Uber and Lyft drivers use Teslas as makeshift robotaxis, raising safety concerns

 A self-driving Tesla carrying a passenger for Uber rammed into an SUV at an intersection in suburban Las Vegas in April, an accident that sparked new concerns that a growing stable of self-styled "robotaxis" is exploiting a regulatory gray area in U.S. cities, putting lives at risk.

Tesla CEO Elon Musk aims to show off plans for a robotaxi, or self-driving car used for ride-hailing services, on Oct. 10, and he has long contemplated a Tesla-run taxi network of autonomous vehicles owned by individuals.

Do-it-yourself versions, however, are already proliferating, according to 11 ride-hail drivers who use Tesla's Full Self-Driving (FSD) software. Many say the software, which costs $99 per month, has limitations, but that they use it because it helps reduce drivers' stress and therefore allows them to work longer hours and earn more money.

Reuters is first to report about the Las Vegas accident and a related inquiry by federal safety officials, and of the broad use by ride-hail drivers of Tesla autonomous software.

While test versions of self-driving cabs with human backup drivers from robotaxi operators such as Alphabet's Waymo and General Motors' Cruise are heavily regulated, state and federal authorities say Tesla drivers alone are responsible for their vehicles, whether or not they use driver-assist software. Waymo and Cruise use test versions of software categorized as fully autonomous while Tesla FSD is categorized as a level requiring driver oversight.

The other driver in the April 10 Las Vegas accident, who was taken to the hospital, was faulted for failing to yield the right of way, according to the police report. The Las Vegas Tesla driver, Justin Yoon, said on YouTube the Tesla software failed to slow his vehicle even after the SUV emerged from a blind spot created by another vehicle.

Yoon, who posts YouTube videos under the banner "Project Robotaxi," was in the driver's seat of his Tesla, hands off the wheel, when it entered the intersection in a suburban part of Las Vegas, according to footage from inside the car. The Tesla on FSD navigated the vehicle at 46 mph (74 kph) and did not initially register a sport-utility vehicle crossing the road in front of Yoon. At the last moment, Yoon took control and turned the car into a deflected hit, the footage shows.

"It's not perfect, it'll make mistakes, it will probably continue to make mistakes," Yoon said in a post-crash video. Yoon and his passenger suffered minor injuries and the car was totaled, he said.

Yoon discussed using FSD with Reuters before he publicly posted videos of the accident but did not respond to requests for comment afterward.

Tesla did not respond to requests for comment. Reuters was unable to reach the Uber passenger and other driver for comment.

Ride-hailing companies Uber and Lyft responded to questions about FSD by saying drivers are responsible for safety.

Uber, which said it was in touch with the driver and passenger in the Las Vegas accident, cited its community guidelines: "Drivers are expected to maintain an environment that makes riders feel safe; even if driving practices don't violate the law."

Uber also cited instructions by Tesla which alert drivers who use FSD to have their hands on the wheel and be ready to take over at any moment.

Lyft said: "Drivers agree that they will not engage in reckless behavior."

GRAND AMBITIONS

Musk has grand plans for self-driving software based on the FSD product. The technology will serve as the foundation of the robotaxi product software, and Musk envisions creating a Tesla-run autonomous ride service using vehicles owned by his customers when they are not otherwise in use.

But the drivers who spoke to Reuters also described critical shortcomings with the technology, including sudden unexplained acceleration and braking. Some have quit using it in complex situations such as airport pickups, navigating parking lots and construction zones.

"I do use it, but I'm not completely comfortable with it," said Sergio Avedian, a ride-hail driver in Los Angeles and a senior contributor on "The Rideshare Guy" YouTube channel, an online community of ride-hailing drivers with nearly 200,000 subscribers. Avedian avoids using FSD while carrying passengers. Based on his conversations with fellow drivers on the channel, however, he estimates that 30% to 40% of Tesla ride-hail drivers across the U.S. use FSD regularly.

FSD is categorized by the federal government as a type of partial automation that requires the driver to be fully engaged and attentive while the system performs steering, acceleration and braking. It has come under increased regulatory and legal scrutiny with at least two fatal accidents involving the technology. But using it for ride-hail is not against the law.

"Ride-share services allow for the use of these partial automation systems in commercial settings, and that is something that should be facing significant scrutiny," Guidehouse Insights analyst Jake Foose said.

The U.S. National Highway Traffic Safety Administration said it was aware of Yoon's crash and had reached out to Tesla for additional information, but did not respond to specific questions on additional regulations or guidelines.

Authorities in California, Nevada and Arizona, which oversee operations of ride-hail companies and robotaxi companies, said they do not regulate the practice as FSD and other such systems fall out of the purview of robotaxi or AV regulation. They did not comment on the crash.

Uber recently enabled its software to send passenger destination details to Tesla's dashboard navigation system - a move that helps FSD users, wrote Omar Qazi, an X user with 515,000 followers who posts using the handle @WholeMarsBlog and often gets public replies from Musk on the platform.

"This will make it even easier to do Uber rides on FSD," Qazi said in an X post.

Tesla, Uber and Lyft do not have ways to tell that a driver is both working for a ride-hailing company and using FSD, industry experts said.

While almost all major automakers have a version of partial automation technology, most are limited in their capabilities and restricted for use on highways. On the other hand, Tesla says FSD helps the vehicle drive itself almost anywhere with active driver supervision but minimal intervention.

"I'm glad that Tesla is doing it and able to pull it off," said David Kidd, a senior research scientist at the Insurance Institute for Highway Safety. "But from a safety standpoint, it raised a lot of hairs."

Instead of new regulations, Kidd said NHTSA should consider providing basic, nonbinding guidelines to prevent misuse of such technologies.

Any federal oversight would require a formal investigation into how ride-hail drivers use all driver-assistance technology, not just FSD, said Missy Cummings, director of the George Mason University Autonomy and Robotics center and a former adviser to NHTSA.

"If Uber and Lyft were smart, they'd get ahead of it and they would ban that," she said.

Meanwhile, ride-hail drivers want more from Tesla. Kaz Barnes, who has made more than 2,000 trips using FSD with passengers since 2022, told Reuters he was looking forward to the day when he could get out of the car and let Musk's network send it to work.

"You would just kind of take off the training wheels," he said. "I hope to be able to do that with this car one day."

https://finance.yahoo.com/news/uber-lyft-drivers-teslas-makeshift-100426649.html

'Hurricane Helene exposes FEMA assistance gap in Appalachian areas'

 As residents of western North Carolina piece together their lives following Hurricane Helene, few will be able to rely on federal flood insurance to help them rebuild.

Roughly 1 in 200 single-family homes in the region is covered by the National Flood Insurance Program (NFIP), according to a Reuters analysis of federal government data – a far lower level of coverage than can be found in the coastal and riverside neighborhoods the program was designed to serve.

That is because the federal program is focused on the flood risks posed only by rising seas and swelling rivers, not the threat posed by the sort of extreme rainfall brought on by Helene.

The storm dumped more than 35 centimeters (14 inches) of rain over three days onto western North Carolina, transforming mountainsides into mudslides and creeks into torrents.

"It's horrendous," said Aaron Smith, who said he was trying to figure out where to take his family after his home in the hamlet of Bat Cave was destroyed. "I don't see anything to go back to."

RISING RAIN RISKS

Asheville, the largest city in the flood-hit region, had in recent years developed a reputation as a climate refuge, drawing residents from more storm-prone areas.

Among the new arrivals: the federal government, which moved its national data center for environmental records there in 2015. The facility was knocked offline by Helene.

Private insurance companies see the area as relatively safe. The industry asked state regulators earlier this year to approve a 99% rate increase for coastal areas, but sought only a 4% hike for some of the mountain counties hit by the storm.

Helene has shown no place is immune to climate impacts, said Jesse Keenan, a Tulane University professor who studies climate migration. "There's no such place as a climate haven," he said.

Private insurers generally do not offer flood coverage. Instead, homeowners and businesses in flood-prone areas turn to the NFIP, which insures 4.7 million properties nationwide.

Heavy rainfall events, such as the one brought by Helene, are likely to become even more damaging with climate change as warmer air can hold more moisture.

Since 1900, precipitation in the United States has increased along with rising temperatures, according to the Environmental Protection Agency, and that rain and snow has increasingly fallen in intense bursts.

Mountain areas can be especially vulnerable to rain-triggered floods. A summer storm that lashed eastern Kentucky for four days in 2022 dropped up to 10 centimeters of rain per hour. The resulting floods swept away homes and killed 39 people.

Despite the growing rainfall risks, the Federal Emergency Management Agency does not consider the risk of rain-induced flooding when it draws up maps that show where people must buy flood insurance in order to qualify for a federally backed home loan. Instead, agency scientists examine patterns of river flooding and coastal storm surges.

As a result, few residents outside of coastal or riverside areas are required to buy flood insurance.

The agency said that approach is set by law and said its maps should not be viewed as a prediction of where flooding will occur. "Where it can rain it can flood," FEMA press secretary Daniel Llargues said.

The mismatch between coverage and exposure is especially stark in Appalachia, where rainfall – not ocean waves – poses the biggest flooding threat and steep mountainsides funnel rainwater into narrow river valleys, said climate scientist Jeremy Porter at First Street risk consultancy.

"That Appalachian region actually becomes the poster child for unknown flood risks across the country," he said.

According to a Reuters analysis of First Street data, 16% of all residential and commercial properties in the 25 North Carolina counties most affected by the storm stood a one in four chance of flooding within 30 years – the same criteria used by FEMA to designate a flood zone.

Roughly 41% of all properties in North Carolina's coastal areas face the same risk.

Federal flood coverage also varies widely by region.

While 43% of single-family homes in North Carolina's coastal Dare County had NFIP policies, just 0.5% of homes had coverage in the western counties hardest hit by Helene, according to a Reuters analysis of federal flood insurance data and census data compiled by the University of Minnesota.

That reflects the fact that FEMA's maps do not account for rainfall -- leaving residents in mountainous areas unaware of their risk, said Carolyn Kousky, an economist at the Environmental Defense Fund.

FEMA should update its maps to reflect that risk, she said.

A 2022 survey by Fannie Mae found that only 37% of residents living in a flood plain knew they faced a high flood risk.

Residents affected by Helene who do not have that flood coverage will be able to apply for up to $30,000 in federal disaster aid, as well as loans from the Small Business Administration - though those can make up only a fraction of the $250,000 worth of coverage available through the federal flood program.

Some community leaders are already grappling with the expense of rebuilding.

"What I worry about is the cost and the time that's going to be needed to restore this community," Asheville Mayor Esther Manheimer told Reuters on Tuesday.

https://finance.yahoo.com/news/hurricane-helene-exposes-federal-assistance-100955771.html

Scott, Rounds Probe NY Fed’s Reported Fail to Prevent Funds Flow to Iran, Terror Proxies

 Ranking Member Tim Scott (R-S.C.) and fellow Senate Banking Committee member, Senator Mike Rounds (R-S.D.), are demanding answers following reports that the Federal Reserve Bank of New York (NY Fed) failed to implement basic anti-money laundering controls on account relationships with the Central Bank of Iraq, resulting in potentially billions of dollars flowing to Iran and its terror proxies. Ranking Member Scott and Senator Rounds called out the NY Fed and Federal Reserve System, organizations instrumental to crafting and implementing Bank Secrecy Act (BSA) and Anti-Money Laundering (AML) laws on the U.S. banking system, for failing to apply the same standards and expectations to their own operations.

In a letter to the leaders of the Federal Reserve Bank of New York and the Board of Governors of the Federal Reserve System, Scott and Rounds write, “According to the report and U.S. officials, ‘as much as 80% of the more than $250 million in dollar wire transfers flowing through them [the Iraqi banks] on some days were untraceable and some portion of that amount went secretly to Iran’s Islamic Revolutionary Guard Corps and the anti-U.S. militias it supports.’ If accurate, this would represent one of the single greatest failures of the U.S. financial regulatory regime.”

The senators continue, “… for over two decades, the NY Fed processed wire transfers and transactions originating from private banks in Iraq to various banks across the globe without conducting or requiring basic Bank Secrecy Act (BSA) and Anti-Money Laundering (AML) ‘know your customer’ compliance. Reportedly, these transactions were facilitated without any disclosure of where the funds originated or the intended recipients—which if true, is astounding. As you know, if these actions were carried out by a commercial bank, the bank and its executives would likely be subject to severe civil and criminal penalties, including permanent closure.”

The letter requests detailed answers on the reporting and on steps the institutions are taking to address these failures. To read the questions and the full letter, click HERE.

BACKGROUND:

Ranking Member Scott has conducted rigorous oversight over the flow of funds to Iran and its terror proxies, particularly following the October 7, 2023, attack on Israel by Hamas. Ranking Member Scott has taken the following actions with regards to Iran:

• Immediately following the Biden-Harris administration’s August 2023 decision to release $6 billion to Iran, Ranking Member Scott led his colleagues in demanding answers from the administration.
• After the October 7, 2023, attack on Israel by Hamas, Ranking Member Scott called for Treasury Secretary Janet Yellen to testify on the release of the $6 billion and for the Senate to investigate the matter.
• Following the attacks, Ranking Member Scott introduced the Revoke Iranian Funding Act (RIFA), a bipartisan bill to permanently freeze $6 billion released by the Biden administration to Iran and direct the Treasury Secretary to provide Congress with the information it needs to prevent Iran from accessing and using sanctioned funds. He also led the Solidify Iran Sanctions Act to permanently extend key sanctions targeted to stop Iran’s malign activity, including the pursuit of nuclear weapons.
• The reporting requirement in RIFA was signed into law as part of the national security supplemental in April 2024.
• Last November 2023, following a wave of attacks on U.S. forces and the Biden administration’s decision to extend an Iran sanctions waiver to allow Iraq to pay Iran for electricity, Ranking Member Scott led a group of 24 senators criticizing the administration’s lack of a cohesive Iran strategy.
• In April 2024, in response to the Biden-Harris administration’s decision to release yet another Iran sanctions waiver potentially worth billions of dollars, Ranking Member Scott led 13 Republican senators in a letter to Treasury Secretary Janet Yellen and Secretary of State Antony Blinken raising concerns that the waiver makes sanctioned Iranian funds, which could be used to fund terrorism, more accessible to the Iranian regime and disregards congressional intent calling for severe restrictions on payments to Iran.
• After Treasury Deputy Secretary Wally Adeyemo admitted in testimony before the Senate Banking Committee that any dollar Iran has access to funds terrorism, Ranking Member Scott sent a letter to Treasury Secretary Janet Yellen requesting an accounting of all international high-value Iranian assets around the world that are currently blocked by U.S. sanctions and to provide additional steps Treasury will take to actively account for current funds that have already been released to Iran.

https://www.banking.senate.gov/newsroom/minority/scott-rounds-demand-answers-on-ny-feds-reported-failure-to-prevent-funds-flowing-to-iran-terror-proxies

Biotech Septerna files for a $100 million IPO

 Septerna, a Phase 1 biotech targeting GPCRs in multiple therapeutic areas, filed on Wednesday with the SEC to raise up to $100 million in an initial public offering.

Septerna is developing orally-available small molecule drugs targeting G protein-coupled receptors (GPCRs). The company's lead and sole clinical-stage program is SEP-786, a small molecule parathyroid hormone 1 receptor (PTH1R) agonist currently enrolling in a Phase 1 trial in patients with the rare endocrine disease hypoparathyroidism, with topline data expected in mid-2025. The company is also developing, SEP-631, a MRGPRX2 negative allosteric modulator (NAM) for the treatment of chronic spontaneous urticaria (CSU) that is currently conducting IND-enabling studies, as well as preclinical programs in thyroid and metabolic diseases. 

The South San Francisco, CA-based company was founded in 2019 and plans to list on the Nasdaq under the symbol SEPN. J.P. Morgan, TD Cowen, Cantor Fitzgerald, and Wells Fargo Securities are the joint bookrunners on the deal. No pricing terms were disclosed.

Relevant Profile: SEPN

https://www.renaissancecapital.com/IPO-Center/News/107029/GPCR-focused-biotech-Septerna-files-for-a-$100-million-IPO

Eton to Acquire Increlex® (mecasermin injection) from Ipsen

 Aligns with Eton's Mission to Develop and Distribute Medicines that Have a Life Changing Impact for Patients with Ultra-rare Conditions

Acquisition to Bolster Eton’s Commercial Pediatric Endocrinology Portfolio

https://www.globenewswire.com/news-release/2024/10/03/2957549/0/en/Eton-Pharmaceuticals-Inc-to-Acquire-Increlex-mecasermin-injection-from-Ipsen.html

Harrow Relaunches TRIESENCE Ophthalmic Product

 Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, announced the relaunch of TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative‑free synthetic corticosteroid that is approved by the U.S. Food and Drug Administration (FDA) for visualization during vitrectomy and for the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids.

In commenting on the announcement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “We are very excited to have brought TRIESENCE back to the U.S. market, providing ophthalmologists access to a trusted FDA-approved product that has benefited millions of Americans. Accomplishing this required rebuilding the entire TRIESENCE supply chain and involved a global collaboration between Harrow and technical experts from our partners around the world. We are grateful for this team’s dedication and commitment, without which we would not have achieved this success.”

In response to Harrow’s relaunch of TRIESENCE, Dr. Rishi Singh, MD, an ophthalmologist and vitreoretinal surgeon of Cleveland Clinic Florida, remarked, “An FDA-approved, preservative-free corticosteroid is critical for office-based and surgical procedures. TRIESENCE is a pharmaceutically elegant injectable suspension that appears as a white backdrop against the back of the retina, enabling a higher degree of visibility of the vitreous and pathologic membranes during vitrectomy. It has long been a trusted, indispensable resource, and its absence has left many ophthalmologists and retina specialists without a reliable alternative.

“The relaunch of TRIESENCE, following more than five years on the FDA Drug Shortage List and two years of inventory depletion, brings much-needed relief for both eyecare professionals and their patients. During its absence, many were forced to adapt with less ideal, off-label solutions such as modifying preserved Kenalog-40, which posed potential risks. Now that TRIESENCE is back, we can confidently provide safer, more effective treatment, improving surgical outcomes and patient care.”

https://www.businesswire.com/news/home/20241003460620/en

CMS readies changes for 2nd round of drug price negotiation program

 The Centers for Medicare & Medicaid Services (CMS) rolled out guidance Oct. 2 as stakeholders prep for the second round of the drug price negotiation program.

Made possible through the Inflation Reduction Act, the federal government has praised the program, saying it drastically lowers the cost of lifesaving drugs.

The negotiation period for the first round of 10 drugs ended in August, with the new prices set to go into effect Jan. 1, 2026. The feds anticipate the first round of negotiations will save people $1.5 billion in out-of-pocket costs in 2026.

CMS will announce the next round, this time selecting 15 drugs, by Feb. 1. Those prices will be effective starting Jan. 1, 2027.

To build on the program, CMS will work with a Medicare Transaction Facilitator to ensure Medicare beneficiaries and pharmacies have access to maximum fair prices. Drug manufacturer participation is voluntary.

The agency will host monthly technical calls for pharmacies, as already done for Part D plans and drug companies. CMS will also hold 15 patient-focused roundtables and one town hall meeting to receive clinical feedback regarding the selected drugs, according to a news release.

“We are continuing to implement the prescription drug law thoughtfully, prioritizing engagement with all interested parties, and ensuring the process is as transparent and inclusive as possible,” said Meena Seshamani, M.D., Ph.D., deputy administrator for CMS, in a statement. “As we approach the second cycle of negotiations, we continue to focus on ensuring people with Medicare prescription drug coverage have access to the innovative cures and therapies they need at prices they can afford.”

The CMS guidance instructs drug companies, health plans, pharmacies and mail-order services how they must adhere to price requirements starting in 2026 using the Medicare Transaction Facilitator.

Last year’s negotiation process between drug companies and the government will remain similar. However, CMS is allowing additional offers and counteroffers if CMS rejects the manufacturer’s first counteroffer.

“CMS believes these revisions to the negotiation process provide further opportunities for productive exchanges between CMS and participating drug companies throughout the negotiation period,” a fact sheet (PDF) said.

Pharma companies, incensed by the government's ability to negotiate drugs, have taken the feds to court in a number of lawsuits. Those efforts have been largely unsuccessful so far.

https://www.fiercehealthcare.com/payers/cms-readies-changes-second-round-drug-price-negotiation-program