BayCityNews

FDA Approves Narcan for Over-the-Counter Use

Federal regulators approved the first over-the-counter naloxone product Wednesday, enabling people to buy the opioid overdose treatment directly from places like pharmacies, convenience stores and online. The U.S. Food and Drug Administration approved the nasal spray naloxone product, commonly known as Narcan, for use without a prescription. Narcan has been approved as a prescription drug since 2015 and is the standard treatment to reverse an opioid overdose by reversing or blocking an opioid’s effects on the brain.

Published

2 months ago

April 3, 2023

Oakland Post

Airmen at the 178th Wing were given Nalaxone (Narcan) through Project DAWN (Deaths Avoided with Nalaxone) on May 6, 2019 at Springfield Air National Guard Base, Ohio. Narcan is used on a person experiencing an opioid overdose. (Senior Airman Amber Mullen/U.S. Air National Guard via Bay City News)

By Eli Walsh
Bay City News

The U.S. Food and Drug Administration approved the nasal spray naloxone product, commonly known as Narcan, for use without a prescription. Narcan has been approved as a prescription drug since 2015 and is the standard treatment to reverse an opioid overdose by reversing or blocking an opioid’s effects on the brain.

More than 101,000 fatal overdoses were reported nationwide between November 2021 and October 2022, driven mostly by opioids like fentanyl.

“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” said Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research. “The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to nonprescription/OTC status.”

A timeline for when Narcan could be available without a prescription and how much it will cost are still to be determined by the manufacturer that received Wednesday’s authorization, the biopharmaceutical company Emergent BioSolutions Inc.

However, according to the FDA, the regulatory process to change naloxone from being solely available as a prescription drug to being available both with and without a prescription could take months and will require a change in labeling for currently approved 4 milligram naloxone nasal sprays.

Other Narcan manufacturers beyond Emergent BioSolutions will also be required to update their existing authorizations to make their products available as over-the-counter drugs.

“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country,” FDA Commissioner Dr. Robert Califf said. “We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

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Supes Introduce Resolution to Keep Port Shelter Site Open for Unhoused Residents

At Tuesday’s meeting of the San Francisco Board of Supervisors, District 10 Supervisor Shamann Walton called a plan to close 118 shelter beds at the Port of San Francisco a “travesty.” Walton, with the support of four other supervisors, introduced a resolution calling on the port and the city’s Department of Homelessness and Supportive Housing (HSH) and its oversight commission to keep the facility known as “Site F” open and operating.

Published

3 weeks ago

May 12, 2023

Oakland Post

Trailers located at “Site F” on property of the San Francisco Port Commission in San Francisco, Calif. on Feb 22, 2023. Site F provides shelter for 118 people experiencing homelessness.

By Joe Dworetzky
Bay City News

At Tuesday’s meeting of the San Francisco Board of Supervisors, District 10 Supervisor Shamann Walton called a plan to close 118 shelter beds at the Port of San Francisco a “travesty.”

Walton, with the support of four other supervisors, introduced a resolution calling on the port and the city’s Department of Homelessness and Supportive Housing (HSH) and its oversight commission to keep the facility known as “Site F” open and operating.

Walton said that the agreement between the port and HSH to wind down and close the site amounted to “forcing homelessness by our very own city departments.”

He noted angrily that the closure would mean that “over 100 people, mostly black, mostly minorities, will be put out on the street with no alternative placement and be evicted by the Port and the [HSH] and sent right back to the street.”

The resolution is a response to an agreement negotiated between staff members of the port and HSH that ends new intake at the site by October 2 and commits to a full closure by the end of the year.

The agreement was previewed for the Port Commission at a meeting on April 11. At that time, port staff said they would return to the commission with the agreement for final voting on April 25, although the agreement was not discussed when the commission met on that date.

Port staff said it would be considered May 9.

Site F was originally set up during the pandemic and was to close at the end of the public health emergency. Although the emergency declaration ended on February 28, the site has continued in operation while the port and HSH negotiated over what would happen with the site.

HSH sought a two-year extension, but the port pushed HSH to present a detailed wind-down plan with specific milestones that would assure that the site was being closed to the port’s satisfaction.

The agreement comes at a time when the city is facing an acute shortage of shelter beds. A federal judge has enjoined the city from clearing tent encampments because there are not enough shelter beds available for the city’s unsheltered population. Testimony in that litigation showed that the city-wide shortfall of shelter beds exceeds 4,000.

Walton’s resolution was co-sponsored by Supervisors Hillary Ronen, Dean Preston, Aaron Peskin and Ahsha Safai.

Walton’s office said they expected the resolution to be considered on May 9th. There are a total of 11 supervisors, so with one more vote in addition to the co-sponsors, the resolution would likely pass.

HSH declined to say whether it would support further discussions to keep the site in operation beyond the wind-down period.

However, Deborah Bouck, a spokesperson for HSH said on Tuesday in response to an email request for comment that the department “is already working to assess everyone at the site for housing and will be matching people to the most appropriate available housing in our system and in the community. For anyone who may not be eligible for housing placement we will ensure they have a placement into other temporary shelters in the district.”

Justin Berton, a spokesperson for the Port said, “The temporary site is located in the heart of a busy industrial area and is not suitable as a long-term place to live…. We will continue to work with all stakeholders for a coordinated wind-down that puts the well-being of the residents first and eventually returns industrial land for industrial use.”

While the port is run separately from the city, Mayor London Breed appoints- and the Board of Supervisors confirms- the members of the commission.

Copyright © 2023 Bay City News, Inc. All rights reserved. Republication, rebroadcast or redistribution without the express written consent of Bay City News, Inc. is prohibited. Bay City News is a 24/7 news service covering the greater Bay Area.

BayCityNews

School Official ‘Welcomes’ D.A. Investigation Into Possible Fraud In District

The interim superintendent for the Stockton Unified School District said Monday that the district welcomed the opportunity for an investigation into alleged fraud that was revealed in a recent state audit report.

Published

3 weeks ago

May 12, 2023

Oakland Post

Shortly before the district held a press conference on Monday morning, San Joaquin County District Attorney Ron Freitas announced his office was initiating an independent investigation into Stockton schools following two grand jury reports and the Fiscal Crisis and Management Assistance Team auditor's report.

By Victoria Franco
Bay City News

“We are not afraid of this news, in fact we welcome this news so we can get back to the business of having our focus on student achievement and student learning instead of the adults of this organization getting us sidetracked,” said Traci Miller, interim superintendent for Stockton Unified School District.

The FCMAT is a state agency that works with California’s education agencies to identify and resolve financial and operational problems.

Earlier this year findings of their “extraordinary audit” had been released and allegedly showed sufficient evidence of fraud, misappropriation of funds and other possibly illegal fiscal practices within the school district.

Miller said the district is happy to have outside investigation, because if there are issues the organization needs to deal with, or if there are adults that are doing something on the backs of the children, then they need to address it.

Following the FCMAT report, the agency recommended that the San Joaquin County superintendent notify the governing board of SUSD, the state controller, the state superintendent of public instruction, and the county district attorney about the possible findings of fraud and possible violations of the state’s Brown Act laws regarding public meetings.

In response to what the school district has done regarding the recommendations, Miller said they have already started working towards getting training for staff. She said policies and procedures have to be revamped that are in the best practices.

The district is working with the California School Boards Association and is in the process of doing trainings, Miller said.

The FCMAT report stated that in May 2021, a district employee met with members of the San Joaquin County Office of Education to discuss concerns about “procurement irregularities in a contract with IAQ Distribution Inc.”

IAQ Distribution Inc. is a distributor of indoor air quality monitoring and disinfection devices.

Allegedly three months later, another employee reached out to the county office with similar concerns.

Freitas said during his press conference that anyone who attempts to commit fraud in the district will be prosecuted to the fullest extent of the law.

BayCityNews

Man Suspected in Death Of 9-Month-Old Baby Arraigned in Court Monday

A man suspected in the death of a 9-month-old boy in Stockton last week appeared briefly in court Monday afternoon for arraignment. Leonel Mateo, 31 of Stockton, was arrested following the death of Osvaldo Rubio, who arrived April 25 at an Oakland hospital with major injuries suspected to be related to child abuse, according to police.

Published

3 weeks ago

May 12, 2023

Oakland Post

Mateo was charged with murder, child abuse resulting in death, child abuse/endangerment as well as firearm possession, according to the San Joaquin County District Attorney's Office.

By Victoria Franco
Bay City News

A man suspected in the death of a 9-month-old boy in Stockton last week appeared briefly in court Monday afternoon for arraignment.

Leonel Mateo, 31 of Stockton, was arrested following the death of Osvaldo Rubio, who arrived April 25 at an Oakland hospital with major injuries suspected to be related to child abuse, according to police.

The infant died two days later, on April 27, from his injuries.

Mateo was charged with murder, child abuse resulting in death, child abuse/endangerment as well as firearm possession, according to the San Joaquin County District Attorney’s Office.

The suspect was told in court that the first charge could possibly result in 25 years to life in prison.

Stockton police detectives and Child Protective Services responded to the hospital on April 25 after being notified that baby Rubio had arrived and conducted an investigation.

A spokesperson with the police department said they couldn’t release any other information about the case due to an ongoing investigation.

A GoFundMe was set up last week by a family member to help pay for the expenses of the child’s funeral.

The page can be found at:

https://www.gofundme.com/f/osvaldo-isaiah-rubio-funeral-services?utm_campaign=p_cp+share-sheet&utm_content=undefined&utm_medium=copy_link_all&utm_source=customer&utm_term=undefined.