Pharmaceuticals

Sanders Threatens to Oppose Biden Health Picks on Drug Costs

Sen. Bernie Sanders (I-Vt.) has indicated he could block President Biden’s likely pick to head the National Institutes of Health if she doesn’t commit in nomination hearings to using her position to help lower drug prices.

Sanders, who leads the Senate Health, Education, Labor, and Pensions Committee, stopped short of saying he would block cancer surgeon Monica Bertagnolli, but she is certain to face tough questioning if she receives the formal nomination.

Sen. Bill Cassidy (R-La.), the ranking member of HELP and a physician, said in an interview that no one has talked to him about a potential NIH nominee.

“I don’t know” Bertagnolli’s stance on drug pricing, Sanders told reporters Tuesday after a hearing to consider a package of drug pricing bills.

As HELP chairman, Sanders leads the committee that must confirm many of the health agency directors, including NIH and the Food and Drug Administration. Sanders wrote in a letter to the president he “will strongly oppose any future nominee to a major federal health agency who is not prepared to significantly lower the price of prescription drugs in this country.”

“One of the reasons is that no administration or Democrat or Republican has been effective in standing up to the pharmaceutical industry,” Sanders said, adding that all of the health agencies have a role to play. “As a nation we’re spending tens and tens of billions of dollars every year on prescription drugs. We’re spending money on research and development. What are the taxpayers getting for the highest prices in the world for prescription drugs? So what I’m saying is, I want the leaders, the nominees of those agencies, any agency to tell us what they’re going to do to lower the cost of prescription drugs.”

While the senator’s letter didn’t single out an agency or position, the NIH director is the only major health vacancy that requires Senate confirmation.

Seizing of Patents?

Sanders made his remarks about two weeks after the White House was reportedly gearing up to nominate Bertagnolli for the top NIH job. A researcher and surgeon who’s currently undergoing her own treatment for cancer, she’s been director of the National Cancer Institute since October.

The White House has yet to announce an intent to nominate, giving Sanders a chance to weigh on in lowering prescription drug costs, which has long been one of his top health priorities.

For any NIH nominee, this likely means Sanders will raise the longstanding issue of whether the agency will use its authority to seize patents to lower drug prices, which are known as march-in rights. Sanders, in a statement last month, said he was “extremely disappointed” about the NIH’s decision not to seize patents on Astellas Pharma Inc.’s Xtandi to lower the price of the prostate cancer drug.

The NIH has never exercised march-in rights. Francis S. Collins, the last permanent director, has said his legal counsel advised him that drug prices weren’t an appropriate use of march-in rights. Rather, the agency should intervene if a company never develops the drug, he said. The NIH should focus instead on improving the underlying technologies in the same way it has for the human genome instead of playing a direct role in lowering drug prices, he said.

While Bertagnolli hasn’t addressed march-in rights specifically, she has made access and equity a centerpiece of her leadership at NCI. The National Cancer Plan released last month calls for health implementation research that in part addresses financial toxicity due to the high cost of treatment.

In his letter, first reported by the Washington Post, Sanders noted he voted against confirming Robert M. Califf’s as FDA commissioner in 2021 “because of his unwillingness to stand up to the greed of the pharmaceutical industry.” Sanders didn’t vote on Califf’s nomination in 2016.

Califf has saidthat while the FDA doesn’t play a direct role in drug pricing, it can support increasing competition by encouraging development of generics and biosimilars. He’s questioned drug makers decisions to charge “the maximum price you can get right out of the gate” based on an “unproven, unvalidated surrogate” under accelerated approval at the Biopharma Congress in February. “It would be nice if we pegged our payments to the value that a product brings to patients.”

The White House didn’t immediately respond to a request for comment.

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