Civica Rx will provide insulin for no more than $30 a vial | CNN Politics

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Civica Rx, a non-profit generic drug maker backed by hospitals, insurers and philanthropies, announced Thursday that it plans to manufacture and sell insulin for no more than $30 a vial. It is expected to be available as soon as early 2024, pending federal approval.

Insulin, which more than 8 million Americans with diabetes depend on, has been a poster child for the soaring cost of prescription drugs.

Though insulin was discovered more than a century ago and costs little to make, the list price of the brand name products that Civica Rx is targeting is roughly $300 per vial, according to the Gary and Mary West Foundation, which co-founded Civica Rx. The cost has nearly tripled since 2010.

The high cost has led an estimated 1 in every 4 people with diabetes to ration or skip doses, according to a study published in 2019 in the medical journal JAMA Internal Medicine. Patients who are Black, Latino or Native American are disproportionately affected since they are more likely to be uninsured or underinsured.

There have been multiple efforts to help diabetics afford their medication, the latest being a $35 cap on insulin prices that President Joe Biden called for in his State of the Union address on Tuesday. Congress, however, has yet to pass such a measure. It was contained in the Democrats’ $1.75 trillion Build Back Better package, which is on hold in the Senate.

Civica Rx, which was founded in 2018 to manufacture generic drugs that are in short supply or subject to price spikes, aims to produce three insulin products that will be available in vials and prefilled pens. They would be interchangeable with Lantus, Humalog and Novolog and be co-developed by GeneSys Biologics, a biopharmaceutical company based in India.

A box of five pen cartridges will cost no more than $55.

Before it can roll out the medications, however, Civica Rx needs to complete clinical trials and receive approval from the US Food and Drug Administration. Also, it must finish building a 140,000-square-foot manufacturing plant in Petersburg, Virginia.

The non-profit is raising $125 million to undertake the insulin effort and has secured commitments for more than two-thirds of the funds, Ken Boyden, executive director of The Civica Foundation, said in a statement.

The venture will eventually be self-sustaining, said Shelley Lyford, vice chair of Civica Rx’s board. It will initially produce enough insulin to cover about 30% of the market.

“Those who are going to benefit greatly from this opportunity that we are providing at Civica are those who are underinsured or uninsured who cannot afford to pay for their drugs,” Lyford said.

Unlike other efforts, which focus mainly on lowering what patients pay for insulin, Civica Rx aims to reduce the price of the medication itself.

“Civica’s goal to produce and sell insulin at very low prices could be an important disruption to the current system,” said Stacie Dusetzina, associate professor of health policy at the Vanderbilt University School of Medicine. “There are a couple of big potential wins for consumers.”

Amazon Pharmacy offers insulin discounts amid price hikes: 'Making ...

Consumers who are struggling to get discounted insulin due to pharmacy restrictions and red tape will soon have another option to order the life-saving medication needed by millions of people.

Amazon Pharmacy said it will begin automatically applying manufacturer coupons to more than 14 commonly-used insulin products to ease consumer purchases. If insurance plans provide additional discounts, consumers will pay even less, officials said.

"We’re making it as simple as possible," said Dr. Vin Gupta, Chief Medical Officer of Amazon Pharmacy.

In March, three insulin makers that dominate the market announced they would slash prices by 70% or more on their respective products. The move followed consumer and political pressure urging Eli Lilly, Novo Nordisk, and Sanofi to lower insulin prices, which soared last decade and promoted some consumers to ration supplies.

Older Americans on Medicare received some price relief through the Inflation Reduction Act, the climate and health bill that caps insulin costs at $35 a month for Medicare enrollees. And President Joe Biden urged Congress to extend that out-of-pocket cap to younger Americans who have private health insurance.

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Consumers search for discounted insulin

Despite efforts to lower the price of this medication required by all with Type 1 diabetes and sometimes necessary with Type 2 diabetes, some consumers struggle to navigate the health system to access cheaper insulin

A report this summer from Democratic Sens. Elizabeth Warren, Richard Blumenthal, and Raphael Warnock found consumers had trouble getting discounted insulin from pharmacies nationwide and were often charged more than what the drug manufacturers promised. The report cited a "confusing thicket of coupons, competing generic drugs, and misleading information" consumers faced when asking about discounted insulin.

The report included a survey of more than 300 pharmacies that found 43% did not stock Lispro, Eli Lilly’s less expensive generic version of insulin, while 79% had the more expensive brand drug Humalog. The report said the average Lispro price for uninsured patients was $97.51, or about four times as much as the $25 Eli Lilly promises for its authorized generic.

Eli Lilly said the company is doing its part to ensure people have access to affordable insulin. A company spokesperson said pharmacies fill 50,000 prescriptions of Lispro each week. And those who are uninsured can download a savings card at insulinaffordability.com to get insulin for $35 per month.

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Discounts applied to Humalog, Lispro, Novolog, and Lantus

Amazon said it will extend the $35-per-month price to Eli Lilly’s Humalog, Humulin, and Lispro products. Other widely-used insulin brands at that price include Novo Nordisk’s Novolog and Sanofi’s Lantus.

Amazon said its website will estimate the consumer’s insurance price. If consumers transfer their prescriptions to Amazon, they will see the actual price with insurance and what it would be without insurance.

The retailer also will apply manufacturer coupons to Insulet's insulin pump, the Omnipod 5 Introket, and Dexcom's G6 and G7 continuous glucose monitors.

Consumers enrolled in a government insurance plan such as Medicare or Medicaid are not eligible to receive manufacturer coupons. Also, the offer can't be combined with other discount programs such as Rxpass or Amazon Prime prescription savings benefit, Amazon officials said.

Charles Henderson, chief executive officer of the American Diabetes Association, said Amazon's new initiative will help diabetes patients with a "transparent purchase process that automatically applies any eligible discounts."

A 2020 survey from T-1 International found 1 in 4 people with Type 1 diabetes rationed insulin because of cost. Patients also struggled to pay the out-of-pocket costs for other needed supplies such as insulin pumps, testing strips, and continuous glucose monitors.

Other tech companies also have sought to offer insulin products. Tech entrepreneur Mark Cuban's Cost Plus Drugs aims to cut out pharmacy benefit managers and deliver lower-priced drugs to consumers. The company has launched a test program for insulin.

Nonprofit CivicaRX plans to make and sell market-discounted biologics that are interchangeable with Lantus, Humalog, and Novolog.

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3 major insulin makers have now slashed the price of the life-saving ...

Amid consumer angst and political pressure over the cost of life-saving insulin, Sanofi announced Thursday it would slash the price of its most-prescribed insulin, Lantus.

Sanofi was the final holdout among three companies that make up 90% of the world's insulin market by value. Earlier in the week, Novo Nordisk followed Eli Lilly Co.'s plans to slash U.S. prices by up to 75% and 70%, respectively.

Sanofi said it will cut the price of Lantus by 78% and short-acting Apidra by 70% as of Jan. 1, 2024.

The prices these companies set for insulin have increasingly been scrutinized by analysts, politicians and patient advocates. In recent years, federal and state laws, Medicare and Medicaid policies, and changing market dynamics for these older insulin drugs have influenced price cuts.

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But more needs to be done, said Elizabeth Pfiester, founder and executive director of T1International, an advocacy organization for people with Type 1 diabetes.

The life-saving medication is needed by millions of people. A 2020 survey from her organization found 1 in 4 people with Type 1 diabetes rationed insulin because of cost. Patients also struggled to pay the out-of-pocket costs for other needed supplies such as insulin pumps, testing strips and continuous glucose monitors.

Her organization is pushing for a federal policy that would cap the cost of insulin.

"It's great that they've chosen to lower the price," Pfiester said of the insulin manufacturers. "But they can choose to raise the price again."

Sanofi drops list price for Lantus

Sanofi's list price is $292 per vial of Lantus, the amount charged before discount programs or reduced prices negotiated by health insurers. When Sanofi cuts the price as of Jan. 1, Lantus will cost about $64 per vial.

The company also announced a price cap that ensures no patient will pay more than $35 for a monthly supply of Lantus.

The Paris-based pharmaceutical company earlier said most people with private insurance already pay $15 or less because of a copay assistance program. The drugmaker's program for the uninsured also offers a 30-day supply for $35.

"The list prices of our insulins do not reflect the actual, net prices paid to Sanofi after various discounts and rebates," Sanofi said in a statement. "Despite the rhetoric about skyrocketing insulin prices, the net price of insulin has fallen for eight consecutive years, making our insulins significantly less expensive for insurance plans."

Sanofi vowed to continue to listen to patients, advocates, caregivers and others to "better understand additional actions we could take to address access or affordability challenges."

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Why is insulin so expensive?

Insulin prices charged by the three major drug manufacturers spiked over the past two decades. From 2002 through 2013, the average price of insulin nearly tripled, according to the American Diabetes Association.

A Senate Finance Committee investigation in 2021 found the drug price increases coincided with lucrative rebate demands from insurers and pharmacy benefit managers, which are drug-pricing middlemen that command steep rebates in exchange for favorable placement on private insurance plan drug formularies.

These pharmacy managers in the past decade began to pit manufacturers against one another by excluding them from large blocks of patients through formulary exclusions, the Senate Finance Committee reported.

Why insulin prices are starting to come down now

Last year's sweeping climate and health bill called the Inflation Reduction Act caps insulin costs at $35 a month for Medicare enrollees. And last month, Biden urged Congress to extend that out-of-pocket cap to younger Americans who have private health insurance.

Washington, D.C., and 22 states have enacted cost-sharing limits for consumers purchasing insulin, according to the American Diabetes Association.

Drugmakers also are bracing for a drug pricing change under Medicaid, the federal health program for low-income families. Medicaid has required drug companies to pay rebates when they significantly raise prices over time. But the amount drug companies paid Medicaid was capped in previous years.

The new provision, part of the American Rescue Plan Act passed in 2021, eliminates the rebate cap beginning next year. In other words, drug companies could face significant financial penalties beginning next year, said Antonio Ciaccia, CEO of 46brooklyn Research, a nonprofit that researches drug pricing.

The elimination of this Medicaid rebate cap, in particular, might be influencing drugmakers decisions to drastically cut insulin list prices, Ciaccia said.

"It's one thing for a drug manufacturer to offer something for free," Ciaccia said. "It's another thing to literally pay for the privilege of doing so."

Market dynamics mean insulin will keep getting cheaper

Drug manufacturers also face changing market dynamics.

Cost Plus Drugs, a company from tech entrepreneur Mark Cuban, aims to cut out pharmacy benefit managers and deliver lower-priced drugs to consumers. The company has launched a test program for insulin.

Meanwhile, CivicaRX plans to make and sell market discounted biologics that are interchangeable with Lantus, Humalog and Novolog.

The nonprofit, which is building a manufacturing facility in Virginia, expects to seek authorization from the Food and Drug Administration for its insulin products beginning next year, a spokeswoman said.

Ciaccia, of 46brooklyn, said these older insulin drugs also face competition from newer insulin products, as well as weight loss drugs such as Ozempic.

"The writing is on the wall from a market perspective," Ciaccia said.

How much does insulin cost?

Prior to companies announcing price cuts, insulin has cost nearly $300 a vial.

Eli Lilly, the first to announce insulin price cuts this month, will slash the drugmaker's most commonly prescribed insulin Humalog to $66.40 per vial, down from $274.70. It will implement price cuts within the final three months this year.

Novo Nordisk, a Danish drugmaker, will cut the price of its top-selling NovoLog to $72.34 per vial, down from $289.36. Novo's discounts will take effect Jan. 1.

Pressure ratchets up

This week, President Joe Biden said he's pleased that Novo followed Lilly's price cuts and urged "others to follow."

U.S. Sen. Bernie Sanders, I-Vt., earlier in the week said on social media that "grassroots pressure" led to the Lilly and Novo price cuts, adding, "Sanofi must follow." The week before, he and U.S. Rep. Cori Bush, D-Mo., introduced a bill that would limit the list price of insulin at $20 per vial.

Dig Deeper

Ken Alltucker is on Twitter at @kalltucker, or can be emailed at alltuck@usatoday.com

Eli Lilly insulin price cut: Drugmaker caps out-of-pocket costs

Eli Lilly and Co. said it will cut prices of its most commonly prescribed insulins up to 70% and expand a program that limits out-of-pocket monthly costs for some consumers.

The Indianapolis drugmaker's price cuts and discounts for insulin come as federal and state lawmakers and patient advocates pressure drug companies and health insurers to improve affordability for the lifesaving medication used by millions of Americans.

“The aggressive price cuts we’re announcing today should make a real difference for Americans with diabetes," said Lilly Chair and CEO David Ricks.

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Eli Lilly discounts Humalog and Humulin insulin

The drugmaker will cut list prices by 70% for the fast-acting injectable Humalog, which is the company's most commonly prescribed insulin. Lilly also will discount an older fast-acting drug, Humulin.

The list price for Humalog U-100, 10 mL vial will drop from $274.70 to $66.40.

The list price for Humulin U-100, 10 mL vials will drop from $148.70 to $44.61.

The price changes will take effect between Oct. 1 and Dec. 31.

Lilly also will reduce the price of its nonbranded, fast-acting insulin to $25 a vial, effective May 1.

On April 1, Lilly also will launch a biosimilar to Sanofi's Lantus that will be a less expensive version of the long-acting insulin. The new drug, Rezvoglar, will be interchangeable with Lantus, which means a pharmacist can substitute the drug without a new prescription. Rezvoglar will cost $92 per five-pack of KwikPens, a 78% discount to Lantus, Lilly said.

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Lilly caps out-of-pocket costs for privately insured patients at $35 a month

Lilly said in a news release that it will cap out-of-pocket costs for privately insured consumers at $35 a month at the "majority of retail pharmacies." Company officials said about 85% of national and local pharmacies will honor the $35 price cap, but the company did not provide a list. Consumers are encouraged to call their local pharmacy and ask about the program.

For those without insurance, the drugmaker offers a program savings card that will cap Lilly insulin at $35 a month. Uninsured consumers can get more information and download the discount card at InsulinAffordability.com.

The price might sound familiar to older Americans on Medicare. The federal Inflation Reduction Act caps insulin costs at $35 a month for people on Part D plans. Last month, President Joe Biden called on Congress to extend that out-of-pocket cap to younger Americans who directly purchase their own health insurance or get coverage through an employer.

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Why is Lilly cutting insulin prices?

A study last year found more than 1.3 million American adults skipped, delayed buying or rationed doses of insulin because of the cost of the medication.

Ricks acknowledged that his company and others must make insulin less expensive for people with diabetes who can't afford the medication.

But he added that other stakeholders must help drive down prices. Employers should share cost savings from drug rebates with their workers, and pharmacies should carry low-cost insulins and make people aware of these options, he said.

“We are driving for change in repricing older insulins, but we know that 7 out of 10 Americans don’t use Lilly insulin," Ricks said. "We are calling on policymakers, employers and others to join us in making insulin more affordable.”

More:Fake Eli Lilly Twitter account falsely claimed insulin 'free'

With 8.4 million Americans needing insulin, advocates hope other drugmakers will follow suit

Insulin is needed by all people with Type 1 and some with Type 2 diabetes.

"Insulin is one of those medicines, particularly for those with Type 1 diabetes, that's in the must-have category," said Dr. Robert Lash, chief medical officer of the Endocrine Society. "If you don't have it, you die."

Some with Type 2 diabetes also need insulin. While skipping a dose might not be life-threatening, these people often need insulin to keep their glucose under control and avoid complications, Lash said.

The American Diabetes Association estimates about 8.4 million Americans rely on insulin.

Lisa Murdock, chief advocacy officer for for American Diabetes Association, said reducing out-of-pocket expenses for the drug is a crucial step. As drug companies have raised the price of insulin, insured consumers have absorbed some of those costs in the form of higher co-payments and deductibles.

Cutting insulin list prices, capping co-payments for the insured and extending the $35 cap to the uninsured will make the medication more affordable for people who use Lilly's products.

"We can only hope that the other major manufacturers of insulin follow suit," Murdock said.

Federal lawmakers target insulin prices

In 2021, the Senate Finance Committee unveiled a sweeping investigation of insulin prices. Drug companies in the past decade raised insulin list prices as pharmacy benefit managers commanded more lucrative rebates, the Senate Finance Committee investigation found.

At the time, Republican Sen. Chuck Grassley of Iowa said drugmakers and drug-pricing middlemen known as pharmacy benefit managers created a "vicious cycle of price increases that have sent costs for patients and taxpayers through the roof."

Drug pricing analysts said Lilly's price cuts might be a sign that the insulin pricing dynamics are shifting. That could be good news for consumers, employers and government payers. But the uninsured and those with skimpy health insurance coverage who depend on insulin might be the biggest beneficiaries, said Antonio Ciaccia, CEO of 46brooklyn Research, a nonprofit that researches drug pricing.

"Any patient that's been stuck paying full out of pocket, this is essentially prohibiting that game from continuing," Ciaccia said. "That's significant, since we know so many patients have struggled with affordability."

Ken Alltucker is on Twitter at @kalltucker, or can be emailed at alltuck@usatoday.com.

State of the Union recap: Biden tells Americans economy roaring ...

WASHINGTON, D.C — President Joe Biden took credit Tuesday for what he said was the country's economic revival while pushing an agenda of reducing prescription drug costs, protecting abortion rights and banning assault weapons.

The economy was reeling two years ago, Biden said in his second State of the Union address delivered in a packed House chamber. In a preview of an expected reelection campaign announcement, he noted that the unemployment rate was at 50-year low while inflation has been easing.

“We’ve been sent here to finish the job,” Biden said, invoking a phrase he used several times in his speech.

But the rancorous atmosphere in the House chamber telegraphed fights ahead, including over budget priorities and avoiding a catastrophic default on the nation’s debt. At several points in Biden’s speech, was interrupted by Republicans, who criticized his handling of border policy and pushed back when he accused them of trying to cut popular entitlements.

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Former House Speaker Nancy Pelosi isn’t sitting behind Biden for his address but she got a special call-out from the president anyway. Biden touts progress on insulin prices while pushing for more: Biden renewed his call to cap the cost of insulin at $35 a month for every American.

Biden renewed his call to cap the cost of insulin at $35 a month for every American. Biden spars with GOP over Social Security and Medicare: The president prompted protests in the chamber from Republican lawmakers when he repeated his accusation that the GOP was trying to cut entitlements. When the protests continued, Biden said he wasn’t arguing that all Republicans back reviewing entitlement programs every five years. “But it’s being proposed,” he said.

Sanders: Biden has 'failed' American people; calls for 'new generation'

Sarah Huckabee Sanders of Arkansas, at age 40 the youngest governor in the country, didn't hesitate to point out that 80-year-old Joe Biden is the oldest president in history – and added that it is time for a "new generation" of Republican leadership.

"Biden and the Democrats have failed you," Sanders said in the formal GOP response to Biden's State of the Union address. "It's time for a change."

Speaking from the governor's mansion in Little Rock, Ark., Sanders cited domestic issues like inflation, immigration, and crime. Also criticizing the president's foreign policy, Sanders said Biden is "unfit" to be Commander-in-Chief.

Citing the Republican majority in the House, Sanders said: "We will hold the Biden administration accountable."

– David Jackson

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Biden calls Paul Pelosi 'tough'

Biden called out the political violence that was unleashed in the wake of Jan. 6, 2021 Capitol attack.

“With democracy, everything is possible. Without it, nothing is,” he said.

Biden introduced Paul Pelosi, the husband of former House Speaker Nancy Pelosi, who was violently attacked in their home by an intruder, saying the assailant was “unhinged by the Big Lie” that the election was stolen.

“Here tonight in this chamber is the man who bears the scars of that brutal attack, but is as tough and strong and as resilient as they get. My friend, Paul Pelosi," he said. “But such a heinous act never should have happened.”

– Swapna Venugopal Ramaswamy

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Biden gets personal and celebrates Cancer Moonshot initiative

Biden celebrated the Cancer Moonshot initiative, aimed at advancing cancer prevention and treatment,

“Our goal is to cut the cancer death rates at least by 50% in the next 25 years. Turn more cancers from death sentences to treatable diseases. Provide more support for patients and their families.” The issue is also deeply personal to Biden, as one of his sons, Beau Biden, passed away due to brain cancer. “It’s personal to so many of us.”

Biden also singled out Maurice and Kandice Barron, a pair of guests invited by First Lady Jill Biden. Their daughter, Ava Barron, was diagnosed with a form of kidney cancer when she was one year old. “She turns four next month,” Biden said to wide cheers from the audience. “They just found out Ava’s beating the odds and is on her way to being cured from cancer.”

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Biden says US stood up to China

Facing Republicans who’ve accused him of being too soft on China, Biden said he responded clearly last week when a Chinese surveillance balloon floated over the United States.

China knows that if U.S. sovereignty is threatened, Americans will act to protect the country.

“And we did,” Biden said, an apparent reference to his decision to shoot down the balloon.

– Maureen Groppe

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Biden: Stop production, trafficking of fentanyl

Citing Americans’ growing dependence on prescription drugs, Biden called for a major campaign to stop the production, sale and trafficking of fentanyl.

Biden noted that fentanyl is killing more than 70,000 Americans a year. But his remarks were met with contempt from some members of Congress.

“It’s your fault!” several Republicans shouted.

– Michael Collins

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Biden says VA working to end 'the silent scourge of suicide'

Biden said when he first appointed Denis McDonough to run the Department of Veterans Affairs, the country was losing up to 25 veterans a day to “the silent scourge of suicide,” and continues to lose 17 per day.

“The VA is doing everything it can, including expanding mental health screenings and a proven program that recruits veterans to help other veterans understand what they’re going through and get the help they need,”

– Erin Mansfield

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Biden calls for higher teacher pay

Biden hasn't touched much on education issues during the address but did take a moment to outline several priorities on that front. Among them: expanding access to preschool and raising teacher pay.

In 2021, teachers made less than 77 cents on the dollar compared with other college graduates. Yet surveys show teachers work more than 50 hours a week on average. Close to 1 in 5 work elsewhere at another job. It's no surprise that nearly half of U.S. schools are short teachers. Some states and districts have proposed or enacted pay bumps but they've been modest at best.

Federal legislation again before Congress this session would set a teacher salary floor of $60,000. While raising teacher pay has garnered the support of some Republicans, the American Teacher Act is unlikely to get far. In some states teachers make less than $50,000 on average.

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Biden urges lawmakers to protect abortion rights

Biden called on lawmakers to “restore” abortion rights after the Supreme Court last year overturned Roe v. Wade, the landmark 1973 decision that established a constitutional right to abortion.

“The vice president and I are doing everything to protect access to reproductive health care and safeguard patient safety,” Biden said, noting that states across the country have implemented abortion bans and restrictions.

“Make no mistake about it. If Congress passes a national ban, I will veto it,” the president vowed.

– Marina Pitofsky

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Biden renews call to stand with Ukraine 'as long as it takes'

Calling Russia’s invasion of Ukraine a “test for the ages,” Biden said the U.S. passed that test by standing for sovereignty.

That matters, Biden said, because it “prevents open season for would-be aggressors.”

His argument – and promise to stand with Ukraine “as long as it takes” – comes as some Republicans are calling for greater scrutiny, or even a curtailment, of U.S. involvement.

– Maureen Groppe

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America’s border problems won’t be fixed until Congress acts, said Biden.

Since launching a new border plan last month, unlawful migration from Cuba, Haiti, Nicaragua, and Venezuela has come down 97%, Biden said.

“We now have a record number of personnel working to secure the border, arresting 8,000 human smugglers and seizing over 23,000 pounds of fentanyl in just the last several months,” he said.

He urged Congress to pass his plan to provide the equipment and officers to secure the border. He also asked Congress to pave a pathway to citizenship for Dreamers, those on temporary status, farm workers, and essential workers.

– Swapna Venugopal Ramaswamy

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Biden highlights ‘courage’ of Brandon Tsay and calls for assault weapon bans

Biden singled out Brandon Tsay’s heroism two weeks ago when he disarmed the Monterey Park shooter who killed 11 people who attended a Chinese Lunar New Year celebration. Tsay, who is in attendance, received a standing ovation from lawmakers as Biden acknowledged him.

“He saved lives. It’s time we do the same as well,” Biden said. “Ban assault weapons once and for all.”

Mass shootings typically lead lawmakers to call for such actions but it’s unlikely that a ban will pass in a divided Congress with many Republican lawmakers who have vowed that they will not waver on gun control.

– Elisabeth Buchwald

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Marjorie Taylor Greene yells at Biden multiple times

Rep. Marjorie Taylor Greene, R-Ga., a fervent opponent of Biden who has called for his impeachment, yelled at him twice during the State of the Union address.

The first time came as Biden said Republicans want to cut Social Security and Medicare – an accusation that Greene refuted when she stood up yelled “Liar!”

Greene later yelled, “China spied on us!” near the end of Biden’s speech.

She also yelled to “close the border” and “it’s your fault” when the president talked about the fentanyl crisis.

– Candy Woodall

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Biden on Tyre Nichols’ death: ‘Something good must come from this’

Biden used his speech to pay tribute to Tyre Nichols, a 29-year-old Black man who died after being beaten by Memphis police officers.

Biden called for more police training and more resources to reduce violent crime, along with more investments in housing, education and training.

Noting that Nichols’ mother and stepfather were seated in the first lady’s box, Biden urged lawmakers to commit themselves to making the words of Nichols’ mother come true: “Something good must come from this.”

– Michael Collins

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Biden invokes Uvalde massacre in call for gun reform

In a call to action on gun violence, Biden invoked his trip to Uvalde, Texas, after the Robb Elementary School shooting where 19 students and two teachers were killed.

“Do something, do something. That was the plea of parents who lost their children in Uvalde, I met with everyone.” Biden said, then pointing to the bipartisan gun reform law he signed. “Thank god we did. Passing the most sweeping gun safety law in three decades.”

– Ken Tran

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COVID is under control but vigilance necessary, says Biden

While COVID-19 deaths are down nearly 90%, and the end of the public health emergency is close, Biden said the country will remember the pain of losing loved ones will never go away for many.

“Families grieving. Children orphaned. Empty chairs at the dining room table. We remember them, and we remain vigilant,” he said.

Biden said it was important to remain vigilant and monitor dozens of variants and support new vaccines and treatments. He urged Congress to fund these efforts and keep America safe.

– Swapna Venugopal Ramaswamy

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Biden: Police departments 'must be held accountable'

Saying Tyre Nichols’ mother wants something good to come from his death at the hands of police officers in Memphis, Biden called for police reform.

“When police officers or departments violate the public trust, they must be held accountable,” he said.

Biden also pointed to an executive order he signed affecting federal officers that banned chokeholds, restricted no-knock warrants, and implemented “other key elements of the George Floyd Act.”

– Erin Mansfield

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Biden urges Congress to act on labor reform

Biden called for Congress to take up labor reform and worker protections as he touted his support for unions and his pledge to be “the most pro-union president.”

“I’m so sick and tired of companies breaking the law by preventing workers from organizing,” said Biden. “Workers have a right to form a union.”

Biden also urged action on additional worker protections and benefits, including paid family and medical leave and affordable child care, specifically calling for the return of the expanded Child Tax Credit.

– Ken Tran

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Biden calls for rebooting the expanded Child Tax Credit

Parents who qualify for the Child Tax Credit (CTC) won’t be getting as hefty checks as last year. That’s because the enhanced CTC, which parents could also opt to receive in installments rather than waiting to receive it in a lump sum payment when they file their taxes, expired.

The enhanced CTC increased payments from $2,000 per qualifying child to $3,600 for children ages 5 and under and $3,000 for children ages 6 through 17. This year it will go back to $2,000 for qualifying children of all ages.

In his remarks, Biden vowed to “restore the full Child Tax Credit which gave tens of millions of parents some breathing room and cut child poverty in half, to the lowest level in history.”

– Elisabeth Buchwald

Child tax credit this year:How much is the Child Tax Credit for 2023? Here's what you need to know about qualifying.

Biden: Ban ‘junk fees’ on hotel bills, other services

Biden urged Congress to pass legislation to ban excess fees that companies often tack onto hotel bills, airline tickets and other services.

“Americans are tired of being played for suckers,” he said.

The Junk Fee Prevention Act, if approved, would bar so-called “resort fees” that can add up to $90 a night on hotel bills, stop cable internet and cell phone companies from charging up to $200 more when a customer switches providers, and prohibit airlines from charging up to $50 roundtrip for families to sit together, Biden said.

– Michael Collins

Junk fees:Biden moves to limit credit fees to $8 for missed payments in latest "junk fee" crack down

Social Security and Medicare benefits draw tension during speech

Biden’s State of the Union address comes as he and Republican House Speaker Kevin McCarthy have started talks on the debt ceiling and government spending.

Tension has been building between the two parties over Social Security and Medicare benefits. McCarthy said Republicans aren’t going to cut those programs, but Democrats say the math will force those cuts if the GOP demands lowered government spending.

Biden in his speech said Republicans want to cut the programs, to which Rep. Marjorie Taylor Greene, R-Ga., stood up and yelled “Liar!” as other members booed the president.

“OK, so we agree,” Biden said. “Social Security and Medicare is off the books.”

Bipartisan cheers returned to the chamber.

– Candy Woodall

Medicare:Medicare launches plan to negotiate prices for the costliest drugs. Here's what to know.

Biden takes credit for deficit cuts

Biden celebrated the government’s deficit cuts seen under his administration in his State of the Union address.

“For the last two years, my administration has cut the deficit by more than $1.7 trillion, the largest deficit reduction in American history,” Biden said. The deficit’s cut was partly a result of higher tax revenues that Biden touted but also the end of spending related to the pandemic.

Biden also took a jab at former President Donald Trump for increases in the federal deficit under Trump’s administration. “Under the previous administration, the American deficit went up four years in a row,” Biden said, to boos and jeers from Republican lawmakers.

– Ken Tran

What happens if the US hits the debt ceiling?:Here's what to expect if we reach debt limit.

Biden says Republicans want to ‘take the economy hostage’ in debt ceiling talks

Biden accused Republicans of wanting to “take the economy hostage” unless he agrees to their demands for spending cuts during debt ceiling talks.

Biden demanded Republicans show “what their plans are.” House Speaker Kevin McCarthy has not specified what Republicans want axed.

“Some Republicans want Medicare and Social Security to sunset every five years,” Biden said, prompting loud boos from Republicans in Congress.

– Joey Garrison

Medicare and debt ceiling fight:How Medicare and Social Security benefits factor into the Kevin McCarthy debt ceiling fight

Biden defends Inflation Reduction Act

President Biden touted the Inflation Reduction Act which he signed into law, saying he was taking on powerful interest to bring health care costs down.

“You know, we pay more for prescription drugs than any major country on earth,” he said. “Big Pharma has been unfairly charging people hundreds of dollars – and making record profits.”

Having capped the cost of insulin at $35 a month for seniors on Medicare, Biden said it was time to help Americans not on Medicare, including 200,000 young people with Type I diabetes who need insulin to save their lives. “Let’s cap the cost of insulin at $35 a month for every American who needs it,” he said. The law also caps out-of-pocket drug costs for seniors on Medicare at a maximum $2,000 per year.

He also promised to veto any attempts to repeal the Inflation Reduction Act.

– Swapna Venugopal Ramaswamy

Credit fees:Biden moves to limit credit fees to $8 for missed payments in latest "junk fee" crack down

Biden tangles with GOP lawmakers over Social Security and Medicare

Biden got into an unusual back and forth with Republicans over whether GOP lawmakers want to end the automatic continuation of Social Security and Medicare.

When some vocally protested, Biden responded: “Anyone who doubts it, contact my office. I’ll give you a copy of the proposal.”

When the protests continued, Biden said he wasn’t arguing that all Republicans back reviewing entitlement programs every five years.

“But it’s being proposed,” he said.

– Maureen Groppe

Medicare debate:How Medicare and Social Security benefits factor into the Kevin McCarthy debt ceiling fight

Cheers and boos for Biden

Progressive members of the House, known as “the Squad,” cheered as President Joe Biden pushed for fair taxes and called out low tax rates for billionaires.

“You tell ‘em, Joe,” said Rep. Rashida Tlaib, D-Mich.

He also had plenty of jeers from the Republican side of the chamber when he slammed former President Donald Trump’s fiscal record and accused the House GOP of trying to cut Social Security and Medicare. The latter attracted loud boos.

Rep. Marjorie Taylor Greene, R-Ga., stood up and yelled, “Liar!” from the back of the chamber.

– Candy Woodall

Talkative Biden:On average, Biden is most talkative president in six decades of State of Union addresses

Biden repeats call for ‘billionaire’s tax’

Biden used his speech to call again for Congress to pass a so-called “billionaire’s tax,” saying some of the biggest corporations in the country are raking in billions of dollars in profits but paying no federal income taxes.

“That’s simply not fair,” he said.

Biden did not spell out the specifics of his proposal. But in the past, he has called for a 20% levy on households with a net worth of more than $100 million.

– Michael Collins

What are the tax brackets?:What are the 2022 US federal tax brackets? What are the new 2023 tax brackets? Answers here

Biden calls climate crisis ‘an existential threat’

Biden said “the climate crisis doesn't care if you're in a red or blue state” as he touted his administration’s work to take on what he called “an existential threat.”

He pointed to the Inflation Reduction Act, which included the largest climate package ever, and investments from his infrastructure law.

He later went off-script, saying, “We’re still going to need oil and gas for a while.”

– Joey Garrison

UN Secretary-General::'No more baby steps' on climate change

Biden to Congress: Continue insurance subsidies that lowered uninsured rates

Biden celebrated the fact that a record number of Americans have health insurance while calling on Congress to continue expanded insurance subsidies that helped boost that rate.

Those enhanced subsidies for people who purchase insurance on their own, instead of getting coverage from the government or an employer, expire after 2025.

“Let’s finish the job and make the savings permanent,” Biden said as he also called for extending expanded Medicaid coverage to all states.

– Maureen Groppe

Biden takes made in America a step further

Biden touted American manufacturing gains and a campaign promise to move more production to the U.S. from foreign countries. Biden then announced, “new standards to require all construction materials used in federal infrastructure projects to be made in America.”

“American-made lumber, glass, drywall, fiber optic cables,” he said. “And on my watch, American roads, American bridges, and American highways will be made with American products.”

Biden’s message echoes former President Donald Trump’s prior State of the Union addresses where he boasted about initiatives to bring back manufacturing jobs that have been lost over the years.

– Elisabeth Buchwald

Insulin costs:Medicare caps insulin costs at $35 a month. Can Biden get that price for all Americans?

Biden touts legislative victories in infrastructure and manufacturing

Biden championed his series of legislative victories that ranged from tackling the country’s supply chain shortage and sweeping investments in domestic manufacturing and infrastructure.

“We’re gonna make sure the supply chain for America begins in America,” Biden said, touting a bipartisan bill he signed that made investments to boost domestic manufacturing of semiconductors.

“To maintain the strongest economy in the world, we need the best infrastructure in the world,” said Biden, pointing to the bipartisan infrastructure bill. “Folks, we’re just getting started.”

– Ken Tran

Why Bono is at SOTU:Here's why musician, advocate Bono is at Biden's State of the Union address

Biden appeals to middle and working class people on manufacturing

In an appeal to middle class and working class people, Biden said he ran for president “to make sure the economy works for everyone” so that everyone can have pride in what they do for a living.

“For decades, the middle class was hollowed out,” he said. “Too many good-paying manufacturing jobs moved overseas. Factories at home closed down. Once-thriving cities and towns that many of you represent became shadows of what they used to be.”

Biden then spoke about his administration’s accomplishments in the manufacturing sector.

– Erin Mansfield

What is fentanyl poisoning?:These State of the Union guests lost their son to it

More:As Biden prepares 2024 reelection run, Dems worry blue-collar voters are slipping away

Biden: ‘COVID no longer controls our lives’

Biden said the nation’s economy is roaring back from the COVID-19 pandemic.

“Two years ago, COVID had shut down our businesses, closed our schools, and robbed us of so much,” he said. “Today, COVID no longer controls our lives.”

Biden said his administration has created 12 million jobs, “more jobs created in two years than any president has ever created in four.”

– Michael Collins

A full House – literally – for State of the Union

President Joe Biden entered a full House chamber Tuesday.

The capacity crowd included House and Senate members, current and former Supreme Court justices, family and honored guests.

Biden’s first words were met with a standing ovation, as he honored Republican and Democratic leaders – but also as he described the state of the union.

The applause came from Democrats and Republicans, and the standing ovations were sometimes led by a row of powerful Senate moderates, including Sens. Joe Manchin, D-W.Va., Lisa Murkowski, R-Alaska, and Kyrsten Sinema, who recently changed her party affiliation to independent.

– Candy Woodall

Biden: Pelosi is 'greatest speaker’ ever

Former House Speaker Nancy Pelosi isn’t sitting behind Biden for his address but she got a special call-out from the president anyway.

“I want to give special recognition to someone who I think will be considered the greatest speaker in the history of the House of Representatives, Nancy Pelosi,” Biden said.

Pelosi stepped down from Democratic leadership after the midterm elections. Biden also congratulated her successor, Rep. Hakeem Jeffries, the first Black American to be House minority leader.

– Maureen Groppe

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Biden begins speech telling McCarthy he looks forward to ‘working together’

Biden began his remarks congratulating Kevin McCarthy, the new Republican House speaker, and saying he looks forward to “working together.”

Biden also congratulated Democratic Leader Hakeem Jefferies, the first African American man to lead a party, and gave shout outs to Senate Leader Chuck Schumer, Senate Republican Leader Mitch McConnell and former House Speaker Nancy Pelosi.

“The story of America is a story of progress and resilience. Of always moving forward. Of never giving up,” Biden said.

– Joey Garrison

Labor Secretary Marty Walsh is designated survivor for 2023 State of the Union

Secretary of Labor Marty Walsh is the designated survivor for this year's State of the Union address.

Every year, a top government official is chosen as the “designated survivor” as a way to maintain the presidential line of succession in case of a catastrophic event where multiple officials in the line are unable to assume office.

– Ken Tran

Marty Walsh:Former Boston mayor Marty Walsh stepping down as Biden Labor Secretary for job with NHL union

Bono is at the State of the Union

Bono, the Irish lead singer of U2, is attending the State of the Union as a guest of first lady Jill Biden.

Bono is a longtime social justice advocate who co-founded the nonprofit ONE Campaign to address poverty and preventable diseases and Prouct RED to address HIV and AIDS in Africa.

He’s sitting next to Paul Pelosi, husband of former Speaker of the House Nancy Pelosi, D-Calif.

– Erin Mansfield

What is fentanyl poisoning?:These State of the Union guests lost their son to it

2 Californians will sit behind Biden

Vice President Kamala Harris and House Speaker Kevin McCarthy may not share a political party. But they do have something in common. Both are from California.

That gave them at least one thing to talk about as they stood on the rostrum, waiting for Biden’s speech to begin.

– Maureen Groppe

Biden gets a Supreme Court majority for speech, if not policies

At least for tonight, President Joe Biden landed a majority of the Supreme Court.

Five sitting Supreme Court justices stepped into the House chamber before the president’s remarks: Chief Justice John Roberts and Associate Justices Elena Kagan, Brett Kavanaugh, Amy Coney Barrett and Ketanji Brown Jackson.

That’s a decent turnout for an event some current and former justices have derided as a “political pep rally” and a “childish spectacle.”

Whether the president can cobble together a majority for any of his policies pending at the court – on immigration, student loan debt relief or environmental rules – remains to be seen.

– John Fritze

Biden to get bipartisan escort into House chamber

Biden will be escorted into the House chamber by a bipartisan group of House and Senate officials, including Senate leaders Chuck Schumer, D-NY, and Mitch McConnell, R-Ky.

–Michael Collins

Face masks uncommon as pre-pandemic normality returns

Few lawmakers were wearing face masks as they filed onto the House floor for Biden’s State of the Union speech.

And unlike last year, members of Congress were allowed to bring guests, a return to pre-pandemic normality.

“Today, COVID no longer controls our lives,” Biden will declare, according to speech excerpts the White House released in advance.

– Maureen Groppe

State of the economy:A look at economy's strengths, weaknesses as Biden sets to boast of record job growth in State of Union

Biden arrives at Capitol

Biden’s motorcade arrived at the Capitol at 8:40 p.m. ahead of his 9 p.m. State of the Union speech.

“Great shape, getting better,” Biden said when a reporter asked him, “What’s the state of the union?” before he departed the White House.

– Joey Garrison

5 big questions for Biden's speech:Is he running? 5 big questions Joe Biden will answer in the State of the Union

Poll: Republicans want GOP leaders to 'stand up’ to Biden

If Biden doesn’t find a receptive audience to his call for the two parties to work together, Republican voters could be the reason.

Most Republicans (64%) want GOP congressional leaders to “stand up” to Biden on matters important to GOP, even if that makes it harder to address critical problems facing the country, according to recent polling from the Pew Research Center.

And more are concerned that GOP lawmakers won’t focus enough on investigating the administration than the share worried that they will focus too much on investigations.

– Maureen Groppe

State of the Union guests:Lawmakers highlight policing, abortion, wrongful imprisonment

Biden approval rating hovering in low 40s ahead of speech

Biden’s second State of the Union address Tuesday comes as he remains under water politically, with more than half of voters disapproving of his job performance, according to most polls.

A Washington Post-ABC poll released this week found 42% of voters approve of Biden’s job performance, while 53% disapprove. That closely matches the FiveThirtyEight average of polls.

Biden’s job performance has stayed below since August 2021 in most polls. Even more troubling for Biden, most Americans can’t identify his achievements. Sixty-two percent of Americans said Biden has accomplished "not very much" or “little or nothing," in the same Washington Post-ABC News poll, while only 36% said he has accomplished "a great deal" or "a good amount."

– Joey Garrison

What to watch for:The State of the Union is Tuesday: Here's what you can expect from Joe Biden's speech

Vice President Kamala Harris chats with House Speaker Kevin McCarthy ahead of speech

Vice President Kamala Harris shook hands with House Speaker Kevin McCarthy, and the two chatted, as they stood behind the rostrum waiting for Biden to enter the House chamber.

This will be the first State of the Union with McCarthy as speaker since Republicans took control of the House during the midterm elections.

– Joey Garrison

Biden heads to the Capitol

Biden left the White House at 8:30 p.m. en route to the Capitol. Vice President Kamala Harris arrived ahead of him along with the majority of his Cabinet.

– Elisabeth Buchwald

Paul Pelosi arrives at State of the Union

Paul Pelosi, the 82-year-old husband of former House Speaker Nancy Pelosi, arrived at the State of the Union about 8:30 p.m. Tuesday.

This marks his first visit to a joint session of Congress since a video release of a brutal October attack that left him with head and hand injuries requiring surgery.

– Candy Woodall

Lawmakers arrive for State of the Union

If handshakes across the aisle are any reliable indication, there was a hint of bipartisanship in the air as lawmakers arrived for President Joe Biden’s first State of the Union before a divided Congress.

There was also the smell of cigars in the House gallery hallways on the third floor, a sign of the changing guard and new House rules.

Several guests and congresswomen were wearing white, as a nod to the suffragettes. That included Rep. Marjorie Taylor Greene, R-Ga., who despite earlier posts did not bring a white balloon into the chamber to troll Biden about what she describes as a delayed response in taking down the Chinese spy balloon.

- Candy Woodall

Biden traveling to Wisconsin and Florida after speech

Biden administration officials will hit the road this week, holding events in at least 20 states to highlight parts of the president’s message.

Biden himself will talk about his economic agenda in Wisconsin Wednesday and will discuss Social Security and Medicare in Florida Thursday.

Vice President Kamala Harris is heading to Georgia and Minnesota. Multiple other cabinet members are also fanning out across the country.

- Maureen Groppe

How would Biden’s billionaire tax work?

Tonight Biden will resurface his plan to levy more taxes on the ultra-wealthy. But how would that work?

Under the current tax system, you don’t have to pay taxes on assets like stocks, homes and artwork that can appreciate over time until you sell it. But if you hold onto them until you die, you won’t have to pay any taxes. And on top of that, heirs that inherit your assets won’t have to pay taxes if they sell them.

The Biden Administration refers to this as a tax loophole, as billionaires benefit the most since they’re more likely than working-class Americans to get compensated via stocks or other assets that appreciate over time or inherit them.

To end the practice, Biden is proposing “minimum income tax” on American households worth more than $100 million. His plan calls for the wealthiest Americans to pay a tax rate of at least 20% on their full income, including unrealized gains from assets that have increased in value since their purchase.

– Elisabeth Buchwald

Taxing billionaires:Should the wealthy pay taxes on expensive art and wine? Joe Biden thinks so. Here's how it would work

Ocasio-Cortez lays out expectations for Biden’s speech, working with Republicans

Ahead of Biden’s address, Rep. Alexandria Ocasio-Cortez, D.-N.Y., said she’s hoping to “hear a really strong vision” from Biden and explained how Democrats and Republicans could find common ground after the GOP gained control of the House during the midterm elections.

The New York lawmaker told CNN she hopes to hear “about not just what we've done so far, but also our plans on executing on the enormous bills and successes that we've had in the last one to two years," saying “There still is implementation and execution on these plans to address our priorities around climate, taxing the rich and so much more.”

– Marina Pitofsky

Biden's 'finish the job' call in State of the Union echoes FDR

Historian Michael Beschloss hears echoes of Franklin D. Roosevelt in Biden’s State of the Union address.

Biden will call on Republicans to work with him to “finish the job” of rebuilding the economy and uniting the country, according to excerpts of the speech released by the White House.

“Finish the job” was used as a rationale for FDR's reelection, Beschloss tweeted about the phrase’s historical lineage. It was also a slogan for the World War I effort. And in a famous radio address during World War II, British Prime Minister Winston Churchill vowed to “finish the job.”

At the start of Biden’s administration, many comparisons – not all of them favorable – were made between the size and scope of Biden’s ambitions, Roosevelt’s programs and the World War II spending that lifted the nation out of the Great Depression.

– Maureen Groppe

Sarah Huckabee Sanders: Biden is more interested in 'woke fantasies' than concerns of everyday Americans

In delivering the Republican response to the State of the Union, Arkansas Gov. Sarah Huckabee Sander plans to attack Biden and the Democrats over a panoply of issues that include inflation, taxes, education and so-called "culture wars."

"And while you reap the consequences of their failures, the Biden administration seems more interested in woke fantasies than the hard reality Americans face every day," Sanders plans to say, according to speech excerpts released by her office.

Another excerpt: "Most Americans simply want to live their lives in freedom and peace, but we are under attack in a left-wing culture war we didn’t start and never wanted to fight."

– David Jackson

State of the Union guests:Lawmakers highlight policing, abortion, wrongful imprisonment

How long does the State of the Union last? What it will take for Biden to set a SOTU record

Biden’s first State of the Union address in 2022 was somewhere between the longest and shortest speeches ever given, according to The American Presidency Project. Will he keep his second address tonight short and sweet, or will he be long-winded?

If he intendeds to break the record for the shortest speech ever, he’d have it keep it under 28 minutes and 55 seconds. That was the time Richard Nixon took to deliver his address in 1972. To beat the longest address ever, he’d have to outdo his fellow Democrat former President Bill Clinton, who went on for 1 hour, 28 minutes and 40 seconds for his final State of the Union speech in 2000. Clinton also claims the spot for the second longest address, clocking in at 1 hour, 24 minutes and 58 seconds in 1995.

– Swapna Venugopal Ramaswamy

Biden to promise investment in ‘places and people that have been forgotten’

Biden will spend part of his address promoting his economic plan and assuring Americans that he wants to invest in “places and people that have been forgotten.”

Amid the economic upheaval of the past four decades, too many people have been left behind or treated like they’re invisible, he will say, according to excerpts of the speech released by the White House.

“Maybe that’s you watching at home,” Biden will say. “You remember the jobs that went away. And you wonder whether a path even exists anymore for you and your children to get ahead without moving away. I get it. That’s why we’re building an economy where no one is left behind. Jobs are coming back, pride is coming back because of the choices we made in the last two years. This is a blue-collar blueprint to rebuild America and make a real difference in your lives.”

– Michael Collins

Biden to praise recovery from Jan. 6 riot, COVID

President Joe Biden will say “the story of America is a story of progress and resilience” in his State of the Union address as he touts a rebounding economy, COVID-19 recovery and democracy that survived the Jan. 6, 2021 Capitol attack, according to excerpts of the speech provided by the White House.

Biden will tout 12 million new jobs created under his presidency – many that came back following the pandemic – to claim economic progress. And he will reflect on a period two years ago when businesses and schools closed at the height of the pandemic.

“Today, COVID no longer controls our lives,” Biden plans to say. “And two years ago, our democracy faced its greatest threat since the Civil War. Today, though bruised, our democracy remains unbowed and unbroken.”

– Joey Garrison

Biden to ask Republicans to work with him in SOTU speech

President Joe Biden will make a plea to Republicans in Congress to work with him. He said after the November elections that Americans sent a divided Congress to Washington because they want them to work together.

“The people sent us a clear message,” Biden will say, according to excerpts released from the White House. “Fighting for the sake of fighting, power for the sake of power, conflict for the sake of conflict, gets us nowhere.”

– Erin Mansfield

Why Sen. Patty Murray and other lawmakers will be wearing crayons at State of the Union

Washington Sen. Patty Murray and some of her Democratic colleagues will be wearing crayon pins to President Joe Biden's State of the Union address Tuesday to signal their support for greater investments in child care. Such care now costs more than $10,000 a year on average, and roughly half of Americans live in a child care desert. Insufficient child care takes a toll on America's economy, recent research shows, costing taxpayers $122 billion annually.

Partisan gridlock has prevented progress on major child care reforms, such as Murray's Child Care for Working Families Act, which would generally cap child care expenses at 7% of a family's household income. Biden, who alluded to that cap in his last State of the Union, has also struggled to gain traction on his child care proposals.

– Alia Wong

Lawmakers to highlight key social issues through guests

Tuesday night’s State of the Union address will be the first year since the beginning of the COVID-19 pandemic where lawmakers are allowed to bring their own guests. As part of tradition, lawmakers tend to invite guests that draw attention to issues important to them.

Several Democratic lawmakers have invited guests to champion abortion access such as Roslyn Roger Collins, president and CEO of Planned Parenthood Metropolitan New Jersey, who will attend the address alongside Rep. Bob Mendendez, D-N.J., according to Planned Parenthood.

In the wake of the brutal beating and subsequent death of Tyre Nichols in Memphis, Tennessee, members of the Congressional Black Caucus are bringing guests who have been impacted by police violence. House Democratic Minority Leader Hakeem Jeffries has invited Gwen Carr, the mother of Eric Garner, who died at the hands of a New York police officer in 2014.

– Christine Fernando and Ken Tran

Republican response: Sarah Huckabee Sanders follows in historic footsteps with her State of the Union response

Arkansas Gov. Sarah Huckabee Sanders is the first former White House press secretary to deliver a formal State of the Union response – she is not, however, the first governor of Arkansas to do the honors.

Back in 1985, the Democrats picked a young governor of Arkansas to deliver their response to President Ronald Reagan.

His name? Bill Clinton ... then-future President Bill Clinton.

Sanders will give the Republican rebuttal after Biden's speech.

– David Jackson

5 big questions for the SOTU:Is he running? 5 big questions Joe Biden will answer in the State of the Union

Biden and China: Spy balloon likely to be addressed

The speech is a chance for Biden to respond to those who have criticized how he handled the suspected Chinese spy balloon that drifted over the United States last week – and to send a public message to China. Republicans have accused Biden of showing weakness by not shooting down the balloon sooner.

Tensions have been rising with China, which the U.S. considers its biggest strategic and economic competitor. The nations have clashed over Taiwan, technology, human rights, Russia’s invasion of Ukraine and other disputes.

The Biden administration has been trying to stabilize the relationship, building what it’s called “guardrails” as it normalizes interaction. But one effort to do that – sending Secretary of State Antony Blinken to China – was postponed because of the balloon incident.

– Maureen Groppe and Michael Collins

Intel chair: China balloon flew over nuke sites

Biden to lay out 'forceful approach’ to combatting fentanyl

The Biden administration will launch a national campaign to educate young people on the dangers of fentanyl, part of the “forceful approach” for going after fentanyl trafficking and reducing overdose deaths.

Other steps include:

Using new large-scale scanners to improve efforts to stop fentanyl from being brought into the U.S. through the southern border.

Working with package delivery companies to catch more packages containing fentanyl from being shipped around the country.

Working with Congress to make permanent a temporary tool that that’s helped federal agents crack down on drugs chemically similar to fentanyl.

– Maureen Groppe

5 big questions on Biden's speech:Is he running? 5 big questions Joe Biden will answer in the State of the Union

Biden to plug job market as recession looms

President Joe Biden is expected to take credit for a booming job market and easing inflation when he speaks to the nation Tuesday night.

But he’ll likely leave out a litany of trouble spots, including a slumping housing market, a monthslong manufacturing downturn and elevated recession risk this year. Meanwhile, inflation is still high and economists pin at least some of the blame on Biden for showering Americans with cash in early 2021 while the economy was already healing.

– Paul Davidson

State of the economy:A look at economy's strengths, weaknesses as Biden sets to boast of record job growth in State of Union

Who is Sarah Huckabee Sanders? Arkansas governor to giver Republican response to Biden's State of the Union address

Sarah Huckabee Sanders, one-time White House press secretary for former President Trump and current governor of Arkansas, will deliver the Republican rebuttal to Biden’s State of the Union address tonight.

Sanders, the youngest governor in the U.S., hails from a prominent political family. Her father Mike Huckabee was the 44th governor of Arkansas, serving from 1996 to 2007 before launching an unsuccessful presidential bid during the 2008 election. The younger Sanders has since cut out her own place in GOP politics, emerging as one of the more high-profile members of the Trump administration.

– Anna Kaufman

Bono, Tyre Nichols’ family members among guests sitting with first lady Jill Biden Tuesday night

The lead singer for the rock group U2, Bono, and Ukraine’s ambassador to the U.S., Oksana Markarova, are among the White House guests attending President Joe Biden’s State of the Union address Tuesday.

Guests are chosen to highlight themes of the president’s speech or because they represent his policy initiatives.

Bono is the cofounder of the ONE campaign to fight poverty and preventable diseases, and (RED), which fights HIV/AIDS in Africa. Other guests who will be sitting with first lady Jill Biden during the speech include:

The mother and stepfather of Tyre Nichols, the 29-year-old Black man who died after being beaten by Memphis police officers.

Brandon Tsay, the man who disarmed the Monterey Park gunman who killed 11 people and injured 10 others during a Lunar New Year celebration.

A Texas woman who almost died because doctors were concerned that intervening when her pregnancy ran into difficulties would violate the state’s abortion ban.

One of the Massachusetts same-sex couples who sued the state for the right to marry in 2001.

– Maureen Groppe

What to expect from tonight's speech:Here's what you can expect from Joe Biden's speech

Biden's speech comes amid job gains

One accomplishment Biden is sure to bring up tonight is the level of job gains under his presidency. Since he took office the unemployment rate went from 6.3% to 3.4%, per the latest jobs data.

Despite recession fears and massive tech layoffs, U.S. employers added 517,000 new jobs last month, well exceeding economists' expectations of around 180,000 new jobs.

The blowout jobs report paved the way for the Federal Reserve to pass more rate hikes aimed at lowering inflation, Fed Chairman Powell said in remarks he delivered earlier today. But the rate hikes could push the economy closer to a recession, which the central bank has avoided so far.

– Elisabeth Buchwald

Biden’s student loan forgiveness plan remains stalled

Biden has yet to fulfill his campaign promise of canceling at least $10,000 in student loan debt. Last year he unveiled a plan to make good on his promise.

However the plan is being stalled by legal challenges. Six states – Nebraska, Missouri, Arkansas, Iowa, Kansas and South Carolina – formed a coalition to fight the proposal. They argue that canceling student loan debt extends beyond the administration’s legal authority.

The Supreme Court is set to hear arguments for the case later this month. The Biden administration claims it is well within their legal realm to proceed with its plan. It cannot do so unless the Court rules in its favor, however.

– Elisabeth Buchwald

Stock market under Biden

Since President Joe Biden took office in January 2021, the Dow Jones Industrial Average gained 10%. Last year the index fell into a bear market, meaning it dropped 20% below a market peak set last January.

During former President Donald Trump's time in office, the Dow gained 56%. That represents an annualized gain of close to 12%, one of the best stock market performances under a Republican president according to data from LPL Financial.

– Elisabeth Buchwald

What time is the State of the Union speech tonight?

Biden’s State of the Union speech is Tuesday at 9 p.m. EST.

How to stream the SOTU

The speech will be livestreamed by USA TODAY.

Who is the designated survivor tonight?

The State of the Union address, delivered to a joint session of Congress and a crowd that includes all nine Supreme Court justices, poses a unique scenario in which every key member of the nation’s leadership is in one room.

That makes it both a momentous affair, and a significant national security risk. For this reason, each year one member of the president’s Cabinet dubbed the "designated survivor" hangs back.

The practice dates back to the Cold War, during which fears of a Soviet Nuclear attack abounded and a fresh urgency surrounded protocols for the order of presidential succession. The designated survivor for 2023 has not yet been announced, but heads of the Departments of Agriculture, Commerce, and Energy have most frequently been chosen.

– Anna Kaufman

What channel is the State of the Union on?

The major TV networks and other news outlets, such as Fox News, MSNBC, CNN and PBS, are providing live coverage of the address.

What is the State of the Union address?

The State of the Union address isn’t just a tradition in the nation’s capital. It's rooted in the Constitution.

Article II of the Constitution says the president shall “from time to time give to the Congress Information of the State of the Union."

That doesn’t mean the president has to give a speech – as they often do today.

"From that very general mandate in the Constitution has evolved into what we recognize today as a yearly event, with lots of pomp and circumstance," Claire Jerry, a curator of political history at the National Museum of American History, told USA TODAY.

– Marina Pitofsky

When did the annual message become known as State of the Union address?

From 1790 to 1946, the speech delivered by the president to Congress was known simply as the "Annual Message."

In 1947 is became the ‘State of the Union’ and has since been referred to by that name.

– Anna Kaufman

What is the origin of the state of the union address?

Article II, Section 3 of the U.S. Constitution states that the president will “give to the Congress Information of the State of the Union, and recommend to their Consideration such Measures as he shall judge necessary and expedient.”

This language birthed the practice, allowing the executive to deliver to a joint session of Congress and the American people.

In the modern era, the speech has become a vehicle for administrations to roll out their policy priorities for the coming year and spotlight key agenda issues.

– Anna Kaufman

Insulin: 1.3 million Americans with diabetes rationed their supply in ...

CNN —

In December, Stephanie Arceneaux of Utah will have been living with type 1 diabetes for 30 years. She was diagnosed at age 6.

“I have seen a lot of changes within how diabetes is cared for,” she said. “I always thought that as I got older, that things would improve, and unfortunately, that has not been the case.”

Arceneaux’s husband and young son also both have type 1 diabetes. All three of them depend on insulin to survive.

“When I first heard stories about individuals with diabetes rationing their insulin, my initial thought was that is so horrible, because I know what it feels like not to have enough insulin in your body. At the same time, I also had this thought, ‘I’m so lucky that I’ve never had to do that,’ ” she said.

“But the more I thought about it, the more I realized that I had spent my entire adult life doing that. I’ve been lucky in that it didn’t cause any serious ramifications that I’m aware of, but I made choices in my life so that I would have the insulin that I needed to live.”

Arceneaux isn’t alone: According to research published Monday in the journal Annals of Internal Medicine, over a million people with diabetes in the US rationed their insulin in the past year.

“The main takeaway is that 1.3 million people rationed insulin the United States, one of the richest countries in the world,” Dr. Adam Gaffney, the lead author of the study and a pulmonologist and critical care doctor at Harvard Medical School and Cambridge Health Alliance, told CNN. “This is a lifesaving drug. Rationing insulin can have life-threatening consequences.”

16.5% of people who use insulin report rationing

Gaffney and his co-authors analyzed the US Centers for Disease Control and Prevention’s 2021 National Health Interview Survey, which included 982 people with diabetes who use insulin. They looked at how commonly these people rationed insulin because of how much it cost.

People were considered to be rationing if they responded positively to questions in the survey about skipping insulin doses, taking less than needed or putting off buying their insulin.

“What we found was that nationwide, about 1.3 million Americans with diabetes rationed insulin annually, and that’s about 16.5% of all those people who use insulin,” Gaffney said.

Some groups said they did so more frequently, such as those with type 1 diabetes; those without health insurance rationed most frequently of all.

Adults under the age of 65 rationed more frequently than those who were 65 and older, with Gaffney noting that almost all of those who were older and rationed less were covered by Medicare.

Two other groups who were more likely to ration insulin than their counterparts were middle-income people and Black Americans.

“We found high rates of rationing of a life-saving drug, and that should really be something of concern for everyone,” Gaffney said.

“We need urgently policy change to ensure that everyone has access to this critical medication without cost barriers,” he said. “And we need to do that today.”

Gaffney and his co-authors said in the study that there are several factors underlying their findings, including that insulin prices in the US are far higher than in other places, and that pharmaceutical companies have increased the price “year upon year, even for products that remain unchanged.”

“By limiting insulin copays to $35 per month under Medicare, the 2022 Inflation Reduction Act may improve insulin access for seniors, who experienced substantial rationing in our study,” they wrote. “However, a similar cap for the privately insured was removed from the bill, and copay caps do not aid the uninsured. Further reform could improve access to insulin for all Americans.”

Rates of diabetes more than double

According to the CDC, more than 37 million adults in the US have diabetes, but 1 in 5 don’t know it. It is the seventh leading cause of death in the country and the No. 1 cause of kidney failure, lower-limb amputations and adult blindness.

The number of adults diagnosed with diabetes has more than doubled in the past year, the CDC said.

Type 1 diabetes is thought to be caused by an autoimmune reaction that stops the body from making insulin. According to the CDC, 5% to 10% of people with diabetes have this kind.

Type 2 diabetes means the body doesn’t use insulin well and can’t keep blood sugar at normal levels. It develops over many years and is usually diagnosed in adults.

Although there’s no known way to prevent type 1 diabetes, type 2 can be prevented or delayed with healthy lifestyle changes, including losing weight and being active.

Food vs. insulin

The choices Arceneaux found herself making in order to ration included not eating – as insulin is needed to cover carbohydrates that a person eats – and rationing things like test strips needed to test her blood sugar, meaning she was unaware of how much insulin she needed to give herself.

She also rationed other care that she needed, she said, and spent a lot of time deciding which medical care was more important for her. She would go to her doctor to get insulin prescriptions, but she wouldn’t do other things that someone with diabetes is supposed to do, such as getting annual eye exams to check for complications like retinopathy.

The cost of insulin plays into her decisions “to a huge extent,” she said.

“If you don’t the have money to buy it, you don’t have the money to buy it,” she said. “So what I found myself doing was doing everything I possibly could, limiting everything I possibly could, so that I could purchase my insulin so that I would have it available.”

When she first moved out on her own, she said, she quickly ran into trouble: She could afford food or insulin but not both. A friend bought groceries to help her through.

“I remember telling her, ‘It’s difficult now. I’m young. I’ve just moved out on my own, but I know that it’s going to be better, you know, in five or 10 years, things are going to get better,’ ” she said. “And here I am. That was when I was 20 years old. I’m now 43, almost 44 years old, and it’s worse now. The costs have skyrocketed.”

She now has insurance through her husband’s employer, but “the cost of the premiums are so high that that leaves very little left over to afford everything that we need.” They often have to rely on donated insulin from other members of the local diabetes community, she said.

Insulin is ‘like oxygen’ for many

The findings of the new study are “so important,” said Dr. Kasia Lipska, an associate professor of medicine at the Yale School of Medicine who sees patients at the Yale Diabetes Center.

“The findings are really concerning in terms of access to insulin among Americans,” said Lipska, who was not involved in the research.

“We have a serious problem. There are many people with diabetes who are rationing insulin, and there are disparities in terms of access, in terms of age, race, income and insurance status,” she said. “I think that this study points to persistent access issues to insulin in our country.”

The findings did not surprise her, she said, but rather back up what she sees in clinical practice. Her own research into a single diabetes center found high rates of insulin rationing.

“We see people in the hospital setting who get admitted to the hospital because of high blood sugars, and then when we sort of ask what happened, turned out that they lack insurance or insurance is inadequate and they couldn’t take their insulin,” Lipska said. “In the outpatient setting, there is not a clinic that goes by where we don’t talk about cost of insulin and figuring out how to get the patient the insulin they need without breaking their budget. These are like daily conversations we have in the Yale Diabetes Center.”

Insulin is “like oxygen” for people with type 1 diabetes, she said, and those who go without can get very sick within hours or days and end up in the hospital with ketoacidosis, a potentially life-threatening complication. It can even be deadly.

Those with type 2 diabetes who don’t have adequate insulin can have high blood sugar levels, putting them at risk for complications such as heart disease, blindness and kidney failure.

‘We’re making sacrifices every day’

“Diabetes is even more expensive now than it was in my 20s,” Arceneaux said. “I know that studies have been done that say that one in four individuals with diabetes ration their insulin, but my guess is that it’s much more than that. We just may not realize that we’re doing it.

“We’re doing what we need to stay alive, and that means getting the insulin that we need,” she said. “So we’re rationing not just our insulin but potentially other things in our life to do that.”

Arceneaux, who is the Utah chapter leader for the nonprofit T1 International, said she hears about rationing all the time.

T1 International is led by people with type 1 diabetes who support local communities, giving them the tools they need to access insulin and diabetes supplies.

Get CNN Health's weekly newsletter Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.

“We deserve the same quality of life that everybody else deserves, and we shouldn’t have to sacrifice so much of our lives just to stay alive. That’s what so many of us that have diabetes are doing: We’re making sacrifices every day that others do not, that others don’t even realize,” Arceneaux said.

“I think that’s unacceptable, and it needs to change. And it needs to change now. We’re tired of waiting,” she said. “People with diabetes are tired of waiting. We need a true price cap on insulin, and we need that to happen today so that we can have everything we need to live.”

California to make its own low-cost insulin, Gov. Newsom says | CNN

CNN —

California will begin making its own low-cost insulin in an effort to make it more financially accessible amid soaring prices for the life-saving medication, Gov. Gavin Newsom announced Thursday.

The move is possible through an allocation of $100 million in the state budget for the manufacture of the medication at a cheaper price.

“Nothing, nothing epitomizes market failures more than the cost of insulin,” he said in a video posted on the governor’s official Twitter page.

Newsom noted that $50 million will go toward funding a California-based manufacturing facility “that will provide new, high-paying jobs and a stronger supply chain for the drug.” The other $50 million will cover the cost of developing insulin products.

More than 8 million Americans with diabetes depend on insulin, which has been notorious for being among prescription drugs experiencing steep price surges.

The high cost has led an estimated 1 in every 4 people with diabetes to ration or skip doses, according to a study published in 2019 in the medical journal JAMA Internal Medicine. Patients who are Black, Latino or Native American are disproportionately affected because they are more likely to be uninsured or underinsured.

Civica Rx, a nonprofit generic drug maker, announced In March that it planned to make and sell insulin for no more than $30 a vial. It is expected to be available as soon as early 2024, pending federal approval.

Why are insulin prices going up? Chuck Grassley explains it

By Madison Black, PolitiFact.com

Chuck Grassley: Insulin prices have "gone THRU THE ROOF for patients/taxpayers bc of manufacturer, health plan & PBM biz practices."

PolitiFact's ruling: True

Here's why: More than 7 million Americans require insulin to treat their diabetes but some people struggle to afford the cost.

On Jan. 14, 2021, Sen. Chuck Grassley, R-Iowa, tweeted, "2day Sen Wyden & I released Finance Cmte report on INSULIN costs Prices hv gone THRU THE ROOF for patients/taxpayers bc of manufacturer, health plan & PBM biz practices They make $$ as % of ballooning list price so no incentive to lower price on 100 yr old drug."

Grassley has a history of attempting to lower the cost of the drug, and Sen. Ron Wyden, D-Oregon, worked with him as the ranking minority member on the Senate Finance Committee when Republicans controlled the Senate.

Is Grassley right when he tweets about why insulin costs so much?

Insulin costs

Between 2012 and 2016, the drug’s cost nearly doubled. A Humalog 50/50 vial costs an average of $390.23.

David Tridgell, a Minneapolis endocrinologist who has had Type 1 diabetes since he was 15, wrote in The Washington Post that patients with Type 1 diabetes tend to use two or three vials of insulin per month. At the current cost of one vial of Humalog 50/50, these patients would spend $780 to $1,170 on their insulin every month. Type 2 Diabetes patients can require even more insulin per month, sometimes requiring six or more vials, Tridgell wrote. This would add up to $2,341 or more every month.

Grassley claims that the increase is tied to the business practices of manufacturers, health plans and PBMs, or pharmacy business managers. A 2019 House Committee on Energy and Commerce hearing featured testimony from CVS Health, Express Scripts, OptumRx, Eli Lilly, Novo Nordisk, and Sanofi. They couldn’t lower the prices of insulin, the companies claimed, because of how PBMs and health insurance companies operate.

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PBMs serve as a liaison between drug companies and health insurance companies, negotiating what insurance companies, pharmacies and patients pay for a drug. They can negotiate rebates, discounts, and other services. These rebates and other benefits are passed on to the health plans. Medicare is barred from participating in these negotiations.

A study published by the American Diabetes Association in 2018 showed that these negotiations encourage high list prices. As these list prices increase, "profits of the intermediaries in the insulin supply chain, such as wholesalers, PBMs and pharmacies, increase because each may receive a rebate, discount or fee calculated as a percentage of the list price."

The study also reported that, because transparency is lacking within the insulin supply chain, "it is unclear precisely how the dollars flow and how much each intermediary profits."

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Some insulin producers blame insulin’s prices on the cost of innovation. However, Mayo Clinic hematologist S. Vincent Rajkumar dismissed this claim in a 2020 paper. Rajkumar wrote that limited innovation exists when it comes to insulin, and that what matters more is affordability.

A U.S. Senate Finance Committee staff report released this year stated, "Eli Lilly reported spending $395 million on (research and development) costs for Humalog, Humulin, and Basaglar between 2014 and 2018, during which time the company spent nearly $1.5 billion on sales and marketing expenses for its insulins."

The report also cited instances of 100-year-old drugs still going up in price. Every time a pharmacy dispenses therapeutic insulin, manufacturers pay PBMs administrative fees as high as 5 percent of the drug’s wholesale acquisition cost, the Senate staff report states. "These fees are a significant revenue stream for PBMs and likely act as a countervailing force against lower list prices—PBMs may be reluctant to push for lower WAC prices since it would reduce their administrative fee-based revenue," the report stated.

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Our ruling

Grassley said that insulin prices have dramatically increased because of manufacturer, health plan, and pharmacy business manager practices. He’s right. Innovations alone aren’t enough to justify the extreme increases in price that have raised insulin costs over the years.

PBMs, with their complicated discount negotiations, and manufacturers, with their continuing drive to increase earnings, both play a role. So do drug stores, pharmacies, and other suppliers who want to be competitive in the marketplace by offering consumers discounts. But the discounts don’t go to everyone with diabetes, and when they do, they vary from vendor to vendor.

Multiple studies in recent years, testimony in public hearings, the drug’s pricing history, and sourcing in federal government reports show examples of complicated procedures related in large part to negotiated discounts for some vendors adding to overall insulin costs.

We rate Grassley’s statement True.

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Sources

Top diabetes, heart disease drugs for Medicare price negotiation

The first 10 prescription drugs the federal government will negotiate under a new federal law were revealed Tuesday, launching a process that could deliver drug discounts by 2026.

The batch of 10 medications include some of the most widely prescribed or expensive drugs older Americans use for conditions such as heart disease, diabetes and autoimmune conditions.

The Biden administration will negotiate prices for these nine drugs: Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica and Stelara. The other drug includes the insulin medications Fiasp and NovoLog, including versions named Fiasp FlexTouch, Fiasp PenFill, NovoLog FlexPen and NovoLog PenFill, the Centers for Medicare & Medicaid Services said Tuesday.

"For far too long, Americans have paid more for prescription drugs than any major economy," President Joe Biden said in a statement early Tuesday. "And while the pharmaceutical industry makes record profits, millions of Americans are forced to choose between paying for medications they need to live or paying for food, rent, and other basic necessities. Those days are ending."

Price changes for the first batch of 10 negotiated drugs won’t take effect until 2026. Over the next two years, another 30 drugs will be selected for negotiated prices beginning in 2027 and 2028.

Even as Big Pharma objects,Medicare's priciest drugs may get cheaper as feds start negotiations

Limits on which prescription drug prices can be negotiated

The 10 selected drugs accounted for about 20% of total spending for Medicare Part D prescription drugs over the past year, officials said. In all, those drugs cost Medicare and enrollees about $50.5 billion from June 1, 2022, through May 31 this year − the period for which costs were evaluated.

Although Medicare picks up most of that tab, about 9 million enrollees spent $3.4 billion in out-of-pocket costs for those drugs − a struggle for many seniors.

The federal government's new drug negotiating power comes from the Inflation Reduction Act, the sweeping climate and health legislation Congress passed last year.

The list did not include the top-selling rheumatoid arthritis drug Humira, which had a two-decade exclusive window before competing biosimilars launched this year.

Administrators followed provisions of the law and earlier guidance when selecting which drugs to negotiate, said Meena Seshamani, a Centers for Medicare & Medicaid Services deputy administrator and director of the Center for Medicare.

Retail drugs were selected only after they have been on the market for seven years without a competing generic version. Physician-administered "biologic" drugs must be on the market for 11 years before being subject to negotiation, Seshamani said.

'Who can afford that'? Patients face costly bills amid FDA's battle over 'orphan drugs'

Some savings to come sooner than others

While consumers won't see discounts from negotiated prices until 2026, other provisions promise more immediate savings. In 2025, enrollees in Medicare's Part D drug plans will have their out-of-pocket expenses for prescriptions capped at $2,000 per year.

Consumer and senior advocates long have sought efforts to slow rising drug prices for brand-name prescriptions for Medicare enrollees and taxpayers. But drug companies and their industry allies have fiercely contested the process, filing eight lawsuits seeking to halt drug negotiations.

Stephen J. Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, which represents pharmaceutical companies, blasted the negotiations as a "rushed process focused on short-term political gain rather than what is best for patients."

"Giving a single government agency the power to arbitrarily set the price of medicines with little accountability, oversight or input from patients and their doctors will have significant negative consequences long after this administration is gone," Ubl said.

CMS Administrator Chiquita Brooks-LaSure told USA TODAY she hopes the drug companies will "want to come to the table" and negotiate despite the lawsuits. Her agency will bargain with drug manufacturers and publish prices next September for prices that will take effect Jan. 1, 2026.

"We want to pay them adequately," Brooks-LaSure said. "We just don't want to be a price taker where they just set whatever price they want to charge and Medicare has no ability to make sure that people are getting the best value for their dollar."

The federal health program for adults 65 and older and disabled people sets reimbursement amounts for medical care from doctors and hospitals, but until now, Medicare has been prohibited from negotiating drug prices under 2003 legislation that expanded Medicare’s prescription drug coverage.

The law also capped Medicare recipients' out-of-pocket insulin costs at $35 a dose beginning this year. Though that provision did not extend to Americans covered by private insurance plans, three major insulin makers said they would slash prices by 70% or more on their respective products.

Medicare wants to trim spending on expensive, widely used drugs

Analysts say that while the price negotiations will start with 10 drugs, it will represent big savings for Medicare. The drugs were targeted for overall cost to Medicare, because of either high list prices or use by a lot of enrollees.

"The goal of this program is really to lower Medicare spending on these drugs," said Juliette Cubanski, deputy director of the program on Medicare policy at KFF, a nonpartisan health foundation.

Eliquis, prescribed to prevent or treat blood clots, was used by 3.7 million Medicare enrollees at a cost of nearly $16.5 billion last year. Drugmaker Bristol Myers Squibb disputed the amount Medicare spent, saying it "fails to take into consideration all rebates, discounts, and fees paid to Medicare and Part D plans," a spokesperson said.

Mariana Socal, an associate scientist at Johns Hopkins Bloomberg School of Public Health's department of health policy and management, said the negotiations should make drug pricing more transparent because Medicare will publish the negotiated prices.

"This will bring great relief to Medicare patients who pay high out-of-pocket costs for their drugs," Socal said. "In addition, the transparent prices will provide more information to empower patients outside of Medicare to demand lower prices as well."

Nick Fabrizio, a senior lecturer in health policy at Cornell University, said Democrats will likely highlight their efforts to lower drug costs. However, he said, it will take time to assess how the price negotiations will affect the drug industry.

“While we may see the impact that this has on lowering health care costs, we will also see whether prescribing habits change to other alternatives that may provide greater reimbursement and whether these price controls hamper research and development by the pharmaceutical industry."

Ken Alltucker is on X, formerly Twitter, at @kalltucker, or can be emailed at alltuck@usatoday.com.

Biden administration to negotiate costs on Medicare's priciest drugs

The Biden administration this week is expected to announce the first 10 prescription drugs the federal government will negotiate under a new federal law that aims to reduce the cost of Medicare's most expensive medicines.

For the first time, the federal government is allowed to negotiate drug prices for older Americans because of the Inflation Reduction Act, the sweeping climate and health legislation passed by Congress last year. The Centers for Medicare & Medicaid Services must publish the list of 10 drugs by Friday, but administration officials have signaled the announcement could come earlier in the week.

Consumer and senior advocates long have sought efforts to rein in drug prices for Medicare enrollees and taxpayers.

The federal health program for adults 65 and older and disabled people sets reimbursement amounts for medical care from doctors and hospitals, but until now, Medicare has been prohibited from negotiating drug prices under 2003 legislation that expanded Medicare’s prescription drug coverage.

Analysts say some expensive and widely used drugs for arthritis, cancer, diabetes or heart disease could be targeted for negotiation. Price changes for the first batch of 10 drugs won’t take effect until 2026. Over the next two years, another 30 drugs will be selected for negotiated prices beginning in 2027 and 2028.

“The negotiation process is going to meet its goal of capturing those drugs that are either used by a lot of people, are very expensive, or both,” said Leigh Purvis, a prescription drug policy principal with AARP Public Policy Institute.

Medicare launches plan on costly drugs:Here's what to know

Big Pharma takes the fight to court

But the pharmaceutical industry is challenging the drug negotiations. Big Pharma and industry allies have filed eight lawsuits seeking to derail drug negotiations. AstraZeneca, Astellas Pharma, Bristol Myers Squibb, Johnson & Johnson, Merck and the drug industry's trade group, PhRMA, have filed legal challenges, as has the U.S., Michigan and Ohio chambers of commerce.

The lawsuits use unique legal theories on why drug negotiations should be halted. In a lawsuit filed Friday at U.S. District Court in Delaware, AstraZeneca said the Inflation Reduction Act's drug negotiation provisions conflict with another federal law, the Orphan Drug Act, which seeks to promote drug industry investment in new therapies for rare diseases.

If the drug negotiations are allowed to continue, U.S. patients "will get delayed access to scientific breakthroughs relative to other parts of the world,” said Dave Fredrickson, AstraZeneca's executive vice president of oncology.

The growing list of lawsuits filed in different courts likely represents a strategy to get a case before the U.S. Supreme Court, said Kelly Bagby, vice president of litigation for the AARP Foundation.

“What they're trying to do is create as much momentum to get to the Supreme Court as quickly as possible,” Bagby said.

Patient on Xarelto looks for negotiated discount

Seniors who rely on expensive prescription drugs are anxiously awaiting which drugs could be discounted through negotiation.

Massachusetts resident Ellen Farmer, 64, takes Xarelto to manage a type of abnormal heartbeat called atrial fibrillation. Her doctor told her she needed to take the blood thinner or she could be at risk for blood clots, heart attack or stroke.

“I was shocked and terrified when the pharmacist told me the monthly copay for Xarelto, after insurance, would be $1,000,” Farmer said. “There was no way I could afford that.”

Farmer is enrolled in Medicare because of a disability caused by her heart condition. And subsidies available to some low-income Medicare recipients − another provision of the IRA − means her monthly copayment has for the drug has been sharply reduced.

She said it “gives me hope” the price of her medication might be cut even more through drug negotiations.

“There are far too many in this country who cannot afford the price of countless medications they need to survive,” Farmer said. “No one should ever have to choose between financial security and their health.”

Insulin costs, vaccines among other benefits

The law does not give Medicare unlimited authority to select which drugs to negotiate. Retail drugs are eligible only after they have been on the market for nine years without a competing generic version. Physician-administered drugs will have 13 years before being subject to negotiation.

While consumers won't see discounts from negotiated prices until 2026, other provisions promise more immediate savings. In 2025, Enrollees in Medicare's Part D drug plans will have their out-of-pocket expenses for prescriptions capped at $2,000 per year.

'Making it as simple as possible:'Amazon Pharmacy offers insulin discounts amid price hikes

The law also capped Medicare recipients' out-of-pocket insulin costs at $35 per dose beginning this year. While that provision did not extend to Americans covered by private insurance plans, three major insulin makers said they would slashed prices by 70% or more on their respective products.

Medicare recipients also won't pay out-of-pocket costs for recommended vaccines such as shingles, whooping cough or tetanus.

The federal law also requires drugmakers to pay federal rebates if they increase prices above inflation levels. In June, Medicare said it would target 43 drugs with price hikes that exceeded this threshold. Officials said the rebates could save consumers money through lower costs, as well as trim Medicare's spending.

Purvis, of AARP Public Policy Institute, said even consumers who don’t take expensive prescriptions will see benefits. The health-related provisions of the federal law are expected to save taxpayers $173 billion over the next decade, according to a Committee for a Responsible Federal Budget analysis.

“They are going to see savings as a result of negotiation," Purvis said.

Ken Alltucker is on X, formerly Twitter, at @kalltucker, or can be emailed at alltuck@usatoday.com