World

Biden picks former FDA Commissioner Dr. Califf to run the agency

November 13, 2021
Dr. Robert Califf
Dr. Robert Califf

WASHINGTON — President Joe Biden announced Friday he has nominated Dr. Robert Califf to serve as the chief of the Food and Drug Administration. The FDA, currently overseen by acting Commissioner Dr. Janet Woodcock, has been without a permanent head since Biden took office in January.

Dr. Califf, a cardiologist, was briefly the agency’s commissioner under the Obama administration beginning in 2016. The White House reportedly ruled out Woodcock after she faced opposition from some members of Congress over her handling of opioids while at the agency.

“I first want to thank Dr. Janet Woodcock for her leadership over the last year,” Biden said in a statement. “She has done an incredible job leading the agency during what has been a busy and challenging time, and both she and the FDA career staff have worked hard and followed the science to ensure the American public can trust the decisions being made by the FDA.”

Dr. Califf, a cardiologist who works at the Duke University School of Medicine and a senior advisor to Google parent Alphabet’s life sciences organization, was briefly the agency’s commissioner under the Obama administration beginning in 2016. He also served as deputy commissioner of the FDA’s medical products and tobacco office.

Biden said Friday that Dr. Califf had “strong bipartisan support” in the Senate in 2016 when he was confirmed by a vote of 89 to 4. “I urge the Senate to swiftly confirm Dr. Califf so he can continue the important work being done at this critical moment,” the president said.

The new selection was expected imminently because Woodcock cannot legally stay on as the acting head past Nov. 15 without a nominee to hold the position permanently.

Shortly after Biden announced his pick, Democratic Sen. Joe Manchin of West Virginia criticized the decision, saying it made “no sense” as he claimed Califf has “significant ties to the pharmaceutical industry.”

Dr. Califf has worked as a consultant to pharmaceutical companies, including Johnson & Johnson and Merck.

“His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction. I could not support Dr. Califf’s nomination in 2016 and I cannot support it now,” Manchin said.

The Pharmaceutical Research and Manufacturers of America, or PhRMA, a major pharmaceutical trade group, praised Biden’s nomination.

“We hope the confirmation process will proceed quickly, and we look forward to continuing to work with the FDA as we fight the pandemic and other deadly diseases,” PhRMA CEO Stephen Ubl said in a statement.

Biden’s nomination comes amid the ongoing COVID pandemic, which has killed at least 759,678 Americans, according to data compiled by Johns Hopkins University.

The FDA has helped bring lifesaving treatments to the market and authorized the use of COVID vaccines, which have shown to be highly effective, especially against severe disease, hospitalization and death.

More than a half-dozen names were floated for the job before the White House decided on Dr. Califf, The Associated Press (AP) reported. “As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA,” Biden said in a statement announcing his decision.

If confirmed by the Senate, Dr. Califf would oversee decisions on COVID-19 vaccines along with a raft of other knotty issues, including the regulation of electronic cigarettes and effectiveness standards for prescription drugs. He would be the first FDA commissioner since the 1940s to return for a second stint leading the agency.

“Rob is a relatively safe choice because he is known in Washington and is widely respected,” said Wayne Pines, a former FDA associate commissioner who has helped several commissioners through the confirmation process. “He will have broad support from FDA stakeholders.”

The FDA regulates the vaccines, drugs and tests used to combat COVID-19. That’s on top of its normal duties regulating a swath of consumer goods and medicines, including prescription drugs, medical devices, tobacco products, cosmetics and most foods.

The White House foresaw no problems when asked about Manchin’s opposition to Dr. Califf. “We feel he’s a qualified person who has the exact experience for this moment,” press secretary Jen Psaki said Friday. FDA watchers said Dr. Califf had several key advantages over other candidates vetted for the job, several of whom would have faced more scrutiny in the Senate.

“He knows how the FDA works, and he avoided making any outrageous decisions as commissioner,” said Diana Zuckerman of the nonprofit National Center for Health Research. “Those are essential if the FDA is going to regain the public trust.” — Agencies


November 13, 2021
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