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    FAA grounds more than 170 Boeing 737 Max 9s after section of Alaska Airlines plane blows out

    The Federal Aviation Administration on Saturday ordered airlines to ground more than 170 Boeing 737 Max 9 aircraft for inspections.
    Alaska Airlines Flight 1282 made an emergency landing after a panel on the side of the plane blew off midflight.
    Alaska and United Airlines said late Saturday that they were grounding their entire fleets of Boeing 737 Max 9s.

    Passenger oxygen masks hang from the roof next to a missing window and a portion of a side wall of an Alaska Airlines Flight 1282, which had been bound for Ontario, California and suffered depressurization soon after departing, in Portland, Oregon, U.S., on Jan. 5, 2024, in this picture obtained from social media.
    Instagram/@strawberrvy | Instagram/@strawberrvy Via Reute

    The Federal Aviation Administration on Saturday ordered a temporary grounding of dozens of Boeing 737 Max 9 aircraft for inspections, a day after a piece of the aircraft blew out in the middle of an Alaska Airlines flight.
    Images and video of Alaska Airlines Flight 1282 that were shared on social media showed a gaping hole on the side of the plane and passengers using oxygen masks before it returned to Portland shortly after taking off for Ontario, California, on Friday afternoon.

    The FAA’s emergency airworthiness directive will affect about 171 planes worldwide and applies to U.S. airlines and carriers operating in U.S. territory, the agency said. Alaska and United Airlines said late Saturday that they were grounding their entire fleets of Boeing 737 Max 9s.
    No serious injuries were reported on the flight, according to federal safety officials. There were 171 passengers and six crewmembers on board, Alaska Air said.
    “Safety will continue to drive our decision-making as we assist the NTSB’s investigation into Alaska Airlines Flight 1282,” FAA Administrator Mike Whitaker said in a statement.
    Large-scale groundings of aircraft by the FAA or other aviation authorities are rare. The FAA has heavily scrutinized the Boeing 737 Max since two fatal crashes grounded the jetliner worldwide almost five years ago. Two other models of the Max, the smallest and largest version, have not yet been cleared by the agency to enter commercial service.
    The section of the fuselage missing appeared to correspond to an exit not used by Alaska Airlines, or other carriers that don’t have high-density seating configurations, and was plugged.

    The National Transportation Safety Board has started its investigation. Chair Jennifer Homendy, at a press briefing in Portland Saturday night, asked the public for help in finding the plane’s missing door.
    Homendy said no passengers were seated at the seat closest to the panel or the middle seat in the row where the door blew out and added that it was fortunate that the plane was still climbing and not at cruising altitude when travelers and crew could have been standing or walking through the cabin.
    “We could have ended up with something more tragic,” she said.
    The incident was described as “an explosive decompression at the window exit,” according to Sara Nelson, president of the Association of Flight Attendants-CWA, the labor union that represents Alaska’s cabin crew and flight attendants at United, Spirit and other carriers.
    Anthony Brickhouse, a professor of aerospace safety at Embry-Riddle Aeronautical University, said such an incident is extremely rare.
    “Rapid decompression is a serious matter,” he said. “To see a gaping hole in an aircraft is not something we typically see. In aviation safety, we would call this a structural failure.”
    The incident is also a reminder to keep your seatbelt fastened when seated, he added.
    “I always advise people on a commercial aircraft, keep your seatbelt on regardless of what the light says,” Brickhouse said.
    Before the FAA issued its directive, Alaska Airlines earlier said it would ground its fleet of Boeing 737 Max 9 planes. On Saturday, the carrier said 18 of the planes “had in-depth and thorough plug door inspections performed as part of a recent heavy maintenance visit,” but later said it would temporarily ground them all.
    “We are in touch with the FAA to determine what, if any, further work is required before these aircraft are returned to service,” Alaska said.
    As of 7 p.m. ET, Alaska said it canceled 160 flights, affecting 23,000 customers.

    Investigation begins

    The National Transportation Safety Board sent a team to Portland on Saturday to investigate the incident.
    United Airlines, the largest operator of the planes in the U.S., had prepared to ground dozens of its Boeing 737 Max 9 aircraft for inspections, CNBC reported earlier. The carrier said late Saturday that it had grounded its entire fleet of 79 Boeing 737 Max 9 aircraft, after earlier saying 30 of the planes had already satisfied the FAA’s inspection requirement.
    The FAA said the inspections will take between four and eight hours per plane.
    The Boeing 737 Max 9 is a larger version of Boeing’s best-selling jetliner, the 737 Max 8. Max planes were grounded worldwide in 2019 after two fatal crashes within about five months of one another. The U.S. lifted its flight ban on the jets in late 2020 after software and training updates.

    Plugged door

    The Boeing 737 Max 9 has an emergency exit door cut behind the wings for use in dense seating cabin configurations, like those used by budget airlines, according to Flightradar24.
    “The doors are not activated on Alaska Airlines aircraft and are permanently ‘plugged,'” Flightradar24 said.
    Boeing didn’t comment beyond its statement when asked about the sealed emergency exit door. Spirit AeroSystems, which makes the fuselages for the 737 Max, confirmed to CNBC that it installed the plugged door on the aircraft.
    “Safety is our top priority and we deeply regret the impact this event has had on our customers and their passengers,” Boeing said in a statement on Saturday. “We agree with and fully support the FAA’s decision to require immediate inspections of 737-9 airplanes with the same configuration as the affected airplane.”
    The company said it is supporting the NTSB’s investigation.
    There are 215 Boeing 737 Max 9 planes in service worldwide, according to aviation-data firm Cirium. In addition to United and Alaska Air, other operators include Aeromexico, Turkish Airlines, Icelandair and Panama’s Copa Airlines.
    Southwest Airlines and American Airlines operate the smaller 737 Max 8.
    Late last year, Boeing urged airlines to inspect aircraft for a “possible” loose bolt in the rudder control system, the latest in a series of manufacturing flaws on Boeing jets that have prompted additional inspections, and slowed deliveries of the jets. More

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    Alaska Airlines grounds Boeing 737 Max 9 fleet after section blows out midair

    Alaska Airlines flight 1282 returned to Portland, Oregon after a section of the plane ripped off midair.
    Video and photos on social media showed a gaping hole on the side of the plane and passengers in oxygen masks.
    Alaska Airlines CEO said the carrier is grounding its fleet of Boeing 737 Max 9 aircraft.

    An Alaska Airlines plane takes off from Los Angeles International Airport (LAX) on December 4, 2023 in Los Angeles, California. 
    Mario Tama | Getty Images News | Getty Images

    Alaska Airlines will temporarily ground its fleet of 65 Boeing 737 Max 9 planes after a section of the plane blew out midflight on Friday, forcing the crew to make an emergency landing.
    “Each aircraft will be returned to service only after completion of full maintenance and safety inspections,” CEO Ben Minicucci said. “We anticipate all inspections will be completed in the next few days.”

    Alaska Airlines Flight 1282 was heading to Ontario, California from Portland, Oregon, when it returned shortly after departure with 171 passengers and six crew aboard, the airline said.
    Images and video of the new Boeing 737 Max 9 shared on social media showed a gaping hole on the side of the plane and passengers using oxygen masks. It landed back in Portland at 5:26 p.m. local time, according to Flightradar24. It had reached an altitude of 16,325 feet before returning to Portland.
    The National Transportation Safety Board said “no serious injuries” were reported. It is sending a team to Portland to investigate, arriving later on Saturday. The Federal Aviation Administration also said it plans to investigate.
    Transportation Secretary Pete Buttigieg said in a Saturday social media post that he had been briefed on the “terrifying incident” and that the FAA plans to “take all appropriate steps going forward.”
    “While this type of occurrence is rare, our flight crew was trained and prepared to safely manage the situation,” Alaska said.

    The plane was certified in November, according to flight-tracking site FlightAware.

    ‘Explosive decompression’

    Boeing also said it was aware of the incident but declined to comment further.
    “We are working to gather more information and are in contact with our airline customer,” it said in a statement. “A Boeing technical team stands ready to support the investigation.”
    The incident was described as “an explosive decompression at the window exit,” said Sara Nelson, president of the Association of Flight Attendants-CWA, the labor union that represents Alaska’s cabin crew and flight attendants at United, Spirit and other carriers.”Our Union strongly believes this decision [to ground the Max 9 fleet] is a prudent and necessary step toward ensuring the safety of all crew and passengers,” she said in a statement. “We will closely monitor the safety inspection process to ensure that aircraft are not returned to service until they are deemed safe for all.”

    ‘Plugged’ exit door

    The Boeing 737 Max 9 has a cabin exit door behind the wings for use in dense seating cabin configurations, like those used by budget airlines, according to Flightradar24.
    “The doors are not activated on Alaska Airlines aircraft and are permanently ‘plugged,'” Flightradar24 said.
    The airline didn’t immediately respond to a question about the door and Boeing declined to comment beyond its statement.
    United Airlines is preparing to ground dozens of its Boeing 737 Max 9 aircraft for inspections, according to a person familiar with the matter.
    There are 215 Boeing 737 Max 9 planes in service worldwide, according to aviation-data firm Cirium. It had more than 5,000 flights scheduled for this year before the Alaska announcement, Cirium said.
    The Boeing 737 Max 9 is a larger version of Boeing’s best-selling jetliner, the 737 Max 8. Max planes were grounded worldwide in 2019 after two fatal crashes within five months. The U.S. lifted its flight ban of the jets in late 2020 after software and training updates.
    Late last year, Boeing urged airlines to inspect aircraft for a “possible” loose bolt in the rudder control system, the latest in a series of manufacturing flaws on the planes that have prompted additional inspections.
    CORRECTION: Alaska Airlines had about 5,000 flights on the 737 Max 9 scheduled for this year. A previous version mischaracterized the number of flights. More

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    A compact crossover is coming for America’s pickup trucks. Here are the top-selling cars of 2023

    America maintained its love affair with pickup trucks in 2023 — but a top-selling vehicle from Toyota Motor nearly ruined their tailgate party.
    Sales of the Toyota RAV4 compact crossover came within 10,000 units of Stellantis’ Ram pickup truck last year.
    CNBC lays out the top 10 best-selling cars in the U.S. in 2023, from Ford, GM, Tesla and others.

    2023 Ford Super Duty F-350 Limited

    DETROIT – America maintained its love affair with pickup trucks in 2023 — but a top-selling vehicle from Toyota Motor nearly ruined their tailgate party.
    Sales of the Toyota RAV4 compact crossover came within 10,000 units of Stellantis’ Ram pickup truck last year, a near-No. 3 ranking that would have marked the first time since 2014 that a non-pickup claimed one of the top three U.S. sales podium positions.

    The RAV4 has rapidly closed the gap: In 2020, the vehicle undersold the Ram truck by more than 133,000 units. Last year, it lagged by just 9,983. Stellantis sold 444,926 Ram pickups last year, a 5% decline from 2022.
    “Trucks are always at the top because they’re bought by not only individuals, but also fleet buyers and we saw heavy fleet buying last year,” said Michelle Krebs, an executive analyst at Cox Automotive. “The RAV4 shows that people want affordable, smaller SUVs, and the fact that there’s also a hybrid version of that makes it popular with people.”
    At 750,789 units sold, Ford Motor’s F-Series pickups, which include the F-150 and its larger siblings, led the industry for the 42nd consecutive year. They were followed by General Motors’ Chevrolet Silverado pickup with sales of 543,780 units.
    Rounding out the top five were the RAV4 at 434,943 units sold and the Tesla Model Y at 394,497, according to data and sales estimates from Motor Intelligence. (Tesla does not disclose regional sales by vehicle.) The Model Y moved up one position in the rankings compared with 2022.

    Toyota RAV4

    The success of the RAV4 is notable. It aligns with Toyota’s growing lead as America’s second bestselling automaker, behind GM but outselling Ford each year since 2020.

    Toyota first overtook Ford during the coronavirus pandemic and has continued to increase its sales lead since, outpacing the Detroit automaker by more than 250,000 units in 2023.

    The Japanese automaker also notably bested GM to become the country’s top-selling automaker for the first time ever in 2021 amid major production and supply chain disruptions caused by the coronavirus pandemic. GM has since reclaimed its crown and outsold Toyota by hundreds of thousands of vehicles in 2022 and 2023.
    Ivan Drury, director of insights at Edmunds, said the RAV4 as well as the Honda CR-V, which ranked sixth last year in sales, offer something completely different than American pickups: Small, economical vehicles that fit many American’s lifestyles and budgets amid high interest rates and economic uncertainty.
    “It’s all these other problems that we’ve experienced throughout the last year that kind of force people into practical purchases,” he said. “I think these vehicles speak to the most practical purchase you can buy.”

    Overall sales

    New vehicle sales were stronger and more consistent than expected throughout 2023, notching the industry’s best year of sales since 2019.
    Motor Intelligence reports automakers sold 15.6 million vehicles in the U.S. in 2023, a 12.3% increase from 2022. That compares with more than 17 million vehicles sold in 2019 before the coronavirus pandemic upending the global auto market.
    December sales, which were reported this week, were surprisingly strong, as automakers upped incentive spending to move products.
    Auto sales to end the year increased 13% compared with December 2022, more than double some analyst forecasts.
    Automotive analysts and forecasters expect sales this year to be between roughly 15.6 million and 16.1 million vehicles. GM said Wednesday it expects the industry to hit 16 million units sold in 2024.
    Here are the 10 bestselling vehicles in the U.S. by unit sales for 2023, according to Motor Intelligence.

    1. Ford F-Series: 750,789 units – up 14.8% from 2022

     2024 Ford F-150 Raptor

    2. Chevrolet Silverado: 543,780 – up 5.9%

    2024 Chevrolet Silverado HD ZR2

    3. Ram pickup: 444,926 – down 5%

    A RAM vehicle is displayed at the New York Auto Show, April 13, 2022.
    Scott Mlyn | CNBC

    4. Toyota RAV4: 434,943 – up 8.8%

    2024 Toyota RAV4

    5. Tesla Model Y: 394,497 – up 56.5%

    Tesla Model Y
    Courtesy: Tesla

    6. Honda CR-V: 361,457 – up 51.8%

    2023 Honda CR-V

    7. GMC Sierra: 295,737 – up 22.4%

    2022 GMC Sierra 1500 Denali Ultimate

    8. Toyota Camry: 290,649 – down 1.5%

    2022 Toyota Camry

    9. Nissan Rogue: 271,458 – up 45.6%

    2021 Nissan Rogue

    10. Jeep Grand Cherokee: 244,594 – up 9.5%

    Jeep Grand Cherokee Trailhawk PHEV Concept More

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    ESPN star Pat McAfee publicly attacks network executive amid Aaron Rodgers controversy

    Highly paid ESPN host Pat McAfee publicly accused a veteran network executive of trying to “sabotage” his show.
    ESPN isn’t planning a suspension of McAfee at this time but is looking into the host’s comments, according to a person familiar with the matter.
    McAfee’s show drew criticism earlier this week when NFL star Aaron Rodgers incorrectly accused ABC late-night host Jimmy Kimmel of being associated with late sex offender Jeffrey Epstein.
    Both McAfee and Kimmel work for Disney.

    PHOENIX, ARIZONA – FEBRUARY 09: Former NFL player and host Pat McAfee speaks on radio row ahead of Super Bowl LVII at the Phoenix Convention Center on February 9, 2023 in Phoenix, Arizona.
    Mike Lawrie | Getty Images

    ESPN’s Pat McAfee problem is getting more complicated.
    On Friday, the host and former NFL punter publicly attacked longtime ESPN executive Norby Williamson, accusing him of “actively trying to sabotage” him by leaking information to reporters.

    The New York Post reported on McAfee’s relatively low ratings Thursday, noting “since the inception of McAfee’s show on ESPN in the fall, Stephen A. Smith and ‘First Take’ are handing McAfee a 583,000 viewer lead-in, and McAfee is maintaining just 302,000, which is a 48% drop.”
    McAfee implied Williamson may have leaked the idea for the story to New York Post reporter Andrew Marchand. Marchand declined to comment.
    “I believe Norby WIlliamson is the guy who is attempting to sabotage our program,” McAfee said. “I’m not 100% sure. That is just seemingly the only human that has information and then somehow that information gets leaked, and it’s wrong.”
    McAfee didn’t specifically say what information was wrong. Over the years, other ESPN talent have speculated that Williamson has leaked private details, including contract information, according to people familiar with the matter. On Friday, former ESPN journalist Jemele Hill posted on social media platform X “I can relate” with regard to McAfee’s comments about Williamson.
    There’s no evidence Williamson has leaked information. Williamson, who has worked for ESPN for nearly 40 years, declined to comment through an ESPN spokesperson.

    There’s also a contingent of ESPN employees who have grumbled about McAfee’s show and his large contract. McAfee signed a five-year, $85 million contract with ESPN in May.
    ESPN management values the importance of both McAfee and Williamson and is looking into the details of why McAfee denigrated an executive, according to a person familiar with the matter. There is no planned suspension for McAfee, and ESPN hopes to find a path forward for both Williamson and McAfee, according to a person familiar with the matter.
    An ESPN spokesperson declined to comment.
    Earlier this week, McAfee found himself in hot water for providing a platform for New York Jets quarterback Aaron Rodgers to disparage a fellow Disney employee. Rodgers, a frequent guest on McAfee’s show, incorrectly suggested ABC late-night talk show host Jimmy Kimmel would be included in court documents related to late sex criminal Jeffrey Epstein. Kimmel fired back Tuesday, tweeting Rodgers’ “reckless words put [his] family in danger.”
    McAfee later apologized over the Kimmel comments.
    “I could see exactly why Jimmy Kimmel felt the way he felt, especially with his position,” McAfee said Wednesday, noting that Rodgers “did go too far.”
    ESPN on Friday also addressed Rodgers’ comments about Kimmel.
    “Aaron made a dumb and factually inaccurate joke about Jimmy Kimmel. It should never have happened. We all realized that in the moment,” ESPN executive Mike Foss told Front Office Sports.
    The New York Post previously reported that McAfee has paid Rodgers “millions” to appear on his show. The former MVP and Super Bowl champion, who has made hundreds of millions of dollars in the NFL, joined the Jets last year after playing for over a decade with the Green Bay Packers. He missed the season with an Achilles tendon injury.
    A representative for Rodgers didn’t immediately respond to a request for comment. More

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    Coinbase is planning a pivotal acquisition that will allow it to launch crypto derivatives in the EU

    Coinbase told CNBC exclusively that it entered into an agreement to buy an unnamed holding company which holds a Mifid II license.
    With a Mifid II license, Coinbase will be able to begin offering regulated derivatives, like futures, in the EU, in addition to spot trading in bitcoin and other cryptocurrencies which it already offers.
    Derivatives could be a key battleground for Coinbase, accounting for roughly 75% of overall crypto trading volumes.

    LONDON, ENGLAND – NOVEMBER 09: In this photo illustration, a flipped version of the Coinbase logo is reflected in a mobile phone screen on November 09, 2021 in London, England. The cryptocurrency exchange platform is to release its quarterly earnings today. (Photo illustration by Leon Neal/Getty Images)
    Leon Neal | Getty Images News | Getty Images

    Coinbase plans to offer crypto-linked derivatives in the European Union, and it’s planning to acquire a company with a license to do so.
    The U.S. cryptocurrency exchange told CNBC exclusively that it entered into an agreement to buy an unnamed holding company which owns a MiFID II license.

    MiFID II refers to the EU’s updated rules governing financial instruments. The EU updated the legislation in 2017 to address criticism that it was too focused on stocks and didn’t consider other asset classes, like fixed income, derivatives and currencies.
    It’s part of a long-standing ambition by Coinbase to serve professional and institutional customers.
    The company, which began 12 years ago, has been seeking to expand its offering to institutions such as hedge funds and high-frequency trading firms over the last several years, looking to benefit from the much higher sizes of transactions done by these kinds of traders.
    If and when Coinbase completes the deal, the move would mark the first launch of derivatives trading by the company in the EU.
    With a MiFID II license, Coinbase will be able to begin offering regulated derivatives, like futures and options, in the EU. The company already offers spot trading in bitcoin and other cryptocurrencies.

    The deal is subject to regulatory approval and Coinbase expects it will close later in 2024.
    “This license would help expand access to our derivatives products by allowing Coinbase to offer them to eligible European customers in select countries across the EU,” Coinbase said in a blog post, which was shared exclusively with CNBC on Friday.
    “As the industry leader in trusted, compliant products and services, we aim for the highest standards for regulatory compliance, and before operationalizing any license or serving any users, this entity must achieve our Five-point Global Compliance Standard.”

    Coinbase said it would look to adhere to rigorous compliance standards that are upheld in the EU, including requirements related to combating money laundering, customer transparency and sanctions.
    The company said it is committed to ensuring a five-point global compliance standard, supported by a team of more than 400 professionals with experience at agencies including the FBI and Department of Justice.
    “We have a long road ahead before finalizing the acquisition and operationalizing the EU MiFID licensed entity, but this is an exciting step forward in our efforts to expand access to our international derivatives offerings and bring a more global and open financial system to 1 billion people around the world,” Coinbase said in its blog post.

    A key battleground

    Derivatives could be a crucial battleground for Coinbase. According to the company, derivatives make up 75% of overall crypto trading volumes. Coinbase has a long way to go to compete with its larger rival Binance, which is a massive player in the market for crypto-linked derivatives, as well as firms like Bybit, OKX and Deribit.
    According to data from CoinGecko, Binance saw trading volume of more than $56.6 billion in futures contracts in the past 24 hours. That’s seismically larger than the amount of volume done by Coinbase. Its international derivatives exchange did $300 million of futures trading volume in the last 24 hours.
    Coinbase does not currently offer crypto derivatives products in the U.K., where they are prohibited. The Financial Conduct Authority banned crypto-linked derivatives in January 2020, saying at the time they are “ill-suited” for retail consumers due to the harm they pose.
    Coinbase currently offers trading in bitcoin futures and ether futures in the U.S., and bitcoin futures, ether futures, “nano” ether futures and West Texas Intermediate crude oil futures in markets outside the U.S.
    Derivatives are a type of financial instrument that derive their value from the performance of an underlying asset.
    Futures are derivatives that allow investors to speculate on what an asset will be worth at a later point in time. They’re generally considered riskier than spot markets in digital assets given the notoriously volatile nature of cryptocurrencies like bitcoin, and the use of leverage, which can significantly amplify gains and losses.

    The company made its first move into derivatives in May, with the launch of an international derivatives exchange in Bermuda. And the company debuted crypto derivatives in the U.S. in November after receiving regulatory approval from the National Futures Association.
    Coinbase had reportedly considered acquiring FTX Europe, the European entity of the now-collapsed crypto venue, but subsequently shelved the idea, according to reporting from Fortune. CNBC has not been able to independently verify Fortune’s reporting.

    Expanding beyond U.S.

    The move into derivatives continues Coinbase’s expansion drive in markets outside of the U.S.
    Coinbase has been aggressively chasing international expansion in the past year as it faces a tougher time at home. The company is the target of a U.S. Securities and Exchange Commission lawsuit alleging it violated securities laws.
    In October, the firm picked Ireland as its primary regulatory base in the EU ahead of an incoming package of crypto laws known as Markets in Crypto-Assets (MiCA), and submitted an application for a single MiCA license, which it hopes to obtain by December. 2024 when the rules are slated to be fully applied.
    Coinbase also recently obtained a virtual asset service provider license from France, which gives it permission to offer custody and trading in crypto assets in the country. More

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    Eli Lilly’s direct drug sales alone may not upend the industry, but others could follow suit

    Eli Lilly is shaking up the pharmaceutical industry with a new website offering telehealth prescriptions and direct home delivery of certain drugs, such as weight loss treatments, to expand patient access.
    The company’s direct-to-consumer push won’t necessarily upend the pharmaceutical industry and the traditional prescription drug supply chain, according to some analysts. 
    But other drugmakers could follow suit with their own direct-to-consumer models and add pressure on what critics call a complex pharmaceutical industry.

    Sopa Images | Lightrocket | Getty Images

    Eli Lilly is shaking up the pharmaceutical industry with a new website offering telehealth prescriptions and direct home delivery of certain drugs, including its red-hot weight loss treatment Zepbound, to expand patient access. 
    The company’s direct-to-consumer push announced Thursday, the first of its kind for a big drugmaker, won’t necessarily upend the pharmaceutical industry and the prescription drug supply chain alone, according to some analysts.

    But other drugmakers could follow suit with their own direct-to-consumer models, according to some analysts. That could add more pressure on what many critics call a complex system for distributing, pricing and prescribing drugs in the U.S. — a structure they say has led to higher prices and fewer choices for patients.
    “There’s always a possibility for disruption. I think you should never rule out any sort of disruption,” BMO Capital Markets analyst Evan Seigerman told CNBC. “I don’t think that is necessarily happening tomorrow, but I think that you should never assume that things can’t change.”
    Lilly’s new platform comes as other companies move to disrupt the drug system in some way, in part as they face more political pressure to cut consumer costs and increase pricing transparency.
    Those actions come as lawmakers target drug supply chain middlemen in new legislation and as the Biden administration takes its own steps to rein in prices of medications, such as by giving Medicare the power to negotiate down drug prices for the first time in its six-decade history.
    Eli Lilly said its new effort — dubbed LillyDirect — aims to increase access to medicines for chronic diseases, including the highly popular weight loss drugs. 

    Those treatments, which have soared in demand over the last year as they help patients shed unwanted pounds, are plagued by supply constraints and concerns about potentially harmful knockoffs. Patients also face long waitlists to meet with obesity medicine specialists who can prescribe the drugs to them, a problem Eli Lilly hopes to address, according to Seigerman.
    Eli Lilly’s Zepbound won Food and Drug Administration approval just two months ago, but some analysts say it could garner more than $1 billion in sales in its first year on the market.

    LillyDirect won’t significantly disrupt the industry

    Eli Lilly’s site eliminates the need for a patient to visit the doctor’s office to get a prescription and, in some cases, for a pharmacy to fill it. 
    But some analysts said Eli Lilly’s site alone will not significantly threaten the traditional drug distribution system, which involves a multitiered network of manufacturers, drug wholesalers, pharmacies and pharmacy benefit managers, or PBMs.
    “I don’t think PBMs and the whole infrastructure that we have are going anywhere,” Seigerman told CNBC. “I think what [Eli Lilly] really did was identify some friction points in getting these products [weight loss drugs] to patients, and they’re coming up with a way to solve for that.” 
    “From my understanding, it’s just that there’s no retail pharmacy where a patient is having to go hunt for that particular [drug] dose, it’s being shipped right to them,” he said of Eli Lilly’s services.
    Eli Lilly’s site connects patients with an independent telehealth provider who can prescribe any FDA-approved weight loss drug or other medications for diabetes and migraines. If the prescribed treatment is Eli Lilly’s, the patient can have a third-party online pharmacy deliver it to their door. 
    Patients will also receive Eli Lilly’s discounts for drugs if they qualify for the company’s savings-card programs, the company noted in a release. One program allows people with insurance coverage for Zepbound, which costs more than $1,000 per month, to pay as little as $25 out-of-pocket. Meanwhile, those whose insurance does not cover the drug may be able to pay as low as $550.
    Some experts view that transparent pricing as a shot across the bow to PBMs, the largest of which are owned by CVS, UnitedHealth Group and Cigna.
    Drugmakers have long complained that they give PBMs steep drug discounts in exchange for higher placement on a formulary — an insurance plan’s list of preferred medications — only for those middlemen to not pass along savings to patients. 
    But Eli Lilly’s savings-card program and new site won’t cut PBMs out of the equation.
    “If you still use your health insurance to get these drugs through [Eli Lilly’s] website, it’s still going to get processed by a PBM,” Jeff Jonas, a Gabelli Funds portfolio manager, told CNBC.
    Patients who get drugs such as Zepbound from Eli Lilly’s site can choose to pay with cash to avoid PBMs altogether. But Bernstein analysts said in a Thursday note that they expect the “vast majority” of potential weight loss drug users to get medications through insurance. 

    Other drugmakers could follow Eli Lilly

    More pharmaceutical companies could adopt a similar approach to Eli Lilly’s.  
    Cantor Fitzgerald analyst Louise Chen said drugmakers could benefit the most from using a direct-to-consumer pharmacy model for high-selling drugs.
    “Cause of the scale of your effort, it [would] probably make sense for bigger drugs,” Chen wrote in an email to CNBC. “You get more bang for the buck and you are reaching more people.”
    But Chen said it may be more difficult for a drugmaker to pursue a direct-to-consumer model with smaller, more specialized drugs, such as treatments for complex, chronic, or rare medical conditions. For example, some drugs require specialized training for administration, such as injecting or infusing a therapy into a patient’s vein through an IV. 
    Drugmakers that do adopt a direct-to-consumer approach could add even more pressure on the nation’s traditional drug supply chain after other companies moved to simplify the system in recent months.
    That includes CVS Health, which announced plans to overhaul its business model for pricing prescription drugs in December, adopting a model similar to billionaire Mark Cuban’s direct-to-consumer pharmacy, Cost Plus Drugs. Health-care giant Cigna also announced in November that its PBM will offer a pricing model similar to Cuban’s venture.
    Cost Plus Drugs aims to drive down the price of medicines broadly by selling them at a set 15% markup over their cost, plus pharmacy fees.
    That company is already shaking up the broader health-care industry: CVS suffered a blow over the summer when a major California health insurer, Blue Shield of California, announced it will no longer use the company as its PBM and instead will partner with several other businesses, including Cuban’s firm and Amazon Pharmacy.  More

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    Florida wins first FDA approval to import cheaper drugs from Canada

    The U.S. Food and Drug Administration approved Florida’s plan to import cheaper prescription drugs from Canada.
    The agency’s greenlight is a first-in-the-nation move that faces fierce opposition from the pharmaceutical industry but could reduce costs for Americans. 
    But Florida’s newly approved plan will likely face hurdles before it takes effect, including potential lawsuits from the pharmaceutical industry.

    Pharmacist Thomas Jensen looks over a prescription drug at the Rock Canyon Pharmacy in Provo, Utah, on May 9, 2019.
    George Frey | Reuters

    The U.S. Food and Drug Administration on Friday approved Florida’s plan to import cheaper prescription drugs from Canada, a first-in-the-nation move that could reduce costs for Americans but faces fierce opposition from the pharmaceutical industry.
    The regulator also said it was committed to working with other states seeking to import drugs from Canada. 

    The FDA’s approval of Florida’s plan is a significant stride forward in a broader, yearslong effort to rein in drug costs in the U.S. Patients shell out significantly more for medicines than they do in Canada and some other countries.
    Drug importation could open up a new and cheaper source of drugs beyond the retail and mail-order pharmacies that Americans typically rely on to fill prescriptions. 
    Along with Florida, other states such as Colorado, North Dakota and Vermont have their own drug importation plans in place, which will require FDA approvals. More than five states have asked the agency to greenlight their programs, according to the National Conference of State Legislatures.
    But Florida’s newly approved plan will likely face hurdles before it takes effect, including potential lawsuits from the pharmaceutical industry.
    Drugmakers have long argued that importation may introduce counterfeit medicines into the U.S. supply chain and harm patients — a concern the FDA previously raised because the agency can’t guarantee the safety of those drugs.

    However, the FDA’s Friday approval appears to have guardrails that aim to mitigate potential safety issues. 
    Before Florida can distribute Canadian drugs, the state must send the FDA details on the medications it plans to import, ensure that those treatments are not counterfeit or ineffective and relabel those drugs to be consistent with FDA-approved labeling. 
    Florida must also submit quarterly reports to the agency about cost savings and potential safety issues, among other obligations. The FDA’s approval allows Florida to import drugs for two years from the date of the first drug shipment. 
    “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Robert Califf said in a statement. 
    The pharmaceutical industry pushed back on the FDA’s move on Friday. 
    Pharmaceutical Research and Manufacturers of America, the industry’s biggest lobbying group, called the FDA’s approval of Florida’s plan “reckless” and said it is considering “all options for preventing this policy from harming patients.”
    “Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health,” Stephen Ubl, CEO of PhRMA, said. “Politicians need to stop getting between Americans and their health care.”
    The group sued the FDA in 2020 over a Trump administration plan to import Canadian drugs, but that lawsuit was later dismissed. 
    President Joe Biden issued an executive order in July 2021 that included a call for the FDA to work with states on plans for importing drugs from Canada.Don’t miss these stories from CNBC PRO: More

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    Cryptocurrency investors eagerly awaiting SEC ruling on bitcoin ETFs

    Omar Marques | Lightrocket | Getty Images

    Crypto investors are eagerly awaiting an imminent ruling from the U.S. Securities and Exchange Commission that will likely approve the trading of a spot bitcoin exchange-traded fund, more than a decade after initial attempts were rejected. 
    13 companies have filed for a spot bitcoin ETF: 

    Grayscale Bitcoin Trust
    Ark/21Shares Bitcoin Trust
    Bitwise Bitcoin ETF Trust
    BlackRock Bitcoin ETF Trust
    VanEck Bitcoin Trust
    WisdomTree Bitcoin Trust
    Valkyrie Bitcoin Fund
    Invesco Galaxy Bitcoin ETF
    Fidelity Wise Origin Bitcoin Trust
    Global X Bitcoin Trust
    Hashdex Bitcoin ETF
    Franklin Templeton Digital Holdings Trust
    Pando Asset Spot Bitcoin Trust

    How the SEC will proceed

    There are two components to the applications:
    1) A 19b-4 filing, which is a form used by exchanges to inform the SEC of a proposed rule change. In this case, a rule change is required under the Securities Exchange Act of 1934 because a spot bitcoin ETF is a new product, and the exchanges — NYSE, Nasdaq and Cboe — must provide rules to explain how the product will trade. The SEC must approve the rule changes before the product can trade.  This is the filing that is facing a deadline of Jan. 10 for the Ark/21Shares Bitcoin Trust. 
    2) Approval of S-1. This is a filing to register a new security with the SEC, in a document that provides information about the specific security. In this case, each company filing for the spot bitcoin ETF has differences in the way the product might be structured. In the case of the Grayscale Bitcoin Trust, an S-3 filing must be approved, which is a simplified security registration form for businesses that have met other reporting requirements. 
    It’s widely anticipated that once the 19b-4 filings are approved, the SEC will separately approve the S-1 applications of all the ETF applicants at once. However, because the applications are different, that is not a slam dunk. The SEC may decide to approve some, but not all, of the S-1s. 
    Wide spread in fee 
    With 13 companies filing for a bitcoin ETF, all of which are similar products, there is substantial interest in what the fee structure will look like. 

    Fidelity’s Wise Origin Bitcoin Fund has announced it will charge 39 basis points, or 0.39%. Invesco’s Galaxy Bitcoin ETF has set its expense ratio at 59 basis points, which are waived for the initial six months and the first $5 billion in assets. Ark/21Shares and Valkyrie will charge 80 basis points. 
    Grayscale Bitcoin Trust currently charges 2% but has said it’s committed to lowering the fee once its application to convert to a bitcoin ETF is approved. 
    Other applicants have not yet announced their fee structure. 
    It is unclear who the main regulator of the crypto industry is
    All this happens against the backdrop of SEC Chair Gary Gensler’s long-running fight with the crypto industry. 
    Gensler has fought several court battles against major crypto players, including a losing battle against Grayscale Bitcoin Trust, which won a case against the SEC last summer. In that case, the U.S. Court of Appeals for the D.C. Circuit ruled that the SEC had already approved a futures-based bitcoin product and that it failed to explain why it had refused to approve a spot-bitcoin product. The court said, in essence, the futures and the spot market are “like” products. If the SEC approved one, it logically had to approve the other. 
    Bitcoin has been ruled to be a commodity, but with the exception of ether, there are no such rulings on other cryptocurrencies. In the absence of clear federal rules, the SEC has taken to regulation by enforcement to demonstrate that many cryptocurrencies are securities, and it therefore has regulatory authority over much of the crypto industry. 
    There is an outstanding case against Coinbase, the largest U.S. crypto exchange, where the SEC alleges that the company violated rules requiring it to register as an exchange. In that case, the SEC has alleged that some of the crypto assets traded on Coinbase are securities and fall under the SEC’s purview. 
    The SEC sued Binance and its founder Changpeng Zhao last June, alleging that Binance and Zhao “engaged in an extensive web of deception, conflicts of interest, lack of disclosure, and calculated evasion of the law,” according to Gensler.
    The case is ongoing, but in November, the U.S. Department of Justice settled different charges against Binance and Zhao, wherein Zhao pleaded guilty to money laundering violations and agreed to pay a $50 million fine and step down from his role as the company’s chief executive. Binance also accepted the appointment of a government monitor to oversee the business. 
    ARK Invest’s Cathie Wood will be our guest on “Halftime Report” at 12:35 p.m. Monday, and on “ETF Edge” on Monday at 1:10 p.m.-1:30 p.m. ET on ETFEdge.cnbc.com. More