Tag Archives: congressional

Biden administration is sending $1 billion more in weapons, ammo to Israel, congressional aides say – The Associated Press

  1. Biden administration is sending $1 billion more in weapons, ammo to Israel, congressional aides say The Associated Press
  2. Exclusive | Biden Moves Forward on $1 Billion in New Arms for Israel The Wall Street Journal
  3. Not even the US government knows the US government line on Rafah Al Jazeera English
  4. Trump’s ‘hush money’ NYC trial live updates: Ex-prez takes shot at Jewish Democrats – calling out Alan Dershowitz by name – in fiery post-court remarks: ‘Ought to have your brain examined’ New York Post
  5. Biden Administration Advances $1 Billion Arms Sale to Israel The New York Times

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Former congressional candidate and pro wrestler arrested in Vegas murder of man who was wrongly imprisoned for cold-case killing – CBS News

  1. Former congressional candidate and pro wrestler arrested in Vegas murder of man who was wrongly imprisoned for cold-case killing CBS News
  2. Retired wrestler and ex-congressional candidate suspected in Las Vegas killing surrenders to police Yahoo! Voices
  3. Ex-WWE star, congressional candidate suspected of murder turns himself in syracuse.com
  4. Report: Death threat over cocaine led to deadly altercation, arrest warrant for former Nevada Congressional candidate Fox 5 Las Vegas
  5. Dan “Big Dan” Rodimer, retired wrestler, sought in Nevada killing The Dallas Morning News

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The fight over Alabama’s congressional redistricting now shifts back to federal court – Yahoo News

  1. The fight over Alabama’s congressional redistricting now shifts back to federal court Yahoo News
  2. Which counties moved on Alabama’s new congressional district map? AL.com
  3. Alabama lawmakers reject 2nd Black majority Congressional district, increase to 40% after Supreme Court ruling Fox News
  4. Legislature approves new Congressional map over objections from Democrats Alabama Political Reporter
  5. Kevin McCarthy should ‘chip in’ on Alabama’s legal fees if he influenced congressional map: Chris England AL.com
  6. View Full Coverage on Google News

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WATCH LIVE: Congressional Democrats announce reintroduction of Freedom to Vote Act – PBS NewsHour

  1. WATCH LIVE: Congressional Democrats announce reintroduction of Freedom to Vote Act PBS NewsHour
  2. WATCH LIVE: House Republicans lead committee hearing on immigration and ‘Biden’s Broken Border’ PBS NewsHour
  3. WATCH: Biden call U.S.-Israel relationship ‘unbreakable’ in meeting with Israeli president PBS NewsHour
  4. WATCH LIVE: McCarthy holds news briefing after Democrats promise to oppose abortion bill PBS NewsHour
  5. WATCH: DeSantis speaks at pro-Israel meeting, calls on Biden to ‘butt out’ of country’s politics PBS NewsHour
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Congressional report: U.S. FDA broke own protocols in approving Biogen Alzheimer’s drug

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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Congressional Investigation into Alzheimer’s Drug Aduhelm Faults the F.D.A. and Biogen – The New York Times

  1. Congressional Investigation into Alzheimer’s Drug Aduhelm Faults the F.D.A. and Biogen The New York Times
  2. House investigation says FDA approval process of Alzheimer’s drug was ‘rife with irregularities’ CNN
  3. House investigation faults FDA, Biogen for Alzheimer’s drug approval The Washington Post
  4. Seeking maximum profits, Biogen set an ‘unjustifiably high price’ for Alzheimer’s treatment, investigation finds STAT
  5. FDA Faulted for Working Improperly With Biogen Before Clearing Alzheimer’s Drug The Wall Street Journal
  6. View Full Coverage on Google News

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Biden ‘confident’ rail strike will be avoided though congressional hurdles loom



CNN
 — 

President Joe Biden said Tuesday he is “confident” a rail strike will be avoided while meeting with the top four congressional leaders, though any one senator could slow down the process of approving legislation that would avert such a strike – and at least one said he was planning to do so.

“I asked the four top leaders in Congress to ask whether they’d be willing to come in and talk about what we’re gonna do between now and Christmas in terms of legislation and there’s a lot to do, including resolving the train strike,” Biden said while meeting with House Speaker Nancy Pelosi, Senate Majority Leader Chuck Schumer, House Minority Leader Kevin McCarthy and Senate Minority Leader Mitch McConnell.

“It’s not an easy call but I think we have to do it,” Biden said. “The economy is at risk.”

On Monday, Biden called on Congress to “immediately” pass legislation to avert a railroad shutdown by officially adopting a September tentative agreement approved by labor and management leaders. Rank-and-file members of four unions have rejected the agreement and are prepared to go on a railroad strike on December 9 without either a new labor agreement or congressional action.

Biden, a longtime labor ally, along with Labor Secretary Marty Walsh and other administration officials helped unions and management reach a tentative deal averting a freight railroad strike in September.

A railroad strike could clog supply chains and lead to a spike in prices on necessities such as gasoline and food – dampening an economy that many fear is heading toward a recession. It could also cost could cost the US economy $1 billion in its first week alone, according to an analysis from the Anderson Economic Group.

Michael Baldwin, president of the Brotherhood of Railroad Signalmen, one of the four unions whose members voted no on the deal, said Tuesday that Biden has let the union and its members down.

“We’re trying to address an issue here of sick time. It’s very important,” Michael Baldwin, the president of the Brotherhood of Railroad Signalmen, told CNN’s Jim Sciutto on “Newsroom.” “This action prevents us from reaching the end of our process. It takes away the strength and the abilities that we have to force bargaining or force the railroads into a situation to actually do the right thing.”

Pelosi said Tuesday the chamber could vote as soon as Wednesday on legislation to adopt the September tentative agreement and avert a possible rail strike. Once passed, Senate action could occur later this week or next, several Senate sources have told CNN. The Senate is expected to have the votes to break a filibuster on the bill to avert a potential railway strike, the Senate sources also said. There are likely to be at least 10 Republicans who will vote with most Senate Democrats to overcome a 60-vote threshold.

After the meeting, McConnell expressed openness to backing the legislation, and told reporters “We’re gonna need to pass a bill.”

But any one senator can slow the process down as timing agreements to move along legislation typically require unanimous consent from all 100 members of the chamber. Vermont Sen. Bernie Sanders, an independent who caucuses with Democrats, criticized the proposed deal to avert a rail strike on Tuesday. Sanders reiterated his threat to slow down rail measure unless he gets sick-leave amendment vote in a tweet Tuesday afternoon.

“At a time of record profits in the rail industry, it’s unacceptable that rail workers have ZERO guaranteed paid sick days. It’s my intention to block consideration of the rail legislation until a roll call vote occurs on guaranteeing 7 paid sick days to rail workers in America,” he wrote.

Any one member can delay a quick vote and potentially put off final action until after the December 9 deadline to avert a strike.

Some Republicans are still skeptical of congressional intervention, arguing they would rather the issue be dealt with administratively.

Maine Sen. Susan Collins, a frequent swing vote, told CNN that the measure “deserves careful consideration.”

“I’m going to wait and listen to the debate at lunch today before reaching any kind of conclusion,” she said.

Iowa Sen. Joni Ernst, a member of GOP leadership, also told CNN she was still evaluating the plan.

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Democrat Marie Gluesenkamp Perez declared winner in Washington’s 3rd Congressional District

The Associated Press has called the House race in Washington state’s 3rd Congressional District for Democrat Marie Gluesenkamp Perez.

Perez currently leads Republican Joe Kent 50.8% to 49.2%, a margin of 4,621 votes, with 70% of votes counted.

The victory for Perez is a Democrat pickup of a seat that has been held by Republicans since 2011.

The seat had been held by Republican Rep. Jaime Herrera Beutler who lost in her primary race after being one of the 10 Republicans to vote to impeach former President Donald Trump over his role in the Capitol Hill riot in January 2021.

2022 MIDTERM ELECTION RESULTS: REPUBLICANS NEED JUST SEVEN SEATS TO CAPTURE THE HOUSE MAJORITY

Democratic candidate Marie Gluesenkamp Perez has been declared the winner in the House race for Washington’s 3rd Congressional District
(AP Images)

Gluesenkamp Perez — who co-owns an auto shop with her husband just across the Columbia River in Portland, Oregon — said that as a small business owner who lives in a rural part of the district, she is more in line with voters.

Kent, a former Green Beret who was endorsed by Trump, has called for the impeachment of President Joe Biden and an investigation into the 2020 election.

REPUBLICANS SPLIT ON TRUMP’S EFFECT ON LACKLUSTER MIDTERMS AS CONTROL OF CONGRESS HANGS IN BALANCE

Joe Kent, a retired Army Special Forces chief warrant officer, and GOP candidate in Washington’s 3rd Congressional District
(Joe Kent campaign)

“What the media says is irrelevant, its another narrative designed to stop voters from ballot curing & to force me to concede – not gonna happen,” Kent tweeted around the time of the AP’s call. 

The results of about two dozen congressional races across the country are still outstanding, and all Republicans need to successfully flip the chamber are seven of them.

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The American flag flies at half-staff over the U.S. Capitol, Thursday, Sept. 8, 2022,
(AP Photo/Jacquelyn Martin)

So far, after Tuesday’s midterm elections results, Republicans have secured 211 seats of the chamber’s 435 members — just shy of a 218-member majority.

The Associated Press contributed to this report.



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CNN Poll: Republicans, backed by enthusiasm and economic concerns, hold a narrow edge ahead of next week’s congressional election



CNN
 — 

An enthusiastic Republican base and persistent concerns about the state of the economy place the GOP in a strong position with about a week to go in the race for control of the US House of Representatives, according to a new CNN Poll conducted by SSRS.

The new survey out Wednesday shows that Democratic enthusiasm about voting is significantly lower than it was in 2018, when the Democratic Party took control of the House. Republican voters in the new poll express greater engagement with this year’s midterm election than Democrats across multiple questions gauging likelihood of vote.

Overall, 27% of registered voters say they are extremely enthusiastic about voting this year, down from 37% just ahead of the 2018 midterm elections, and the decline in enthusiasm comes almost entirely among Democrats. Four years ago, 44% of Democratic registered voters said they were extremely enthusiastic about voting; now, just 24% say the same. Among Republicans, the number has dipped only narrowly, from 43% to 38%.

Although overall enthusiasm about voting now is lower than in October 2010, the Republican enthusiasm advantage now is similar to the partisan gap found in CNN polling then, ahead of a very strong GOP midterm performance. Back then, as now, Republican voters were 14 points more likely to say they were extremely enthusiastic about voting in the midterm (31% of Republican voters were extremely enthusiastic vs. 17% of Democratic voters).

In the new poll, Republicans top Democrats on a generic ballot question asking voters which party’s candidate they would support in their own House district by 51% to 47% among likely voters, narrowly outside the poll’s margin of sampling error. Among registered voters, the race is about even, with 47% behind the Republicans and 46% the Democrats. Closely divided generic ballot numbers have often translated into Republican gains in the House.

Republican standing in the battle for the House this year is bolstered by broad concerns about the state of the nation’s economy. The economy and inflation are far and away the top issue for likely voters in this final stretch, with about half of all likely voters (51%) saying those will be the key issue determining their vote for Congress this year. Abortion, the second-ranking issue, lands as the top concern for 15% of likely voters. Other issues tested were chosen by fewer than 10% of likely voters each, including voting rights and election integrity (9%), gun policy (7%), immigration (6%), climate change (4%) and crime (3%).

Republican and independent likely voters are broadly focused on the economy, with 71% of Republicans and 53% of independents calling it the top issue in their vote. Democratic likely voters are more split, with the economy and abortion the top issue for near-equal shares – 29% say abortion, 27% the economy and inflation.

Those likely voters who say the economy is their top concern break heavily in favor of Republicans in their House districts, 71% to 26%. By an even wider margin, they say they trust the GOP more specifically to handle the economy and inflation (71% Republicans vs. 18% Democrats).

The poll finds a widespread and expanded perception that the economy is already in a recession, with a broad majority also saying things in the country are not going well generally.

Overall, 75% of Americans say that the economy is in a recession, up from 64% who felt that way this summer. Majorities across party lines see the economy as already in recession, including 91% of Republicans, 74% of independents and 61% of Democrats. A majority overall (55%) say they are dissatisfied with their own personal financial situation, up from 47% who felt that way this spring. Most Republicans (57%) and independents (62%) express dissatisfaction with their finances, while Democrats are more likely to be satisfied (55% satisfied, 45% dissatisfied).

Nearly three-quarters of Americans (74%, including 72% of likely voters) say things in the country are going badly today. That’s a slight improvement from this summer, when 79% of all adults rated things poorly, but is similar to how Americans felt about the state of the country just ahead of the 2010 midterms (75% said things were going badly) and significantly worse than just before Election Day 2018 (44% said things were going badly in early November). The last time a majority of Americans said things in the US were going well was January 2020, before the Covid-19 pandemic.

Amid this growing economic malaise and stagnant negativity about the nation, President Joe Biden’s approval rating has also dipped in the new poll. Overall, 41% of adults say they approve of the president’s performance, down from 44% in the most recent CNN polling though still ahead of its low point this summer. Among likely voters, Biden’s rating stands at 42%, about on par with Donald Trump among likely voters in 2018 (41% approved) and Barack Obama in 2010 (43% approved).

The new CNN Poll was conducted by SSRS October 26 through 31 among a random national sample of 1,508 adults using sample drawn from a probability-based panel, including 1,290 registered voters and 992 likely voters. Surveys were either conducted online or by telephone with a live interviewer. Results for the full sample have a margin of sampling error of plus or minus 3.2 percentage points; it is 3.4 points among registered voters and 3.8 among likely voters. Likely voters were identified through a series of questions about their intention to, interest in and past history of voting.

Half of Americans have confidence that the results of US elections reflect the will of the people, with Republicans less confident than Democrats in the fairness of the process and more likely to reject the idea that losing candidates have a responsibility to concede.

Fifty percent of adults say they’re at least somewhat confident that elections in America today reflect the will of the people, with the rest expressing little or no confidence. That represents a modest improvement from CNN’s polling this summer, when just 42% described themselves as confident. The shift is due largely to a modest rebound in trust among independents (49% say they’re at least somewhat confident in elections, up from 38%) and Republicans (41%, up from 29%). Trust remains highest among Democrats – 61% express at least some confidence, similar to the 57% who said the same this summer.

Still, increased GOP confidence in the election system doesn’t translate into an increased willingness to accept the results of the 2020 presidential election: 66% of Republicans say they don’t believe Biden legitimately won the election, unchanged from July.

The vast majority of Americans, 82%, say that losing candidates in their state have an obligation to accept the results and concede, but 17% say that losing candidates don’t face such an obligation. A quarter of Republicans say losing candidates don’t have an obligation to concede, compared with 7% of Democrats. Within the GOP, that view is concentrated among election deniers: 33% of Republicans who deny that Biden won the presidency fairly don’t think losing candidates should be obliged to acknowledge their loss, a view shared by only 8% of Republicans who accept the results of the 2020 election.

Republicans are also less likely than Democrats to say that challenges by their own party’s losing candidates would be detrimental to public trust in the nation’s election system. A 71% majority of Democrats and Democratic-leaning independents say that a losing candidate from their party who challenged the results would be doing more to decrease confidence in American elections than to increase it. A smaller 54% majority of Republicans and Republican-leaners say that a losing GOP candidate would decrease confidence in elections by challenging the results.

On both the Republican and Democratic sides, partisans are more likely than independents who lean toward their party to say that their candidate would be increasing confidence in elections by challenging results, and those without college degrees are also more likely than those with degrees to see such a move as confidence-inducing. On the GOP side, self-described conservatives are more likely than self-described moderates to say that challenging election results inspires confidence in the system; there’s not much of a similar ideological gap on the Democratic side.

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Mary Peltola defeats Sarah Palin to become first Native Alaskan woman to win congressional race

Former state legislator Mary Peltola beat former governor Republican governor Sarah Palin to become the first Democrat to represent Alaska in Congress in almost fifty years.

Ms Peltola, a former state representative whose mother was Yup’ik, will also be the first Native Alaskan to represent the state since it formally joined the union as a state in 1959.

She responded to the result by tweeting: “It is a GOOD DAY.”

NBC News reported that Ms Peltola had secured 51.5 per cent of the vote (91,206 votes), while Ms Palin managed 48.5 per cent 85,987 votes).

Alaska’s sole congressional seat opened earlier this year when Representative Don Young, the longest-serving Republican congressman, died. Mr Young won a special election himself in 1973.

House Speaker Nancy Pelosi congratulated Ms Peltola on being the first Alaska Native ever elected to Congress.

“Her valuable and unifying perspective, deep experience in public service and commitment to working families will strengthen the work of our Caucus and the Congress,” Ms Pelosi said in a statement.

The race serves as a boon to Democrats after they held a seat in a special election in New York’s 19th district last week. It also shows the salience of protecting abortion rights after the Supreme Court’s Dobbs v Jackson decision overturned Roe v Wade earlier this year. Ms Peltola ran heavily on protecting abortion rights along with focusing heavily on worker’s rights and fishing in the state.

Ms Peltola win marks Alaska’s first test of its new ranked-choice voting system, wherein the top four voter recipients head to the general election. In the general election, voters rank their choices in order of preferences.

Sarah Palin’s bid to return to frontline politics fell short

(Getty Images)

After the first round of votes are counted, the candidate who earned the fewest number of votes is eliminated and voters’ second choice earns their votes. This continues until one candidate receives more than half the vote.

The Democrat’s victory comes despite the fact Republicans’ aggressive “Rank the Red” campaign to ensure that Republican voters ranked Mr Begich and Ms Palin as their top-two choices.

Ms Peltola will serve the duration of Mr Young’s term until January and then will also have to run for a full term against Ms Palin and Nick Begich, along with Libertarian candidate Chris Bye after fellow Republican Tara Sweeney ended her campaign.

Ms Palin hit the national stage in 2008 when Republican presidential candidate John McCain made her his surprise pick as vice-presidential candidate – the first Republican woman chosen for the role.

She had served as mayor of Wasilla before being elected governor in 2006.

Her vice presidential run made her a hero of right-wing media, even as she accused Barack Obama of “palling around” with terrorists and made a series of gaffes that were highly scrutinised.

Nevertheless, Ms Palin earned the affection of many movement conservatives and she resigned the governorship less than a year after she became a right-wing celebrity.

She frequently appeared on Fox News and campaigned for conservative primary challengers – including against her fellow Alaskan Senator Lisa Murkowski, when she endorsed Tea Party challenger Joe Miller in the 2010 Republican primary.

Her persona also served as a precursor for President Donald Trump’s hostile takeover of the Republican Party and Ms Palin was the only former Republican presidential or vice presidential former nominee to endorse Mr Trump in the 2016 GOP primary. Mr Trump would later return the favour when he endorsed Ms Palin’s congressional run fairly early and campaigned with her this year.

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