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US

Factbox: FACTBOX Georgia on his mind: Donald Trump troubled by more legal woes

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Jan 25 (Reuters) – Donald Trump could learn soon whether he or any associates will be charged or cleared of wrongdoing in a Georgia probe into his efforts to overturn his 2020 election defeat, one of a series of legal threats looming over the Republican former U.S. president:

GEORGIA ELECTION TAMPERING PROBE

On Tuesday, the prosecutor in the state of Georgia spoke to a judge on behalf of a special grand jury empanelled in May to investigate Trump’s alleged efforts to influence that state’s 2020 election results.

Fani Willis, the Fulton County district attorney and a Democrat who will ultimately decide whether to pursue charges against Trump or anyone else, said the grand jury had completed its task and decisions were “imminent.”

The investigation focuses in part on a phone call Trump made to Georgia Secretary of State Brad Raffensperger, a Republican, on Jan. 2, 2021. Trump asked Raffensperger to “find” enough votes needed to overturn Trump’s election loss in Georgia.

Legal experts said Trump may have violated at least three Georgia criminal election laws: conspiracy to commit election fraud, criminal solicitation to commit election fraud and intentional interference with performance of election duties.

Trump could argue that his discussions were constitutionally protected free speech.

U.S. CAPITOL ATTACK

The U.S. Justice Department has investigations under way into both Trump’s actions in the 2020 election and his retention of highly classified documents after departing the White House in 2021.

Both investigations involving Trump are being overseen by Jack Smith, a war crimes prosecutor and political independent. Trump has accused the FBI, without evidence, of launching the probes as political retribution.

A special House of Representatives committee investigating the deadly Jan. 6, 2021, assault by Trump supporters on the U.S. Capitol urged the Justice Department to charge Trump with corruption of an official proceeding, conspiracy to defraud the United States, conspiracy to make a false statement and inciting or aiding an insurrection.

The request is non-binding. Only the Justice Department can decide whether to charge Trump, who has called the Democratic-led panel’s investigation a politically motivated sham.

MISSING GOVERNMENT RECORDS

U.S. Attorney General Merrick Garland appointed Smith to investigate whether Trump improperly retained classified records at his Florida estate after he left office in 2021 and then tried to obstruct a federal investigation.

Garland also appointed former U.S. Attorney Robert Hur for Maryland to investigate the removal of classified records in President Joe Biden’s possession dating to his time as vice president.

It is unlawful to willfully remove or retain classified material.

In Trump’s case, the FBI seized 11,000 documents from the former president’s Mar-a-Lago Florida estate in a court-approved Aug. 8 search. About 100 documents were marked classified; some were designated top secret, the highest level of classification.

Trump has accused the Justice Department of engaging in a partisan witch hunt.

NEW YORK ATTORNEY GENERAL CIVIL LAWSUIT

New York Attorney General Letitia James said in a civil lawsuit filed in September that her office uncovered more than 200 examples of misleading asset valuations by Trump and the Trump Organization business between 2011 and 2021.

Former U.S. President Donald Trump speaks during a rally in Commerce, Georgia, U.S. March 26, 2022. REUTERS/Alyssa Pointer/File Photo

A Democrat, James accused Trump of inflating his net worth by billions of dollars to obtain lower interest rates on loans and get better insurance coverage.

A New York judge ordered that an independent monitor be appointed to oversee the Trump Organization before the case goes to trial in October 2023.

James seeks to permanently bar Trump and his children Donald Jr., Eric and Ivanka Trump from running companies in New York state, and to prevent them and his company from buying new properties and taking out new loans in the state for five years.

James also wants the defendants to hand over about $250 million that she says was obtained through fraud.

Trump has called the attorney general’s lawsuit a witch hunt. A lawyer for Trump has called James’ claims meritless.

James said her probe also uncovered evidence of criminal wrongdoing, which she referred to federal prosecutors and the Internal Revenue Service for investigation.

DEFAMATION CASE

E. Jean Carroll, a former Elle magazine writer, has filed two lawsuits accusing Trump of having defamed her when he denied her allegation that he raped her in New York’s Bergdorf Goodman department store dressing room in late 1995 or early 1996.

Trump accuses her of lying to drum up sales for a book.

Carroll first sued Trump after he denied the accusation in June 2019 and told a reporter at the White House that he did not know Carroll, that “she’s not my type,” and that she concocted the claim to sell her new memoir.

The second lawsuit arose from an October 2022 social media post where Trump called the rape claim a “hoax,” “lie,” “con job” and “complete scam,” and said “this can only happen to ‘Trump’!”

That lawsuit includes a battery claim under the Adult Survivors Act, which starting last Nov. 24 gave adults a one-year window to sue their alleged attackers even if statutes of limitations have expired.

A U.S. judge on Jan. 13 rejected as “absurd” Trump’s effort to dismiss the second lawsuit.

Trump and Carroll are awaiting a decision from a Washington, D.C., appeals court on whether, under local law, Trump should be immune from Carroll’s first lawsuit over his June 2019 comments.

That lawsuit would likely be dismissed if the court decided that Trump spoke within his role as president, and continue if Trump spoke in his personal capacity as Carroll argues.

Any decision would have no effect on Carroll’s second defamation and battery lawsuit. A trial in the first lawsuit is scheduled for April 10.

NEW YORK CRIMINAL PROBE

Although Trump was not charged with wrongdoing, his real estate company was found guilty on Dec. 6 of tax fraud in New York state. A judge this month sentenced Trump’s namesake real estate company to pay a $1.6 million criminal penalty, the maximum the judge could impose.

Jurors convicted the Trump Organization, which operates hotels, golf courses and other real estate around the world, of paying personal expenses for top executives including former chief financial officer Allen Weisselberg, and issuing bonus checks to them as if they were independent contractors.

Weisselberg, the company’s former chief financial officer, pleaded guilty and was required to testify against the Trump Organization as part of his plea agreement. He is also a defendant in James’ civil lawsuit.

Reporting by Joseph Ax, Luc Cohen, Karen Freifeld, Sarah N. Lynch, Jonathan Stempel and Jacqueline Thomsen; Editing by Howard Goller

Our Standards: The Thomson Reuters Trust Principles.

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Entertainment

Taylor Swift concert fiasco leads to U.S. Senate grilling for Ticketmaster

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WASHINGTON, Jan 24 (Reuters) – U.S. senators slammed Live Nation Entertainment’s lack of transparency and inability to block bot purchases of tickets on Tuesday, in a hearing called after a major fiasco involving ticket sales for Taylor Swift’s upcoming concert tour.

Live Nation Entertainment Inc (LYV.N) subsidiary Ticketmaster, which has been unpopular with fans for years, has drawn fresh heat from U.S. lawmakers over how it handled ticket sales last fall for Swift’s “Eras” tour, her first in five years. Experts say Ticketmaster commands more than 70% market share of primary ticket services for major U.S. concert venues.

“We apologize to the fans, we apologize to Ms. Swift, we need to do better and we will do better,” Joe Berchtold, who is president and chief financial officer of Live Nation, told the U.S. Senate Judiciary Committee hearing on Tuesday.

“In hindsight there are several things we could have done better – including staggering the sales over a longer period of time and doing a better job setting fan expectations for getting tickets,” Berchtold said.

Republican Senator Mike Lee said in an opening statement that the Ticketmaster debacle highlighted the importance of considering whether “new legislation or perhaps just better enforcement of existing laws might be needed to protect the American people.”

LACK OF COMPETITION

Senators slammed Berchtold for Live Nation’s fee structure and inability to deal with bots which bulk buy tickets and resell them at inflated prices.

“There isn’t transparency when no one knows who sets the fees,” Democratic Senator Amy Klobuchar said, responding to Berchtold’s claim that Live Nation fees fluctuate based on “ratings.”

Republican Senator Marsha Blackburn called Live Nation’s bot problem “unbelievable,” pointing out that much smaller companies are able to limit bad actors in their systems.

“You ought to be able to get some good advice from people and figure it out,” she said.

[1/2] Taylor Swift arrives at the 2022 MTV Video Music Awards at the Prudential Center in Newark, New Jersey, U.S., August 28, 2022. REUTERS/Eduardo Munoz

“I’m not against big per se, but I am against dumb,” Republican Senator John Kennedy said, referring to Live Nation’s dominance in the ticket sales market. “The way your company handled ticket sales for Ms. Swift was a debacle, and whoever in your company was in charge of that should be fired.

“If you care about the consumer, cut the price! Cut out the bots! Cut out the middle people and if you really care about the consumer, give the consumer a break!”

Jack Groetzinger, cofounder of ticket sales platform SeatGeek, testified that the process of buying tickets is “antiquated and ripe for innovation” and called for the breakup of Live Nation and Ticketmaster, which merged in 2010.

“As long as Live Nation remains both the dominant concert promoter and ticketer of major venues in the U.S., the industry will continue to lack competition and struggle,” he told lawmakers.

Ticketmaster has argued that the bots used by scalpers were behind the Taylor Swift debacle, and Berchtold asked for more help in fighting the bots that buy tickets for resale.

Other witnesses include Jerry Mickelson, president of JAM Productions, who has been among critics of Ticketmaster.

In November, Ticketmaster canceled a planned ticket sale to the general public for Swift’s tour after more than 3.5 billion requests from fans, bots and scalpers overwhelmed its website.

Senator Klobuchar, who heads the Judiciary Committee’s antitrust panel, has said the issues that cropped up in November were not new and potentially stemmed from consolidation in the ticketing industry.

In November, Ticketmaster denied any anticompetitive practices and noted it remained under a consent decree with the Justice Department following its 2010 merger with Live Nation, adding that there was no “evidence of systemic violations of the consent decree.”

A previous Ticketmaster dispute with the Justice Department culminated in a December 2019 settlement extending the consent agreement into 2025.

Reporting by Diane Bartz, Moira Warburton and David Shepardson; editing by Jonathan Oatis

Our Standards: The Thomson Reuters Trust Principles.

Diane Bartz

Thomson Reuters

Focused on U.S. antitrust as well as corporate regulation and legislation, with experience involving covering war in Bosnia, elections in Mexico and Nicaragua, as well as stories from Brazil, Chile, Cuba, El Salvador, Nigeria and Peru.

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US

Ex-FBI official worked for sanctioned Russian oligarch, prosecutors say

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NEW YORK, Jan 23 (Reuters) – A former top FBI official was charged on Monday with working for sanctioned Russian oligarch Oleg Deripaska, as U.S. prosecutors ramp up efforts to enforce sanctions on Russian officials and police their alleged enablers.

Charles McGonigal, who led the FBI’s counterintelligence division in New York before retiring in 2018, pleaded not guilty to four criminal counts including sanctions violations and money laundering at a hearing in Manhattan federal court.

He was released on $500,000 bond, following his arrest over the weekend.

Prosecutors said McGonigal, 54, in 2021 received concealed payments from Deripaska, who was sanctioned in 2018, in exchange for investigating a rival oligarch.

McGonigal was also charged with unsuccessfully pushing in 2019 to lift sanctions against Deripaska.

Sanctions “must be enforced equally against all U.S. citizens in order to be successful,” FBI Assistant Director in Charge Michael Driscoll said in a statement. “There are no exceptions for anyone, including a former FBI official.”

Separately on Monday, federal prosecutors in Washington said McGonigal received $225,000 in cash from a former member of Albania’s intelligence service, who had been a source in an investigation into foreign political lobbying that McGonigal was supervising.

McGonigal faces nine counts in that case, including making false statements to conceal from the FBI the nature of his relationship with the person.

“This is obviously a distressing day for Mr McGonigal and his family,” the defendant’s lawyer Seth DuCharme told reporters after the Manhattan hearing. “We’ll review the evidence, we’ll closely scrutinize it, and we have a lot of confidence in Mr McGonigal.”

Deripaska, the founder of Russian aluminum company Rusal (RUAL.MM), was among two dozen Russian oligarchs and government officials blacklisted by Washington in 2018 in reaction to Russia’s alleged meddling in the 2016 U.S. election.

He and the Kremlin have denied any election interference.

Also charged in the Manhattan case was Sergey Shestakov, a former Soviet diplomat who later became an American citizen and Russian language interpreter for U.S. courts and government agencies.

Prosecutors said Shestakov he worked with McGonigal to help Deripaska, and made false statements to investigators.

Shestakov pleaded not guilty on Monday and was released on $200,000 bond.

The enforcement of sanctions are part of U.S. efforts to pressure Moscow to stop its war in Ukraine, which the Kremlin calls a “special military operation.”

Deripaska was charged last September with violating the sanctions against him by arranging to have his children born in the United States.

The following month, British businessman Graham Bonham-Carter was charged with conspiring to violate sanctions by trying to move Deripaska’s artwork out of the United States.

Deripaska is at large, and Bonham-Carter is contesting extradition to the United States.

Reporting by Luc Cohen in New York; Editing by Rosalba O’Brien, Bill Berkrot, Jonathan Oatis and Marguerita Choy

Our Standards: The Thomson Reuters Trust Principles.

Luc Cohen

Thomson Reuters

Reports on the New York federal courts. Previously worked as a correspondent in Venezuela and Argentina.

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Business

Feds seized nearly $700 million from FTX founder Bankman-Fried

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Jan 20 (Reuters) – Federal prosecutors have seized nearly $700 million in assets from FTX founder Sam Bankman-Fried in January, largely in the form of Robinhood stock, according to a Friday court filing.

Bankman-Fried, who has been accused of stealing billions of dollars from FTX customers to pay debts incurred by his crypto-focused hedge fund, has pleaded not guilty to fraud charges. He is scheduled to face trial in October.

The Department of Justice revealed the seizure of Robinhood shares earlier this month, but it provided a more complete list of seized assets Friday, including cash held at various banks and assets deposited at crypto exchange Binance.

The ownership of the seized Robinhood shares, valued at about $525 million, has been the subject of disputes between Bankman-Fried, FTX, and bankrupt crypto lender BlockFi.

The most recent asset seizure reported by the DOJ took place on Thursday, when prosecutors seized $94.5 million in cash from an account at Silvergate Bank which was associated with FTX Digital Markets, FTX’s subsidiary in the Bahamas. The DOJ seized more than $7 million from other Silvergate accounts associated with Bankman-Fried and FTX.

The DOJ previously seized nearly $50 million from an FTX Digital Markets account at Moonstone Bank, a small bank in Washington state.

DOJ also said that assets in three Binance accounts associated with Bankman-Fried were subject to criminal forfeiture, but did not provide an estimate of the value in those accounts.

Reporting by Dietrich Knauth; Editing by Noeleen Walder and Daniel Wallis

Our Standards: The Thomson Reuters Trust Principles.

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Business

Texas AG to halt most of Citigroup’s municipal offerings on gun law row

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Jan 18 (Reuters) – Citigroup Inc (C.N) has discriminated against the firearms sector, the office of Texas Attorney General Ken Paxton said, making a decision that “has the effect” of Texas halting Citi’s ability to underwrite most municipal bond offerings in the state.

Republicans have been ramping up pressure on the finance industry over environmental, social and governance (ESG) investment practices. Texas enacted a law in 2021 prohibiting government contracts with entities that discriminated against the firearms industry.

“It has been determined that Citigroup has a policy that discriminates against a firearm entity or firearm trade association”, the assistant attorney general chief of the public finance division of Texas AG wrote on Wednesday in the letter seen by Reuters.

“Citi’s designation as an SB-19 discriminator has the effect of halting its ability to underwrite most municipal bond offerings in Texas,” Paxton’s office told Reuters, referring to the law.

Until further notice, The Texas AG will not approve any public security issued on or after Wednesday in which Citigroup purchases or underwrites the public security, she added in the letter.

“Citi does not discriminate against the firearms sector and believe we are in compliance with Texas law”, a Citigroup spokesperson said in an emailed statement to Reuters, adding that the company would remain engaged with the Texas AG office to review options.

In 2018, Citigroup put restrictions on new retail business clients that sell guns, requiring that they pass background checks. That followed a high school shooting in Florida in February of that year in which 17 people died.

Bloomberg News first reported the news on Thursday.

Reporting by Lavanya Ahire and Akanksha Khushi in Bengaluru,Additional reporting by Urvi Dugar and Mrinmay Dey; Editing by Bradley Perrett, Bernadette Baum and David Gregorio

Our Standards: The Thomson Reuters Trust Principles.

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US

Trump executive Weisselberg prepares for jail on Rikers Island

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NEW YORK, Jan 10 (Reuters) – A longtime executive for Donald Trump is expected to be sent to New York’s notorious Rikers Island jail after being sentenced on Tuesday for helping engineer a 15-year tax fraud scheme at the former president’s real estate company.

Allen Weisselberg, the Trump Organization’s former chief financial officer, pleaded guilty in August, admitting that from 2005 to 2017 he and other executives received bonuses and perks that saved the company and themselves money.

Weisselberg is expected to be sentenced to five months behind bars, after paying nearly $2 million in taxes, penalties and interest and testifying at the criminal trial of the Trump Organization, which was convicted on all counts it faced.

The sentence will be imposed by Justice Juan Merchan, who oversaw the trial in a New York state court in Manhattan. Weisselberg would likely serve 100 days with time off for good behavior.

Those days will probably not be easy for Weisselberg, 75, at a jail known for violence, drugs and corruption. Nineteen inmates there died last year.

“You’re going into a byzantine black hole,” said Craig Rothfeld, a prison consultant helping Weisselberg prepare for lockup.

50-YEAR RELATIONSHIP

Many convicts in New York City facing one year or less behind bars head to Rikers Island, which lies between the New York City boroughs of Queens and the Bronx and houses more than 5,900 inmates.

Rothfeld spent more than five weeks at Rikers in 2015 and 2016 as part of an 18-month sentence for defrauding investors and tax authorities when he was chief executive of the now-defunct WJB Capital Group Inc.

He now runs Inside Outside Ltd, which advises people facing incarceration. Another client is Harvey Weinstein, the former Hollywood movie producer convicted twice of rape.

After being sentenced, Weisselberg will likely be driven to Rikers and trade his street clothes for a uniform and sneakers with velcro straps.

Rothfeld said he hopes Weisselberg will be segregated from the general population, and not placed in a dorm with inmates who may not know him but will know his boss, who is seeking the presidency in 2024.

“Certainly Mr. Weisselberg’s 50-year relationship with the former president is on all our minds,” Rothfeld said.

A spokesman for the city’s Department of Correction said the agency’s mission is “to create a safe and supportive environment for everyone who enters our custody.”

Rikers is scheduled to close in 2027.

STAR WITNESS

Weisselberg was the star government witness against his employer.

He told jurors that Trump signed bonus and tuition checks, and other documents at the heart of prosecutors’ case, but was not in on the tax fraud scheme.

Though no longer CFO, Weisselberg remains on paid leave from the Trump Organization. He testified in November that he hoped to get a $500,000 bonus this month.

Weisselberg testified that the company is paying his lawyers. It is paying Rothfeld as well, a person familiar with the matter said. Rothfeld declined to comment.

Trump was not charged and has denied wrongdoing. The Manhattan District Attorney’s office is still investigating his business practices.

Merchan will also sentence the Trump Organization on Friday. Penalties are limited to $1.6 million.

Weisselberg remains a defendant in New York Attorney General Letitia James’ $250 million civil lawsuit alleging that Trump and his company inflated asset values and Trump’s net worth.

Rothfeld said he advised Weisselberg not to go outside at Rikers because of the risk of violence in courtyards, and not to interject himself into conversations between other inmates.

“The goal is to keep to yourself,” Rothfeld said.

Reporting by Karen Freifeld; Editing by Richard Chang

Our Standards: The Thomson Reuters Trust Principles.

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Business

Exclusive: FTX’s former top lawyer aided U.S. authorities in Bankman-Fried case

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Jan 5 (Reuters) – FTX’s former top lawyer Daniel Friedberg has cooperated with U.S. prosecutors as they investigate the crypto firm’s collapse, a source familiar with the matter said, adding pressure on founder Sam Bankman-Fried who was arrested on criminal fraud charges last month.

Friedberg gave details about FTX in a Nov. 22 meeting with two dozen investigators, the person said. The meeting, held at the U.S. Attorney for the Southern District of New York’s office included officials from the Justice Department, Federal Bureau of Investigation, and the U.S. Securities and Exchange Commission, the source said. Emails between attendees scheduling the meeting with those agencies were seen by Reuters.

At the meeting, he told prosecutors what he knew of Bankman-Fried’s use of customer funds to finance his business empire, the source said. Friedberg recounted conversations he had with other top executives on the subject and provided details of how Bankman-Fried’s hedge fund Alameda Research functioned, the source said.

Friedberg’s cooperation has not been previously reported. He has not been charged and has not been told he is under criminal investigation, the source said. Instead, he expects to be called as a government witness in Bankman-Fried’s October trial, the person said.

Friedberg’s lawyer, Telemachus Kasulis, the FBI and FTX did not respond to requests for comment on his cooperation. The SEC, the Department of Justice and Bankman-Fried’s spokesman declined to comment.

Bankman-Fried is accused of diverting billions of dollars in FTX client funds to Alameda to bankroll venture investments, luxury real estate purchases, and political donations. On Tuesday, he pleaded not guilty in Manhattan federal court.

Manhattan U.S. Attorney Damian Williams, who is leading the criminal case against now bankrupt FTX, said last month: “If you participated in misconduct at FTX or Alameda, now is the time to get ahead of it.”

Two of Bankman-Fried’s closest associates, Caroline Ellison, Alameda’s former chief executive, and Gary Wang, FTX’s former chief technology officer, pleaded guilty to fraud and agreed to cooperate. A lawyer for Ellison didn’t respond to a request for comment. Wang’s lawyer declined to comment.

MEETING WITH PROSECUTORS

FTX filed for bankruptcy protection on Nov. 11. A few days later, on Nov. 14, Friedberg received a call from two FBI agents based in New York. He told them he was willing to share information but needed to ask FTX to waive his attorney-client privilege, according to a person familiar with the matter and emails viewed by Reuters.

Friedberg wrote to FTX the next day asking the company to waive his privilege so he could cooperate with prosecutors, according to the email seen by Reuters. FTX did not do so, but agreed with Friedberg on the points he could disclose to investigators, the person said.

Friedberg then wrote back to the two FBI agents, telling them in an email reviewed by Reuters: “I want to cooperate in all respects.”

The U.S. Attorney’s Office set up a meeting where Friedberg signed so-called proffer letters prepared for him by the SEC and other agencies, according to the source and an email exchanged by participants. Proffer letters typically describe a potential agreement between authorities and individuals who are witnesses or subjects of an investigation.

“THROUGH THICK AND THIN”

Prior to his work advising FTX, Friedberg advised a mix of banking, fintech, and online gaming companies.

One of his previous employers, a Canadian online gaming firm named Excapsa Software, where he was general counsel, also drew controversy due to a cheating scandal involving a poker site it operated called Ultimate Bet. A Canadian gaming commission in 2008 fined Ultimate Bet $1.5 million for failing to enforce measures to prevent fraudulent activities. Excapsa has since dissolved.

According to an audio recording available on the website PokerNews, Friedberg and some other Ultimate Bet associates privately discussed that year how to handle the scandal and minimize the amount of refunds owed to players. Friedberg previously told NBC News that the audio was illegally recorded but NBC’s article did not say that Friedberg challenged its authenticity.

Friedberg first represented Bankman-Fried in 2017 as outside counsel while at U.S. law firm Fenwick & West, where he chaired its payment systems group, the source familiar with the matter said. At the time, the source said Friedberg advised Bankman-Fried on running Alameda, which he founded that year.

In 2020, when Bankman-Fried launched a separate exchange for U.S. customers called FTX.US, Friedberg moved in-house as FTX’s chief regulatory officer.

In a now-deleted blog post published that year on FTX’s website, Bankman-Fried wrote that Friedberg was FTX’s legal advisor “from the very beginning,” noting he had been “with us through thick and thin.”

Friedberg resigned from his position on Nov. 8, a day after Bankman-Fried disclosed to top executives that FTX was almost out of money, according to the source and three other people briefed on the talks, along with text messages his legal team exchanged at the time.

Additional reporting by Hannah Lang; editing by Megan Davies and Anna Driver

Our Standards: The Thomson Reuters Trust Principles.

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Business

Congressional report: U.S. FDA broke own protocols in approving Biogen Alzheimer’s drug

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WASHINGTON, Dec 29 (Reuters) – The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen’s (BIIB.O) Alzheimer’s drug Aduhelm, which was “rife with irregularities,” a congressional report showed on Thursday.

The FDA’s interactions with Biogen were “atypical” and did not follow the agency’s documentation protocol, according to a staff report on the findings of an 18-month investigation conducted by two House of Representatives committees into the drug’s regulatory review, approval, pricing, and marketing.

The FDA approved Aduhelm in June 2021 under an accelerated approval pathway over the objections of its panel of outside advisers, who did not believe data definitively proved the drug’s benefit to patients.

It was authorized based on evidence that it could reduce brain plaques, a likely contributor to Alzheimer’s, rather than proof that it slowed progression of the lethal mind-wasting disease.

The Medicare program restricted its coverage, which has led to severely limited use of the Biogen drug.

Biogen set an “unjustifiably high” price by initially setting Aduhelm’s price at $56,000 per year despite a lack of demonstrated clinical benefit in a broad patient population, the report said, adding that the company’s own internal projections showed it expected the drug to be a burden to Medicare and costly to patients.

“The findings in this report raise serious concerns about FDA’s lapses in protocol and Biogen’s disregard of efficacy and access in the approval process for Aduhelm,” the report, prepared by the staffs of the House Committee on Oversight and Reform and House Committee on Energy and Commerce, concluded.

The agency should ensure that all substantive interactions with drug sponsors are properly memorialized, establish a protocol for joint briefing documents with drug sponsors, and update its industry guidance on the developments and review of new Alzheimer’s Drugs, the report recommended.

Biogen and other drugmakers should communicate to the FDA any concerns over safety and efficacy to the FDA as well as take value and patient access into consideration when setting prices, the report said.

An FDA spokesperson said the FDA’s decision to approve Aduhelm was based on scientific evaluation of the data contained in the application.

He pointed to the FDA’s internal review finding its staff’s interactions with Biogen appropriate.

“It is the agency’s job to frequently interact with companies in order to ensure that we have adequate information to inform our regulatory decision-making. We will continue to do so, as it is in the best interest of patients,” he said, adding that the agency will continue to use the accelerated approval pathway whenever appropriate.

The FDA has already begun implementing some of the report’s recommendations, the spokesperson said.

“Biogen stands by the integrity of the actions we have taken,” the Cambridge, Mass.-based biotech company said in an emailed statement.

“As stated in the congressional report, an (FDA) review concluded that, ‘There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation,'” Biogen said.

Documents obtained by the committees show that FDA staff and Biogen held at least 115 meetings, calls, and email exchanges over a 12-month period starting July 2019.

The total number of meetings is unknown because the FDA failed to keep a clear record of informal meetings and interactions between its staff and Biogen representatives. The investigation identified an additional 66 calls and email exchanges that were not memorialized.

The FDA inappropriately collaborated with Biogen on a joint briefing document for the Peripheral and Central Nervous System (PCNS) Advisory Committee, the report said, with FDA and Biogen staff working closely for months ahead of the Nov. 6, 2020 meeting to prepare the document, which failed to adequately represent differing views within the agency.

“Using a joint briefing document afforded Biogen advance insight into FDA’s responses and direct guidance from the agency in drafting the company’s own sections. For example, in an exchange of the draft briefing document on October 9, 2020, FDA staff asked Biogen to move a paragraph drafted by the agency into Biogen’s section of the memorandum—a change reflected when the document was finalized,” the report made public to media organizations said.

When none of the advisory panel members voted to approve Aduhelm, the FDA pivoted to using its accelerated approval pathway – typically used for rare diseases or small patient populations that lack access to effective treatments – despite having considered the drug under the traditional approval pathway for nine months, the report said.

It did so on a substantially abbreviated timeline, approving it after three weeks of review, and for a broad label indication of “people with Alzheimer’s disease” that was unsupported by clinical data, the report said.

Internal documents obtained by the investigation showed that Biogen accepted the indication despite its own reservations over the lack of evidence Aduhelm could help patients at disease stages outside of its clinical trials.

Reporting by Ahmed Aboulenein; editing by Diane Craft

Our Standards: The Thomson Reuters Trust Principles.

Ahmed Aboulenein

Thomson Reuters

Washington-based correspondent covering U.S. healthcare and pharmaceutical policy with a focus on the Department of Health and Human Services and the agencies it oversees such as the Food and Drug Administration, previously based in Iraq and Egypt.

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US

Slipping over Mexico border, migrants get the jump on U.S. court ruling

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CIUDAD JUAREZ, Mexico Dec 28 (Reuters) – Even before the U.S. Supreme Court on Tuesday opted to keep in place a measure aimed at deterring border crossings, hundreds of migrants in northern Mexico were taking matters into their own hands to slip into the United States.

The contentious pandemic-era measure known as Title 42 had been due to expire on Dec. 21, but last-minute legal stays pitched border policy into limbo and made many migrants decide they had little to lose by crossing anyway.

After spending days in chilly border cities, groups of migrants from Venezuela and other countries targeted by Title 42 opted to make a run for it rather than sit out the uncertainty of the legal tug-of-war playing out in U.S. courts.

“We ran, and we hid, until we managed to make it,” said Jhonatan, a Venezuelan migrant who scrambled across the border from the Mexican city of Ciudad Juarez into El Paso, Texas with his wife and five children, aged 3 to 16, on Monday night.

Giving only his first name and speaking by phone, Jhonatan said he had already spent several months in Mexico and had not wanted to enter the United States illegally.

But the thought of failing after a journey that took his family through the perilous jungles of Darien in Panama, up Central America and into Mexico was more than he could bear.

“It would be the last straw to get here, and then they send us back to Venezuela,” he told Reuters.

On Tuesday, the U.S. Supreme Court granted a request by a group of Republican state attorneys general to put on hold a judge’s decision invalidating Title 42. They had argued its removal would increase border crossings.

The court said it would hear arguments on whether the states could intervene to defend Title 42 during its February session. A ruling is expected by the end of June.

[1/3] Migrants run to hide from the U.S. Border Patrol and Texas State Troopers after crossing into the United States from Mexico, in El Paso, Texas, U.S., December 23, 2022. REUTERS/Jose Luis Gonzalez

Reuters images showed migrants racing across a busy highway alongside the border last week, one man barefoot and carrying a small child – the kind of risky crossing that alarms migrant advocates.

“We’re talking about people who come to request asylum … and they’re still crossing the border in very dangerous ways,” said Fernando Garcia, director of the Border Network for Human Rights.

John Martin, the deputy director at El Paso’s Opportunity Center for the Homeless, said the number of migrants his shelter has taken in are increasingly people who crossed illegally, including many Venezuelans.

“At one point, the majority were documented; now I’m seeing it reverse,” he said.

The agency’s El Paso sector was registering about 2,500 daily migrant encounters in mid-December, but the number dipped through Christmas to just over half that by the time of the court decision, CBP figures show.

On Tuesday before the Supreme Court ruling, a Venezuelan migrant in Ciudad Juarez who gave his name as Antonio said he was waiting to see whether U.S. border surveillance would let up, hoping to make money in the United States to send home.

“If they don’t end Title 42,” he said, “we’re going to keep entering illegally.”

Elsewhere along the border, other migrants said they felt they had run out of options.

“We don’t have a future in Mexico,” said Cesar, a Venezuelan migrant in Tijuana who did not give his last name, explaining why he has attempted once to cross the border fence to get into the United States, and plans to try again.

Reporting by Daina Beth Solomon in Mexico City and Jose Luis Gonzalez in Ciudad Juarez; Additional reporting by Lizbeth Diaz and Ted Hesson; Editing by Dave Graham and Gerry Doyle

Our Standards: The Thomson Reuters Trust Principles.

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Capitol riot panel’s final report sets out case to try Trump

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WASHINGTON, Dec 22 (Reuters) – The congressional panel probing the Jan. 6, 2021 attack on the U.S. Capitol released its final report late on Thursday, outlining its case that former U.S. President Donald Trump should face criminal charges of inciting the deadly riot.

The House of Representatives Select Committee also made public the transcripts of a number of its interviews and witness testimonies earlier on Thursday and on Wednesday.

The report, which runs to more than 800 pages, is based on nearly 1,200 interviews over 18 months and hundreds of thousands of documents, as well as the rulings of more than 60 federal and state courts.

The report lists 17 specific findings, discusses the legal implications of actions by Trump and some of his associates and includes criminal referrals to the Justice Department of Trump and other individuals, according to an executive summary released earlier this week. It report also lists legislative recommendations to help avert another such attack.

On Monday, the committee asked federal prosecutors to charge the Republican former president with four crimes, including obstruction and insurrection, for what they said were efforts to overturn results of the November 2020 election and sparking the attack on the seat of government.

“Rather than honor his constitutional obligation to ‘take care that the laws be faithfully executed,’ President Trump instead plotted to overturn the election outcome,” the House panel had said earlier in a 160-page summary of its report.

In comments posted on his Truth Social network after the final report’s release, Trump called it “highly partisan” and a “witch hunt”. He said it failed to “study the reason for the (Jan. 6) protest, election fraud.”

The request by the Democratic-led panel to the Justice Department does not compel federal prosecutors to act, but marked the first time in history that Congress had referred a former president for criminal prosecution. Trump announced in November that he would run for president again.

Among the transcripts released on Wednesday and Thursday was one that showed a former lawyer for ex-White House aide Cassidy Hutchinson told her to “downplay” her knowledge of events leading to the Capitol riot, telling her “the less you remember, the better.”

Attorney Stefan Passantino advised Hutchinson in preparing for a February deposition before the panel to say that she could not recall certain events, she told the committee in September, according to the transcript of her testimony.

Trump gave a fiery speech to his supporters near the White House the morning of Jan. 6, and publicly chastised his vice president, Mike Pence, for not going along with his plan to reject ballots cast for Democrat Joe Biden.

The former president then waited hours to make a public statement as thousands of his supporters raged through the Capitol, assaulting police and threatening to hang Pence.

The 2020 election results were being certified by Pence and lawmakers when the Capitol was attacked after weeks of false claims by Trump that he had won that election.

Reporting by Kanishka Singh in Washington; Editing by Kenneth Maxwell

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