Senior FDA official resigns following baby formula crisis, turmoil in agency

Frank Yiannas has resigned from his post as the Food and Drug Administration’s deputy commissioner for food policy and response, following the baby formula crisis and a series of internal breakdowns at the main agency tasked with overseeing food safety in the U.S.

Yiannas confirmed the move to POLITICO on Wednesday, which was first reported by Food Fix. He’s held the position since December 2018.

An FDA spokesperson said Yiannas' resignation was effective Tuesday.

"The FDA remains committed to providing an update on steps to strengthen the Human Foods Program at the end of January and additional updates on the organizational structure, including how responsibilities of Mr. Yiannas’ position will be handled moving forward, by the end of February," the spokesperson said.

Yiannas was among the senior FDA officials involved in the Biden administration’s hobbled response to the infant formula crisis. FDA officials were warned months before about food safety concerns at a key plant in Sturgis, Mich. operated by Abbott Nutrition. The plant issued a recall of some formula products, after reports that babies died after drinking formula from the facility and FDA inspectors finding strains of a bacteria that can be deadly to infants. Abbott has maintained that there is no link between the deaths and the formula at the plant.

Yiannas, FDA Commissioner Robert Califf and Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition, acknowledged to lawmakers last May a string of failures that contributed to the crisis — including a breakdown in internal FDA communication that the officials said prevented them from knowing aboutthe safety issues until just weeks before the recall. Yiannas and Califf also said a whistleblower report alleging food safety problems at the plant, which was mailed in October 2021, did not reach the FDA’s highest rungs until mid-February 2022, despite being sent directly to top FDA officials.

As POLITICO has reported, Mayne and Yiannas have personal differences, which havecreated tension at the senior levels of an agency already struggling to make decisions. Key industry leaders, despite the internal FDA breakdowns, generally respected Yiannas and believed his role was being minimized at the agency.

"It's disappointing that the structure and culture of the FDA foods program continuously failed to fully leverage his extensive food safety expertise," said Brian Ronholm, former deputy undersecretary of food safety at the Agriculture Department.

Yiannas, a former vice president in charge of food safety at Walmart, later met with formula manufacturers and retail distributors as the Biden administration scrambled to address shortages triggered by the Abbott recall as the empty shelves turned into a political crisis for President Joe Biden.

Yiannas’ resignation comes as the FDA is poised to announce a series of steps it’s taking to address the findings of a recent external review following the infant formula crisis and other breakdowns at the FDA.

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Bivalent booster cuts risk of XBB.1.5 symptomatic infection by about half

A new CDC study has found that the Covid-19 bivalent booster reduces the risk of symptomatic infection from the most common subvariant circulating in the U.S. right now by about half.

Additional new data, set to be published on the CDC website on Wednesday, also shows that individuals who received an updated vaccine reduced their risk of death by nearly 13 fold, when compared to the unvaccinated, and by two fold when compared to those with at least one monovalent vaccine but no updated booster.

CDC officials said during a briefing on Wednesday that the new findings were "reassuring." But only 15.3 percent of eligible Americans — or about 50 million people — have received the new shot, which was rolled out in September.

Meanwhile, the highly transmissible Omicron subvariant XBB.1.5 — nicknamed “the Kraken” by some — is now the dominant SARS-CoV-2 strain in the U.S., projected by the CDC to make up just over 49 percent of cases in the country as of last week.

Earlier this month, the WHO said XBB.1.5 is the most transmissible variant to date, and is circulating in dozens of countries. Though a catastrophic wave has not emerged in the U.S. yet, there has nevertheless been a spike in deaths this month, with an average of 564 people dying of Covid-19 each day as of Jan. 18, compared with an average of 384 around the same time in December.

The new vaccine efficacy study, which used data from the national pharmacy program for Covid testing, found that the bivalent booster provided 48 percent greater protection against symptomatic infection from the XBB and XBB.1.5 subvariants among people who had the booster in the previous two to three months, compared with people who had only previously received two to four monovalent doses.

It also provided 52 percent greater protection against symptomatic infection from the BA.5 subvariant, though according to CDC estimates, BA.5 only accounted for about 2 percent of U.S. cases last week.

CDC officials cautioned that the findings reflected a population-level rate of protection, and that individual risk of infection varies.

“It's hard to interpret it as an individual's risk, because every individual is different,” said Ruth Link-Gelles, the author of the vaccine effectiveness study published in MMWR Wednesday. “Their immune system is different, their past history of prior infection is different. They may have underlying conditions that put them at more or less risk of COVID-19 disease.”

She also said it was unclear, given the limitations of the study, how long the bivalent booster protection will last.

“It's too early to know how waning will happen with the bivalent vaccine,” she said. “What we've seen in the past is that your protection lasts longer for more severe illness. So even though you may have diminished protection over time against symptomatic infection, you're likely still protected against more severe disease for a longer period of time.”

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Manchin meets with McCarthy as Dems skewer debt talks

Most congressional Democrats say there’s nothing to negotiate.

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Police: Shooting that killed 2 at youth program was targeted

DES MOINES, Iowa — An 18-year-old who police say was involved in an ongoing gang dispute walked into the common area of an alternative education program for at-risk students and fatally shot two teenagers in a premeditated attack — chasing one of them down and shooting him several more times when he tried to run, according to a charging document released Tuesday.

Police said the shooting on Monday that also left the founder of the Starts Right Here program with life-threatening injuries was a targeted attack. The founder, 49-year-old William Holmes, underwent surgery and was in serious condition.

Police on Tuesday identified those killed as 18-year-old Gionni Dameron and 16-year-old Rashad Carr.

Holmes, an activist and rapper who goes by the stage name Will Keeps, joined a gang as a 13-year-old in Chicago but moved to Iowa more than two decades ago and dedicated his life to helping young people in need, according to his LinkedIn page.

Eighteen-year-old Preston Walls of Des Moines was charged with two counts of first-degree murder, one count of attempted murder and one count of criminal gang participation. He made a brief court appearance Tuesday, with a preliminary hearing scheduled for Feb. 3.

Walls is jailed on $1 million bond. The Polk County public defender's office, which will provide his attorney, declined comment.

Walls was on supervised release for a weapons charge, and he cut off his ankle monitor 16 minutes before the shooting, police said.

“There was nothing random about this,” Police Sgt. Paul Parizek said.

Investigators say in the charging document that Walls had a 9 mm semiautomatic handgun with a high-capacity extended magazine concealed on him when he entered a common area of the program. The affidavit said Holmes tried to escort Walls out, but Walls pulled away, drew the gun and shot the two teenagers several times.

The document said one victim tried to flee, but Walls chased him down “and shot him multiple more times.” The document blacked out the name of the victim except the first letter of the last name, “C,” indicating it was Carr.

Holmes was struck by the gunfire. His family said in a statement Tuesday that he “has a long recovery ahead and we are deeply appreciative for the care he is receiving.”

Despite his injuries, Holmes is “now more determined than ever to continue with his work with at-risk youth and looks forward to, once again, working hand-in-hand with other community leaders on the mission of Starts Right Here,” they wrote.

Responding officers saw a suspicious vehicle leaving the area and stopped it. Police said Walls ran but was found hiding in a brush pile with the 9 mm handgun next to him. The ammunition magazine, which has a capacity of 31 rounds, contained three, police said.

According to the affidavit, the shooting was captured on surveillance video, and Walls' clothing and his Glock firearm matched those seen on the video.

The Starts Right Here board of directors said in a statement that classes were cancelled for the remainder of the week and that grief counselors will be available. The program which began in 2021 helps at-risk youth in grades 9-12 and is affiliated with the Des Moines school district.

“These actions are contrary to all that we stand for and point out more must be done,” the board said. “These two students had hope and a future that will never be realized."

Dameron’s father, Gary Dameron, 37, said his son was on track to graduate this spring. He planned to attend barber college and become a barber, just like his dad.

Gary Dameron said he has known Holmes for years and reached out to him personally to get his son enrolled in Starts Right Here. Despite the police claim that the shooting was gang-related, he said his son was not involved in a gang, describing him as “family-oriented” with a “goofy” sense of humor.

“He just had one of those personalities that when he came in the room, everybody kind of gravitated to him,” Gary Dameron said.

Gionni Dameron turned 18 on Friday, his father said.

Dameron said his son and Carr were best friends. He described Carr as “very respectable,” cool and soft-spoken.

Last year, Walls was charged with three counts alleging that he knowingly resisted or obstructed a West Des Moines police officer while armed with a firearm and intoxicated, court records show.

His attorney in that case, Jake Feuerhelm, said that in the incident last May, Walls was part of gathering of young people that police approached. While they were trying to sort out what was happening, Walls, who was 17 at the time, took off. Because he was armed while fleeing from police, he was charged, Feuerhelm said.

Feuerhelm said he didn’t know whether Walls was part of the school program.

Keeps said in his LinkedIn profile that he was just 15 when he saw a friend die at the hands of a rival gang. A gun pointed at him jammed and he was beaten but survived.

“I moved to Des Moines in my 20’s and began a new life, focusing on my future and how I wanted to be remembered,” Keeps wrote. “I wanted to help others to make a change so they wouldn’t have to go through life feeling uncared for, unloved, or in a home that wasn’t safe.”

The Starts Right Here website says 70% of the students it serves are members of minority groups, and it has had 28 graduates since it began. The school district said the program serves 40 to 50 students at any given time.

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Lawmakers to codify abortion rights in state constitution, sending it to voters

ALBANY, N.Y. — The next decision will be with voters on whether New York will enshrine abortion rights in the state constitution.

The state Assembly and state Senate were slated to vote Tuesday afternoon on the second passage of a resolution first passed last July that would protect abortion rights in the state constitution, giving it additional strength in the wake of the overturning of Roe v. Wade last June by the U.S. Supreme Court.

It is expected to pass both chambers by an overwhelming majority.

After the two separately elected legislatures vote on the measure, it can go before voters as early as this November. But lawmakers will direct it to be put on the ballot in 2024 — a presidential year in a heavily blue state that would improve its chances of passage.

"Here in New York we will never let the extremist, anti-choice agenda to prevent anyone from accessing reproductive health care," Assembly Speaker Carl Heastie said Tuesday at a rally near the state Capitol with abortion-rights activists.

New York added stronger abortion rights into state law in 2019 and approved new laws last year to shield providers and patients from out-of-state litigation.

But in the wake of the Roe vs. Wade decision, abortion rights advocates and some lawmakers pushed to enshrine the protections in the constitution as a way to make it harder to overturn by any future legislature.

The amendment adds new protected classes to the constitution’s existing Equal Protection Clause, which prohibits discrimination based on a person’s race, color, creed or religion. It would also bar intentional government discrimination based on a person’s ethnicity, national origin, age, disability or sex, including sexual orientation, gender identity, gender expression, pregnancy, pregnancy outcomes and reproductive health care and autonomy.

"We're modernizing our constitution to recognize that all these categories of New Yorkers should have equal rights under the constitution to be protected from discrimination," Sen. Liz Krueger (D-Manhattan) said at a news conference. "Because guess what we've learned recently? The courts can change and suddenly protections you thought you had because some court cases aren't there anymore."

Gov. Kathy Hochul hailed the measure, and she proposed new lawsin her State of the State address earlier this month that would allow pharmacists to directly prescribe contraceptive pills and increase Medicaid reimbursement rates for reproductive health providers.

"I’m the first governor in the state of New York to ever have had a pregnancy, ever raise children, ever had to go through all the screaming," Hochul, the first woman governor, said at the rally. "I know more than any governor before me of what it’s like to be a woman and whether someone else in Washington has the right to take away what I should be able to decide on my own."

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McDaniel vs. Dhillon: Inside the battle for the RNC

An early showdown destined to shape the 2024 election cycle is happening this week inside a luxury waterfront hotel in Orange County, Calif., where weeks of shadow-boxing between incumbent Republican National Committee chair Ronna McDaniel and her foremost challenger, conservative lawyer Harmeet Dhillon, will transition into a high-stakes political brawl.

McDaniel is seeking a fourth two-year term, counseling stability atop the RNC ahead of the coming presidential election, while Dhillon is waging an insurgent campaign to unseat her, arguing that change is needed following the GOP’s abysmal midterm performance.

The sparring has grown intense, with the two camps trading accusations of mismanagement, intimidation, and other misdeeds. And in interviews with POLITICO this week, neither candidate showed any sign of easing up ahead of this week’s RNC winter meeting in Dana Point.

“We just can’t afford to take our foot off the gas,” McDaniel said, projecting confidence she would prevail over Dhillon.

Dhillon, meanwhile, asserted that with stronger leadership, Republicans “might have won bigger in the 2022 election, and we would be ready to win in 2024.”

Friday’s election among the 168 RNC members will follow two days of meet-and-greets, debates and glad-handing among the other typical party business. Measured by public statements of support, McDaniel would appear safe: She has more than 100 members publicly backing her, while Dhillon has fewer than 30. (MyPillow CEO Mike Lindell is also running, but few RNC members take him seriously.)

But the bitter tenor of the fight, the enormous stakes for the GOP going into the 2024 elections and the uncertainty of a secret-ballot election have elevated the contest into a political battle royale.

Dhillon on Monday emailed her latest pitch to RNC members — pledging to make changes that include moving her family from California to Washington (McDaniel commutes from Michigan), banning “extremely loud entertainment” at committee events, and maintaining a “culture of collegiality and cooperation” inside the party.

In the subsequent interview, Dhillon went chapter-and-verse on the failings she sees under McDaniel: The RNC has overspent on consultants and “frivolous expenditures that don't win elections.” It has fallen behind Democrats in encouraging voting before Election Day and making sure as many of its voters’ ballots are counted as possible. And, she argued, the party “whiffed” in shaping the GOP’s midterm message — arguing that the RNC has to lead, not follow, when the party is out of power.

McDaniel rejected the accusations that the RNC fumbled the midterms, arguing that her efforts to build the party infrastructure “made it a better election than it would have otherwise been” and that Dhillon and her other critics simply “don’t understand what the RNC’s job actually is.”

“The infrastructure we built made it so a Republican could get to the finish line,” she said, noting that more than 4 million more GOP voters turned out nationwide than Democrats. “But the difference between why one Republican did and didn’t is down to the campaign, the candidate and messaging, which the RNC does not have control over.”

Dhillon said losing Republican candidates such as Arizona’s Kari Lake, Pennsylvania’s Mehmet Oz and Georgia’s Herschel Walker were no more flawed than the Democrats who beat them. Republicans just have to get as “efficient” as Democrats, she said, at turning out their voters and making sure their ballots are counted.

“John Fetterman could not even speak and articulate for himself during much of his campaign, and he got elected,” she said, referring to the new Pennsylvania senator, who suffered a stroke mid-campaign. “So I disagree with that explanation.”

Hanging over the contest is the shadow of former president Donald Trump, who has ties to both candidates but has not made an endorsement in the race.

Dhillon and McDaniel have this in common: Neither was eager to finger Trump for the GOP’s recent electoral failings — including his role in actively discouraging Republican voters from casting mail ballots or elevating several of the cycle’s most disappointing candidates.

But Dhillon is seeking to walk a fine line as she maintains a coalition of MAGA die-hards and Never Trumpers who share an interest in ousting McDaniel. It’s meant assuming some new and nuanced positions for an attorney who, after the 2020 election, cheered Rudy Giuliani’s suggestion that he found cause to overturn Pennsylvania’s results, solicited donations for Trump’s election defense fund on Twitter, and wrote an op-ed on Townhall.com entitled “Republican lawyers are fighting to stop the steal.”

Among those backing Dhillon are such Trump diehards as activist Charlie Kirk, Arizona GOP Chair Kelli Ward and Stop the Steal organizer Caroline Wren.

Yet in the interview, Dhillon rejected Trump’s claims of a stolen 2020 election and confirmed Joe Biden as the rightful winner. She noted that she did not personally file or litigate any of the lawsuits filed by Trump allies seeking to challenge the election.

“The time to ensure the integrity of an election is before the election,” she said. “And if you haven't prepared for that, don't start scrambling and hiring lawyers after the fact. It's too late.”

McDaniel, meanwhile, faces blowback from Trump skeptics who argue she doesn’t push back on Trump enough. In an email to RNC members first reported by the Washington Post, Tennessee committeeman Oscar Brock wrote that “the reality is that every time Donald Trump says jump, Ronna asks, ‘How high?’”

McDaniel has responded by pledging repeatedly to keep the 2024 primary process neutral and promising to bridge divisions inside the party. “I’m running a unity campaign, and part of that is, as party chair, not attacking other Republicans,” she said.

But Dhillon said some Republicans have told her they are already skeptical of McDaniel’s assurances, given that she tapped Trump loyalist David Bossie to run the 2024 GOP debates. McDaniel’s backers, meanwhile, have privately raised doubts about what the RNC would look like under Dhillon, who has suggested she will hire MAGA hardliners to run the organization.

The whisper campaigns have been relentless, and they have been accompanied by an effort to whip up a grassroots uprising on Dhillon’s behalf — prompting McDaniel to denounce some of the scorched-earth tactics.

One Dhillon ally published RNC members’ contact information, encouraging GOP voters to hound them to oppose McDaniel, while Kirk, a MAGA activist with a massive following, threatened in an email to RNC members last month to replace them with activists who “better represent the grassroots voice.”

“It’s intentionally inflaming passions based on things that aren’t true,” McDaniel said, warning that the nastiness bodes ill for 2024, “with Republicans attacking other Republicans to the point that we can’t come together after.”

Dhillon rejected McDaniel’s suggestion that her longshot campaign is unnecessarily dividing the party ahead of a critical presidential election. “This is not personal,” she said. “You have to point out the reasons for change. I try to do that as persuasively and civilly as possible.”

While the arithmetic appears formidable for Dhillon, she insisted still has an “excellent chance” of pulling off an upset. While POLITICO has previously reported that party insiders believe she has about 60 votes, Dhillon herself would not talk numbers.

She did, however, offer an explanation for why so few members have publicly endorsed her. Some committed to McDaniel before she entered the race and “don't want to offend her,” she said, while others are running for leadership posts of their own and don't want to alienate the incumbent and her supporters. And some, she suggested, fear their state party’s finances could be affected if they cross the sitting chair.

In a late bid to lower the race’s temperature, Dhillon vowed if elected to work with Republicans she has clashed with — including elected officials, such as Senate Republican Leader Mitch McConnell, whom she has attacked at times, and even McDaniel herself.

“She's an important leader in the party,” Dhillon said, inviting McDaniel to stay on in a leadership role. “She has a lot of skills and I'm sure she has things that could teach me.”

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Trump tries to intervene as Navarro faces trial for defying Jan. 6 committee

Donald Trump is once again making a last-ditch bid to help a former aide avoid prosecution for defying the Jan. 6 select committee.

A lawyer for Trump issued a letter this week endorsing the decision by former White House adviser Peter Navarro to blow off a subpoena from the Jan. 6 select committee by making blanket claims of executive privilege.

The Jan. 23 letter, filed in federal court, comes less than a week before Navarro is slated to go to trial for contempt of Congress for refusing to appear before the select committee last year.

“This confirms President Trump’s position that, as one of his senior advisors, you had an obligation to assert executive privilege on his behalf and fully comply with the principles of confidentiality stated above when you responded to the Committee’s subpoena,” the attorney, Evan Corcoran, wrote on Trump’s behalf.

The letter appears calculated to undercut the ruling of U.S. District Court Judge Amit Mehta rejecting Navarro’s effort to dismiss the cases against him. Mehta noted in a 39-page opinionlast week that Navarro had presented no evidence that Trump actually asserted executive privilege on his behalf — even though he made explicit assertions to block the testimony of other former aides.

“Defendant has failed to come forward with any evidence to support the claimed assertion of privilege,” Mehta wrote. “And, because the claimed assertion of executive privilege is unproven, Defendant cannot avoid prosecution for contempt.”

Mehta is unlikely to consider Corcoran’s letter sufficient to derail Navarro’s trial. Navarro had initially claimed in court arguments that Trump told him, during a private conversation, to assert executive privilege before the Jan. 6 committee. But Corcoran’s letter makes no reference to such an assertion.

It’s the second time Trump has made a last-second bid to disrupt the pending contempt trials for aides who defied the select committee. Days before longtime ally Steve Bannon faced a criminal trial for contempt, Trump took the opposite tack — writing a letter to Bannon waivingany potential executive privilege and clearing the way for Bannon to testify to the committee. Prosecutors dismissed the gambit as a stunt to disrupt the trial, and Bannon ultimately took no steps to actually comply with the select committee’s subpoena, even after Trump’s explicit permission.

Navarro, like Bannon, both claimed that they were categorically “immune” from appearing before the Jan. 6 committee to discuss their involvement in efforts to overturn the results of the 2020 election. They said their sensitive conversations with Trump were protected by executive privilege and therefore they could not be compelled by Congress to discuss them. But U.S. District Court Judge Carl Nichols rejected Bannon’s contention, noting that longstanding legal precedents don’t permit witnesses to defy congressional subpoenas even over assertions of executive privilege.

And in both cases, prosecutors noted that there was no evidence Trump had asserted privilege on Bannon or Navarro’s behalf.

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