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My son has a terminal disease — why FDA delays are failing families like mine

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I’ve spent over 40 years on the front line against a terminal illness that killed my brothers and put my 14-year-old son into a wheelchair. This week, I asked Food & Drug Administration (FDA) Commissioner Dr. Martin Makary to leave his gilded office and come visit my home, because I fear that he’s lost touch with terminally ill children like Ryu. 

I’m Ryu’s full-time caretaker. Like most rare disease families, we rely on one income and have limited financial resources. What we do have are astronomical medical expenses; Ryu’s steroids alone are $30,000 per month. My husband and I thankfully found a nonprofit that covered the remaining $2,000 after our insurance paid their portion — but other expenses fall squarely on us. 

It’s easy to ignore these struggles when you’re a powerful official in Washington, D.C. In my house, Ryu struggles to breathe because of Duchenne muscular dystrophy, the same illness that I watched kill my brothers Angelo and Antonio at ages 20 and 22. Experimental drugs could let Ryu avoid their fate, but we can’t access them under a regulatory environment that appears to prioritize bureaucratic caution over the lives of dying children. 

I’M A PHYSICIAN AND I’M WORRIED THAT OUR HEALTH AGENCIES ARE FACING INCREASING CHAOS

A year ago, the rare disease community thought Dr. Makary would be our strongest ally. He promised to “remove barriers and exercise regulatory flexibility” to deliver meaningful treatments for patients. Families listened and dared to believe that the system would finally reflect the urgency of the conditions we face.

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But our hopes were dashed over and over again as therapies were subjected to extended review cycles, accelerated approval pathways were ignored, and previously authorized treatments were paused, restricted, or effectively sidelined.

The upcoming departure of FDA’s Director of the Center for Biologics Evaluation and Research, Dr. Vinay Prasad, the man Makary assigned to make these life-and-death decisions, creates an opportunity for a reset. He oversaw the committee in charge of treatment approvals, so he is seen by many in the rare disease community as responsible for delaying treatments rather than delivering them.

Now, as Dr. Makary considers Dr. Prasad’s successor, he has a chance to appoint someone who understands that families should have the right to make their own decisions about which medicines are “risky” for their declining loved ones.

LOUISIANA SOCIAL WORKER FIGHTS STATE RED TAPE BLOCKING HER FROM HELPING SPECIAL NEEDS KIDS

Risk is a big part of Ryu’s day-to-day, and our whole family is intimately acquainted with it. At night, he relies on a machine to keep his lungs functioning because they could fail at any time. He always dreamed of being a Navy SEAL; now he just hopes to live long enough to cast his first ballot.

Despite this, he is the happiest kid I know. And it’s important that Dr. Makary knows what that looks like, because when he and Dr. Prasad talk about risk, they’re doing so based on what the paperwork tells them. They make decisions that, from their offices, seem like they can be reviewed and revisited. 

But when I hear “risk,” I see Ryu’s quality of life irreversibly decline by the day. His calves are so tight that he cannot flatten his feet, so he wears special braces for some relief. During the day he wears a gait belt just to align his hips as his muscles deteriorate, and at night, he cannot even turn himself over without our help.

DR. MEHMET OZ, STEPHANIE CARLTON: CALIFORNIA WAS HORRIBLY WRONG ABOUT GENDER AND KIDS

Under Ryu’s current treatment, these changes are irreversible. That’s why treatment options must be expanded — and not at the speed of the FDA, but at the speed of terminal rare diseases. 

Families understand risk better than anyone. We are not asking for reckless approvals or the abandonment of scientific standards. What we need is a system that recognizes that doing nothing is a decision that is deadly, 100% of the time.

If the FDA wants to rebuild trust, it needs to start with the families who have been burned. That means involving patient communities earlier in the process and being transparent about decision making. Regulatory timelines must align with the urgency of the diseases being treated, curing the current and ongoing mismatch.

FDA policies can be revisited, revised, and reversed. Leadership comes and goes. But for families like mine, there are no do-overs. The accelerated approval process was created for a reason — because rare disease patients do not get resets. 

That is why this moment matters: because even when a ship is wildly off course, a great leader can save the journey.

I invited Commissioner Makary to come and sit in my living room and meet Ryu, to see firsthand what it means when decisions are delayed and hope is put on hold. Not as a symbolic gesture, but as a reminder that behind every application, every dataset, every rejected therapy, there is a child whose future is being decided.

In the end, regulators will not be judged by how cautious they were, but by whether their actions kept our children alive. 

Families like mine cannot afford more delays.

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JUST IN: ‘Squad’ Congressional Candidate Arrested

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JUST IN: ‘Squad’ Congressional Candidate Arrested

A Democratic congressional nominee who defeated a sitting member of Congress earlier this year was arrested Thursday during a major protest against Israeli Prime Minister Benjamin Netanyahu outside the United Nations in New York City.

Darializa Avila Chevalier, the Democratic nominee for New York’s heavily Democratic 13th Congressional District, was taken into custody as demonstrators gathered near U.N. headquarters ahead of Netanyahu’s address to the General Assembly.

Avila Chevalier defeated five-term Rep. Adriano Espaillat in June’s Democratic primary after campaigning as a critic of U.S. support for Israel and receiving the backing of New York City Mayor Zohran Mamdani.

Now, just months after that upset victory, she was among the politicians, activists and entertainers arrested during Thursday’s demonstration.

The protest, organized by Jewish Voice for Peace, drew roughly 250 people to First Avenue and East 39th Street, just blocks from U.N. headquarters.

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Demonstrators sat in the roadway while protesting Netanyahu’s appearance and U.S. support for Israel’s military operations in Gaza.

Police arrested protesters who blocked the road and refused orders to move.

Avila Chevalier defended her decision to participate and sharply condemned Netanyahu.

“As the Democratic Nominee for New York’s 13th Congressional District, I refuse to allow a war criminal to roam the streets of our city unchallenged,” she said.

“I refuse to play host to a man who has overseen the slaughter or injury of more than 64,000 children in Gaza with American taxpayer dollars.”

The description of Netanyahu as a “war criminal” reflects Avila Chevalier’s position. Netanyahu and the Israeli government have rejected accusations that Israel’s military campaign constitutes genocide and have maintained that Israel is targeting Hamas while seeking to minimize civilian casualties.

The International Criminal Court has issued an arrest warrant for Netanyahu alleging war crimes and crimes against humanity. Netanyahu and Israel reject the allegations and dispute the court’s jurisdiction.

Avila Chevalier’s arrest comes after a Democratic primary campaign in which U.S. policy toward Israel emerged as a significant dividing line between her and Espaillat.

She has advocated ending U.S. military support for Israel and has aligned herself with the Democratic Party’s democratic-socialist and pro-Palestinian wing.

Espaillat’s support for Israel became one of the issues Avila Chevalier used to challenge the longtime incumbent.

She ultimately defeated him in the June Democratic primary, securing the nomination in a district covering parts of northern Manhattan and the Bronx.

Thursday’s demonstration showed that she has no intention of softening her position after winning the nomination.

As police led her away, Avila Chevalier told reporters:

“We’re standing against war. Stop the genocide. U.S. dollars for health care, for housing, for education. Not for bombing children.”

She was not the only New York political figure taken into custody.

New York City Council Member Chi Ossé was also arrested during the demonstration.

Ossé similarly condemned U.S. financial support for Israel.

“I’m sick and tired of my taxpayer dollars going towards an active genocide,” Ossé said.

Council Member Alexa Avilés was also among those arrested.

The protest attracted a number of prominent activists and entertainers as well.

Actor Hannah Einbinder and whistleblower Chelsea Manning were among those taken into custody, while other reports identified actor Susan Sarandon among those arrested.

The NYPD said more than 100 people were arrested during the protests surrounding Netanyahu’s appearance.

The demonstration unfolded as Netanyahu addressed the United Nations amid intense international criticism of Israel’s military campaign in Gaza.

Netanyahu used his appearance to defend Israel’s conduct and push back against allegations surrounding the war.

The Israeli government maintains that its military campaign is directed against Hamas and points to the Oct. 7, 2023, Hamas attack on Israel, in which about 1,200 people were killed and 251 were taken hostage, as the catalyst for the war.

Palestinian health officials say more than 73,000 people have been killed in Gaza during the ensuing Israeli military campaign. Those figures do not distinguish in their topline count between civilians and combatants.

The political fight over the war has increasingly spilled into Democratic electoral politics in the United States.

Avila Chevalier’s primary victory over Espaillat was one of several 2026 races in which candidates critical of U.S. support for Israel defeated established Democratic politicians.

Her victory also positioned her to potentially become another democratic-socialist voice in Congress if elected in November.

Thursday’s arrest underscored how central the issue remains to her political identity.

Avila Chevalier did not merely issue a statement condemning Netanyahu’s appearance.

She joined demonstrators in the street outside the United Nations and was taken into police custody alongside other protesters.

For a congressional nominee only months away from the general election, it was an unusually visible act of protest.

And it offered voters a clear look at the kind of politics Avila Chevalier intends to bring to Washington if she wins the seat in November.

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Jeanine Pirro Makes Massive Announcement – WH In Total Shock

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Jeanine Pirro Makes Massive Announcement – WH In Total Shock

U.S. Attorney Jeanine Pirro is launching a new federal division in Washington dedicated to pursuing fraud against the government and recovering taxpayer money.

The U.S. Attorney’s Office for the District of Columbia announced Wednesday the creation of its new Fraud and Asset Recovery Division, a specialized unit that will bring prosecutors, investigators, auditors and support personnel together to pursue civil fraud cases.

The new division will put a particular emphasis on the False Claims Act, one of the federal government’s most powerful tools for recovering money lost through fraud.

Pirro tied the sweeping reorganization directly to the Trump administration’s campaign against fraud, waste and abuse throughout the federal government.

“President Trump has prioritized the elimination of fraud, waste, and abuse involving federal agencies and programs,” Pirro said.

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“This new Fraud and Asset Recovery Division will reinforce and consolidate our resources to hold fraudsters accountable and recover taxpayer dollars.”

Pirro then delivered an unmistakable warning to anyone attempting to defraud the government.

“We are sending a clear message: those who cheat the federal government will face decisive, coordinated action,” Pirro said.

The new division represents a significant restructuring inside one of the country’s most consequential U.S. Attorney’s Offices.

Pirro’s office is expanding and realigning resources from its existing Affirmative Civil Enforcement unit, which had operated within the Civil Division.

Officials said the change is intended to separate proactive civil enforcement work from much of the Civil Division’s massive defensive caseload.

That workload, according to the Justice Department, had limited the personnel and resources available to launch affirmative investigations and pursue fraud litigation.

The new structure is designed to change that.

Rather than forcing fraud investigations to compete with defensive civil litigation for resources, prosecutors and investigators will now have a dedicated division focused on finding fraud, pursuing cases and recovering federal money.

Assistant U.S. attorneys will work alongside investigators, auditors and support staff inside the new operation.

Dan Schiffer will serve as chief of the Fraud and Asset Recovery Division, while Sean M. Tepe will serve as deputy chief.

One of their primary weapons will be the False Claims Act.

Originally enacted in 1863 amid widespread fraud involving Civil War government contractors, the law allows the federal government to pursue individuals and companies that knowingly submit false claims for government money.

Those found liable can face triple the government’s damages along with additional civil penalties.

The law also contains powerful whistleblower provisions allowing private individuals to bring lawsuits on behalf of the federal government and potentially receive a portion of money successfully recovered.

And the amount of money involved is enormous.

False Claims Act settlements and judgments exceeded $6.8 billion during fiscal year 2025 — the highest single-year total in the law’s history.

Whistleblowers filed a record 1,297 qui tam lawsuits during the same year, while the federal government opened 401 new investigations.

Since Congress substantially strengthened the False Claims Act in 1986, settlements and judgments have surpassed $85 billion.

Pirro’s office already has experience pursuing major civil fraud cases.

According to the Justice Department, previous cases handled by the Washington office have involved allegations against government contractors accused of improperly billing commercial and international costs to federal contracts, software manufacturers accused of false disclosures and intentional overbilling, medical-device companies accused of misbranding and off-label marketing, and pharmaceutical manufacturers accused of violating federal medication regulations.

The new division will go beyond False Claims Act cases.

Its responsibilities will also include civil collections for federal agencies, enforcement of agency and inspector-general subpoenas and civil asset forfeiture actions.

The U.S. Attorney’s Office Financial Litigation Unit is also being folded into the Fraud and Asset Recovery Division.

That unit is responsible for collecting money already owed to the federal government, including criminal fines, special assessments, restitution, civil judgments and settlements.

It also handles certain debts owed to federal agencies, including student-loan debts owed to the Department of Education.

The result is a division with responsibilities on both sides of the government’s financial enforcement system: investigating suspected fraud and pursuing money already determined to be owed.

The restructuring comes as the Justice Department intensifies federal fraud enforcement nationwide.

But Pirro’s Fraud and Asset Recovery Division is specifically housed inside the U.S. Attorney’s Office for the District of Columbia, placing a dedicated civil fraud operation in the nation’s capital and at the center of the federal government.

The announcement itself does not accuse any newly identified company, contractor, nonprofit or individual of wrongdoing, and the Justice Department has not announced the division’s initial investigative targets.

Officials also have not publicly specified the division’s total staffing level or additional budget.

What the Justice Department has made clear is its objective.

Pirro is consolidating prosecutors, investigators, auditors and financial-enforcement personnel into a single operation charged with aggressively pursuing fraud against federal programs and recovering money for taxpayers.

The numbers illustrate the potential stakes.

More than $6.8 billion was recovered through False Claims Act settlements and judgments in fiscal 2025 alone.

More than $85 billion has been recovered since the law was strengthened in 1986.

And now Pirro’s Washington office is establishing an entire division dedicated to expanding that work.

For individuals and companies doing business with the federal government, Pirro’s message was direct:

Those who cheat the government should expect a coordinated response.

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Senate Vote 50-49 On Save America Act — Dems Stunned!

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Senate Vote 50-49 On Save America Act — Dems Stunned!

The SAVE America Act secured 50 votes in the U.S. Senate during a dramatic late-night showdown, giving supporters of the Republican-backed election legislation a significant boost even as a procedural hurdle prevented the measure from advancing.

The 50-49 vote came during the Senate’s marathon June 4-5 “vote-a-rama,” when Sen. Mike Lee of Utah brought forward the voting provisions of the House-passed legislation.

At the center of the proposal are two major changes to federal election law: requiring documentary proof of U.S. citizenship to register to vote in federal elections and requiring eligible photo identification when casting a ballot.

The proposal also includes provisions directing states to verify voter rolls and remove noncitizens who are found to be improperly registered.

Lee’s amendment drew 50 votes in support and 49 against.

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But that was not enough.

Because the amendment faced a budget point of order under the Senate’s reconciliation rules, Lee needed 60 votes to waive the objection.

His motion fell 10 votes short.

The result meant the proposal could not be added to the broader reconciliation package despite attracting 50 Senate votes.

The late-night tally nevertheless marked an improvement for supporters following an earlier attempt by Sen. Lindsey Graham of South Carolina.

Graham’s broader amendment failed 48-50 after four Republicans — Susan Collins of Maine, Lisa Murkowski of Alaska, Mitch McConnell of Kentucky and Thom Tillis of North Carolina — joined Democrats in opposing the effort.

Lee then brought forward a narrower version focused on the SAVE America Act’s voting provisions.

This time, Collins voted in support.

Murkowski, McConnell and Tillis remained opposed.

The result: 50-49.

That distinction quickly became a major talking point for supporters of the legislation.

They had demonstrated that 50 sitting senators were prepared to vote for the proposal, but Senate procedural rules still stood between those votes and adoption of the amendment.

Vice President JD Vance has the constitutional authority to break a 50-50 Senate tie when one occurs. But the vote before senators Thursday night required 60 votes to waive the budgetary objection, meaning a vice-presidential tiebreaker could not overcome that particular hurdle.

The fight is therefore far from over.

The SAVE America Act has become one of the Republican Party’s major election-policy priorities heading toward the 2026 midterms.

Supporters argue that requiring documentary proof of citizenship would strengthen enforcement of the existing prohibition against noncitizen voting in federal elections and increase confidence that voter rolls contain only eligible voters.

Opponents see the legislation very differently.

Federal law already prohibits noncitizens from voting in federal elections, and critics argue that requiring additional citizenship documentation could make registration more difficult for some eligible American citizens who do not readily possess the required documents.

Those competing arguments have fueled an increasingly intense battle over the legislation.

The House previously approved the SAVE America Act, while President Donald Trump, Vice President Vance and Republican lawmakers have pushed for its enactment.

But the Senate has been the major obstacle.

The chamber voted earlier this year to begin consideration of the legislation, yet supporters have not demonstrated the 60 votes generally needed to overcome a filibuster and bring contested legislation to a final vote.

Republicans subsequently attempted to use the reconciliation process to advance the election provisions alongside a massive immigration and border-security package.

That strategy created a different obstacle.

Senate reconciliation rules restrict the types of provisions that can be included in budget legislation, allowing senators to raise points of order against provisions considered outside those limits.

Overcoming such an objection requires 60 votes.

That is precisely where Lee’s amendment failed.

The underlying proposal attracted 50 votes.

The motion needed 60.

The outcome immediately renewed Republican debate over Senate procedure and the future of the legislation.

Lee has argued that the 50-vote showing demonstrates that the original House-passed proposal has simple-majority support in the Senate, even though supporters remain short of the votes necessary to overcome the chamber’s procedural barriers.

The dispute also places renewed attention on the filibuster.

Republican leaders have repeatedly acknowledged that the 60-vote threshold remains a central obstacle to moving the SAVE America Act through the Senate under ordinary procedures.

But eliminating the legislative filibuster would itself require sufficient support among Republican senators, and GOP leaders have not demonstrated that those votes exist.

That leaves supporters searching for another path.

For now, the SAVE America Act remains stalled.

But the late-night vote established an important piece of the Senate math surrounding the legislation.

An earlier attempt attracted only 48 votes.

Lee’s narrower proposal attracted 50.

That still wasn’t enough to clear the 60-vote procedural threshold.

But it demonstrated that 50 senators were willing to back the voting provisions when they were put before the chamber — a result supporters are certain to point to as they continue pushing for another vote.

The immediate effort failed.

The broader fight over the SAVE America Act did not.

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