Senators Grill NIH Director Nominee on Drug Prices, Gender-Affirming Care

WASHINGTON — Members of the Senate Health, Education, Labor and Pensions Committee questioned Monica Bertagnolli, MD, President Biden’s nominee to lead the National Institutes of Health (NIH), about the high cost of prescription drug prices, the limits of transgender care, and rebuilding faith in the agency, during her confirmation hearing on Wednesday.

Biden tapped Bertagnolli, a surgical oncologist and director of the National Cancer Institute since October 2022, to serve as NIH director in May, after Francis Collins, MD, PhD, stepped down in late 2021.

In her opening statement, Bertagnolli, who grew up in rural Wyoming, said she was inspired to become a physician by her uncle, a primary care physician who worked mainly with veterans all across the state.

She also recalled the challenges her father experienced as a cancer patient, and shared her own recent diagnosis with breast cancer, for which she has completed treatment.

In laying out her vision for the agency, a key theme for Bertagnolli was equity. “NIH can and must support research that is equitable and accessible to all populations,” she said, stressing the need to diversify clinical trials.

While she’s seen how NIH research can save lives, she’s also seen how some patient outcomes have been compromised by preventable factors. She recalled the “tragedy” she observed sitting beside patients at the moment they were offered medications they couldn’t afford.

“We should be able to guarantee that the American people are getting a return on their investment by ensuring that healthcare recommendations are available and affordable for everyone,” she said.

Lowering Drug Prices, Preserving Innovation

In that vein, Committee Chairman Sen. Bernie Sanders (I-Vt.) argued in his opening remarks that despite the fact that taxpayer dollars fund the NIH, and agency-funded basic research is largely responsible for innovation and new discoveries, drug companies have made billions of dollars each year by price-gouging Americans for their products.

“We need an NIH director who is prepared to take on the greed of the pharmaceutical industry and use every tool at his or her disposal to substantially lower the outrageous cost of prescription drugs,” Sanders said.

Sanders asked Bertagnolli about one mechanism he believes would help rein in these high prices: the “reasonable pricing clause” in NIH contracts. “If the federal government puts money into the research and development of a drug, will you insist that the price is not higher than it is in other countries?” he asked.

Bertagnolli stressed her commitment to ensuring that the benefits of NIH research are “affordable and available” to all Americans, but said she could not provide “further specifics” about how she would achieve those goals at this time.

Committee Ranking Member Sen. Bill Cassidy, MD (R-La.) pressed Bertagnolli to commit to precisely the opposite stance: excluding reasonable pricing clauses from NIH contracts. He said the clauses have “discouraged the uptake of breakthrough discoveries” by the private sector and that former NIH Director Harold Varmus, MD, rescinded the clauses decades ago, as he blamed the policy mechanism for driving industry away from potential scientific collaborations.

“History tells us that if you do it, patients are damaged,” Cassidy said of the clauses, despite whatever “rhetoric” may be circulating in their favor.

Again, Bertagnolli said she could not commit to “any specific action” right now, “but I will work with you on this issue.”

Gender-Affirming Care

On the issue of gender-affirming care, Sen. Tommy Tuberville (R-Ala.) expressed concern over a recent NIH-funded study that examined the physical and psychosocial functioning of transgender youth after 2 years of hormone therapy.

Two young people died by suicide during the course of the study, Tuberville said. “That’s obviously a tragedy, but what concerned me even more is the fact that the NIH was funding research, and beyond that, I believe the NIH even called the study a success.”

Tuberville asked Bertagnolli what she would do to ensure that nothing similar ever happens under her oversight.

“Any research that we do that involves human beings, people, is conducted according to the highest ethical principles, so that we make sure that the research is intended to do no harm, to achieve benefits, and is done in ways that we have maximum respect for the dignity of people,” she said.

Tuberville also questioned Bertagnolli about how she would help rebuild trust in public institutions, particularly among people in rural states like Alabama and her home state of Wyoming.

Bertagnolli said that she believes deeply in the importance of the doctor-patient relationship and in “education at all levels,” as well as “our patients joining us in research to the fullest extent possible. Not science here, and people here, but people joining us to do science. I think that also engenders great trust in the process if it’s done in a respectful and appropriate way.”

Bertagnolli was the first woman to lead the National Cancer Institute and, if confirmed, would be the first surgeon and only the second woman to serve as director of the NIH, after Bernadine Healy, MD, who led the agency from 1991 to 1993.