Washington, Nov. 12 (BUS): President Joe Biden on Friday selected Dr. Robert Califf, a former Food and Drug Administration commissioner and eminent medical researcher, to lead the powerful regulatory agency once again.
Califf’s nomination comes after months of concern that the agency close to the center of the government’s response to COVID-19 lacks a permanent leader. The Associated Press (AP) reported that more than six names for the job were put forward before the White House made a decision on Cliff.
Cardiologist and clinical trial specialist Califf, 70, served as the Food and Drug Administration’s commissioner for the last 11 months of President Barack Obama’s second term. Prior to that, he spent one year as the agency’s second-in-command after more than 35 years as a researcher at Duke University, where he helped design studies for several of the world’s largest drugmakers.
Califf faced some concerns about his associations with the drug industry in 2016, but it was finally confirmed by a landslide 89-4 vote in the Senate.
Since leaving the government, he has served as a political advisor to the tech giant Google, in addition to his ongoing academic work at Duke.
“As the FDA considers many decisions related to vaccine approval and more, it is critical that we have a firm, independent hand in FDA guidance,” Biden said in a statement announcing his decision.
If confirmed by the Senate, Califf will oversee decisions about COVID-19 vaccines along with a host of other complex issues, including e-cigarette regulation and efficacy criteria for prescription drugs. He will be the first FDA commissioner since the 1940s to return for a second term to lead the agency.
“Rob is a relatively safe option because he is known in Washington and is well respected,” said Wayne Pines, a former commissioner of the Food and Drug Administration who has helped several of the commissioners through the confirmation process. “It will get broad support from stakeholders in the Food and Drug Administration.”
The U.S. Food and Drug Administration regulates the vaccines, drugs, and tests used to combat COVID-19. This is in addition to her regular duties regulating a range of consumer goods and medicines, including prescription drugs, medical devices, tobacco products, cosmetics and most foods.
Dr. Janet Woodcock, the agency’s longtime director of medicines, has been acting as an acting commissioner since January. For several months she was expected to be nominated for permanent position, but her nomination faced opposition from key Democratic lawmakers, including Senator Joe Manchin of West Virginia, over her handling of opioid painkillers during his more than 30 years in the agency.
The White House faced a legal deadline in mid-November to name a permanent commissioner or nominate another acting commissioner.
Califf arrived at the Food and Drug Administration in 2015 determined to update how the agency reviews drug and device study data. But his brief stint as commissioner was dominated by unrelated drug controversies, including the rise in opioid addiction and overdose.
He was among the first Food and Drug Administration officials to publicly acknowledge missteps in the agency’s oversight of pain relievers including OxyContin, widely blamed for triggering the ongoing opioid epidemic, now driven by heroin and fentanyl.
“If opioid addiction and opioid abuse is an enemy, then we in the Food and Drug Administration — like every other part of society — have underestimated the cohesion of the enemy,” Califf told the Associated Press in a 2016 interview. “So we have to adapt.”
Despite those sentiments, Manchin said in a statement Friday that he opposes Califf’s nomination, calling for a “culture change at the Food and Drug Administration.”
“Dr. Manchin, who was one of only four senators who voted against his confirmation in 2016, said Califf’s nomination and his important ties to the pharmaceutical industry take us backwards, not forwards.
The White House expected no problems when asked about Manchin’s opposition to Califf.
“We feel he is a qualified person who has the exact experience of this moment,” press secretary Jen Psaki said Friday.
Powerful pharmaceutical and medical lobby groups released strong support statements Friday, as did a number of physician and patient groups.
Califf has worked as a consultant for major drug manufacturers including Eli Lilly, Merck & Co. He is a board member of two smaller biotech companies.
Federal ethics codes do not require government officials to sell all of their investments, but they must disavow matters that may affect those investments. As part of the audit process, FDA candidates disclose and sell stocks, funds, and other investments that could cause a conflict of interest.
Food and Drug Administration watchdogs said Califf had several major advantages over other candidates vetted for the job, many of whom would have faced more scrutiny in the Senate.
“He knows how the FDA works, and he avoids making any nefarious decisions as a commissioner,” said Diana Zuckerman of the nonprofit National Center for Health Research. “These are necessary if the FDA is to regain public confidence.”
His first duties will include relieving burnout and raising morale among the Food and Drug Administration’s 18,000 employees. The agency’s medical auditors have been straining for months under the crushing workload of the coronavirus pandemic, while the agency’s reputation for scientific independence has been damaged by public controversy.
Two congressional committees are investigating the agency’s June approval of a controversial Alzheimer’s drug, against the recommendation of its outside experts, and three of them have resigned over the decision. Then in September, two of the FDA’s top vaccine regulators announced they were leaving the agency after disagreeing with the Biden administration’s plan to make boosters for COVID-19 vaccines widely available.
In recent weeks, the Food and Drug Administration has allowed additional doses of all three COVID-19 vaccines for certain groups, but not as widely as Biden originally suggested. Pfizer recently applied to extend eligibility for its booster to all adults, a request the Food and Drug Administration is expected to grant.
The FDA’s latest issues came after months of turmoil between the agency and the White House under President Donald Trump, who has falsely accused the agency of deliberately slowing down its review of COVID-19 vaccines to influence the presidential election.
NS