Bertagnolli confirmed as new head of National Institutes of Health

The Senate on Tuesday voted 62 to 36 to confirm cancer surgeon Monica M. Bertagnolli as the director of the National Institutes of Health, ensuring that America’s flagship biomedical agency will have a permanent leader following a months-long dispute involving a key senator that threatened to derail her nomination.

Bertagnolli will be the second woman ever to lead the nearly $48 billion agency, which plays a central role in the U.S. scientific agenda by funding grants to hundreds of thousands of researchers, overseeing clinical trials on its Maryland campus and supporting other endeavors to develop drugs and therapeutics.

NIH has not had a permanent director since December 2021, with Lawrence A. Tabak, a longtime NIH official, serving as the agency’s acting leader. Biden officials and advocates had spent months urging the Senate to move quickly on Bertagnolli’s nomination, arguing that the vacancy threatened American biomedical research. The agency has been the subject of multiple congressional probes in the wake of the coronavirus pandemic and has been attacked by Florida Gov. Ron DeSantis (R) and other prominent Republicans who say NIH leaders mismanaged the virus response and have demanded that the agency be overhauled.

“We firmly believe that Dr. Bertagnolli is the right leader at the right time,” Research!America, a nonprofit medical and health research group, wrote to Senate leaders last week, warning that threats to the funding and policies behind scientific innovation “have never been more pronounced.”

Bertagnolli, a Harvard-trained physician and former chief of surgical oncology at the Dana-Farber Brigham Cancer Center in Boston, currently leads the $7.3 billion National Cancer Institute, the largest of the 27 institutes and centers that constitute NIH. President Biden nominated Bertagnolli to be NIH director in May - 175 days ago - but her confirmation was delayed by Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, who in May vowed to block Biden’s nominees and not allow them to receive confirmation hearings until the president’s team provided a comprehensive plan to lower U.S. drug prices.

Sanders allowed Bertagnolli’s nomination to move forward in September after he received a White House commitment “to keep working to lower the price of prescription drugs,” he said in a statement, and the federal health department took actions to rein in future costs of a potential covid-19 treatment. But the Senate health committee chairman still voted against Bertagnolli following her confirmation hearing, saying that he remained unhappy about her stated plans for NIH, and he cited data that Americans consistently pay higher prices than people in other countries for drugs that were developed with NIH support.

“Dr. Monica Bertagnolli is an intelligent and caring person, but has not convinced me that she is prepared to take on the greed and power of the drug companies and health care industry and fight for the transformative changes the NIH needs at this critical moment,” Sanders said in a statement last month. The Vermont senator has pressed NIH to reinstate a “reasonable pricing” clause, which the agency initially crafted to contain the price of HIV drugs in the early 1990s before it was dropped amid pressure from the drug industry.

In her confirmation hearing last month, Bertagnolli refused to commit to reinstate the clause but pledged that she would work with Sanders on efforts to lower drug prices.

“I will do whatever I am able to … make sure that affordable and accessible care is available for everyone who needs it,” she said, adding that she could not share specifics about her plans.

Other lawmakers have raised their own concerns with NIH, saying that the agency is too bureaucratic and lost public trust during the pandemic.

“First and foremost, you will be tasked to rebuild the relationship with Congress and the public - being a leader that represents the interests of all Americans and not just of the scientific community,” Sen. Bill Cassidy (La.), the top Republican on the Senate health committee, said at Bertagnolli’s confirmation hearing last month before voting to support her. “This means making the agency more transparent and accountable to Congress, while also advancing cutting-edge science.”

Bertagnolli was raised on a ranch in Wyoming, attended Princeton University as an undergraduate and then studied medicine at the University of Utah. She later served as president of the American Society of Clinical Oncology and led the Alliance for Clinical Trials in Oncology, where she worked with thousands of cancer specialists to test new cancer therapies.

“She’s a different kind of leader for NIH. But I think it’s time for someone who really understood clinical research and the importance of clinical trials to be at the helm,” FDA Commissioner Robert M. Califf said in an interview this week.

The head of the nation’s cancer institute was also diagnosed with breast cancer herself last year and has spoken about how the experience has helped her personalize the disease. Califf said that Bertagnolli regularly calls his younger brother, a physician who’s been diagnosed with cancer, to check on his case - a personal touch that impressed him.

“I got a real sense of Monica … it’s quite remarkable,” Califf said.

Bertagnolli is likely to face scrutiny from congressional Republicans probing the U.S. government’s covid response, who have targeted several current and former NIH officials - including Anthony S. Fauci, who led NIH’s infectious-disease center, and Francis S. Collins, the agency’s former director - alleging that NIH-funded research into bat coronaviruses in China may have inadvertently contributed to the start of the pandemic. NIH and its former officials have also been blamed for their pandemic response on the campaign trail; DeSantis, who is running for president, has said that NIH and other federal health agencies need to be “brought to heel” after their leaders encouraged shutdowns and other measures.

Fauci, Collins and other current and former senior officials have denied Republicans’ allegations about the agency’s potential role in the origins of the pandemic. U.S. intelligence agencies have been inconclusive about the likely origins of covid-19 and have refused to rule out the possibility of a lab leak, although virologists generally favor the theory that the pandemic began with a natural spillover from infected animals.

Bertagnolli told senators in her confirmation hearing that she was committed to probing the origins of the pandemic and would “make a valid assumption” about the virus after reviewing available data.