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FDA requires federal investigation into approval

FDA calls for federal investigation into approval

Biogen shares fell on Friday after the head of the Food and Drug Administration called for an investigation into the recent approval of the company’s Alzheimer’s drug, Aduhelm.

Acting FDA Commissioner Dr. Janet Woodcock asked the Office of the Inspector General to investigate interactions between the US agency and Biogen representatives prior to the drug’s approval on June 7.

“I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” Woodcock wrote in a letter sent Friday.

Shares of Biogen fell by more than 3% after the announcement.

Biogen’s stock surged last month after the FDA approved the biotech company’s drug, the first medication cleared by US regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

That decision marked a departure from the advice of the agency’s independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At least three members of the panel have resigned in protest following the agency’s approval.

Federal regulators faced intense pressure from friends and family members of Alzheimer’s patients asking to fast-track the drug, scientifically known as aducanumab. STAT News and other media outlets reported FDA officials used a regulatory shortcut to gain approval in order to get the drug on the market sooner.

Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists expect plays a role in the devastating disease.

It’s rare for an FDA chief to call for an investigation into the agency’s own decisions. It’s the latest setback for the company and the drug, which has been controversial since it showed promise in 2016.

In March 2019, Biogen pulled development of the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the medication after all.

When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”

Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it harder for other companies to enroll patients in their own drug trials.

Some doctors have said they won’t prescribe aducanumab because of the mixed data package supporting the company’s application.

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F.D.A. Requests Federal Investigation of Alzheimer’s Drug Approval

F.D.A. Requests Federal Investigation of Alzheimer’s Drug Approval

The Food and Drug Administration on Friday called for a federal investigation into the process that led to the approval of a new drug for Alzheimer’s disease that has sparked harsh criticism from lawmakers and the medical community.

In a letter to the independent office of the Inspector General of the Department of Health, Acting Commissioner of the FDA, Dr. Janet Woodcock, the scrutiny the agency has been through regarding the approval process for the drug known as Aduhelm. She pointed to interactions between representatives from drug developer Biogen and the agency, saying that some “may have occurred outside of the formal correspondence process”.

“To the extent that these concerns could undermine public confidence in the FDA’s decision, I believe it is critical that the disputed events be verified by an independent body,” wrote Dr. Woodcock. She noted that the review should investigate whether communications between agency staff and Biogen representatives violated FDA rules.

The unusual request to examine the decision-making process of one’s own employees for an individual drug approval is likely to exacerbate the controversy surrounding the approval of Aduhelm. The FDA approved the drug a month ago, overcoming stout objections from its own independent advisors who said there wasn’t enough evidence to know if the drug was effective.

After the decision, three of these experts left an FDA advisory panel.

Dr. Woodcock’s request for an investigation came a day after the FDA narrowed its recommendations on who should receive the drug. After initially being recommended for all Alzheimer’s patients, the agency’s new guidelines should only prescribe it to people with mild cognitive problems.

Biogen did not immediately respond to a request for comment.

STAT, the medical news organization, first reported that Dr. Billy Dunn, the agency’s head of neuroscience, in early May 2019 held an off-the-book meeting with a Biogen manager, Dr. Al Sandrock, exit. While it is not uncommon for pharmaceutical company executives to meet frequently with FDA officials, it is uncommon to provide data that would be part of an FDA application outside of a formal framework.

A few months earlier, Biogen had discontinued two late-stage studies of the drug after early analysis found the drug would not prove effective. However, the Biogen researchers who analyzed the data soon concluded that the decision to stop the studies was premature and that the drug might be effective after all.

The meeting between Dr. Dunn and Dr. Sandrock was a first step in resuming the talks that led to approval last month.

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Supreme Court docket Justice Clarence Thomas says federal marijuana legal guidelines could also be outdated

Supreme Court Justice Clarence Thomas says federal marijuana laws may be outdated

Clarence Thomas, Assistant Justice of the U.S. Supreme Court, listens during a ceremony on the South Lawn of the White House in Washington, DC, the United States, on Monday, October 26, 2020.

Al Drago | Bloomberg | Getty Images

Supreme Court Justice Clarence Thomas said Monday that federal laws against the sale and cultivation of marijuana are inconsistent, making a national ban unnecessary.

“A ban on the interstate use or cultivation of marijuana may no longer be necessary or appropriate to support the federal government’s piecemeal approach,” wrote Thomas, one of the court’s most conservative judges, in a statement.

The court’s decision not to hear a new case related to tax deductions alleged by a medical marijuana dispensary in Colorado prompted Thomas to issue a statement relating more broadly to federal marijuana laws.

Thomas stated that a 2005 judgment in the Gonzales v. Raich, which stated that the federal government could enforce the ban on marijuana possession, may be out of date.

“Federal policy over the past 16 years has severely undermined its rationale,” added Thomas. “The federal government’s current approach is a half-in, half-out regime that both tolerates and prohibits the local use of marijuana.”

Thomas referred to several guidelines that contradict the 2005 ruling. These include Justice Department memoranda from 2009 and 2013 stating that the government would not interfere with state marijuana legalization programs or prosecute individuals for marijuana activities if it was in accordance with state law.

He added that since 2015, Congress has repeatedly banned the Justice Department from using federal funds to meddle in the implementation of state medical marijuana laws.

“Given all these developments, one can understand why a normal person might think that the federal government has withdrawn from its once absolute ban on marijuana,” he wrote.

With 36 states allowing medical marijuana use and 18 recreational use, Thomas claimed marijuana companies do not experience “equal treatment” under the law.

The problem is a provision in tax law that prohibits companies that deal in marijuana and other controlled substances from deducting their business expenses. The IRS is cracking down on marijuana companies like the Colorado medical marijuana dispenser by conducting investigations into their tax deductions.

“Under this rule, a company that is still in the red after paying its workers and leaving the lights on could still owe a sizable federal income tax,” wrote Thomas.

The judiciary also found a consequence of the federal marijuana ban, stating that most marijuana companies operate entirely in cash due to restrictions preventing state financial institutions from providing banking services to these companies. This makes these companies more vulnerable to break-ins and robberies, according to Thomas.

All of these questions regarding federal marijuana laws threaten, Thomas argues, the principles of federalism.

“If the government is now satisfied with allowing states to ‘act as laboratories, then it may no longer have authority to enter the[t]The central police powers of the states. . . Define criminal law and protect the health, safety and wellbeing of its citizens, “said Thomas.

Legal experts like Joseph Bondy, a cannabis law expert on the board of directors of the National Organization for the Reform of Marihuana Laws, agreed with the judiciary’s testimony, predicting that arguments about the injustice of federal marijuana laws would continue. Law & Crime reported on Monday.

While Bondy noted that Thomas’ testimony may not have actual legal implications, he told Law & Crime that it was still “sending out a message that may temper the views of some people in Congress,” including “one of our Republican senators.” “

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Serving to Drug Customers Survive, Not Abstain: ‘Hurt Discount’ Beneficial properties Federal Help

Helping Drug Users Survive, Not Abstain: ‘Harm Reduction’ Gains Federal Support

GREENSBORO, NC – The skinny young man quietly walked into the room while waiting for the free supplies to help keep him from dying: sterile water and a stove to dissolve illegal drugs; clean syringes; Alcohol swabs to prevent infection; and naloxone, a drug that can reverse overdoses. A sign on the wall – “We stand to love drug users for who they are” – felt like a hug.

It was the first day on which the contact point in a residential area here opened its doors since it was closed due to the coronavirus in spring 2020. “I am very happy that you have all opened again,” the man, whose first name is Jordan, said a volunteer who handed him a full paper bag while heavy metal music played over a loudspeaker in the background. He asked for extra naloxone for friends in his rural county, an hour away, where it was in short supply during the pandemic.

The death toll from overdose rose nearly 30 percent to more than 90,000 in the twelve months that ended in November, according to preliminary federal data released earlier this month – suggesting 2020 beat recent records for such deaths Has. The astounding surge during the pandemic is due to many factors including widespread job losses and displacement; decreased access to addiction treatment and medical care; and an illicit drug supply that became even more dangerous after the country was closed.

But the forced isolation for people struggling with addiction and other mental health issues is possibly one of the greatest. Now, with the nation reopening, the Biden government supports the controversial approach the center is taking here known as harm reduction. Rather than giving drug users abstinence, the main goal is to reduce their risk of dying or developing infectious diseases like HIV by providing them with sterile equipment, tools to check their drugs for fentanyl and other deadly substances, or even a safe place to nap Will be provided .

Such programs have long been under attack to facilitate drug use, but President Biden has made expanding harm reduction efforts one of his drug policy priorities – the first president to do so. The American Rescue Act earmarked $ 30 million specifically for evidence-based harm reduction services, the first time Congress has raised funds specifically for that purpose. Funding, while modest, is a victory for the programs, both symbolically and practically, as they often run on tight budgets.

“It’s a tremendous signal to recognize that not everyone who uses drugs is ready for treatment,” said Daliah Heller, director of drug-use initiatives at Vital Strategies, a global health organization. “Harm reduction programs say, ‘Okay, you do drugs. How can we help you stay safe and healthy and alive in the first place? ‘”

Although some programs like this one, run by the North Carolina Survivors Union, managed to keep holding some supplies – handing them through windows, offering roadside collection, or even mailing them – practically all of them stopped during the pandemic To invite drug users. Many customers, like Jordan, stopped coming and lost a trustworthy safety net.

Some former Greensboro Center regulars have died or disappeared. Many lost their homes or jobs. At the same time, the center was flooded with new customers and is now having problems keeping enough supplies on hand.

“The struggle that people are having right now, unrecognized and unanswered, is really difficult,” said Louise Vincent, Executive Director of the Survivors Union.

Yet many elected officials and communities continue to refuse to provide people with medication for drug use, including recently introduced test strips to screen drugs for the presence of illegally manufactured fentanyl, which appears in most overdose deaths. Some also say that syringes from harm reduction programs litter the neighborhoods or that the programs lead to an increase in crime. Researchers deny both claims.

West Virginia has just passed law making syringe service programs very difficult to operate, despite an increase in HIV cases from intravenous drug use. The North Carolina Legislature pondered a similar proposal this spring, and elected officials in Scott County, Indiana, whose syringe exchanges helped contain a major HIV outbreak six years ago, voted this month to end it. Mike Jones, a local commissioner who voted to end the program, said at the time that he feared the syringes being distributed could contribute to overdose deaths.

“I know people who are alcoholics and I don’t buy them a bottle of whiskey,” he said. “And I know people who want to kill themselves and I won’t buy them a bullet for their gun.”

Many harm reduction programs are carried out by people who have previously or are still using drugs, and their own struggles with addiction, mental illness, or other health problems have also flared up during the pandemic. In Baltimore, Boston, New York and elsewhere, beloved movement leaders themselves have died of overdoses, chronic health problems, and other causes in the past year. Her death left gaps in efforts to continue providing services.

Ms. Vincent, whose own opioid addiction stemmed from a long battle with bipolar disorder, made a brief return to illicit drug use this spring. She was keen to prevent withdrawal, she said after trying unsuccessfully to switch from methadone to another anti-craving drug, buprenorphine. She later learned that the small amount of fentanyl she was using was mixed with xylazine – an animal sedative that can cause weeping ulcers on the skin. She ended up in the hospital with her hemoglobin level so low that she needed a blood transfusion.

At the start of the pandemic, Ms. Vincent said street drug prices soared. Then drugs that were sold as heroin, methamphetamine, or cocaine were trimmed with unknown additives. Fentanyl was ubiquitous – including increasingly in counterfeit pills sold as prescription pain relievers or anti-anxiety drugs. But also substances like xylazine, which appears in illegal drugs from Philadelphia to Saskatchewan.

“It’s just poison,” said Ms. Vincent, who is being treated with methadone again. “The drug supply is like nothing we’ve seen before.”

On the afternoon of the center’s reopening, a young woman asked for a refresher on how to inject naloxone and if Ms. Vincent could explain what a meth overdose looks like. An older man asked if there was anything to eat besides clean syringes; a volunteer put a pastry in the microwave for him.

In addition to running the program here, Ms. Vincent is the executive director of the National Urban Survivors Union, a larger nonprofit, promoting harm reduction services across the country. In 2016, her 19-year-old daughter died of a heroin overdose while she was in an inpatient treatment center where naloxone was not available, she said.

Naloxone is more common now, but Ms. Vincent wants another life-saving tool to be disseminated: drug control programs that would allow people to find out exactly what substances are in illicit drugs before using them. Such programs exist legally in other countries including Canada, the Netherlands and New Zealand. Another type of harm reduction program used in other countries – where people use illicit drugs under medical supervision if they overdose – remains illegal here after a group trying to start one in Philadelphia so far lost in court.

“We cWe could have a real-time monitoring system instead of waiting for death reports from the coroner, ”Ms. Vincent said. “It would change the game, wouldn’t it?”

She found the xylazine in the drugs she recently took with a device called a Fourier Transform Infrared Spectrometer that a donor gave to her group this year. It can determine which substances contain samples of street drugs in minutes.

Jordan, who is 23 years old, had traveled from Stokes County, near the Virginia border, where the pre-pandemic overdose rate was nearly double the national average. His cousin, he said, was hospitalized weeks earlier after overdosing on a “really bad batch” of fentanyl that were found to contain traces of heavy metals in tests.

“At least 50 people in my area were rescued from here by Narcan,” he said, picking up several boxes of 10 vials of the injectable form of the antidote. “Even my grandmother knows how to manage it.”

Many harm reduction programs, including this one, help or sometimes even offer people to put people on drug treatment. But Jordan is one of the many drug users who are not interested in this path, at least for the moment. The next programs are in Greensboro or Winston-Salem, each a healthy drive from home. And treating food cravings like buprenorphine or methadone, which have been shown to save lives, “doesn’t really work for me,” he said.

The county that includes Greensboro, North Carolina’s third largest city, had 140 fatal overdoses last year, up from 111 the year before. The numbers don’t include the people who died from infections caused by injecting drugs, including the fiancée of a woman who walked into the center at dusk on the day of the reopening and called out to Ms. Vincent, “Where’s Louise?”

She met Ms. Vincent when they were both patients in a methadone clinic six years ago and regularly came to the center for injections and naloxone. She and her fiancé had tried to stop drug use during the pandemic, unnerved by the strange new adulterants that were showing up in the stash. But her fiancé started developing a high fever last December and was admitted to a hospital intensive care unit, seriously ill with endocarditis, a heart valve infection that can result from injecting medication. He died just before Christmas.

“Do you all have a meeting tonight?” Asked Ms. Vincent, referring to the self-help groups the center held several times a week before the pandemic.

“You’ll start again soon,” Mrs. Vincent assured her. “Being connected is much more important than any of us thought.”

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Coronary heart Issues After Vaccination Are Very Uncommon, Federal Researchers Say

Heart Problems After Vaccination Are Very Rare, Federal Researchers Say

The coronavirus vaccines manufactured by Pfizer-BioNTech and Moderna could have caused heart problems in more than 1,200 Americans, including about 500 who were under 30, according to data reported Wednesday by researchers at the Centers for Disease Control and Prevention .

Still, the benefits of vaccination far outweighed the risks, and CDC advisors strongly recommended vaccination for all Americans 12 and older.

The reported heart problems are myocarditis, which is inflammation of the heart muscle; and pericarditis, inflammation of the lining of the heart. The risk is higher after the second dose of an mRNA vaccine than after the first, the researchers reported and much higher in men than in women.

Overall, however, the side effect is very rare – only 12.6 cases per million second doses given. The researchers estimated that out of a million second doses given to boys ages 12-17, the vaccines could cause a maximum of 70 cases of myocarditis, but would prevent 5,700 infections, 2,215 hospitalizations, and two deaths.

Agency researchers presented the data to members of the Advisory Committee on Immunization Practices, which makes recommendations on vaccine use in the United States. (The scientists grouped pericarditis with myocarditis for reporting purposes.)

Most of the cases were mild, with symptoms like fatigue, chest pain, and irregular heartbeat that cleared up quickly, the researchers said. Of the 484 cases reported in Americans under the age of 30, the CDC has definitely linked 323 cases to vaccination. The rest are still being investigated.

“These events are really very rare, extremely rare,” said Dr. Brian Feingold, an expert on pediatric heart inflammation at UPMC Children’s Hospital in Pittsburgh. “That has to be seen in the context of illness and morbidity and mortality in connection with Covid.”

Separately, more than a dozen state and professional medical organizations said in a joint statement Wednesday that myocarditis “is an extremely rare side effect and affects an extremely small number of people after vaccination.”

Federal researchers also presented early safety data on Wednesday on the six million vaccine doses given to children ages 12 to 15. The side effects – usually fatigue and pain at the injection site – were similar to those seen in young people aged 16-25.

“So far, the Covid-19 vaccines approved in the USA have shown a high level of safety,” said Dr. Matthew F. Daley, Principal Investigator at Kaiser Permanente Colorado and a member of the Advisory Committee.

The CDC advisors met when the Biden administration publicly admitted that it expects to miss its target of at least partially vaccinating 70 percent of Americans by July 4, will be immunized.

About two in 100,000 people aged 15 to 18 – about two-thirds of them male – are hospitalized with myocarditis each year, according to data presented at the meeting. Patients with the most severe cases may need mechanical assistance, such as a ventilator or a heart transplant.

Even people with mild symptoms may have to abstain from exercise for about six months after recovery. It is unclear what typically causes the condition or why it is more common in young men than women.

Updated

June 23, 2021 at 4:46 p.m. ET

The first cases of coronavirus vaccine-related myocarditis were reported in Israel, mostly in young men ages 16-19. Israel recorded 148 cases, 95 percent of them mild, from December to May.

In the United States, too, myocarditis was more common in men and boys: up to 80 percent of the cases diagnosed after the second dose were in men. There was also a marked difference in age, with the side effect becoming more common in people in their late teens and early 20s.

As of June 21, about 318 million doses of coronavirus vaccine had been administered in the United States and 150 million people are considered fully protected. Most symptoms of myocarditis appeared within about four days of the first or second dose.

“We have clear evidence here that vaccinated cases started within the first week,” said Dr. Tom Shimabukuro, a vaccine expert at the CDC, who presented the new data. There is also a dose effect, he said, adding, “The rates are higher with both vaccines after the second dose.”

The vast majority of patients with the side effect made a full recovery, noted Dr. James de Lemos, a cardiologist at the University of Texas Southwestern Medical Center at Dallas, who reported one of the first cases in January.

Covid-19 itself can cause heart problems in young people. A large study of college athletes showed that 2.3 percent of those who recovered from Covid-19 had heart abnormalities associated with myocarditis.

“Even in young men, myocarditis will be far more common if you get Covid than if you get a vaccine,” said Dr. de Lemos.

More than 4,000 children infected with the coronavirus developed a multisystem inflammatory syndrome that includes cardiac symptoms. Some children have also died while none died from the vaccination, noted Dr. Fine gold. “You can say no to the vaccine, but you take different risks.”

The CDC recommends vaccination for all Americans over the age of 12. But on Wednesday officials suggested that anyone who develops myocarditis after the first dose should postpone a second dose until they discuss the risks with a doctor.

The CDC’s recommendations may influence decisions about whether to vaccinate children under 12 years of age when vaccines become available for that age group. Some experts have questioned whether the benefits to children outweigh the potential risks, as the chances of developing serious illness from the virus in young children are small.

Still, the agency reported this month that Covid-19-related hospitalizations among teenagers in the United States were about three times higher than influenza-related hospitalizations in the last three flu seasons.

The total number of infections has fallen sharply since January, but as more adults have been vaccinated, the proportion of children in the total has increased. About a third of the new infections reported in May were in Americans ages 12 to 29, and there have been 316 deaths in that age group since April.

Vaccination becomes an even more pressing priority given more contagious variants of the coronavirus now circulating in the United States, said Dr. Paul Offit, a member of the Food and Drug Administration’s Vaccination Safety Committee, in an interview.

“We’re still a long way from where we need to be” in terms of the percentage of Americans who should be vaccinated, said Dr. Offit, who is also a pediatrician at the Philadelphia Children’s Hospital. “And you will go into winter when you have a generally underinoculated population.”

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Controversial below Trump, federal vacation below Biden

Controversial under Trump, federal holiday under Biden

(L-R) Ninety-four-year-old activist and retired educator Opal Lee, known as the Grandmother of Juneteenth, speaks with U.S. President Joe Biden after he signed the Juneteenth National Independence Day Act into law in the East Room of the White House on June 17, 2021 in Washington, DC.

Drew Angerer | Getty Images

The scene at the White House on Thursday might have been hard to fathom just one year ago.

A diverse crowd of lawmakers, activists and community leaders — including pop icon Usher, with whom many photos were taken — gathered in the East Room to witness President Joe Biden sign into law a new federal holiday: Juneteenth, which on June 19 commemorates the end of slavery in the United States.

With coronavirus infections near record lows in the U.S. amid a full-bore vaccination campaign at all levels of government, few members of the indoors, in-person crowd were seen wearing masks.

“We are gathered here, in a house built by enslaved people,” said Vice President Kamala Harris, the first Black woman to hold the title. “We are footsteps away from where President Abraham Lincoln signed the Emancipation Proclamation, and we are here to witness President Joe Biden establish Juneteenth as a national holiday.”

“We have come far and we have far to go, but today is a day of celebration,” Harris said.

As she spoke, the president stepped off the podium and approached the front row, then knelt down to embrace Opal Lee, the 94-year-old Texas activist credited as a driving force behind the push for the new holiday.

“I’ve only been president for several months, but I think this will go down, for me, as one of the greatest honors I will have had as president,” Biden told the crowd before signing the bill into law.

The 11th national annual holiday was established just two days before Juneteenth itself, and less than three weeks after the 100th anniversary of the Tulsa race massacre. It also came on the heels of the first anniversary of the death of George Floyd, the unarmed Black man whose caught-on-tape murder in police custody triggered a nationwide eruption of civil unrest.

At a time when Republicans and Democrats agree on virtually nothing, they came together this week to vote overwhelmingly in favor of making Juneteenth a federal holiday.

Yet just a year ago in mid-June of 2020, all of those factors — Tulsa, Juneteenth, the waves of protest and the Covid pandemic — posed problems for then-President Donald Trump, who had come under fire for announcing plans to hold a rally in Tulsa on the holiday.

“I made Juneteenth very famous,” Trump told The Wall Street Journal after moving the date of the rally. “It’s actually an important event, an important time. But nobody had ever heard of it.”

The contrast between Trump’s final Juneteenth as president and Biden’s first could hardly be more stark. It illustrates not only the seismic changes at play in the nation and how they shaped the present, but also the difference in how the two presidents have approached issues of race.

The path to a federal holiday

Juneteenth celebrates the date in 1865 when enslaved Black people in Texas finally heard that they had been freed under the Emancipation Proclamation, which President Abraham Lincoln had issued more than two years earlier.

The Confederate Army under Gen. Robert E. Lee had surrendered at Appomattox in Virginia on April 9, 1865, a capitulation that led to the end of the Civil War. But it wasn’t until June 19 that Union forces under Gen. Gordon Granger arrived in the coastal city of Galveston, Texas, to deliver General Order No. 3, officially ending slavery in the state.

“The people of Texas are informed that, in accordance with a proclamation from the Executive of the United States, all slaves are free,” the order reads.

Lincoln had been shot at Ford’s Theatre by Confederate sympathizer John Wilkes Booth just five days after Lee’s surrender.

The name “Juneteenth” evolved from numerous different names and spellings over the course of decades, historians note.

While the vast majority of states already recognize Juneteenth as a holiday, activists such as Opal Lee have fought for decades for the day to receive federal designation.

In 1939, when Lee was 12 years old, a White mob set fire to her family’s home. No one was arrested. In 2016, Lee, then 89, began to walk from her hometown of Fort Worth, Texas, to Washington, D.C. — some 1,400 miles — to advocate for making Juneteenth a national holiday.

“The fact is none of us are free till we’re all free,” Lee told The New York Times in a June 2020 interview.

One year later, Lee attended the White House ceremony to designate Juneteenth as the the first new holiday since Martin Luther King Jr. Day in 1983.

Previous attempts to pass a Juneteenth bill in Congress were unsuccessful. In 2020, one such bill was blocked in the Senate by Ron Johnson, R-Wis., who objected to the cost of giving federal employees another day off.

This time around, he backed off, saying in a statement: “It is clear that there is no appetite in Congress to further discuss the matter.”

The reason why?

“In two words, it’s George Floyd,” said Karlos Hill, chair of the African and African-American Studies Department at the University of Oklahoma, in an interview with CNBC.

In May 2020, video of former Minneapolis police officer Derek Chauvin kneeling on Floyd’s neck for more than nine minutes had set off a firestorm of protests around the country. The officer’s conduct drew condemnation from across the political spectrum, and prompted lawmakers to draft a police reform bill in Floyd’s name.

Chauvin in April was found guilty on charges of second-degree murder, third-degree murder and second-degree manslaughter.

“It took something that stark to change the conversation,” Hill said.

“These things are connected deeply,” Hill said, explaining that the shock of Floyd’s death “created a space and opportunity for Juneteenth.”

Few lawmakers — even those with complaints about the bill — stood in the way this week, when the legislation introduced by Sen. Edward Markey, D-Mass., flew through Congress.

The bill was approved unanimously in the Senate on Tuesday night. A day later, it passed the House in an overwhelming 415-14 vote. The 14 votes against were all Republicans, while 195 GOP lawmakers voted yes.

Among the Republican criticisms were that the decision to name the holiday “Juneteenth National Independence Day” clashed with the existing Independence Day on July 4. They pointed out that the holiday has also been referred to as Jubilee Day, Emancipation Day and other names throughout its history.

Others complained, like Johnson, about the estimated hundreds of millions of dollars in revenue lost by giving federal workers another day off. And some lawmakers railed against Democrats for rushing the bill to the House floor, bypassing congressional committees and the opportunity to vote on amendments in the process.

One Republican, Matt Rosendale of Montana, issued a statement before the final vote announcing his opposition to the measure because, he claimed, it was an effort to further “identity politics” and “critical race theory” in America.

Sen. John Cornyn, R-Texas, dismissed Rosendale’s stance as “kooky.”

The 14 House members who voted against the bill are: Rosendale; Mo Brooks, R-Ala.; Andy Biggs, R-Ariz.; Scott DesJarlais, R-Tenn.; Tom Tiffany, R-Wis.; Doug LaMalfa, R-Calif.; Mike Rogers, R-Ala.; Ralph Norman, R-S.C.; Chip Roy, R-Texas; Paul Gosar, R-Ariz.; Tom McClintock, R-Calif.; Ronny Jackson, R-Texas; Thomas Massie, R-Ky.; and Andrew Clyde, R-Ga.

Trump’s Juneteenth

In a statement Friday afternoon celebrating Juneteenth, Republican National Committee Chairwoman Ronna McDaniel said of her party: “We enthusiastically welcome its adoption as our newest national holiday after President Trump called for it last year.”

In September, Trump as part of a series of overtures to Black voters did promise to establish Juneteenth as a national holiday. But there is much more to Trump’s relationship to Juneteenth than McDaniel’s statement suggests.

In June 2020, with the pandemic raging, no vaccines in sight and then-candidate Biden holding a clear edge in the polls, Trump announced he would return to the campaign trail to hold in-person events.

The marquee event of his campaign kickoff: a rally in Tulsa, Oklahoma, on June 19.

The Trump campaign initially defended the scheduling decision as an opportunity for him to tout his “record of success for Black Americans.” But critics called it a slap in the face for Trump to pick Juneteenth to come to Tulsa, the site of one of the worst White-on-Black massacres in U.S. history, to re-launch his re-election campaign in the middle of a national upheaval about racism.

The Wall Street Journal’s Michael Bender, in an adapted excerpt from his forthcoming book about Trump’s election loss to Biden, reported that top campaign official Brad Parscale had selected the time and place for the rally, and that he had “dug in” after others urged him to make changes.

Bender reported that Trump, bewildered by the backlash to the rally date, had asked a Black Secret Service agent if he knew about Juneteenth. The agent said that he did know about it, adding, “It’s very offensive to me that you’re having this rally on Juneteenth,” according to Bender.

Less than a week before the rally, Trump tweeted he would move the event to June 20, after hearing from “many of my African American friends and supporters” who have “reached out to suggest that we consider changing the date out of respect for this Holiday.”

On Juneteenth itself, Trump’s White House issued a proclamation celebrating the holiday as a reminder of “both the unimaginable injustice of slavery and the incomparable joy that must have attended emancipation.”

Less than a month earlier, the Floyd video had prompted millions of people to participate in marches and demonstrations against systemic racism and police brutality. Numerous protests led to outbreaks of violence and looting in major cities.

Before the event at Tulsa’s BOK Center, Trump, who at that point was still active on Twitter, took to the social media app to issue an ominous threat for potential counterdemonstrators.

“Any protesters, anarchists, agitators, looters or lowlifes who are going to Oklahoma, please understand you will not be treated like you have been in New York, Seattle or Minneapolis,” Trump tweeted. “It will be a much different scene.”

The Rev. Al Sharpton, who gave a Juneteenth address in Tulsa that Friday, at the time accused Trump of “provoking an incident” with the tweet.

Trump’s crowd in Tulsa fell short of expectations, failing to fill thousands of seats in the nearly 20,000-capacity arena. But in attendance was Herman Cain, a prominent Black businessman, conservative commentator and former Republican presidential candidate.

The 74-year-old Cain, a stage 4 cancer survivor, was photographed at the event sitting next to other people, none of whom appeared to be wearing masks.

In early July, Cain was hospitalized with the coronavirus, and he was put on a ventilator as his condition worsened. He died July 30, making him among the most high-profile people in the U.S. to succumb to the virus. Cain’s associates have said there is “no way of knowing for sure” how or where he caught Covid.

The Journal’s Bender reported that Trump raged about his lack of support from Black voters on the day after the Tulsa rally.

“I’ve done all this stuff for the Blacks — it’s always Jared [Kushner, Trump’s son-in-law,] telling me to do this,” Trump told one confidant, Bender reported. “And they all f—— hate me, and none of them are going to vote for me.”

Hill said that the U.S. is now “in a different reality” compared with last June, “in a sense that we’ve witnessed the full fallout from George Floyd.”

“We’ve gone on as if things have rectified themselves, and that’s just not the case,” Hill said. As a federal holiday, “Juneteenth might, just might, give pause to that.”

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Politics

Juneteenth turns into federal vacation after Biden indicators invoice

Juneteenth becomes federal holiday after Biden signs bill

President Joe Biden signed law Thursday introducing Juniteenth, the date to commemorate the end of slavery in the United States, as a federal holiday.

Biden signed the bill two days before June 15 himself, which is June 19 each year, in what he called “one of the greatest honors” of his presidency.

“We have come a long way and we still have to go a long way. But today is a day of celebration,” said Vice President Kamala Harris, who addressed the president at the signing ceremony at the White House.

“Big nations don’t ignore their most painful moments,” Biden told the crowd in the East Room, which included dozens of politicians, activists and community leaders. “You hug her.”

United States President Joe Biden applauds Vice President Kamala Harris as they arrive in the East Room of the White House in Washington on June 17, 2021 to sign the National Independence Day Act of June 2021.

Carlos Barria | Reuters

“In short, this day doesn’t just celebrate the past. He calls for action today, ”said Biden.

National Independence Day in June will be the 12th public holiday, including Inauguration Day, and the first new day since then-President Ronald Reagan signed Martin Luther King Jr. Day in 1983.

Juneteenth celebrates the emancipation of the last of the enslaved African Americans. On that day in 1865, Union soldiers, led by General Gordon Granger, arrived in the coastal city of Galveston, Texas to deliver General Order No. 3 that officially ended slavery in the state.

The final act of liberation came months after the Confederate Army’s surrender ended the Civil War and more than two years after President Abraham Lincoln issued the Emancipation Proclamation.

Lincoln was assassinated on April 15, 1865, two months before his proclamation reached Texas.

Most federal workers will be celebrating June 10th on Friday this year because June 19th falls on a Saturday. The New York Stock Exchange won’t close for June thenth this year, but it will evaluate the closing markets for the holiday in 2022, according to the exchange.

The Securities Exchange Commission will close its offices on Friday for the new holiday, a spokesman said. The SEC’s online data platform, EDGAR, “will also be closed and will not accept filings or assist in assisting applicants,” the spokesman said.

The Holiday Bill was passed with overwhelming support in both houses of Congress this week. The Senate unanimously approved the bill Tuesday night, and the House of Representatives passed it by 415 votes to 14. The only votes against the law came from the Republicans.

Prior to the House vote, some GOP lawmakers complained about the name of the holiday and others expressed concern about the cost of another federal workforce day off. Some also railed against the Democrats for putting the bill to the vote without first allowing the committees to review the law and propose changes.

Still, most of the House Republicans, even those who opposed parts of the bill, voted in favor.

The Juniteenth Bill was sponsored in the Senate by Edward Markey, D-Mass, and the House version, sponsored by Rep. Sheila Jackson Lee, D-Texas, was endorsed by 166 legislators.

The 14 votes against were:

  • Rep Mo Brooks, R-Ala.
  • Rep Andy Biggs, R-Ariz.
  • Rep. Scott DesJarlais, R-Tenn.
  • Rep Tom Tiffany, R-Wis.
  • Rep. Doug LaMalfa, R-Calif.
  • Rep. Mike Rogers, R-Ala.
  • Rep. Ralph Norman, RS.C.
  • Rep. Chip Roy, R-Texas
  • Rep. Paul Gosar, R-Ariz.
  • Rep. Tom McClintock, R-Calif.
  • Rep Matt Rosendale, R-Mont.
  • Rep Ronny Jackson, R-Texas
  • Rep. Thomas Massie, R-Ky.
  • Rep. Andrew Clyde, R-Ga.

– CNBC’s Bob Pisani contributed to this report

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Business

Republicans Push Biden to Divert Federal Help for Infrastructure

Republicans Push Biden to Divert Federal Aid for Infrastructure

WASHINGTON — From California to Virginia, many states that faced devastating shortfalls in the depths of the pandemic recession now find themselves flush with tax revenues because of a rebounding economy and a soaring stock market. Lawmakers who worried about budget cuts are now proposing lucrative increases in school spending, tax cuts and direct payments to their residents.

That turnaround is partly the product of strong income tax receipts, particularly in states that heavily tax high earners and the wealthy, whose finances have fared well in the crisis. The unexpectedly rosy picture is raising pressure on President Biden to repurpose hundreds of billions of dollars of federal aid approved this year, in order to help fund a potential bipartisan infrastructure deal.

Last week, Senator Mitt Romney, Republican of Utah, suggested that Mr. Biden and Republican negotiators look to “some of the funding that’s been sent to states already under the last few bills” to help pay for that agreement. “They don’t know how to use it,” Mr. Romney said. “They could use that money to finance part of the infrastructure relating to roads and bridges and transit.”

Some economists and budget experts support that push, arguing that the money could be better spent elsewhere and that states’ spending plans could add to a risk of rapid inflation breaking out across the country. Other researchers and local budget officials say that the federal aid is rescuing harder-hit cities and states, like New York City and Hawaii, from a cascade of layoffs and spending cuts.

Biden administration officials say they continue to support distributing the full $350 billion in state, local and tribal aid that was contained in the $1.9 trillion economic assistance package that Mr. Biden signed in March. They say the aid will help ensure that the economic rebound does not repeat the years of state and local budget cutting that followed the 2008 financial crisis, which slowed the recovery from recession and contributed to millions of Americans waiting years to reap its benefits.

“We still feel strongly that the state and local plan is critical to ensuring we have a strong insurance policy for the type of strong growth we want, the type of equitable recovery the country deserves,” Gene Sperling, a senior adviser to Mr. Biden who oversees fulfillment of the March assistance package, said in an interview, “and to coming back from the 1.3 million jobs lost at the state and local level.”

Even if the administration wanted to recoup or divert the funds, it is unlikely that it could repurpose the money or make significant changes to how it is used without congressional action.

The debate over the state and local funding comes as Mr. Biden navigates a critical week of negotiations with Republicans over infrastructure in search of a deal, and as he prepares to travel to Cleveland on Thursday to speak about the economy. How to pay for any new spending is a primary hurdle in the talks, with Mr. Biden pushing to raise taxes on corporations and Republicans preferring increased user fees like the gas tax.

Repurposing unspent funds could help advance an agreement, particularly given Republican opposition to bankrolling state aid in previous rescue packages. Democrats pushed hard to include lucrative financial assistance for states, cities and tribes in Mr. Biden’s rescue bill. Republicans fought those efforts, warning they would serve as a “bailout” to high-tax, high-spend liberal states. They also cited a series of projections from Wall Street firms and other analysts suggesting that many states’ revenues were faring better than officials had feared in the early months of the pandemic.

It increasingly looks like many liberal states are not being “bailed out” — but also that some of them do not need more federal money. That is particularly true in states that do not rely primarily on the tourism or hospitality industries for tax revenues. Those with progressive tax systems that have caught surging revenues from investment income enjoyed by wealthy residents — like Silicon Valley moguls — are also faring well.

California officials expect a $15 billion surplus this fiscal year, after fearing a $54 billion shortfall. Virginia has seen nearly $2 billion in unanticipated revenues. As has Oregon, where economists recently upgraded the state’s revenue forecasts — moving it from projected deficits to surplus — in a report that surprised and delighted many lawmakers.

“It’s extremely surprising,” said Mark McMullen, the Oregon state economist.

“Obviously, when the shutdowns first set in and we saw these catastrophic employment losses, we treated them as a normal recession in our forecasts,” he said.

But surging income tax revenues and several rounds of federal assistance have now put the state “above our prepandemic forecasts,” Mr. McMullen added.

The strong revenue figures come as more federal relief money is just beginning to roll out the door. The Treasury Department began sending funds to states this month and has so far distributed more than $100 billion — about half of what is available to be disbursed immediately. Local governments are expected to receive the rest next year, although states still experiencing a sharp rise in unemployment will get a lump sum right away.

The Committee for a Responsible Federal Budget estimates that state and local governments have received a total of nearly $1 trillion in relief money in the past year. State and local revenues were running about 7 percent above their prepandemic levels in the last quarter — excluding the federal aid they have received.

Marc Goldwein, the senior policy director for the committee, said that states like Hawaii and Nevada that rely heavily on tourism clearly needed the assistance, but that for many others, the money was unnecessary.

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The reasons vary, but Mr. Goldwein noted that home values have been surging around the country, providing a boost to property taxes; that states that were struggling from sagging oil prices have seen those prices pick up; and that consumers have been spending at a healthy clip thanks to stimulus checks and expanded jobless benefits.

“State and local governments, by and large, are frankly swimming in revenue,” Mr. Goldwein said. “It’s pretty clear to me that we spent a lot of money on states that we didn’t need to.”

Some economists, like Harvard’s Lawrence H. Summers, a former Treasury secretary under President Bill Clinton, have pushed Mr. Biden to repurpose the state and local aid for longer-term infrastructure projects, in hopes of easing what Mr. Summers warns is a dangerous buildup of inflationary pressure. Administration officials view high inflation as a much lower risk than Mr. Summers does.

Other analysts warn that state budget situations could sour if the stock market dips sharply or economic growth fizzles. Many cities, like New York, have struggled with sluggish tax revenues and still are reliant on federal to help avoid further layoffs.

New York expects to receive more than $22 billion in Covid-19 federal aid, according to the nonpartisan Citizens Budget Commission. Despite the funds, the city is still anticipating budget gaps in the coming years, the result of declining revenues like property taxes.

In retrospect, said Lucy Dadayan, a senior research associate at the Tax Policy Center, the March law should have included “more targeted funding” for the states and cities that need it most.

“I would still be all for helping state and local governments — more local governments than state governments, given what we know,” Ms. Dadayan said.

Treasury Department officials say the Biden administration wants states to have sufficient resources to cover immediate costs related to emerging from the pandemic and to be able to pay for more expansive services to help people who were hardest hit.

But many states and cities are eyeing windfall spending plans that go well beyond repairing their safety nets. Gov. Gavin Newsom of California, a Democrat facing a recall vote, has proposed a series of spending increases, including $1,100 stimulus checks to individuals and tax credits for filmmakers.

In Florida, the revenue forecast for 2021 has been revised upward twice in the past year. The state is now expected to get $8.8 billion from the federal government. Ben Watkins, the director of the Florida Division of Bond Finance, said the state was using the relief money to invest in infrastructure and water quality projects and directing some of its surplus funds to hurricane preparedness.

He described the windfall as staggering.

“It’s a good problem to have,” Mr. Watkins said, “but that doesn’t mean that it’s not excessive.”

States have substantial leeway in how they use the money, though they are prohibited from using the funds to subsidize tax cuts. Several Republican-led states have sued the Treasury Department, arguing that the restriction infringes on state sovereignty.

The lawsuits do not appear to be slowing the delivery of the funds. Ohio failed to win an injunction blocking the restrictions from being enforced this month, and Missouri had its case thrown out of court after a federal judge said the state did not demonstrate that the law caused it harm.

The Treasury Department plans to closely monitor how the money is spent and whether states are using budget gimmicks to actually fund tax cuts. The agency maintains that the federal government has a right to place conditions on how federal funds are used and that states are allowed to decline the money. A Treasury Department official said that no state had indicated yet that it would reject the funds.

In the meantime, states that are flush with revenues are pressing ahead with their plans. Nebraska approved a $26 million corporate tax cut last week, and lawmakers have told The Omaha World-Herald that they believe that by keeping the federal funds in a separate account from the state’s general fund, they will be in compliance with the law.

Nicholas Fandos and Dana Goldstein contributed reporting.

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Business

Defying Critics, Biden and Federal Reserve Insist Financial Restoration Stays on Observe

Defying Critics, Biden and Federal Reserve Insist Economic Recovery Remains on Track

“We should be on our way to a fantastic American comeback summer, full speed ahead,” said Senator Mitch McConnell of Kentucky, the Republican leader, on the chamber floor this month. “From vaccinations to job growth, the new Biden administration has inherited favorable trends in all directions.”

“But in several ways, the choices made by the Democratic elected have helped slow the return to normal,” he added.

Critics have also questioned the wisdom of the Fed’s commitment to keeping interest rates low and buying bonds even as prices begin to rise. Pennsylvania Republican Senator Patrick J. Toomey said last month that while the Fed “claims this inflation spurt will be mild and temporary,” it “may be time for the central bank to consider the alternative.”

Mr Biden’s advisors say they continue to monitor the risk of consumer prices rising, forcing a swift policy response that could curb economic growth. They say these risks remain small and that they see no reason to change course on the president’s agenda, including the proposed infrastructure and social programs that the president claims will prop the economy for years to come. That agenda could prove to be tougher, even among Congress Democrats, if employment growth continues to disappoint and inflation rises higher than expected.

Fed officials also remain intrepid. They show no signs of a rate hike anytime soon and continue to buy $ 120 billion worth of government bonds every month. Officials have only given the earliest indications that they may tip toe off this emergency policy. They argue that their job is to manage risk and the risk of early aid withdrawal is greater than the risk of the economy overheating.

“I don’t think it would be good for the industries we believe will be successful if the recovery continues so that we can complete this recovery early,” said Randal K. Quarles, Fed vice chairman of oversight, at a hearing of the House of Representatives committee this week when lawmakers pushed it on looming inflation. The Fed is independent from the White House but is responsible for keeping prices in check.

The voters give Mr. Biden good marks for his previous economic responsibility. A solid majority of Americans – including many Republicans – support the president’s plans to levy taxes on high wage earners and businesses to fund new spending on water pipes, electric vehicles, education, childcare, paid vacations, and other programs Conducted by online research company Survey Monkey through May 9th.

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Health

Vaccinated People Could Go With out Masks in Most Locations, Federal Officers Say

Vaccinated Americans May Go Without Masks in Most Places, Federal Officials Say

John Moore, a virologist at Weill Cornell Medicine in New York, said people would need to assess their own comfort levels in different situations, depending on the size of the congregation and the number of cases in the area.

“Would I go to a humble dinner party with vaccinated friends?” he said. “Absolutely. But going to a bar or a large crowd of people with a badly vaccinated condition – that would be uncomfortable without a mask.”

“I know people my age who are very, very upset about any kind of intermingling,” added Dr. Moore added, who said he was in his 60s. “It’s going to take a lot of adjustments, but I think it’s a good idea and appropriate for science.”

In a way, the agency is asking neighbors, coworkers, and total strangers to trust each other in order to do the right thing, some scientists noted. Throwing off masks can rekindle a national vaccination passport debate as immunity verification becomes increasingly important in unmasked settings such as offices and restaurants.

Ellie Murray, an epidemiologist at Boston University School of Public Health, said, “Basically, it depends on people monitoring people around them, or business owners checking vaccination status in some way, or just relying on some kind of honor to code.”

To justify the recommendations, agency officials cited several recent studies showing vaccines are more than 90 percent effective at preventing in-practice mild and serious illness, hospitalization and deaths from Covid-19.

Among them was a study of 6,710 health care workers in Israel, including 5,517 fully vaccinated workers, that found the Pfizer BioNTech vaccine 97 percent in preventing symptomatic infections among the fully vaccinated and 86 percent in preventing asymptomatic ones Infections was effective for them.