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Tuesday, 18 April 2023

Abortion pill manufacturer to pay $765K to U.S. to settle suit over incorrect labeling


Just days before the Biden administration asked the Supreme Court to preserve access to a key abortion medication, the Justice Department issued a routine, but little-noticed announcement that the manufacturer of the drug — Danco Laboratories — had settled claims it violated customs laws.

Further, the federal government will award a bounty-like payment of about $116,000 to the anti-abortion legal entity that blew the whistle on the alleged violations.

Danco’s only product is mifepristone, the drug at the center of the legal case before the Supreme Court and one of two parts of most medication abortions in the U.S.

Under the settlement dated March 31 and released last week, Danco agreed to pay $765,000 to the U.S. to resolve allegations that, from 2011 to 2019, the company failed to both properly label imports of the drug as originating in China and pay customs duties on imports lacking those labels.



Under the deal, Danco denied the allegations leveled by the Life Legal Defense Foundation in a lawsuit filed in a Sherman, Texas, federal court back in January 2021. However, the drugmaker said it was settling to “avoid the delay, uncertainty, inconvenience, and expense of protracted litigation,” according to the agreement.

The DOJ’s April 12 press release about the settlement names Danco, but does not mention the now high-profile abortion drug at the center of the dispute, mifepristone.

"Danco is committed to operating ethically and legally and reaffirms that this case did not concern the safety or efficacy of Danco’s product," the company said in a statement. "The settlement allows Danco to continue to focus on providing high quality, safe, and effective medication to women in the United States."

Life Legal, a Napa, Calif.-based nonprofit group that opposes abortion, brought its suit under whistleblower provisions of the False Claims Act. That allows third parties to file challenges on behalf of the U.S. government and claim between 15 percent and 30 percent if the action is successful.

Life Legal will receive approximately $116,000 from Danco’s payments to the Justice Department over the next roughly nine months, according to the settlement.

In a particularly awkward provision for Danco, which was specifically founded to ease access to medication abortion by distributing mifepristone in the U.S., the drug firm agreed to pay over $46,000 directly to the anti-abortion organization to cover its legal fees and costs related to the suit.


The suit was filed nine days after Joe Biden was sworn into office in January 2021, seemingly setting up a showdown between a president who supports abortion rights and the drugmaker. In accordance with federal law, the complaint was kept under seal while the government investigated. A judge unsealed portions of the records earlier this month.

Last week, the Justice Department and Danco asked the Supreme Court to preserve access to mifepristone after a lower court suspended FDA approval of the drug. Justice Samuel Alito issued a short-term stay while the court considers the request.



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Macron doubles down on French 'independence' amid pension reform crisis

The French president said fiscal discipline was needed to not depend on "foreign powers."

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Angela Merkel receives Germany's highest honor

Merkel is only the third German chancellor to receive the award, but some felt it was too soon to rank her among the country's greats.

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Two men charged with running covert Chinese ‘police station’ in Manhattan


NEW YORK — Brooklyn federal prosecutors Monday arrested and charged two men with operating an “undeclared overseas police station” in lower Manhattan on behalf of the Chinese government.

Prosecutors charged the men, Lu Jianwang and Chen Jinping, with conspiring to act as agents of China as well as obstructing justice by deleting their communications with an official for China’s Ministry of Public Security.

Last year, the human rights group Safeguard Defenders accused China of operating more than 100 overseas police outposts in numerous foreign countries. The stations ostensibly provide diplomatic services to Chinese citizens abroad but also covertly harass Chinese dissidents, the group said.

The station identified Monday occupied an entire floor of an office building in Manhattan’s Chinatown before closing in 2022, according to prosecutors. During its operation, it was tasked with “helping locate a person of interest” to the Chinese government, prosecutors said.

The defendants were set to appear in court Monday afternoon.

Brooklyn U.S. Attorney Breon Peace said the case “reveals the Chinese government’s flagrant violation of our nation’s sovereignty.”

“Such a police station has no place here in New York City — or any American community,” Peace said in a statement Monday.

Brooklyn federal prosecutors also unsealed two other related cases Monday: one charging 34 officers of China’s national police with harassing Chinese nationals in New York and elsewhere in the U.S., and another charging eight Chinese government officials with directing an employee of a U.S. telecommunications company to remove Chinese dissidents from its platform.

Prosecutors described the 34 officers as having created a “troll farm” consisting of thousands of fake online personas on social media sites, including Twitter, to target Chinese nationals living in the U.S. who held political views in opposition to those of the People’s Republic of China or who promoted democracy in China.



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Dems plan to push Feinstein-replacement strategy this week


Senate Majority Leader Chuck Schumer wants to move this week to temporarily replace the ailing Dianne Feinstein on the Judiciary Committee — a move that at least one Republican is likely to hold up.

Schumer said Monday afternoon that he wants to quickly sub in another senator for Feinstein (D-Calif.), whose absence from the Judiciary panel is hampering Democrats’ ability to easily confirm more of President Joe Biden's nominees to the federal bench. The New York Democrat said he is angling to have a conversation with Minority Leader Mitch McConnell about the matter soon.

Feinstein is “hopeful on returning soon," Schumer said, adding: "We think the Republicans should allow a temporary replacement till she returns. I hope the Republicans will join us in making sure this happens since it is the only right and fair thing to do.”

Reshuffling the panel’s roster this week would require unanimous consent from all senators, which means just one Republican could block it. Sen. Tom Cotton (R-Ark.) has already signaled he will not consent to doing anything to ease confirmation of Biden’s judicial picks. If Republicans delay or block the resolution to replace Feinstein, they would effectively make it tougher for Democrats to confirm more judges — which Biden's party can normally do unilaterally with a 51-49 majority.

The judiciary panel's chair, Dick Durbin (D-Ill.), has repeatedly delayed committee votes on lifetime appointees during Feinstein’s treatment for shingles. Democrats still have some judicial nominees ready for floor votes, but that list will run dry relatively soon without action at the Judiciary Committee.

With Feinstein absent — and her timetable to ever return to Washington increasingly uncertain — the committee is evenly split between Democrats and Republicans. That means judicial nominees without bipartisan support cannot come to the Senate floor without laborious procedural votes to shake them loose.



If Feinstein is temporarily replaced, Durbin could more easily win confirmation for those nominees. And the stakes are extra-high now: Confirming judges is one of the top Senate Democratic priorities given GOP control of the House.

Given that Republicans can filibuster any changes to committee lineups, it would take several days as well as the votes of at least 10 GOP senators to replace Feinstein on the panel. Schumer declined to say on Monday whether he would force that floor debate if Cotton or any other Republican blocks a quick switcheroo.

And who Democrats pick as a potential Feinstein replacement may weigh heavily on that endgame. Schumer said he needs to talk to the caucus about who would take her spot on the Judiciary panel, which she was once in line to chair.

Feinstein rejected any talk of resigning in a statement last week, asking that she be removed from the committee until she returns to the Senate in order to allow Judiciary’s work to continue.



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'Hypocrisy': New York Democrats deride Judiciary Committee's Manhattan hearing


NEW YORK — New York Democrats condemned the GOP-led House Judiciary Committee’s hearing in Manhattan on Monday as an attempt to undermine the credibility of the district attorney investigating former President Donald Trump.

They blasted the proceedings as a political stunt while also defending New York's crime rates.

“I think it’s the highest level of hypocrisy,” New York City Mayor Eric Adams said on MSNBC.

He later told reporters outside the hearing: “It is really troubling that Americans’ taxpayer dollars are being used to come here on this junket to do an examination of the safest big city in America.”

A rowdy crowd of anti-Trump protestors demanded to be let inside the federal building in lower Manhattan as the committee heard testimony from a formerly incarcerated bodega clerk and the mother of a homicide victim, among others who testified.

The hearing — titled “Victims of Violent Crime in Manhattan” — was called by the committee in the wake of the arraignment of the former president, who, ever since being criminally indicted by a grand jury in Manhattan, has attacked Alvin Bragg, the district attorney leading the case, for not addressing local crime instead.



His GOP allies have leveled similar criticisms. Rep. Jim Jordan, who chairs the committee, called New York a “city that has lost its way" during the hearing.

“Here in Manhattan, the scales of justice are weighed down by politics,” Jordan later added during the hearing, accusing Bragg of taking a “soft-on-crime approach to the real criminals.”

The mayor and other Democrats were quick to point out Monday that crime in many major categories is on the decline. A letter sent to Jordan last week cited recently released NYPD statistics showing murders are down roughly a tenth from at this time last year. Shootings and transit crimes have decreased, too.

The full picture of crime statistics in New York is more of a mixed bag, though. Felony assaults are up, driven largely by domestic incidents and attacks on police officers, and major felony arrests are at a high not seen in more than two decades.

Adams also pointed to data reported in the New York Daily News Monday morning suggesting that residents of Jordan’s home state of Ohio are far more likely to die from gun violence than New Yorkers.

Wirepoints, an Illinois-based nonprofit, found in February that New York City had among the lowest homicide rates among the nation's largest cities.

Adams said neither he nor anyone from his administration was asked to speak.

Rep. Adriano Espaillat, who represents New York’s 13th District, also took issue with Republicans on the committee criticizing crime in the state without backing stronger federal gun control legislation.

“The common denominator in most homicides across the country is a gun,” he said during the hearing.

The GOP’s embrace of the issue of crime in their attacks against Bragg — and the other side’s full-throated response — is indicative of just how salient the issue remains in New York politics, and of its soreness for Democrats in the wake of midterm losses and a much closer than anticipated gubernatorial race. Even public safety-focused Democrats like Adams have struggled to make voters think they’re making headway on the issue.

Manhattan Democratic Rep. Jerry Nadler, a former chair of the committee, warned voters not to be "fooled."

“This hearing is being called for one reason and one reason only: to protect Donald Trump," he said at the news conference with Adams.



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Monday, 17 April 2023

Washington used to abhor talking about mental health. No more.


For six weeks, while Sen. John Fetterman received treatment for clinical depression at Walter Reed Medical Center, handwritten cards poured into his Washington office. His staff fielded phone calls from constituents passing along well wishes. Others called simply to thank him for being upfront about his condition.

When one of Fetterman’s senior aides checked into a hotel in Pittsburgh recently, a middle-aged woman saw their Senate ID and asked for whom they worked. When the aide told her, the woman responded: “He’s so brave.”

The reaction has been, overall, a shocking and pleasant surprise to Fetterman’s team, which worried about their boss and felt anxious about how the public would respond to revelations that he has depression.

What they and others have discovered is that the country is increasingly open about it. And that the politics are changing around it.

Sen. Tina Smith (D-Minn.) penned a personal essay about Fetterman and how the news of his depression dredged up old feelings about her own fight with the disease in her teens, and again as a young mom. Republican Sen. Katie Britt’s team sent cookies and brownies to Fetterman’s office almost once a week, the senior Fetterman aide told POLITICO. And before President Joe Biden kicked off his budget speech in Philadelphia last month, he spoke directly to the senator: “John, if you can hear this at all, we’re with you, pal. We’re with you,” he said, drawing cheers from the crowd.

“It was like, damn, this is cool. You never know how it’s going to go, you know? There’s no playbook for what John did,” said the Fetterman aide. “But if you can learn anything from John Fetterman, it’s that it’s OK. Things can get better. It is OK to get help. That’s what he wants people to take away from this.”

Fetterman’s return to the Hill on Monday will provide the most visible example of the nation’s capital — a city where public figures often fight to keep personal battles shrouded in secrecy — slowly embracing an issue that affects 1 in 5 Americans in a given year. From Congress to the White House, policymakers have begun leaning into mental health as a key policy priority.



“In the ’50s and ’60s, nobody said the word cancer. We talk about cancer now. We need to get to that point where we talk about depression. We talk about bipolar disorder. We talk about PTSD. We talk about schizophrenia, and acknowledge that these are illnesses for which there is treatment, and people can have satisfying, fulfilling lives,” said Lynn Bufka, associate chief of practice transformation at the American Psychological Association and a licensed psychologist in Maryland.

“So anytime we have more visible figures talking about the reality, it helps people to see ‘Oh, that person is a lot like me.’”

Not only are politicians opening up about their private struggles and decisions to seek treatment but they are doing it while staying in office, said Jason Kander, the former secretary of state of Missouri. Kander, a rising star in the Democratic party, ran for Kansas City mayor in the 2019 election. He dropped out after revealing he had post-traumatic stress disorder and depression after his service in Afghanistan.

“I announced that I was leaving public life for a while to go get help … now I’m a public person again, and I’m trying to be that role model as best I can. But there’s a difference between that next level of what John Fetterman is doing,” Kander said in an interview. “I’m aware of the social media comments that are like, ‘Oh, whatever happened to that guy after he made that announcement?’ And that’s fine, but it’s really great that in the case of John Fetterman, or Ruben Gallego, people see, ‘Oh, they made this announcement, and their pursuit continued.’”

The shift in Washington can be attributed to a number of factors, Bufka said. After decades of advocacy work from the APA and other organizations focused on mental health education, the media now talks about mental health more. The Covid pandemic also greatly exacerbated the crisis, forcing politicians to face the issue head on as one impacting their constituents — and their own lives.

Biden followed a similar path. He had spoken in the past about mental health and worked on the issue as vice president, announcing Obama White House efforts to increase access to mental health services. But during the 2020 campaign, the issue became personalized as he faced questions about his son Hunter’s struggles with mental health and addiction.

“The idea that we treat mental health and physical health as though somehow they’re distinct — it’s health,” Biden said during the interview with CNN. “... I’m confident, confident, he’s going to make it.”

The focus continued into his presidency. During his first State of the Union address, Biden talked about how the pandemic impacted kids, increasing social isolation, anxiety and learning loss. As part of his “unity agenda,” he outlined the White House’s strategy for combating the mental health crisis: creating healthy learning environments, strengthening system capacity and connecting more Americans to care.

The American Rescue Plan included funding to expand Certified Community Behavioral Health Clinics, invest in the 988 suicide prevention hotline and launch projects to tackle the impacts of social media and kids. Biden’s latest budget requests $139 million for research and another $16.6 billion to increase mental health care programs in the Veterans Affairs Medical Care program.



“Having the White House be public about this is is meaningful. And I suspect — I would never deign to speak for the president — but I suspect that the contemporary veterans in his family have helped him understand this,” said Rep. Seth Moulton (D-Mass.), who has spoken about his PTSD after serving in the military.

There has been no shortage of administration officials talking about the growing crisis, including Domestic Policy Council Adviser Susan Rice, and Surgeon General Vivek Murthy, who has said in interviews that he accepted Biden’s offer to serve a second term because of the dire state of the country’s emotional health.

During White House events, Murthy has talked about about his own struggles with mental health as a young boy and about his uncle, who died by suicide after a silent battle with depression.

Still, the steps forward don’t negate the reality that a stigma still exists, Smith said. She suspected that if one were to do the math, there were likely dozens of members of Congress choosing to not talk about their mental health, fearful of what it could mean for their political careers.

Even as Fetterman’s openness has been met with a positive response, stories like the one of Tom Eagleton, the Democratic running mate for presidential nominee George McGovern who withdrew from the ticket after acknowledging was treated for clinical depression and received electroshock therapy, still haunt politicians.

Then there was former Rep. Patrick Kennedy who left politics to focus on his addiction and bipolar disorder. He entered a rehabilitation center after crashing his car into a barricade on Capitol Hill in 2006. In a 2016 interview, Kennedy noted that there were moments he knew he needed help, well before that breaking point. But back then, politicians didn’t talk about these things.

“It is getting better, but individuals still take risks when they speak out … people are still willing to jump to the conclusion that because you have a mental health issue, that means are you really capable of serving? Can you really do what you need to do?” Smith said.

“But to me, it’s worth it. The positive side of it is the people out there, especially the young people, who see folks like me — who by all appearances have my act together — being open about it. That creates a door for them to walk through.”



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