WASHINGTON — Sen. Bernie Sanders’ rare move to delay President Biden’s health care nominees has put the drug pricing firebrand and the White House in a standoff — and public health advocates worry the feud could squeeze out an otherwise uncontroversial pick to lead the country’s top science agency.
Sanders, the chair of the health committee charged with scheduling the confirmation hearing for National Institutes of Health nominee Monica Bertagnolli, has said he will not schedule the hearing until the Biden administration promises more drug pricing reform. He’s not the only Democrat withholding support: Massachusetts Sen. Elizabeth Warren also wants Bertagnolli to sign a pledge that she won’t join pharmaceutical company boards after her tenure as director, according to three people familiar with internal deliberations.
But as days tick by and another summer recess looms, scientists and advocates are increasingly alarmed — and frustrated — that the White House isn’t putting more pressure on Sanders to schedule her hearing. While a hearing is not required before the whole Senate votes, it would be highly unusual and could alienate Sanders, an independent, from Democratic leadership.
The NIH has been without a permanent head since December 2021, even as the agency grapples with potential budget limits under the new debt ceiling negotiation, other vacancies including the hole left by Anthony Fauci, and the advent of new research — or controversy over old.
“People in the biomedical community are very anxious because there’s a lot going on at the NIH,” said former director Harold Varmus, a Clinton appointee. “An agency as big as ours needs a Senate-confirmed director and we haven’t had one for over a year and a half.”
Varmus joined with the two other living directors, Elias Zerhouni and Francis Collins, to write a letter to Senate leadership late last month urging action and endorsing Bertagnolli.
“The longer this drags out, the harder it is to do and also the more embarrassing it is for the administration,” said Joe Allen, executive director of the Bayh-Dole Coalition, which has fought back on Sanders’ push to require “reasonable” prices from pharmaceutical companies that work with government-funded research. “If you can’t get your nominee through a Democratic-controlled Senate, it makes people think, ‘Well, what the world is going on up there?’”
A White House spokesperson said “the president shares the senator’s concerns on drug pricing” and pointed to efforts including Medicare drug price negotiation, passed last year in the Inflation Reduction Act, and a monthly insulin cap in the program. “We look forward to working with the Senate to get Dr. Monica Bertagnolli confirmed.”
Neither the White House spokesperson nor a Sanders spokesperson answered questions on whether the two groups had been in contact about the issue. Bertagnolli has not yet spoken with Sanders, according to two people familiar with the process.
Separately, Warren is meeting with Bertagnolli on Tuesday. The pledge not to work for a pharmaceutical company post-NIH is Warren’s top concern, according to three people familiar with deliberations.
Food and Drug Administration Commissioner Robert Califf — who has consulted for several major drugmakers and returned to the agency after a stint with Alphabet — signed a similar pledge when he was confirmed. However Bertagnolli has held out on the agreement, said two people who cautioned that could change after her meeting with Warren.
Spokespeople for Warren did not immediately respond to a request for comment.
With the Senate coming to Washington just 13 days this month and staying home for all of August, Bertagnolli’s earliest chance is likely in September, amid the oncoming storm of budget deliberations and weeks ahead of an election cycle. In the meantime, deputy director Lawrence Tabak’s more than 18-month tenure as acting director has been renewed indefinitely as Bertagnolli awaits her vote.
Critics say Sanders’ demands in particular are unreasonable and could jeopardize Bertagnolli’s nomination. The Vermont Independent, who has made high prescription drug costs a tenet of his committee leadership, is demanding that the White House go beyond pricing provisions laid out in last year’s Inflation Reduction Act, which include Medicare negotiation for certain medicines and a cost increase cap.
For the NIH, Sanders’ demands include reinstating a “reasonable pricing” clause, or a requirement that when the agency shares research with pharmaceutical companies, they have to sell the subsequent drug or vaccine at a price showing the “reasonable relationship” between its cost, taxpayer investment, and public need.
The clause was in effect for five years in the early ’90s, and though “reasonable” was never quite defined, NIH researchers said that the requirement fueled a drop in collaborations with outside contractors like drugmakers. Varmus peeled back the requirement in 1995, saying at the time that it had “driven industry away from potentially beneficial scientific collaborations” and that NIH should not be involved in pricing.
In a 2021 review of Varmus’ decision, NIH researchers wrote “there is no reason to doubt the negative impact from the use of the clause.”
Varmus doesn’t regret striking it down either, he told STAT, though he said he doesn’t hold a position on the issue now — just on it being Bertagnolli’s anchor today. “It’s a problem that needs to be worked out, but it shouldn’t be worked out by holding Monica’s nomination hostage.”
There are other levers the NIH could pull to manage prices and competition, including marching in on patent rights — which it has declined to do repeatedly — and instituting patent limits on government-funded drugs, said Lisa Larrimore Ouellette, a Stanford economic policy researcher.
Both are intensely controversial, and if the agency is going to undertake either, it should be a confirmed director, not an acting head, who does so, she and other experts said.
“It’s bad for an agency like this to go without leadership,” said Richard Frank, director of the USC-Brookings Schaeffer Initiative on Health Policy. But, he added: “It’s not obvious that the White House making a lot of noise publicly and trying to do something that potentially embarrasses Bernie Sanders would advance the case.”