On NIH, Sanders ain’t budging

From: POLITICO Pulse - Wednesday Jul 12,2023 02:22 pm
Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
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By Megan R. Wilson and Daniel Payne

Presented by

PhRMA

With help from Ben Leonard, Alice Miranda Ollstein and Carmen Paun

Driving the Day

Sens. Elizabeth Warren and Bernie Sanders

Sen. Bernie Sanders is holding up the nomination of Monica Bertagnolli to lead the NIH, while Sen. Elizabeth Warren wants her to agree not to work for any major drug company for four years after leaving the agency. | John Locher/AP Photo

THE TANGLE OVER NIH NOMINEE — The confirmation of Monica Bertagnolli, President Joe Biden’s nominee to lead the National Institutes of Health, is running into roadblocks from Bernie Sanders as the Vermont Independent senator clashes with the administration over Biden’s drug pricing agenda, POLITICO’s Adam Cancryn reports.

Sanders, who chairs the Senate committee responsible for vetting Bertagnolli’s candidacy, said in a recent interview that he began warning the administration in January that he wanted more unilateral actions to slash drug prices. He has since said he would oppose all health nominees until the White House met his demands.

The role has been open for a year and a half, frustrating medical research groups that believe it’s critical to have a confirmed leader to provide stability for the agency — particularly ahead of looming budget negotiations on Capitol Hill.

Sanders insists he feels no pressure to move on Bertagnolli’s nomination as long his requests remain unmet, telling POLITICO, “The public is probably more on my side.”

Bertagnolli, a renowned cancer surgeon, had already done a stint atop the government’s National Cancer Institute, where she was well liked by staff scientists and clinicians. And throughout the broader medical research community, support for her was instant and full-throated.

Yet two months after her nomination, what many viewed as a slam-dunk selection has become the latest personnel headache for a White House that’s struggled to get its nominees through the narrowly divided Senate.

A second senator, Elizabeth Warren (D-Mass.), has made her own demands, pressuring Bertagnolli to sign expanded ethics agreements that include swearing off working for or on behalf of major drug companies for four years after leaving NIH. Bertagnolli has so far resisted over concerns about the scope of those commitments, two people familiar with the matter told Adam.

Bertagnolli met with Warren on Tuesday to discuss the senator’s ethics demands, but the session broke without an agreement.

In response to questions about Sanders’ demands, the White House declined to comment on the record.

But a White House official pointed to the passage of the Inflation Reduction Act, a top Biden administration priority that allowed Medicare to negotiate the price of some high-cost drugs and said the administration remains committed to getting Bertagnolli confirmed.

WELCOME TO WEDNESDAY PULSE. I’m Megan Wilson, your friendly health care lobbying reporter, filling in today. Don’t forget to tip Daniel and me at mwilson@politico.com and dpayne@politico.com.

TODAY ON OUR PULSE CHECK PODCAST, host Megan Messerly talks with Carmen Paun, who explains what’s behind the Biden administration’s plan to combat the growing threat of so-called Tranq Dope — a lethal combination of fentanyl and the horse tranquilizer xylazine — which has led to a surge in deaths in the U.S.

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A message from PhRMA:

Research and development of cancer medicines after their initial FDA approval can help expand treatment populations, find new ways of treating a cancer or help patients earlier in their cancer battle. Unfortunately, provisions in the Inflation Reduction Act put this progress in jeopardy by selecting medicines for price setting before many of these critical advancements can be fully realized. Read the new report.

 
In Congress

Person at counter in CVS Pharmacy near a sign with MinuteClinic hours

There’s a bipartisan move in Congress to require more transparency from the pharmacy benefit managers that negotiate discounts with drugmakers and decide which medicines plans will cover. | Ted Shaffrey/AP Photo

FIRST IN PULSE: CONGRESS CLOSES ON PBM DISCLOSURE — The Senate Finance Committee is releasing the next in its parade of legislation targeted at pharmacy benefit managers — an industry that Democrats and Republicans on Capitol Hill argue drives up the cost of drugs.

Sens. Catherine Cortez Masto (D-Nev.) and Thom Tillis (R-N.C.) — along with Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) — plan to unveil legislation that would require PBMs, which manage prescription drugs for health insurers, to report a broader range of data about their business practices. The lawmakers seek comment on their proposal.

The bill would require PBMs to submit annual reports to the Medicare drug plans that detail information about the treatments the plan covers, the discounts PBMs negotiate with drugmakers on medicines and the fees they collect.

It’s the latest in a plan from Wyden and Crapo, who released a roadmap in April of PBM-focused legislation they want the committee to pursue.

ALSO JUMPING INTO THE FRAY — In the House, PBMs are coming under additional scrutiny this morning as the Education and the Workforce Committee marks up a package of legislation that includes measures aimed at their business practices.

As Ben and I reported yesterday, Chair Virginia Foxx (R-N.C.) and ranking member Bobby Scott (D-Va.) unveiled four bills focused on transparency in the health care sector, including a sweeping proposal that would codify the rules that require hospitals and insurance companies to disclose the prices of their services and establish new disclosures for PBMs.

The package also includes bills that would require PBMs to disclose compensation to plan fiduciaries, ensure that fiduciaries aren’t barred from getting cost or quality-of-care information about their plan and mandate that insurers pay only for claims from hospitals that have “accurate billing practices.”

 

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Abortion

LAWSUIT CHALLENGES IDAHO ‘ABORTION TRAFFICKING’ LAW — Progressive advocacy groups are taking Idaho to federal court over its first-in-the-nation law criminalizing anyone who helps a minor leave the state for an abortion or obtain abortion pills by mail without informing a parent, Alice reports.

The Northwest Abortion Access Fund, the Indigenous Idaho Alliance and one individual plaintiff say the law is unconstitutionally vague in a way that could chill free speech — including discussing options with a teenager who has an unwanted pregnancy — and infringes on the right to interstate travel.

The state’s law, which took effect earlier this year, makes it a felony punishable with two to five years of prison time for any adult to assist a minor in procuring an abortion with the intent to conceal the abortion from the minor’s parents. People could be charged under the law even if the abortion happens in a state where the procedure is legal and parental consent isn’t required.

 

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Around the Agencies

NEW HHS NONDISCRIMINATION PROPOSAL Applicants for grants from the Department of Health and Human Services would face more scrutiny about their nondiscrimination policies under a proposal from the agency’s Office for Civil Rights, Ben reports.

The proposed rule is aimed at bolstering anti-discrimination protections based on sexual orientation and gender identity. It would also broaden them in some programs at HHS agencies, including the Health Resources and Services Administration.

“This is the next step in rebuilding the department’s civil rights infrastructure,” OCR Director Melanie Fontes Rainer told POLITICO.

The proposed rule attempts to fortify regulations against legal challenges by creating a new process for people with religious objections to seek an exemption.

 

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Around the World

U.N. CALLS OUT U.S. FOR BLACK MATERNAL MORTALITY — The United Nations Population Fund said in a report today that the disparity in maternal mortality among Black women compared with white women across nine countries in the Americas is the starkest in the U.S., Carmen reports.

Black women and girls are three times more likely to die while giving birth or within six weeks of giving birth than non-Afro-descendent and non-Hispanic women, the UNFPA said. The U.S. is followed by Suriname, where Black women and girls are 2.5 times more likely to die, and Brazil and Colombia, where they’re 1.6 times more likely to die.

The report looked at the treatment and care women of African descent received in nine countries in North and South America during pregnancy, including the U.S. It found that they are systematically neglected and mistreated across the countries studied, causing pregnancy complications and delayed interventions, which often lead to death.

The U.N. body recommended that governments address the issue by tackling what it calls systemic racism and sexism leading to the disparity, including collecting better data on maternal health by race and eliminating outdated medical teaching infrastructure about Black people’s ability to feel pain.

WHAT WE’RE READING

STAT reports on why maternal mortality data is difficult to count.

Reuters reports that most patients who use weight-loss drugs like Wegovy stop doing so within a year.

 

A message from PhRMA:

A new report showcases the vital role of post-approval R&D in nine critical oncology treatments. This research can help expand treatment populations, find new ways of treating a cancer or help patients earlier in their cancer battle. Unfortunately, provisions in the Inflation Reduction Act put this progress in jeopardy by selecting medicines for price setting before many of these critical advancements can be fully realized. See how post-approval R&D in cancer is at risk.

 
 

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