Press release from the Humboldt County Sheriff’s Office:

On Jan. 13, deputies with the Humboldt County Sheriff’s Office Marijuana Enforcement Team (MET) served a search warrant in the 200 block of Cougar Rd. in Shelter Cove. The warrant service was the culmination of a month-long investigation initiated after deputies intercepted a parcel containing multiple pounds of processed marijuana being shipped out of state.

During the investigation, Fredrick Hoss, 60, of Shelter Cove, was identified as the individual who sent the package. Hoss was on scene at the time of the warrant service and found to be in possession of a firearm, 10g of methamphetamine, and 15 lbs. of marijuana being processed for sales.

Hoss was arrested and booked into the Humboldt County Correctional Facility on the following charges:

• Felon in possession of a firearm—PC 29800(a)(1)
• Prohibited person in possession of ammunition—PC 30305(a)(1)
• Maintaining a drug house—H&S 11366.5
• Possession of methamphetamine—H&S 11377
• Possession of marijuana for sale—H&S 11359

Anyone with information about this case or related criminal activity is encouraged to call the Humboldt County Sheriff’s Office at (707) 445-7251 or the Sheriff’s Office Crime Tip line at (707) 268-2539.

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CORRECTION: Hoss was not actually booked into jail on the struck-through charge above — apparently due to an administrative oversight, according to Sheriff’s Office public information officer Meghan Ruiz. Ruiz said that the office will ask the District Attorney’s Office to add the charge if/when those charges are filed in court.

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With less than one week before President-elect Donald J. Trump returns to the White House, local leaders and human rights advocates are bracing for what could be the “largest mass deportation campaign” in U.S. history. The anticipated crackdown on immigration enforcement has triggered panic in undocumented communities, fueling rampant misinformation on social media and false reports of U.S. Immigration and Customs Enforcement (ICE) sweeps in dozens of California cities, including Eureka.

A post making the rounds on social media claims ICE “showed up at Winco in Eureka” on Monday and “started doing a raid/making arrests of customers.” Other posts have claimed federal immigration officials are “actively conducting raids” at local shopping centers. None of the reports proved to be true.

“We do not have any evidence to support that ICE was in fact in town over the past two days conducting any enforcement action,” Humboldt County Sheriff spokesperson Meghan Ruiz wrote in an emailed response to the Outpost’s inquiry. Ruiz added that federal immigration officials do not notify the sheriff’s office when they’re in town due to Humboldt’s Sanctuary Ordinance, a voter-approved measure that prohibits local law enforcement agencies from cooperating with ICE.

Centro del Pueblo, a local nonprofit community service group, called out the false reports in a recent Instagram post and asked their followers to avoid repeating rumors. 

“Town Center Watchers and organized community went to Winco, Costco, Walmart, Target and all Valley East/west hotels, Blue Lake casinos and Loleta today … and confirmed with workers of these places that ICE DID NOT HAVE ACTIVITY TODAY IN HUMBOLDT IN THESE PLACES,” the translated post states. “HELP US KEEP OUR COMMUNITY SAFE AND INFORMED.”

Reached for additional comment, Fourth District Supervisor Natalie Arroyo urged community members to verify information before sharing it on social media. “Please, only share information if it’s accurate and you can determine the source,” Arroyo told the Outpost. “There is a broad concern that some of this may be coming from a place of urging people to self-deport or trying to frighten people into taking similar actions that are based on fear.”

While local and state sanctuary laws limit cooperation with ICE, federal agents can still conduct immigration enforcement. Humboldt’s ordinance notes that sanctuary laws “do not prevent undocumented immigrants from being prosecuted for criminal activity, and state and federal laws address the situation of serious, criminal offenders.”

With that in mind, Arroyo encouraged community members to read the local ordinance — linked here — to understand what it can and cannot do.

The Humboldt County Human Rights Commission’s Sanctuary Ordinance Standing Committee will host a virtual public meeting at 5 p.m. on Thursday to discuss the status of the local sanctuary ordinance and what protections it may offer undocumented residents. 

“Right now, our hope is to provide people with information,” Committee Chair Guy Arnoff told the Outpost in a recent phone interview. “I think that will give us the kick we need to make sure that we’re looking into the right things and that our local authorities are upholding the sanctuary ordinance as much as they’re allowed to.”

“I can’t speak for everybody on our committee, but I don’t want people to be scapegoat immigrant communities and I don’t want people to feel like they’re alone,” he added. 

The committee will consider sending a letter to the Humboldt County Board of Supervisors and local law enforcement agencies “urging cautious compliance.” Several local officials will be available to answer questions, including Humboldt District Attorney Stacey Eads, members of the Board of Supervisors and a representative of the sheriff’s office. 

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The Sanctuary Ordinance Standing Committee will meet virtually at 5 p.m. on Thursday, Jan. 16. You can find a copy of the agenda and remote viewing/participation instructions at this link.

PREVIOUSLY: Weekend Shooting Incidents in Arcata, Hoopa and McKinleyville; Sheriff’s Office Investigating Possible Connections Between Them All

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Press release from the Humboldt County Sheriff’s Office:

In December 2024, Humboldt County Sheriff’s Office (HCSO) deputies responded to multiple shooting incidents. Investigations were launched and a suspect, Dauwin Poe, 19, of McKinleyville, was identified as the suspected shooter. Poe has now been taken into custody on several charges relating to shootings in Humboldt County and the City of Eureka’s jurisdiction. 

On Dec. 28 around 12 a.m., Poe and Cote Lincoln, 38, of Hoopa, got into an altercation with several individuals at Toni’s 24-Hour Restaurant, Arcata. Several individuals involved in the altercation left the restaurant and fled the area at a high rate of speed. One of the involved parties in the altercation fled in their vehicle to the McKinleyville area. Poe and Lincoln were identified as pursuing the subject’s vehicle into McKinleyville. Once the vehicles passed the 1300 block of Central Ave., Poe shot at the subject’s vehicle. Both vehicles then dispersed the area and the Sheriff’s Office was called to investigate. No one was injured in this shooting incident. 

On Dec. 28 around 11 p.m., Poe was present during a physical altercation involving several adult males that occurred in Hoopa near the Hoopa Modular Building plant. During that altercation, one 23-year-old male sustained non-life-threatening gunshot wounds to the chest and side area, and was taken to a local hospital for treatment. Poe was positively identified as the person responsible for shooting the victim.

Poe is also a suspect in a shooting incident being investigated by the Eureka Police Department (EPD), wherein a shooting occurred on 3^rd St. in Eureka on Dec. 27, just a few hours before the incident at Toni’s. EPD placed a BOLO (“be on the lookout”) for Poe. 

On Jan. 9, Poe was located by HCSO deputies at the Humboldt Courthouse and booked into the Humboldt County Correctional Facility (HCCF) on charges related to an additional incident being investigated by EPD for the following charges:

• Threats to commit death or great bodily injury—PC 422(a)
• Exhibit a firearm—PC 417(a)(2)
• Conspiracy to commit a crime—PC 182(a)(1)

While in custody, Poe continued to be investigated by HCSO investigators for involvement in the shooting incidents. Based upon the corroborating evidence, HCSO investigators were able to add the following charges:

• Attempted murder—PC 664/187(a)
• Shooting at inhabited dwelling/vehicle—PC 246
• Conspiracy to commit a crime—PC 182(a)(1)

On Jan. 11, Lincoln was located and arrested for his involvement in the incident relating to the shooting in the 1300 block of Central Avenue following the altercation at Toni’s. Lincoln was booked at HCCF for the following warrant charges:

• Conspiracy to commit a crime—PC 1832(a)(1)
• Shooting at inhabited dwelling/vehicle—PC 246

This case is still under investigation.

Anyone with information about this case or related criminal activity is encouraged to call the Humboldt County Sheriff’s Office at (707) 445-7251 or the Sheriff’s Office Crime Tip line at (707) 268-2539.

The June 2026 primary is 17 months from now.

Press release from the James Gore for State Senate campaign:

Sonoma County Supervisor and North Coast native son James Gore today announced his candidacy for California State Senate, District 2, to follow term-limited Senator Mike McGuire, who will be headed for another leadership position, as the North Coast’s next elected state leader. Gore cited the need for dramatic progress on California’s thorniest issues, and his record of bringing significant change at the local government level, as his prime reason for running.

“Two things light my world: my family and the call of public service. The mission of being a public servant, working relentlessly each day to deliver for our community, is a tremendous privilege.

“I’m running because our North Coast way-of-life is threatened by climate disasters, affordability issues, and a deepening divide between urban and rural community priorities,” said James. “Bold action is required, we need to do more than nibble around the edges.

“As your senator, I will tackle the problems plaguing California – housing, homelessness, cost of living, climate change, etc. – with the same gusto I’ve applied locally.

“As a county supervisor, collaboration has produced remarkable things,” continued Gore, who was a central figure in Sonoma County’s efforts to recover from a series of devastating wildfires in 2017, 2018, and 2020. “Working together, we’ve rebuilt Sonoma County, greatly enhanced our communities’ preparations for wildfire threats, and shared what we’ve learned with other communities.

“I’ll be a can-do senator who delivers for this district. I won’t disappear into the Sacramento abyss. I’ll be a loud voice for you and for change that makes your life better.”

Supervisor Gore’s home district was devastated by the October 2017 Northern California Fire Siege, where Sonoma County lost more than 5,300 homes. His leadership in the response helped galvanize his community towards a hard-wrought, successful recovery. As the wildfires, floods, droughts, pandemic, and other disasters have continued, James has stepped forward as a statewide and national champion on resiliency in the face of extreme weather and natural disasters.

Prior to his election to county supervisor in 2014, President Barack Obama appointed James as Assistant Chief of the U.S. Department of Agriculture’s (USDA’s) Natural Resources Conservation Service (NRCS). There James led: nationwide conservation efforts at the intersection of agriculture, business, and the environment; expansion of services in persistent poverty areas; and efforts on climate change mitigation and the protection of Pacific salmon habitats.

Supervisor Gore has won the trust and support of his local government colleagues at the state and national levels having been elected to lead both the California State Association of Counties (2022-23) and the National Association of Counties (2024-current). In these positions, he has been the voice of advocacy at the state and national levels on a variety of local community needs.

Family and service intertwined during his Peace Corps service in the South American nation of Bolivia when James and his future wife, Elizabeth, met while helping local communities build water management systems, improve agricultural practices, and develop a campaign that linked seven isolated communities medical & dental care and education.

The Gore family has deep roots in Sonoma County going back several generations. James proudly hails from Healdsburg where he and his wife Elizabeth, co-founder of Hello Alice, live with their children. They are all avid outdoors people.

See James’ announcement video, which was sent to supporters this morning: https://www.youtube.com/watch?v=aQQIZzBD0jo

Learn more about his campaign at JamesGore4Senate.com

As much of Los Angeles smolders, wind warnings return and fire crews stand guard, scientists say almost unprecedented climatic conditions throughout Southern California led up to the disaster.

Last summer was one of the hottest on record, and the extreme swings between wet and dry conditions over the past two years has been unusually severe. Two rainy winters — which promoted heavy growth of brush — have been followed by near-zero rainfall for the past eight months and counting.

This pattern of weather whiplash, likely exacerbated by climate change, hasn’t been seen in Southern California since 1992-1993, and before that, 1907-1908. “We find only three instances where an anomalously dry start to the wet season follows back-to-back wet water years,” a team of UCLA researchers wrote in a report released on Monday.

Soil moisture levels across much of the region from Santa Barbara to San Diego hover between just 2% and 5% of average — leaving dust where there should be mud.

Also, an important measure called “vapor pressure deficit” has exceeded norms. Calculated from a combination of temperature and relative humidity, it reflects the ability of air to draw moisture from the landscape.

“The way to think about vapor pressure deficit is that it is the drying power of the air,” said John Battles, a UC Berkeley forest ecology professor.

Readings from Jan. 8 show an extreme deficit across much of inland Southern California. Such conditions can draw much of the moisture from living plants, so fires become almost unstoppable once they start.

“When it’s that dry, wind has ultimate power,” said UC Merced climatology professor John Abatzoglou.

In Malibu Canyon, local gauges recorded 53 degrees Fahrenheit and relative humidity of 36% on Jan. 4. Three days later, on the day that the Palisades and Eaton fires began, the air temperature was 64 degrees while the relative humidity had dropped to 13%, more than doubling the vapor pressure deficit.

These levels are “literally off the charts,” Battles said.

This combination of conditions crossed a dangerous threshold, priming the landscape throughout much of Southern California for high risk of wind-whipped fires. Across seven counties, drought has sapped the air, soil and vegetation of moisture.

The National Weather Service has declared red flag conditions for nearly all of Southern California. The warnings are triggered when relative humidity is 15% or less and gusts are 25mph or stronger. Both conditions must occur simultaneously for at least 3 hours in a 12-hour period. Fire weather watches are dry areas flagged as high to extreme danger with critical weather conditions within the next 48 hours.

The National Weather Service issued a warning Tuesday of critical fire weather or red flag warnings from the Mexican border to San Luis Obispo County. The alert predicted gusts up to 50 mph, humidity of a lip-splitting 10%, and virtually no chance that rain would relieve the conditions anytime soon. This comes on the heels of the third hottest summer in coastal Southern California since at least 1895.

The threat goes far beyond Los Angeles, affecting much of Southern California. Across Orange County “current live and dead fuel moistures remain at or below established critically low thresholds,” said Sean Doran, a public information officer with the Orange County Fire Authority. He called Tuesday’s fire danger level in Orange County “extreme.” The county has dried-out canyons, near residential areas, full of ultra-flammable chaparral and sage scrub.

Chaparral and sage scrub in Orange County’s Upper Newport Bay is bone-dry after months with no rain. Jan. 11, 2025. Fire officials called the danger “extreme” in the county. Photo by Marla Cone, CalMatters

Officials and researchers routinely weigh samples of vegetation, dehydrate them and weigh them again. This allows them to calculate the “live fuel moisture” percentage, which tells them how flammable the landscape is.

These measurements and related data are critical to firefighters, who monitor them regularly so they can gauge the risk of a fire erupting and determine which tools, vehicles and equipment are needed to fight the blazes, explained Scott McLean, a Cal Fire public information officer.

Last May, the live fuel moisture content of Santa Monica Mountains chamise — a prominent chaparral plant — was a wet and heavy 143%. That means that the weight of the water in the plants was almost 1.5 times the weight of its woody material. (A reading of 100% means equal parts water and plant mass.)

By November, live fuel moisture in the same region had dipped to just over 60%.

Even more recently, on Jan. 7, measurements from Santa Barbara vegetation showed levels of 61% — substantially below the 77% average for this time of year. That means their water weight was less than two-thirds of their plant material.

“Once the live fuel moisture hits around 60%, that is the critical danger zone,” said UC Merced’s Abatzoglou, explaining that below this level, vegetation loses much of its resistance to fire.

To put it another way, he said, at and below about 60%, “the live fuels behave and burn more like dead fuels.”

“Once the live fuel moisture hits around 60%, that is the critical danger zone…The live fuels behave and burn more like dead fuels.”
— UC Merced climatology professor John Abatzoglou.

Abatzoglou cited research from 2009 suggesting that a critical threshold between vegetation that can and cannot support a large fire lies around 79% — which would put current conditions much deeper into the danger zone.

Dead vegetation, baked by the sun for months or years, is also perilously dry. “By January 7th of 2025, dead-fuel moisture was 6th lowest on record for that date,” the UCLA team wrote in Monday’s report.

Brush clearing wouldn’t help much, experts say

While President-elect Donald Trump has claimed on social media that incompetent state leadership led to the wildfires and hindered efforts to tame the flames, experts say there is little that could have prevented the disaster.

The extremely dry conditions have been aggravated by winds gusting up to 100 miles per hour — what UCLA climate researcher Daniel Swain recently likened to using an atmospheric blow dryer on bone-dry terrain.

Alexandra Syphard, a senior research ecologist at the Conservation Biology Institute and an adjunct professor at San Diego State University, said the extreme conditions have rendered humans powerless, at least in the nearterm, to subdue wildfire threats.

“I do not believe there is anything that wildland management could have done to qualitatively or substantially alter the outcome of these fires,” she said.

“I do not believe there is anything that wildland management could have done to qualitatively or substantially alter the outcome of these fires.”
— Alexandra Syphard, Conservation Biology Institute research ecologist

While thinning trees or conducting controlled burns can reduce fire dangers in some forests, the same approach does not work in the areas of Southern California dominated by chaparral, Syphard said. These areas are too vast to clear brush, encompassing thousands of square miles.

She said such clearing tends to increase fire danger in chaparral landscapes by killing off both mature plants and the natural seed bank in the soil, triggering a long-lasting conversion to grasslands, which she says create an “explosively flammable” duff layer each summer and fall.

The best preventative strategies for reducing fire danger in a chaparral landscape, Syphard said, are to “create very strategically placed fuel breaks that enable safe firefighter access” as well as to “rethink where homes are constructed and how to make houses more resilient.”

Reducing greenhouse gas emissions, though it’s not likely to provide any immediate relief of the dangers facing millions of Californians living in or near flammable landscapes, is another difficult but necessary solution, experts say. Global warming is conditioning the already arid Southwest to burn.

As much as 88% of the increasing average vapor pressure deficit in the western United States is linked to human-caused warming, according to a 2021 UCLA paper. Compared to the 1980s and 1990s, the number of days with an extreme vapor pressure deficit nearly doubled in the first two decades of this century, the researchers found.

“These are global conditions playing out … There’s very little California can do to reshape these weather patterns.”
— John Battles, UC Berkeley forest ecology professor

And with rates of global emissions increasing in spite of international pledges to reduce them, this increasing aridity is only going to get worse.

“This change in risk requires urgent and effective societal adaptation and mitigation responses,” the UCLA scientists wrote.

The new UCLA report noted that linking weather anomalies to climate change “requires deep analysis.” But the authors were confident about one potential connection: “The clearest way in which climate change may have intensified the January 2025 wildfires is the anomalously warm summer and fall of 2024,” they wrote.

With or without a climate change link, the extremes seen in Southern California over the past two years have been exceptional, including a hurricane-driven cloudburst in August 2023, an extraordinarily wet February last year that delivered an average of almost half an inch of rain daily, and a dry streak that is quickly catching up with 1962-1963 as the longest in the region’s history.

Battles, at UC Berkeley, said the likely role of climate change in the weather extremes that are clobbering California makes direct human intervention almost negligible, and better planning key to safety.

“These are global conditions playing out … There’s very little California can do to reshape these weather patterns,” he said.

“With the climate making things drier, we need to think about how we transition into a new state, and how we deal with wildfire and development and public safety. These are not hard science questions, but they’re super hard policy questions.”

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CalMatters.org is a nonprofit, nonpartisan media venture explaining California policies and politics.

Days before a Kentucky judge blocked federal rules protecting LGBTQ students last week, California Assemblymember Kate Sanchez proposed similar changes to California law. On Jan. 6 she introduced her first bill of the session, which would ban transgender females from playing on girls’ sports teams with the California Interscholastic Federation.

Congressional Republicans were on the same page; on Tuesday they passed a bill to ban transgender athletes from women’s sports at the elementary through college level, which would jeopardize federal funding for schools that don’t comply.

Sanchez says her bill and other legislation like it would assure a safe, fair playing field for girls.

“There is a definite difference between biological boys and females in sports, especially at this age,” said Sanchez, a Rancho Santa Margarita Republican who represents Temecula and Murrieta. “This is the intent of the bill, to protect the integrity and fairness of girls’ sports.”

Civil rights and LGBTQ advocates argue that the bill would turn civil rights protections against vulnerable students. Kel O’Hara, an attorney with Equal Rights Advocates, a San Francisco-based gender justice organization, said more than half the states have passed restrictions on transgender students’ participation in sports. Those bills target “a problem that doesn’t exist,” they said.

About 3.3% of high school students identified as transgender in 2023, according to the Centers for Disease Control and Prevention. Only a small number of students of any gender are elite athletes.

“It’s a dog whistle from our perspective,” O’Hara said. “There’s no evidence that trans students, particularly trans girls, are dominating girls’ sports.”

Sanchez pointed to a lawsuit that two female students in Riverside Unified School District filed in November, alleging that a trans girl had displaced them from the cross-country team. The lawsuit argued that the transgender teammate received a top spot in competitions because of faster times, knocking the plaintiffs out of key parts of a cross-country meet. Sanchez said that’s evidence that transgender girls hold an edge over their teammates.

“I think when you look at it from the perspective and lens of biology, males have a very clear and undeniable advantage, so that plays into part of the legislation we’re trying to advance now,” she said.

O’Hara disputed that transgender girls outperform their teammates. They said that benefits of high school sports extend beyond athletic competition, so trans girls who are banned from teams also lose opportunities to develop teamwork, leadership skills and a sense of community.

“These bills try to convince queer and trans young people that they don’t belong and they’re not safe,” they said. “They want students to give up hope and go home.”

Pushback against transgender rights, particularly in schools, has become a conservative call to arms. More than a dozen red states have sued the Biden administration over changes to the federal education rights law, Title IX, which extended its discrimination protections to LGBTQ students. On Thursday a federal judge in Kentucky ruled in the states’ favor, striking down the new rules.

In the fall, several college teams garnered national attention when they forfeited their games against a San José State University women’s volleyball team because of its transgender athlete.

President-elect Donald Trump suggested at campaign rallies that he would “keep men out of women’s sports” using executive power to implement a ban.

“Transgender kids — like any student — deserve the chance to benefit from all that sports have to offer, in an environment that both affirms and validates their gender identity.”
— Assemblymember Chris Ward, a San Diego Democrat

Sanchez thinks the American public is moving in that direction. She pointed to a 2023 Gallup poll showing that 69% of Americans think transgender athletes should not be allowed to play on teams that match their gender identity, up 7 percentage points from Americans’ views on the matter in 2021.

Not surprisingly, opinions varied along party lines. The poll found 86% of Republicans opposed transgender athletes playing on teams aligned with their identity, while Democrats were split nearly evenly.

About 40% of voters in Sanchez’ district are Republican, 30% Democratic, with the rest registered with third parties or citing no party preference. She said her office has received calls in support of the bill.

Last year Sanchez passed other successful education bills, including one to protect student athletes from severe heat conditions and another to make epinephrine injectors available at schools. Both passed with nearly unanimous bipartisan support.

This bill will likely be different. Assemblymember Chris Ward, a San Diego Democrat and chair of the Legislative LGBTQ Caucus, said members “will not stand by as anyone attempts to use kids as political pawns.

“Participating in sports leads to better outcomes in academics and mental health,” he said in a statement, “and transgender kids — like any student — deserve the chance to benefit from all that sports have to offer, in an environment that both affirms and validates their gender identity.”

Carl DeMaio, a freshman Republican Assembly member from San Diego, said he’s co-sponsoring the bill, which he thinks maintains “dignity, respect and fairness” for all players. DeMaio, who is gay, said other members of the LGBTQ community have told him they don’t believe transgender females should compete on girls’ teams, and he compared the policy to the use of performance-enhancing drugs.

“If you allow biological males to compete in girls’ sports, you are not maintaining fairness and you are robbing these girls of their dreams,” DeMaio said.

Sanchez said she’s committed to her legislation and expects that it will align with upcoming federal policies on transgender rights, including Tuesday’s House bill.

O’Hara argued that protecting female athletes doesn’t have to come at the expense of transgender girls.

“Why does protecting some students have to mean discriminating against others?” they asked. “Why are we approaching civil rights laws as a zero-sum game?”

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CalMatters.org is a nonprofit, nonpartisan media venture explaining California policies and politics.

Gov. Gavin Newsom’s ambitious plan to produce a cheap, generic insulin for the 3.2 million Californians with diabetes is behind the schedule he announced and unlikely to make it to market for several years, industry experts say.

Civica, Inc., the nonprofit drug manufacturer contracted to produce insulin for California, has not started clinical trials or applied for approval from the federal Food and Drug Administration, both of which are likely to take more than a year to complete.

During his 2023 State of the State tour, Newsom announced California would begin selling insulin for $30 a vial with a “2024 delivery in terms of timeline,” pending FDA approval.

That target has come and gone.

Realistically, the state is at least one year away, if not more, multiple industry experts told CalMatters.

“You could be anywhere from 12 months to two or three years before you get your actual approval — and that’s if nothing goes wrong,” said James Bruno, a longtime chemical and pharmaceutical consultant for drug manufacturers.

A 2020 law aimed partially at bringing down insulin prices allowed Newsom to negotiate the 10-year, $50 million contract with Civica. Newsom earmarked an additional $50 to seed the construction of a drug manufacturing facility in California.

In the meantime, insulin prices have dropped nationally as a result of public pressure, the Biden administration’s 2023 cap on insulin prices for some seniors with Medicare, and changes to Medicaid rules that tied drug prices to inflation. At least 25 states and the District of Columbia have also implemented monthly co-pay caps to help offset continuing expenses for diabetics.

California is not one of those states. Newsom in October rejected a $35 monthly insulin copay cap. In his veto message, he cited the state’s $100 million investment in insulin production as an example of his administration’s efforts to reduce costs without a price cap.

The state’s effort to manufacture insulin is “getting at the underlying cost, which is the true sustainable solution to high-cost pharmaceuticals. With copay caps however, the long-term costs are still passed down to consumers through higher premiums from health plans,” Newsom wrote in his veto message.

Newsom spokesperson Elana Ross said in a statement that the governor remains committed to making affordable insulin, but did not answer questions about an updated timeline for when insulin would make it to market or how much money the state has paid to Civica for meeting various manufacturing goals.

“That process is underway and moving forward, though there have been delays, which is not unusual,” Ross said. “The priorities of both the administration and Civica continue to be quality and price, and all parties continue to advance development toward FDA approval with those north stars.”

Ross also refused to answer CalMatters’ questions about the state’s plans to develop a manufacturing plant in California. Industry experts say it would take far more money than the $50 million California has budgeted, and many years to build one from the ground up.

Allan Coukell, chief government affairs officer at Civica, said manufacturing has begun at the company’s new pharmaceutical plant in Virginia but there is no timeline for when the first insulin — a generic for glargine — will be available on the market.

“We want to be careful about setting expectations. We’re working through the process and it’s going well,” Coukell said.

FDA approval for new drugs takes years

Bringing a drug to market, even a generic one, takes years, experts say. And biologics, like insulin, which are produced by living organisms such as cells and bacteria, are even more complicated.

FDA approval requires the manufacturer to be able to prove that its manufacturing plant and processes are safe and repeatable. The manufacturer must demonstrate that its raw drug substances are pure and potent. It has to show that the drug is stable in its packaging, and it must conduct extensive analytical and clinical testing to establish that the drug is safe and highly similar to the brand-name product.

“You have to show the FDA that if it quacks like a duck (and) walks like a duck, it is a duck in every aspect compared to the innovator molecule,” said Govind Rao, a professor of chemical and biochemical engineering at the University of Maryland, Baltimore County.

The FDA approved Semglee in 2021, the first interchangeable biosimilar insulin, four years after the manufacturer submitted its initial application and two-and-a-half years after the manufacturer resubmitted the application addressing concerns from the agency. The primary clinical trial took a little over one year to complete, according to government records.

Rezvoglar, approved later in 2021, received FDA approval a year after submitting its application. It took another year for the FDA to grant interchangeability status to Rezvoglar, meaning it can be substituted at the pharmacy for Lantus, the brand name insulin glargine, without needing a separate prescription.

The length of time it takes for a company to develop a drug, get FDA approval and bring it to market is highly variable, said David Gaugh, executive vice president for the Association for Accessible Medicines, a trade organization for generic drug manufacturers. It depends on how experienced the company is and what its data looks like, Gaugh said.

“I would make a general statement that it’s probably going to be somewhere between two and four years” to bring a biosimilar insulin to market from start to finish, Gaugh said.

Civica, a nonprofit founded by hospitals facing drug shortages, is not an untested drug manufacturer. It produces about 80 generic drugs for hospitals across the country. Insulin is Civica’s first biosimilar product. A year before contracting with California, Civica independently announced it would produce insulin by 2024.

It is possible for the FDA to fast-track drug applications that are high-profile or politically sensitive like insulin, pharmaceutical consultant Bruno said, but even then the review process is at minimum six months.

A spokesperson for the FDA said the agency cannot confirm or deny the existence of a pending product application, but the typical review cycle is 12 months from the time of submission. That would put Newsom’s insulin project more than a year behind his stated schedule.

California aimed to disrupt pharmaceutical market

When he announced the Civica deal in early 2023, Newsom made it clear that the project’s goal was to disrupt the practices used by drug makers, insurers and their distributors to jack up prices. By eliminating those players and wielding its enormous purchasing power, California could offer insulin at-cost to people who need the drug to survive.

“This is a big deal, folks. This is not happening anywhere else in the United States,” Newsom said during his 2023 State of the State speech in Downey. “This fundamentally lowers the cost, period, full stop.”

Insulin is frequently held up as the poster child for a broken health care market. People have relied on the drug for more than 100 years, but its price keeps increasing partially because demand is high and drug distributors and insurers could profit. Between 2012 and 2021, the price for a one-month supply of insulin increased nearly 200%, peaking at $541 per month in 2019, according to the Health Care Cost Institute.

The three major brand-name insulin manufacturers — Eli Lilly, Novo Nordisk and Sanofi — cut prices between 65% to 80% in 2024.

Former Sen. Richard Pan, a Democrat from Sacramento and a pediatrician, said the state’s plan to produce insulin by 2024 sounded “ambitious” but he was not involved in the contracting discussions. Pan authored the 2020 legislation that enabled California to pursue the deal with Civica and establish CalRx, the brand under which future state generics will be sold.

“I had to trust the administration was having conversations and had information about how far along they were in their process and whether they were able to hit a 2024 deadline,” Pan said.

Some health economists say recent moves by major insulin manufacturers to drastically lower prices will cause companies that are in the process of producing new biosimilar insulins to pull out of the market because there isn’t enough of a profit incentive to recoup the cost of producing a cheaper generic.

In that case, Pan said California’s plan to produce a biosimilar insulin becomes even more important. If major manufacturers can drive competition out of business, they could just increase prices again down the road, Pan said.

“Someone can say ‘Oh if it’s already down that much, is it still worth doing or not?’ Well, it’s one way to keep (prices) down,” Pan said. “If we can still produce it for less than they’re selling it, why not make that…available to Californians and our Medicaid program and save some money.”

Pan’s legislation also allowed the state to negotiate a lower price point for naloxone, a drug used to reverse opioid overdoses. In that instance, California leveraged its purchasing power and is acting as a distributor for an existing drug on the market rather than supporting research and development as well as manufacturing costs.

In addition to price drops, Eli Lilly and Sanofi created financial assistance programs to cap consumer out-of-pocket costs at $35 per month.

Those savings aren’t necessarily universal, however, depending on the type of insulin patients need or prefer. In a statement at the time, Sen. Scott Wiener, author of the 2023 bill that would have capped out-of-pocket insulin costs for Californians at $35 per month, called Newsom’s veto a “major setback” for diabetics.

“This is a missed opportunity that will force them to wait months or years for relief from the skyrocketing costs of medical care when they could have had it immediately,” Wiener said.

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Supported by the California Health Care Foundation (CHCF), which works to ensure that people have access to the care they need, when they need it, at a price they can afford. Visit www.chcf.org to learn more.

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