from FDA stakeholders.
The FDA regulates drugs, vaccines, and tests that are used to combat Covid which it does along with regulating a huge array of consumer goods and medicines, which include medical devices, prescription drugs, cosmetics, most foods, and tobacco products.
The agency’s longtime drug director, Dr. Janet Woodcock, has been serving as the acting commissioner since January. She was expected to be tapped for the permanent post, but her nomination received criticism from key lawmakers from the Democrats. This included Sen, Joe Manchin of West Virginia.
He criticized her handling of opioid prescription painkillers during her 30-year tenure.
A legal deadline of mid-November was given to the White House to nominate a permanent commissioner.
In 2015, Califf arrived at the agency in order to determine how to modernize the agency regarding the review of drugs.
Unrelated pharmaceutical controversies dominated his brief time as commissioner. This included opioid addiction and overdoses that were surging.
Califf was one of the first few officials of the FDA who acknowledged that they mishandled OxyContin, which was a painkiller that sparked the opioid epidemic that is ongoing and is now driven by heroin and fentanyl.
He said that they underestimated the tenacity of the addiction to opioids and misuse of opioids so now, they have to adjust.
Manchin said that he opposes Califf’s nomination despite these sentiments and said that there needs to be a change in the culture at the FDA.
Manchin said that they would be taken backward instead of forwards due to Califf’s ties with the pharma industry.
When asked about Manchin’s opposition to Califf, the White House saw no problems.
Jen Psaki, the press secretary said that they felt that he was a qualified person who has the experience for this very moment.