Biden officials urge states to keep expired doses — Democrats search for unity on drug pricing plans — Biden nominees sail through Senate hearing

From: POLITICO Pulse - Wednesday Jun 09,2021 02:08 pm
Presented by the Pharmaceutical Care Management Association: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
Jun 09, 2021 View in browser
 
POLITICO's Pulse newsletter logo

By Sarah Owermohle and Adam Cancryn

Presented by the Pharmaceutical Care Management Association

With Rachel Roubein, Alice Miranda Ollstein, Susannah Luthi, Dan Goldberg, Joanne Kenen and Daniel Lippman

Editor’s Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our s each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day’s biggest stories. Act on the news with POLITICO Pro.

Quick Fix

— The Biden administration says states should hold onto J&J doses because the expiration date could be extended.

— Democrats are struggling to find common ground on drug pricing reforms, as Senate leaders champion different proposals.

— Meanwhile, there was a glimmer of bipartisanship during a hearing on Biden nominees to lead emergency response and the agency for substance misuse and mental health.

WELCOME TO WEDNESDAY PULSE — where the war of pandemic memoirs is getting real: The husband/wife duo that founded BioNTech are set to share their story one week before their vaccine partner, Pfizer CEO Albert Bourla, publishes his. Send tips (and books?) to sowermohle@politico.com and acancryn@politico.com.

 

A message from the Pharmaceutical Care Management Association:

The Biden Administration postponed the effective date for the Medicare rebate rule until 2023. Despite the delay, uncertainty remains. The cleanest path forward to avoid disruption to Part D, caused by monthly premium increases, is for Congress to quickly repeal the rebate rule outright.

 
Driving the Day

BIDEN ADMIN WANTS STATES TO KEEP EXPIRING J&J DOSES White House officials are telling states they can set aside unused Johnson & Johnson vaccine doses once they expire rather than throw them away, four sources with knowledge told POLITICO’s Rachel Roubein.

White House aides in private calls with governors and state officials on Tuesday said the FDA is expected to examine whether the vaccine’s shelf life is longer than three months.

The guidance to quarantine the J&J doses is meant to ensure they won’t be discarded and can be used if the agency does extend the vaccine’s shelf life. Biden health officials said the expiration dates of the coronavirus vaccines were initially conservative, since the shots are so new. But on Tuesday, they sounded optimistic that additional data could show the shots last longer, according to two sources.

This comes after POLITICO reported last week that the Biden administration is considering donating states’ unused doses of vaccines to countries in need.

States have built up reserves of J&J’s single-dose shot as demand for vaccines has plummeted in recent weeks, raising urgent questions from officials about whether they’ll have to dump some J&J supply starting at the end of the month. The falling demand has affected J&J in particular, since the 11-day pause on its use came right as supply began outpacing demand in many states.

SENATE WADES THROUGH DRUG PRICING QUAGMIRE — Finance Committee Chair Ron Wyden (D-Ore.) spent the Memorial Day recess lobbying his colleagues to back a bill to empower Medicare to negotiate prescription drug prices — but consensus remains elusive, POLITICO’s Alice Miranda Ollstein reports.

Wyden is still trying to strike a deal among his Democratic colleagues, but has advocated a mix of House Democrats' government negotiation bill, H.R. 3, and policies like the one he and GOP Sen. Chuck Grassley of Iowa backed last year to fine drugmakers that excessively raise prices.

One obstacle to that approach: whether prices negotiated by Medicare would also apply for other public and private insurance plans.

The committee’s Dems remain all over the place: Some, like Sens. Elizabeth Warren (D-Mass.) and Debbie Stabenow (D-Mich.) insist that Medicare negotiation must be part of the package. Others like Sens. Tom Carper (D-Del.) and Catherine Cortez Masto (D-Nev.) want to instead use last year’s narrower bipartisan drug-pricing bill as a starting point.

And Sen. Bob Menendez (D-N.J.), a long-time defender of the pharmaceutical industry and critical vote in a 50-50 Senate, is not yet on board with any policy under discussion.

“Show me how it’s going to reduce the cost to the patient, not just the government,” he said. “We keep taking money from the pharmaceutical industry and then we never see the reduction in the cost of prescription drugs. How is that solving the problem?”

BIDEN NOMINEES SAIL THROUGH SENATE HEARING — President Joe Biden's picks to lead emergency response and addiction care had a largely smooth hearing before the Senate’s health panel Tuesday.

Both Dawn O’Connell, nominee for HHS Assistant Secretary for Preparedness and Response, and Miriam Delphin-Rittmon, nominee to serve as Assistant Secretary for Mental Health and Substance Use, pledged to tackle care inequities, take lessons from the ongoing pandemic and work across the aisle.

Each woman has previous experience with the offices they are set to helm, earning them bipartisan praise during the hearing. “Candidly, I wish that this hearing was held months ago,” ranking member Richard Burr (R-N.C.) said to O’Connell in his opening remarks. “This is not a political or a personal choice for any administration.”

He vented that there had been an acting assistant secretary for too many months during a pandemic—much like the situation at FDA, where the Biden administration has yet to name a permanent commissioner.

“I have the greatest respect for Janet Woodcock, she is leading the FDA ably, and I think she has all of the qualifications needed for this moment, but we need a fully confirmed person in that role,” Burr said. Woodcock, FDA’s longtime drug chief, was an early favorite for the permanent post. Instead, she’s served as acting commissioner for months .

 

DON'T MISS THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT: POLITICO will feature a special edition of our Future Pulse newsletter at the 2021 Milken Institute Future of Health Summit. The newsletter takes readers inside one of the most influential gatherings of global health industry leaders and innovators who are turning lessons learned from the past year into a healthier, more resilient and more equitable future. Covid-19 threatened our health and well-being, while simultaneously leading to extraordinary coordination to improve pandemic preparedness, disease prevention, diversity in clinical trials, mental health resources, food access and more. SUBSCRIBE TODAY to receive exclusive coverage from June 22-23.

 
 
Regulations

BIDEN ON CUSP OF WITHDRAWING ANOTHER TRUMP RULEThe White House budget office on Monday cleared the administration’s proposal to retract a Trump rule linked to insulin and EpiPen discounts, dealing another blow to the former president’s evaporating drug pricing legacy.

The rule would have required certain 340B health centers to pass discounts for insulin and epinephrine to patients. But it was narrowly focused — pertaining to roughly 1,000 facilities — and 340B groups argued it would increase administrative burdens and possibly limit access. HHS could publish the retraction at any time in the coming days.

Patient advocates are bristling. The Diabetes Leadership Council launches a TV and digital ad campaign today calling for “less talk, more action” on drug pricing reforms that ensure patients’ drug costs “reflect all discounts and rebates.”

Around the Nation

TODAY: NEVADA MAKES ITS PUBLIC OPTION OFFICIAL — Gov. Steve Sisolak will sign legislation today making Nevada the second state to offer a version of the public option on its Obamacare exchange, POLITICO’s Dan Goldberg reports.

The bill requires insurers to offer plans starting in 2026 that reduce premiums by at least 5 percent, with an aim toward cutting them by 15 percent over four years. It also instructs the state to apply for a federal waiver that would allow union plans to be sold on the exchange.

 

Advertisement Image

 
Vaccines

PRO-VAX KIDS, ANTI-VAX PARENTS — Now that the U.S. has started vaccinating children, a thorny issue is emerging, POLITICO’s Joanne Kenen writes: Whether children should be allowed to get the shot if it’s contrary to their parents’ wishes.

Under current laws, a Kaiser Family Foundation review found 41 states already require parental consent to vaccinate people under age 18, with only a handful allowing exceptions. Several states have already passed or are considering laws that would prohibit mandating Covid vaccines as well.

— By contrast, only a single state — Minnesota — is considering a bill that would allow eligible minors to consent to getting vaccinated by themselves. Two cities, San Francisco and Philadelphia, are similarly moving to allow minors age 12 and above to self-consent.

The issue may take on more urgency as the nation moves deeper into the vaccination effort, though; a KFF survey found that only one in three parents plan to vaccinate their 12-17 year-old children soon, and about one in four say they definitely won’t get their kids the shot.

PHARMACIST GETS 3-YEAR SENTENCE FOR SPOILING VACCINESA Wisconsin hospital pharmacist is headed to prison after he tried to spoil hundreds of Moderna vaccine doses by removing them from cold storage.

Fifty-seven people received doses of those vaccines before the tampering was discovered. The pharmacist, Steven Brandenburg, pleaded guilty in February and received a three-year sentence on Tuesday.

Around the Agencies

SCOOP: CMS TAPS ERIN RICHARDSON AS CHIEF OF STAFF — The top executive at the Federation of American Hospitals is in line to be CMS Administrator Chiquita Brooks-LaSure’s chief of staff, POLITICO’s Susannah Luthi and Rachel Roubein report.

Richardson would leave her post as senior vice president of government affairs for the lobby representing for-profit health systems. Prior to joining FAH, she was an Obama-era Domestic Policy Council adviser and a House Ways and Means Committee staffer.

— CMS has been slow to fill key political posts in the administration’s first months, despite its central role in implementing much of the Biden health agenda. But hiring could pick up now that Brooks-LaSure is officially installed. Jon Blum, another Obama-era CMS alumnus, was recently named the agency’s principal deputy administrator.

 

A message from the Pharmaceutical Care Management Association:

Medicare beneficiaries appreciate the Biden Administration’s decision to delay the prescription drug rebate rule which would increase Medicare Part D premiums 25% and cost taxpayers $170 billion. Congress and the Administration should now permanently repeal the rebate rule and instead advance real solutions that lower the costs of prescription drugs.

 
Names in the News

Cybele Bjorklund is leaving Johns Hopkins University and Medicine to be the senior vice president for policy and government strategy at startup Virta Health, which is focused on reversing Type 2 diabetes, according to an internal announcement obtained by PULSE. Bjorklund had spent the last two years as Johns Hopkins’ vice president for federal strategy.

Joy Fitzgerald will be UnitedHealth Group’s chief diversity, equity and inclusion officer. She joins the insurer from Eli Lilly, where she most recently held the same role.

Sara Roszak is the National Association of Chain Drug Stores ’ new senior vice president of health and wellness strategy and policy and president of its foundation. She most recently served as NACDS’ vice president for pharmacy care and health strategy and as the NACDS Foundation’s vice president of research programs.

 

SUBSCRIBE TO "THE RECAST" TODAY: Power is shifting in Washington and in communities across the country. More people are demanding a seat at the table, insisting that politics is personal and not all policy is equitable. The Recast is a twice-weekly newsletter that explores the changing power dynamics in Washington and breaks down how race and identity are recasting politics and policy in America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear critical new voices that challenge business as usual. Don't miss out, SUBSCRIBE . Thank you to our sponsor, Intel.

 
 
What We're Reading

A member of an FDA advisory committee has resigned over the agency’s authorization of a controversial Alzheimer’s treatment, STAT’s Andrew Joseph reports.

In Foreign Affairs, a group of health experts lay out a roadmap for waging what they predict will be a years-long fight to contain Covid-19 around the world.

A Houston-based hospital system suspended more than 170 employees for failing to comply with its Covid-19 vaccine mandate, The Washington Post’s Dan Diamond reports.

 

Follow us on Twitter

Joanne Kenen @joannekenen

Adriel Bettelheim @abettel

Jason Millman @jasonmillman

Lauren Morello @lmorello_dc

Sara Smith @sarasmarley

Adam Cancryn @adamcancryn

Tucker Doherty @tucker_doherty

Dan Goldberg @dancgoldberg

David Lim @davidalim

Susannah Luthi @SusannahLuthi

Alice Miranda Ollstein @aliceollstein

Sarah Owermohle @owermohle

Carmen Paun @carmenpaun

Rachel Roubein @rachel_roubein

Darius Tahir @dariustahir

Erin Banco @ErinBanco

Lauren Gardner @Gardner_LM

Katherine Ellen Foley @katherineefoley

 

Follow us

Follow us on Facebook Follow us on Twitter Follow us on Instagram Listen on Apple Podcast
 

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings

This email was sent to by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA

Please click here and follow the steps to .

More emails from POLITICO Pulse