FDA says new regulations are needed to manage CBD risks

 The Food and Drug Administration (FDA) on Thursday called for new regulations for the cannabidiol (CBD) market, saying the agency needs to provide additional oversight to manage the risks involved in using those products. 

Janet Woodcock, the principal deputy commissioner of the FDA, said in a release that the agency conducted a review and determined that a new “regulatory pathway” is needed to balance the public’s desire to use CBD with the necessary oversight. She said the FDA is prepared to work with Congress to enact the regulations. 

The agency said CBD use has raised some safety concerns especially for long-term users, and studies have shown that it can lead to liver damage, interactions with certain medicines and harm to the male reproductive system. Exposure to CBD can be especially “concerning” to children and those who are pregnant. 

Woodcock said some regulations to help manage the risk include adding clear labels, preventing contaminants, limiting CBD content and instituting minimum ages to purchase these products. 

She said the existing regulations for food and dietary supplements only provide “limited tools” for managing the risks of CBD use. She said the working group she chairs has examined studies related to a CBD-based drug and published scientific literature and studies but has not found sufficient evidence to determine how much CBD can be consumed without harm being caused to a person. 

Woodcock said the FDA does not plan to pursue regulations that permit CBD use in dietary supplements or conventional foods as a result. 

She said CBD can also pose a danger to animals who are fed it, and people could be exposed to CBD without realizing through the animals’ meat, eggs and milk. 

“The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate,” she said. “We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities.”

The 2018 Farm Bill federally legalized hemp and derivatives like CBD.

https://thehill.com/policy/healthcare/3831630-fda-says-new-regulations-are-needed-to-manage-cbd-risks/

OIG knocks NIH oversight of alliance that oversaw funds to Wuhan lab

 A federal watchdog agency for the Department of Health and Human Services (HHS) says in a report released this week that the National Institutes of Health (NIH) failed to carry out sufficient oversight into research conducted using millions in federal funds, including research carried out at the Wuhan Institute of Virology, which has been aggressively scrutinized amid the coronavirus pandemic.

The Office of Inspector General (OIG) for HHS said in its report that the NIH did not make enough of an effort to ensure that requirements tied to federal grant awards were complied with, despite the potential risks that were known and the monitoring procedures that were developed.

The report focused on the awards that were distributed through the EcoHealth Alliance, a nonprofit non-governmental organization dedicated to protecting wildlife and public health from emerging diseases. The OIG looked into three NIH grants awarded to EcoHealth totaling about $8 million, which in turn were awarded to several recipients, including the Wuhan Institute of Virology.

Other recipients included the University of North Carolina at Chapel Hill as well as the Institute of Epidemiology Disease Control And Research in Bangladesh. The organizations each conducted research into zoonotic diseases, which are infections spread between animals and humans.

NIH policies dictate that grant recipients adhere to certain requirements, particularly when it came to gain-of-function research, enhancing a pathogen’s ability to cause infection in order to understand its potential to cause outbreaks.

Gain-of-function research has gained notoriety throughout the pandemic, with lawmakers such as Sen. Rand Paul (R-Ky.) questioning whether COVID-19 could have originated from the lab in Wuhan.

According to the OIG, monitoring of research was done by reviewing lab reports, performing audits and corresponding directly with the award recipients. However, it was found that EcoHealth failed to submit timely progress reports to the NIH, which in turn did not follow up with the nonprofit in a “timely” manner.

“EcoHealth’s failure to submit a progress report in a timely manner and NIH’s failure to follow up on a missing progress report limited NIH’s ability to effectively monitor its grant award to EcoHealth and evaluate whether the special terms and conditions were met,” the OIG report read.

These lapses in oversight were noted to be particularly noteworthy due to concerns NIH had previously raised with EcoHealth regarding the type of research being conducted. EcoHealth was also unable to provide scientific documents from the Wuhan Institute when they were requested by NIH.

The OIG found no evidence that EcoHealth obtained these documents from the Wuhan Institute, and the organization confirmed the lab was not responsive to document requests.

In April 2020, NIH directed EcoHealth to stop providing funding to the Wuhan Institute due to concerns the lab may have been involved in the release of the coronavirus responsible for COVID-19.

Apart from these oversight failures, the watchdog agency determined EcoHealth had spent $89,171 of its grants in ways that fell outside of federal requirements and recommended that these funds be refunded to the U.S. government. In a response letter, EcoHealth President Peter Daszak said they have already reimbursed NIH for these unallowed costs.

Going forward, the OIG recommended that NIH enhance its monitoring and documentation requirements for foreign grant recipients and define what is considered to be “immediate notification.”

The NIH concurred with all of the OIG’s recommendations.

https://thehill.com/policy/healthcare/3831891-watchdog-knocks-nih-oversight-of-alliance-that-oversaw-funds-to-wuhan-lab/

SNAP payments to shrink in 32 states as emergency benefits end next month

 Emergency benefits that have helped boost payments to SNAP recipients during the COVID-19 pandemic are set to end soon, leaving families with less money and high grocery prices.

SNAP, which stands for Supplemental Nutrition Assistance Program, used to be called the Food Stamp Program. For nearly three years, households have been receiving an additional $95 or more on top of their normal allotment.

In 17 states, those added emergency benefits have already expired as of January 2023. Those states are Alaska, Arizona, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Kentucky, Mississippi, Missouri, Montana, Nebraska, North Dakota, South Dakota, Tennessee and Wyoming, according to the U.S. Department of Agriculture’s Food and Nutrition Service.

In one state, South Carolina, the emergency allotment will expire after the January 2023 payments are issued.

In the remaining 32 states, plus Washington, D.C., Guam and the U.S. Virgin Islands, the extra money will dry up starting with the March 2023 benefit month, according to the FNS.

Oklahoma is one of the states where the added benefits are set to expire.

“The agency knows these additional benefits have been critical to meeting the needs of Oklahomans during such difficult times,” acknowledged Deb Smith, Director of Adult and Family Services.

Oklahoma state officials said people should plan for a return to their pre-pandemic SNAP benefits beginning March 1.

“We know that these increased benefits have been important to so many Oklahomans over the last three years and that this change will impact some SNAP users harder than others, particularly our senior and disabled neighbors,” said Chris Bernard, President/CEO of Hunger Free Oklahoma. “Undoubtedly, this will create an increased demand on our charitable organizations across the state and an increased need for Oklahomans to support their local food pantries and food banks.”

In 2021, more than 41 million Americans were using SNAP benefits to help afford food.

Households that also receive Social Security payments may see their SNAP benefits shrink even more than $95. That’s because as the Social Security cost-of-living adjustment for 2023 kicks in, it increases those households’ incomes, and may reduce the amount of SNAP help they’re eligible for.

FNS estimates nearly half of SNAP households also receive Social Security, and most will see a change in their SNAP benefits as a result of the 8.7% Social Security boost. “However, all impacted households will experience a net gain, as the adjustment increases Social Security benefits more than it decreases SNAP benefits,” the agency said.

https://thehill.com/changing-america/respect/poverty/3831423-snap-payments-to-shrink-in-32-states-as-emergency-benefits-end-next-month/

Top FDA safety official resigns

 A top Food and Drug Administration (FDA) safety official submitted his resignation this week, citing progress on tackling the U.S. infant formula shortage while also expressing frustrations with the structure of the agency.

Frank Yiannas, the FDA’s deputy commissioner for food policy and response, joined the agency in 2018 after having previously worked for several decades in food safety for Walmart and the Walt Disney World Co. His last day with the agency is set for Feb. 24.

In his resignation letter to FDA Commissioner Robert Califf, Yiannas noted he had considered leaving in February 2022 due to his concerns over the “decentralized structure of the foods program” that he and Califf found themselves working with.

Yiannas, however, said he decided to postpone his exit in light of the infant formula incidents — the presence of bacteria in powdered formula that led to at least two deaths — and subsequent shortages that were reported to the FDA around that same time.

During the infant formula shortage last year, Yiannas publicly expressed his dissatisfaction with how information about the ongoing crisis was shared. In an interview with The Washington Post published in May, he said he had not been made aware of a whistleblower complaint about unsanitary conditions at a baby formula plant until four months after it was sent to the FDA.

“How does this happen?” Yiannas said at the time. “There were early signals, and in any safety profession you want to take those seriously to stop the domino effect. That didn’t happen.”

The Justice Department announced last week it has launched a criminal investigation into the Abbott plant in Michigan due to evidence of the unsanitary conditions.

Yiannas wrote in his letter to Califf that improvements that have been made since the crises first started have encouraged him to leave the agency.

“With the Abbott facility now reopened, infant formula availability more prevalent, and — very importantly — the necessary monitoring, data systems, and insights now in place through the 21 Forward platform to help address the current and any future infant formula supply chain challenges, I believe the time is right for me to leave and vacate this position,” Yiannas wrote.

He added that public organizations like the FDA that undergo crises like the infant formula shortage should conduct thorough reviews to understand how such emergencies occurred.

The official also wrote he believed the FDA would be more effective if it adapted a more “integrated structure” as well as a “fully empowered and experienced Deputy Commissioner for Foods” who had direct oversight over the relevant offices.

“The agency thanks Mr. Yiannas for his service and dedication to the FDA’s public health mission. Mr. Yiannas has served as a valued member of the agency’s leadership team, spearheading important initiatives including the New Era of Smarter Food Safety to help create a safer and more digital, traceable food system for our country,” an FDA spokesperson said in a statement to The Hill.

https://thehill.com/policy/healthcare/3831595-top-fda-safety-official-resigns/

FDA panel: Replace original Covid vaccine with bivalent omicron shots for all doses

 The Food and Drug Administration’s independent advisory committee on Thursday recommended replacing Pfizer and Moderna’s original Covid vaccine used in the U.S. for everyone’s first two immunizations with the new bivalent omicron shots.

If the FDA accepts the advisors’ recommendation, the U.S. would likely phase out the companies’ vaccines developed in 2020 against the original strain of Covid that first emerged in Wuhan, China.

Instead, the drugmakers’ bivalent omicron shots that target the omicron BA.5 subvariant as well as the original strain would be used for the entire vaccination series.

Currently, Pfizer’s and Moderna’s omicron shots are only authorized as a booster, while the first two doses are still their old shots based on the original Covid strain.

The possible change would only impact people who have not yet received their two-dose primary vaccination series.

The 21 members of the FDA committee unanimously backed the recommendation, agreeing that it would simplify the U.S. Covid vaccination program.

“This is absolutely the right thing to do for the program. It will make things simpler,” said Dr. Melinda Wharton, a senior official at the National Center for Immunization and Respiratory Diseases, a division of the Centers for Disease Control and Prevention.

The recommendation to adopt a single formulation across all doses comes as the FDA is trying to streamline Covid vaccination so that the system is easier for the public and health-care workers to understand.

“The overall thought here is that getting towards one vaccine composition for everyone will ultimately be much, much more helpful,” said Dr. Peter Marks, who heads the FDA’s vaccine division.

The FDA has proposed moving to a system that resembles how the agency updates and rolls out flu shots every year. The agency would select a Covid vaccine formulation in June to target the variant that is expected to dominate in the fall and winter. That formulation would be used by all manufacturers for all doses.

Under the proposal, most people who have been exposed to the Covid spike protein twice, either through vaccination or infection, would only receive one Covid shot a year moving forward. Older adults and people with compromised immune systems may need two shots because they don’t mount as strong of an immune response.

https://www.cnbc.com/2023/01/26/fda-advisors-recommend-using-covid-omicron-shots-for-all-doses.html

US arms sales jump by 50% in 2022 amid concerns over war in Ukraine, China aggression

 Mounting security concerns across the globe, stemming from Russia’s invasion of Ukraine to China’s aggressive posture in the Far East, prompted U.S. arms sales to surge by nearly 50 percent in 2022, the Defense Security Cooperation Agency (DSCA) said Thursday.

The DSCA, a subsidiary of the Defense Department, reported that during fiscal year 2022 the U.S. saw roughly $52 billion worth of arms sales compared to the nearly $35 billion in sales reported in 2021.

"Perhaps most importantly, [we attribute this to] the understanding among our partners and allies that we're back in an age of great power competition," DSCA Director James Hursch said. "They see what's happened in Ukraine."

"Central European countries, for example, are looking to get some of the same capabilities that have worked well for the Ukrainian army and to increase their own capabilities for deterrence," he added. "Allies are looking at China and the situations with China in Asia and thinking they need to increase their capabilities."

The increase is not only down to nations looking to expand their defense capabilities but existing partners looking to modernize their security measures.

"As we continue to improve our equipment, it tends to get more costly," he said, explaining that High Mobility Artillery Rocket Systems (HIMARS) are more expensive than howitzers.

"And that's the sort of upgrade that several of our allies and partners are looking to do," he added. 

The DSCA has also reportedly helped allied countries expand surveillance, and more than 40 defense advisers were deployed to nearly two dozen nations through DSCA's Ministry of Defense Advisors Program to advise on weapons procurement and national security strategies. 

The increase in defense sales is not expected to slow down any time soon as several nations, including top allies like Sweden and Finland, which are looking to join NATO, have expanded their defense budgets.

As nations continue to provide Ukraine with not only Soviet-era equipment but more modern defenses from their stockpiles, they are also looking to replenish and boost their defensive postures.

The U.S. alone committed nearly $15 billion in security assistance for Ukraine from the onslaught of the invasion on Feb. 24 through the end of 2022, using presidential drawdowns from existing stocks as well as through the Ukraine Security Assistance Initiative.

Hursch said the DSCA has been "intimately involved" in working with "theater" demands from Ukraine and the U.S. European Command while shaping weapons packages authorized under drawdown orders. 

The director said that despite efficient gains made in 2022, they are still working through post-COVID bottlenecks to make acquisitions more streamlined.

Increased work with allied nations is also critical in helping forecast demands based on regional needs, Hursch said.

"I think the centrality of our security cooperation mission will only continue to increase," he said. "If you look at the National Defense Strategy and the National Security Strategy, you will see stronger words about the need to work with partners and allies – integrated deterrence has a very strong role for working with partners and allies."

https://www.foxbusiness.com/economy/us-arms-sales-jump-50-2022-security-concerns-war-ukraine-china-aggression

CytomX Hits Milestone in Collaboration with Astellas

 Achievement of clinical candidate is the first in the multi-target collaboration and triggers a $5 million milestone payment to CytomX-

-CytomX-retained US co-commercialization and economic rights for select programs-

https://finance.yahoo.com/news/cytomx-therapeutics-announces-milestone-achievement-120000436.html