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  • ✇Ars Technica - All content
  • This year’s summer COVID wave is big; FDA may green-light COVID shots earlyBeth Mole
    Enlarge (credit: Getty | Thomas Trutschel) With the country experiencing a relatively large summer wave of COVID-19, the Food and Drug Administration is considering signing off on this year's strain-matched COVID-19 vaccines as soon as this week, according to a report by CNN that cited unnamed officials familiar with the matter. Last year, the FDA gave the green light for the 2023–2024 COVID shots on September 11, close to the peak of SARS-CoV-2 transmission in that year's su
     

This year’s summer COVID wave is big; FDA may green-light COVID shots early

Od: Beth Mole
20. Srpen 2024 v 01:53
This year’s summer COVID wave is big; FDA may green-light COVID shots early

Enlarge (credit: Getty | Thomas Trutschel)

With the country experiencing a relatively large summer wave of COVID-19, the Food and Drug Administration is considering signing off on this year's strain-matched COVID-19 vaccines as soon as this week, according to a report by CNN that cited unnamed officials familiar with the matter.

Last year, the FDA gave the green light for the 2023–2024 COVID shots on September 11, close to the peak of SARS-CoV-2 transmission in that year's summer wave. This year, the summer wave began earlier and, by some metrics, is peaking at much higher levels than in previous years.

Currently, wastewater detection of SARS-CoV-2 shows "very high" virus levels in 32 states and the District of Columbia. An additional 11 states are listed as having "high" levels. Looking at trends, the southern and western regions of the country are currently reporting SARS-CoV-2 levels in wastewater that rival the 2022–2023 and 2023–2024 winter waves, which both peaked at the very end of December.

Read 8 remaining paragraphs | Comments

  • ✇Ars Technica - All content
  • Path to precision: Targeted cancer drugs go from table to trials to bedsideBeth Mole
    Enlarge (credit: Aurich Lawson) In 1972, Janet Rowley sat at her dining room table and cut tiny chromosomes from photographs she had taken in her laboratory. One by one, she snipped out the small figures her children teasingly called paper dolls. She then carefully laid them out in 23 matching pairs—and warned her kids not to sneeze. The physician-scientist had just mastered a new chromosome-staining technique in a year-long sabbatical at Oxford. But it was in the dining room
     

Path to precision: Targeted cancer drugs go from table to trials to bedside

Od: Beth Mole
5. Srpen 2024 v 13:00
Path to precision: Targeted cancer drugs go from table to trials to bedside

Enlarge (credit: Aurich Lawson)

In 1972, Janet Rowley sat at her dining room table and cut tiny chromosomes from photographs she had taken in her laboratory. One by one, she snipped out the small figures her children teasingly called paper dolls. She then carefully laid them out in 23 matching pairs—and warned her kids not to sneeze.

The physician-scientist had just mastered a new chromosome-staining technique in a year-long sabbatical at Oxford. But it was in the dining room of her Chicago home where she made the discovery that would dramatically alter the course of cancer research.

Read 29 remaining paragraphs | Comments

  • ✇Ars Technica - All content
  • Buying shady weight loss drugs online is a bad idea, in case you were wonderingBeth Mole
    Enlarge (credit: https://www.uschemlabs.com/product/semaglutide-2mg-5-vials/) Buying counterfeit weight loss drugs from illegal online pharmacies that don't require prescriptions is, in fact, a very bad idea, according to a study published Friday in JAMA Network Open. The counterfeit drugs are sold as equivalents to the blockbuster semaglutide drugs, Ozempic and Wegovy, which are prescription only. When researchers got their hands on three illegal versions, they found that t
     

Buying shady weight loss drugs online is a bad idea, in case you were wondering

Od: Beth Mole
2. Srpen 2024 v 23:52
Buying shady weight loss drugs online is a bad idea, in case you were wondering

Enlarge (credit: https://www.uschemlabs.com/product/semaglutide-2mg-5-vials/)

Buying counterfeit weight loss drugs from illegal online pharmacies that don't require prescriptions is, in fact, a very bad idea, according to a study published Friday in JAMA Network Open.

The counterfeit drugs are sold as equivalents to the blockbuster semaglutide drugs, Ozempic and Wegovy, which are prescription only. When researchers got their hands on three illegal versions, they found that the counterfeit drugs had low-purity semaglutide, had dosages that exceeded the labeled amount, and one had signs of bacterial contamination.

The three substandard drugs tested came from three different illegal online pharmacies, which sold them as generic semaglutide drugs for weight loss, appetite suppression, diabetes, and cardiovascular health. However, the researchers, led by scientists at the University of California, San Diego, and the University of Pécs in Hungary, had initially tried purchasing counterfeit drugs from six such sellers.

Read 4 remaining paragraphs | Comments

  • ✇Semiconductor Engineering
  • Chip Industry Week In ReviewThe SE Staff
    BAE Systems and GlobalFoundries are teaming up to strengthen the supply of chips for national security programs, aligning technology roadmaps and collaborating on innovation and manufacturing. Focus areas include advanced packaging, GaN-on-silicon chips, silicon photonics, and advanced technology process development. Onsemi plans to build a $2 billion silicon carbide production plant in the Czech Republic. The site would produce smart power semiconductors for electric vehicles, renewable energy
     

Chip Industry Week In Review

21. Červen 2024 v 09:01

BAE Systems and GlobalFoundries are teaming up to strengthen the supply of chips for national security programs, aligning technology roadmaps and collaborating on innovation and manufacturing. Focus areas include advanced packaging, GaN-on-silicon chips, silicon photonics, and advanced technology process development.

Onsemi plans to build a $2 billion silicon carbide production plant in the Czech Republic. The site would produce smart power semiconductors for electric vehicles, renewable energy technology, and data centers.

The global chip manufacturing industry is projected to boost capacity by 6% in 2024 and 7% in 2025, reaching 33.7 million 8-inch (200mm) wafers per month, according to SEMIs latest World Fab Forecast report. Leading-edge capacity for 5nm nodes and below is expected to grow by 13% in 2024, driven by AI demand for data center applications. Additionally, Intel, Samsung, and TSMC will begin producing 2nm chips using gate-all-around (GAA) FETs next year, boosting leading-edge capacity by 17% in 2025.

At the IEEE Symposium on VLSI Technology & Circuits, imec introduced:

  • Functional CMOS-based CFETs with stacked bottom and top source/drain contacts.
  • CMOS-based 56Gb/s zero-IF D-band beamforming transmitters to support next-gen short-range, high-speed wireless services at frequencies above 100GHz.
  • ADCs for base stations and handsets, a key step toward scalable, high-performance beyond-5G solutions, such as cloud-based AI and extended reality apps.

Quick links to more news:

Global
In-Depth
Market Reports
Education and Training
Security
Product News
Research
Events and Further Reading


Global

Wolfspeed postponed plans to construct a $3 billion chip plant in Germany, underscoring the EU‘s challenges in boosting semiconductor production, reports Reuters. The North Carolina-based company cited reduced capital spending due to a weakened EV market, saying it now aims to start construction in mid-2025, two years later than 0riginally planned.

Micron is building a pilot production line for high-bandwidth memory (HBM) in the U.S., and considering HBM production in Malaysia to meet growing AI demand, according to a Nikkei report. The company is expanding HBM R&D facilities in Boise, Idaho, and eyeing production capacity in Malaysia, while also enhancing its largest HBM facility in Taichung, Taiwan.

Kioxia restored its Yokkaichi and Kitakami plants in Japan to full capacity, ending production cuts as the memory market recovers, according to Nikkei. The company, which is focusing on NAND flash production, has secured new bank credit support, including refinancing a ¥540 billion loan and establishing a ¥210 billion credit line. Kioxia had reduced output by more than 30% in October 2022 due to weak smartphone demand.

Europe’s NATO Innovation Fund announced its first direct investments, which includes semiconductor materials. Twenty-three NATO allies co-invested in this over $1B fund devoted to address critical defense and security challenges.

The second meeting of the U.S.India Initiative on Critical and Emerging Technology (iCET) was held in New Delhi, with various funding and initiatives announced to support semiconductor technology, next-gen telecommunications, connected and autonomous vehicles, ML, and more.

Amazon announced investments of €10 billion in Germany to drive innovation and support the expansion of its logistics network and cloud infrastructure.

Quantum Machines opened the Israeli Quantum Computing Center (IQCC) research facility, backed by the Israel Innovation Authority and located at Tel Aviv University. Also, Israel-based Classiq is collaborating with NVIDIA and BMW, using quantum computing to find the optimal automotive architecture of electrical and mechanical systems.

Global data center vacancy rates are at historic lows, and power availability is becoming less available, according to a Siemens report featured on Broadband Breakfast. The company called for an influx of financing to find new ways to optimize data center technology and sustainability.


In-Depth

Semiconductor Engineering published its Manufacturing, Packaging & Materials newsletter this week, featuring these top stories:

More reporting this week:


Market Reports

Renesas completed its acquisition of Transphorm and will immediately start offering GaN-based power products and reference designs to meet the demand for wide-bandgap (WBG) chips.

Revenues for the top five wafer fab equipment (WFE) companies fell 9% YoY in Q1 2024, according to Counterpoint. This was offset partially by increased demand for NAND and DRAM, which increased 33% YoY, and strong growth in sales to China, which were up 116% YoY.

The SiC power devices industry saw robust growth in 2023, primarily driven by the BEV market, according to TrendForce. The top five suppliers, led by ST with a 32.6% market share and onsemi in second place, accounted for 91.9% of total revenue. However, the anticipated slowdown in BEV sales and weakening industrial demand are expected to significantly decelerate revenue growth in 2024. 

About 30% of vehicles produced globally will have E/E architectures with zonal controllers by 2032, according to McKinsey & Co. The market for automotive micro-components and logic semiconductors is predicted to reach $60 billion in 2032, and the overall automotive semiconductor market is expected to grow from $60 billion to $140 billion in the same period, at a 10% CAGR.

The automotive processor market generated US$20 billion in revenue in 2023, according to Yole. US$7.8 billion was from APUs and FPGAs and $12.2 billion was from MCUs. The ADAS and infotainment processors market was worth US$7.8 billion in 2023 and is predicted to grow to $16.4 billion by 2029 at a 13% CAGR. The market for ADAS sensing is expected to grow at a 7% CAGR.


Security

The CHERI Alliance was established to drive adoption of memory safety and scalable software compartmentalization via the security technology CHERI, or Capability Hardware Enhanced RISC Instructions. Founding members include Capabilities Limited, Codasip, the FreeBSD Foundation, lowRISC, SCI Semiconductor, and the University of Cambridge.

In security research:

  • Japan and China researchers explored a NAND-XOR ring oscillator structure to design an entropy source architecture for a true random number generator (TRNG).
  • University of Toronto and Carleton University researchers presented a survey examining how hardware is applied to achieve security and how reported attacks have exploited certain defects in hardware.
  • University of North Texas and Texas Woman’s University researchers explored the potential of hardware security primitive Physical Unclonable Functions (PUF) for mitigation of visual deepfakes.
  • Villanova University researchers proposed the Boolean DERIVativE attack, which generalizes Boolean domain leakage.

Post-quantum cryptography firm PQShield raised $37 million in Series B funding.

Former OpenAI executive, Ilya Sutskever, who quit over safety concerns, launched Safe Superintelligence Inc. (SSI).

EU industry groups warned the European Commission that its proposed cybersecurity certification scheme (EUCS) for cloud services should not discriminate against Amazon, Google, and Microsoft, reported Reuters.

Cyber Europe tested EU cyber preparedness in the energy sector by simulating a series of large-scale cyber incidents in an exercise organized by the European Union Agency for Cybersecurity (ENISA).

The Cybersecurity and Infrastructure Security Agency (CISA) issued a number of alerts/advisories.


Education and Training

New York non-profit NY CREATES and South Korea’s National Nano Fab Center partnered to develop a hub for joint research, aligned technology services, testbed support, and an engineer exchange program to bolster chips-centered R&D, workforce development, and each nation’s high-tech ecosystem.

New York and the Netherlands agreed on a partnership to promote sustainability within the semiconductor industry, enhance workforce development, and boost semiconductor R&D.

Rapidus is set to send 200 engineers to AI chip developer Tenstorrent in the U.S. for training over the next five years, reports Nikkei. This initiative, led by Japan’s Leading-edge Semiconductor Technology Center (LSTC), aims to bolster Japan’s AI chip industry.


Product News

UMC announced its 22nm embedded high voltage (eHV) technology platform for premium smartphone and mobile device displays. The 22eHV platform reduces core device power consumption by up to 30% compared to previous 28nm processes. Die area is reduced by 10% with the industry’s smallest SRAM bit cells.​

Alphawave Semi announced a new 9.2 Gbps HBM3E sub-system silicon platform capable of 1.2 terabytes per second. Based on the HBM3E IP, the sub-system is aimed at addressing the demand for ultra-high-speed connectivity in high-performance compute applications.

Movellus introduced the Aeonic Power product family for on-die voltage regulation, targeting the challenging area of power delivery.

Cadence partnered with Semiwise and sureCore to develop new cryogenic CMOS circuits with possible quantum computing applications. The circuits are based on modified transistors found in the Cadence Spectre Simulation Platform and are capable of processing analog, mixed-signal, and digital circuit simulation and verification at cryogenic temperatures.

Renesas launched R-Car Open Access (RoX), an integrated development platform for software-defined vehicles (SDVs), designed for Renesas R-Car SoCs and MCUs with tools for deployment of AI applications, reducing complexity and saving time and money for car OEMs and Tier 1s.

Infineon released industry-first radiation-hardened 1 and 2 Mb parallel interface ferroelectric-RAM (F-RAM) nonvolatile memory devices, with up to 120 years of data retention at 85-degree Celsius, along with random access and full memory write at bus speeds. Plus, a CoolGaN Transistor 700 V G4 product family for efficient power conversion up to 700 V, ideal for consumer chargers and notebook adapters, data center power supplies, renewable energy inverters, and more.

Ansys adopted NVIDIA’s Omniverse application programming interfaces for its multi-die chip designers. Those APIs will be used for 5G/6G, IoT, AI/ML, cloud computing, and autonomous vehicle applications. The company also announced ConceptEV, an SaaS solution for automotive concept design for EVs.

Fig. 1: Field visualization of 3D-IC with Omniverse. Source: Ansys

QP Technologies announced a new dicing saw for its manufacturing line that can process a full cassette of 300mm wafers 7% faster than existing tools, improving throughput and productivity.

NXP introduced its SAF9xxx of audio DSPs to support the demand for AI-based audio in software-defined vehicles (SDVs) by using Cadence’s Tensilica HiFi 5 DSPs combined with dedicated neural-network engines and hardware-based accelerators.

Avionyx, a provider of software lifecycle engineering in the aerospace and safety-critical systems sector, partnered with Siemens and will leverage its Polarion application lifecycle management (ALM) tool. Also, Dovetail Electric Aviation adopted Siemens Xcelerator to support sustainable aviation.


Research

Researchers from imec and KU Leuven released a +70 page paper “Selecting Alternative Metals for Advanced Interconnects,” addressing interconnect resistance and reliability.

A comprehensive review article — “Future of plasma etching for microelectronics: Challenges and opportunities” — was created by a team of experts from the University of Maryland, Lam Research, IBM, Intel, and many others.

Researchers from the Institut Polytechnique de Paris’s Laboratory of Condensed Matter for Physics developed an approach to investigate defects in semiconductors. The team “determined the spin-dependent electronic structure linked to defects in the arrangement of semiconductor atoms,” the first time this structure has been measured, according to a release.

Lawrence Berkeley National Laboratory-led researchers developed a small enclosed chamber that can hold all the components of an electrochemical reaction, which can be paired with transmission electron microscopy (TEM) to generate precise views of a reaction at atomic scale, and can be frozen to stop the reaction at specific time points. They used the technique to study a copper catalyst.

The Federal Drug Administration (FDA) approved a clinical trial to test a device with 1,024 nanoscale sensors that records brain activity during surgery, developed by engineers at the University of California San Diego (UC San Diego).


Events and Further Reading

Find upcoming chip industry events here, including:

Event Date Location
Standards for Chiplet Design with 3DIC Packaging (Part 2) Jun 21 Online
DAC 2024 Jun 23 – 27 San Francisco
RISC-V Summit Europe 2024 Jun 24 – 28 Munich
Leti Innovation Days 2024 Jun 25 – 27 Grenoble, France
ISCA 2024 Jun 29 – Jul 3 Buenos Aires, Argentina
SEMICON West Jul 9 – 11 San Francisco
Flash Memory Summit Aug 6 – 8 Santa Clara, CA
USENIX Security Symposium Aug 14 – 16 Philadelphia, PA
Hot Chips 2024 Aug 25- 27 Stanford University
Find All Upcoming Events Here

Upcoming webinars are here.

Semiconductor Engineering’s latest newsletters:

Automotive, Security and Pervasive Computing
Systems and Design
Low Power-High Performance
Test, Measurement and Analytics
Manufacturing, Packaging and Materials


The post Chip Industry Week In Review appeared first on Semiconductor Engineering.

  • ✇Ars Technica - All content
  • Top FDA official overrules staff to approve gene therapy that failed trialBeth Mole
    Enlarge / Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration on March 18, 2021 in Washington, DC. (credit: Getty | Susan Walsh) The Food and Drug Administration (FDA) on Thursday announced expanded approval for a gene therapy to treat Duchenne muscular dystrophy (DMD)—despite the fact that it failed a Phase III clinical trial last year and that the approval came over the objections of three of FDA's own exper
     

Top FDA official overrules staff to approve gene therapy that failed trial

Od: Beth Mole
21. Červen 2024 v 23:26
Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration on March 18, 2021 in Washington, DC.

Enlarge / Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration on March 18, 2021 in Washington, DC. (credit: Getty | Susan Walsh)

The Food and Drug Administration (FDA) on Thursday announced expanded approval for a gene therapy to treat Duchenne muscular dystrophy (DMD)—despite the fact that it failed a Phase III clinical trial last year and that the approval came over the objections of three of FDA's own expert review teams and two of its directors.

In fact, the decision to expand the approval of the therapy—called Elevidys (delandistrogene moxeparvovec-rokl)—appears to have been decided almost entirely by Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research.

Elevidys initially gained an FDA approval last year, also over objections from staff. The therapy intravenously delivers a transgene that codes for select portions of a protein called dystrophin in healthy muscle cells; the protein is mutated in patients with DMD. Last year's initial approval occurred under an accelerated approval process and was only for use in DMD patients ages 4 and 5 who are able to walk. In the actions Thursday, the FDA granted a traditional approval for the therapy and opened access to DMD patients of all ages, regardless of ambulatory status.

Read 11 remaining paragraphs | Comments

  • ✇Ars Technica - All content
  • FDA’s review of MDMA for PTSD highlights study bias and safety concernsBeth Mole
    Enlarge / MDMA is now in the FDA's hands. (credit: Getty | PYMCA/Avalon) The safety and efficacy data on the use of MDMA (aka ecstasy) for post-traumatic stress disorder therapy is "challenging to interpret," the Food and Drug Administration said in a briefing document posted Friday. The agency noted significant flaws in the design of the underlying clinical trials as well as safety concerns for the drug, particularly cardiovascular harms. On Tuesday, June 4, the FDA will con
     

FDA’s review of MDMA for PTSD highlights study bias and safety concerns

Od: Beth Mole
1. Červen 2024 v 01:46
MDMA is now in the FDA's hands.

Enlarge / MDMA is now in the FDA's hands. (credit: Getty | PYMCA/Avalon)

The safety and efficacy data on the use of MDMA (aka ecstasy) for post-traumatic stress disorder therapy is "challenging to interpret," the Food and Drug Administration said in a briefing document posted Friday. The agency noted significant flaws in the design of the underlying clinical trials as well as safety concerns for the drug, particularly cardiovascular harms.

On Tuesday, June 4, the FDA will convene an advisory committee that will review the evidence and vote on MDMA's efficacy and whether its benefits outweigh its risks. The FDA does not have to follow the committee's recommendations, but it often does. If the FDA subsequently approves MDMA as part of treatment for PTSD, it would mark a significant shift in the federal government's stance on MDMA, as well as psychedelics, generally. Currently, the US Drug Enforcement Administration considers MDMA a Schedule I drug, defined as one with "no currently accepted medical use and a high potential for abuse." It would also offer a new treatment option for patients with PTSD, a disabling psychiatric condition with few treatment options currently.

As Ars has reported previously, the submission of MDMA for approval is based on two clinical trials. The first trial, published in Nature Medicine in 2021, involved 90 participants with moderate PTSD and found that MDMA-assisted psychotherapy significantly improved Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores compared with participants who were given psychotherapy along with a placebo. In the second study, published in September in Nature Medicine, the finding held up among 104 participants with moderate or severe PTSD (73 percent had severe PTSD).

Read 7 remaining paragraphs | Comments

  • ✇Latest
  • Rescheduling Marijuana Does Not Address Today's Central Cannabis IssueJacob Sullum
    The Justice Department yesterday confirmed that the Drug Enforcement Administration  (DEA) plans to move marijuana from Schedule I of the Controlled Substances Act (CSA), a list of completely prohibited drugs, to Schedule III, which includes prescription medications such as ketamine, Tylenol with codeine, and anabolic steroids. The Associated Press notes that the change, which is based on an August 2023 recommendation by the Department of Health
     

Rescheduling Marijuana Does Not Address Today's Central Cannabis Issue

1. Květen 2024 v 21:10
cannabis leaves | MIS Photography

The Justice Department yesterday confirmed that the Drug Enforcement Administration  (DEA) plans to move marijuana from Schedule I of the Controlled Substances Act (CSA), a list of completely prohibited drugs, to Schedule III, which includes prescription medications such as ketamine, Tylenol with codeine, and anabolic steroids. The Associated Press notes that the change, which is based on an August 2023 recommendation by the Department of Health and Human Services (HHS) that resulted from a review President Joe Biden ordered in October 2022, "would not legalize marijuana outright for recreational use."

That is by no means the only thing rescheduling marijuana will not do. Biden wants credit for "marijuana reform," which he hopes will help motivate young voters whose turnout could be crucial to his reelection. The announcement of the DEA's decision seems designed to maximize its electoral impact. But voters should not be fooled: Although moving marijuana to Schedule III will facilitate medical research and provide a financial boost to the cannabis industry, it will leave federal pot prohibition essentially untouched.

Rescheduling marijuana will not resolve the conflict between the CSA and the laws of the 38 states that recognize cannabis as a medicine, 24 of which also allow recreational use. State-licensed marijuana businesses will remain criminal enterprises under federal law, exposing them to the risk of prosecution and forfeiture. While an annually renewed spending rider protects medical marijuana suppliers from those risks, prosecutorial discretion is the only thing that protects businesses serving the recreational market.

Even if they have state licenses, marijuana suppliers will be in the same legal position as anyone who sells a Schedule III drug without federal permission. Unauthorized distribution is punishable by up to 10 years in prison for a first offense and up to 20 years for subsequent offenses. That is less severe than the current federal penalties for growing or distributing marijuana, which include five-year, 10-year, and 20-year mandatory minimum sentences, depending on the number of plants or amount of marijuana. But distributing cannabis, with or without state permission, will remain a felony.

That reality suggests that banks will remain leery of providing financial services to state-licensed marijuana suppliers, which entails a risk of potentially devastating criminal, civil, and regulatory penalties. The dearth of financial services has forced many cannabis suppliers to rely heavily on cash, which is cumbersome and exposes them to a heightened risk of robbery. It also makes investment in business expansion difficult.

Although federal arrests for simple marijuana possession are rare, cannabis consumers likewise will still be committing crimes, even if they live in states that have legalized marijuana. Under 21 USC 844, possessing a controlled substance without a prescription is a misdemeanor punishable by a minimum $1,000 fine and up to a year in jail. Moving marijuana to Schedule III will not change that law, which only Congress can do. Nor did President Joe Biden's mass pardons for people convicted of simple marijuana possession under that statute, which apply only retrospectively, "decriminalize the use of cannabis," as he promised to do during his 2020 campaign.

Biden has repeatedly decried the barriers to education, employment, and housing that marijuana convictions create. But contrary to what he claims, his pardons do not entail expungement of criminal records and therefore do not eliminate those barriers. Nor did the pardons address the various legal disabilities associated with marijuana convictions, cannabis consumption, or participation in the cannabis industry, which include loss of Second Amendment rights (a policy that Biden defends) and ineligibility for admission, legal residence, and citizenship under immigration law. Rescheduling marijuana likewise will not remove those barriers and disabilities.

Moving marijuana to Schedule III will not even make it legally available as a medicine, which would require regulatory approval of specific products. Doctors can legally prescribe Marinol (a.k.a. dronabinol), a synthetic version of THC listed in Schedule III, and Epidiolex, a cannabis-derived CBD solution listed in Schedule V. But they will not be able to prescribe marijuana even after it is moved to Schedule III unless the Food and Drug Administration approves additional cannabis-based medications.

The medical "recommendations" that authorize patients to use marijuana for symptom relief under state law are not prescriptions, and they do not make such use compliant with the CSA. So rescheduling marijuana not only will not legalize recreational use; it will not legalize medical use either.

What will rescheduling do? It should make medical research easier by eliminating the regulatory requirements that are specific to Schedule I, and it will provide an important benefit to state-licensed marijuana suppliers by allowing them to deduct standard business expenses when they pay federal income taxes.

Under Section 280E of the Internal Revenue Code, which is aimed at sticking it to drug dealers, taxpayers may not claim a "deduction or credit" for "any amount paid or incurred during the taxable year in carrying on any trade or business" that involves "trafficking" in Schedule I or Schedule II drugs. As that provision has been interpreted by tax courts, marijuana businesses can still deduct the "cost of goods sold," which counterintuitively means they can deduct the expenses associated with obtaining and maintaining an inventory of cannabis products. But they cannot deduct any other business expenses, including rent, utilities, salaries and benefits, office supplies, security, cleaning services, insurance, and legal fees.

That rule results in a crushing financial burden, forcing marijuana retailers to pay an effective tax rate as high as 70 percent or more. But because Section 280E applies only to businesses that sell drugs in Schedule I or Schedule II, moving marijuana to Schedule III will eliminate that disadvantage.

"I cannot emphasize enough that removal of § 280E would change the industry forever," cannabis lawyer Vince Sliwoski writes. "Having worked with cannabis businesses for 13 years, I view taxation as the largest affront to marijuana businesses—more than banking access, intellectual property protection problems, lack of bankruptcy, you name it. This would be HUGE." In addition to making it much easier to turn a profit, Sliwoski says, the tax change would help attract investors and give marijuana businesses "more leverage" in negotiating those deals.

Aside from those practical changes, rescheduling represents a historic federal about-face on the benefits and hazards of marijuana. Schedule I is supposedly reserved for drugs with a high abuse potential and no accepted medical use that cannot be used safely even under a doctor's supervision. Explaining its rationale for recommending marijuana's reclassification, HHS acknowledged that the drug does not meet those criteria—a point that critics had been making for half a century.

HHS cited "credible scientific support" for marijuana's use in the treatment of pain, nausea and vomiting, and "anorexia related to a medical condition." Regarding abuse potential and safety, it noted that marijuana compares favorably to "other drugs of abuse," such as heroin (Schedule I), cocaine (Schedule II), benzodiazepines like Valium and Xanax (Schedule IV), and alcohol (unscheduled). "The vast majority of individuals who use marijuana," HHS said, "are doing so in a manner that does not lead to dangerous outcomes to themselves or others."

In agreeing to follow the HHS recommendation, the DEA likewise is implicitly admitting that the federal government has been lying about marijuana for decades. But that long-overdue reversal falls far short of addressing today's central cannabis issue: the conflict between federal prohibition and state tolerance, which extends to recreational use in jurisdictions that account for most of the U.S. population. Repealing the federal ban—a step that Americans overwhelmingly support—would resolve that conflict. And while Biden cannot do that on his own, he has stubbornly resisted the idea, even as he emphasizes the irrationality and injustice of the war on weed.

The post Rescheduling Marijuana Does Not Address Today's Central Cannabis Issue appeared first on Reason.com.

  • ✇Latest
  • DEA Finally Expected To Reclassify MarijuanaJoe Lancaster
    The federal government is finally expected to change the way it regulates marijuana, such that the drug would no longer be completely forbidden. The change is welcome, but it does not go far enough. "The U.S. Drug Enforcement Administration will move to reclassify marijuana as a less dangerous drug," the Associated Press reported on Tuesday. The proposal "would recognize the medical uses of cannabis and acknowledge it has less potential for abuse
     

DEA Finally Expected To Reclassify Marijuana

30. Duben 2024 v 21:34
An American flag, with marijuana leaves incorporated, flies with the U.S. Capitol building in the background. | Bill Clark/CQ Roll Call/Newscom

The federal government is finally expected to change the way it regulates marijuana, such that the drug would no longer be completely forbidden. The change is welcome, but it does not go far enough.

"The U.S. Drug Enforcement Administration will move to reclassify marijuana as a less dangerous drug," the Associated Press reported on Tuesday. The proposal "would recognize the medical uses of cannabis and acknowledge it has less potential for abuse than some of the nation's most dangerous drugs. However, it would not legalize marijuana outright for recreational use."

The policy would signal a welcome shift from decades of prohibitionist drug policy. Since 1970, the federal government has regulated marijuana under Schedule I of the Controlled Substances Act, intended for drugs with "a high potential for abuse" and "no currently accepted medical use in treatment." Other Schedule I substances include heroin and peyote.

That description has always been ridiculous when applied to marijuana, but especially in recent years, as more than two-thirds of U.S. states, plus three territories and the District of Columbia, now allow marijuana for medical use—not to mention that 24 states, two territories, and D.C. further allow recreational use.

The proposed reclassification stems from President Joe Biden's October 2022 announcement calling on Attorney General Merrick Garland and Secretary Xavier Becerra of the Department of Health and Human Services (HHS) to "initiate the administrative process to review expeditiously how marijuana is scheduled under federal law."

In August 2023, HHS delivered its recommendation: Marijuana should be reclassified from Schedule I to Schedule III. According to the DEA, Schedule III drugs have "a moderate to low potential for physical and psychological dependence" and can be prescribed by a doctor. Examples include ketamine, Tylenol with codeine, and anabolic steroids. Marijuana would not be completely legalized, though: Schedule III substances are still subject to regulation on their sale and use.

Even now, if the DEA decides to reschedule marijuana, nothing will change right away: The proposal "still must be reviewed by the White House Office of Management and Budget," the A.P. notes, after which "the DEA will take public comment on the plan…. After the public comment period,…the agency would publish the final rule."

Marijuana prohibition is an antiquated notion, and its end is long overdue. Nearly 90 percent of Americans now think marijuana should be legal in some capacity, according to a Gallup poll conducted earlier this year, with 57 percent favoring full legalization and another 32 percent preferring that it be legal only for medical use.

Even the government's excuses for keeping cannabis illegal have never stood up to scrutiny. When HHS decided to recommend reclassification last year, it effectively reversed itself and contradicted its own long-held position on the topic; the DEA has previously declined to reschedule marijuana five times. As Reason's Jacob Sullum wrote in January, "The [HHS] reversal shows that marijuana's classification has always been a political question rather than a legal or scientific matter."

"It is significant for these federal agencies, and the DEA and [Food and Drug Administration] in particular, to acknowledge publicly for the first time what many patients and advocates have known for decades: that cannabis is a safe and effective therapeutic agent for tens of millions of Americans," said Deputy Director Paul Armentano of the National Organization for the Reform of Marijuana Laws (NORML) in an emailed statement. But that's not far enough, Armentano argues: "Just as it is intellectually dishonest and impractical to categorize cannabis in the same placement as heroin, it is equally disingenuous and unfeasible to treat cannabis in the same manner as anabolic steroids and ketamine."

Rescheduling marijuana so that people can use it without fear of being put in prison is a welcome first step. But the best solution would be for Congress to simply decriminalize it altogether.

The post DEA Finally Expected To Reclassify Marijuana appeared first on Reason.com.

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  • Supreme Court Denies Red State Effort to Intervene in Mifepristone CaseJonathan H. Adler
    The Supreme Court is scheduled to hear oral argument in FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine, the combined cases concerning the Food & Drug Administration's regulation of mifepristone, on March 26. This morning, on the Orders List, the Court denied a motion to intervene filed by Missouri, Kansas, and Idaho. These states argued that the should be allowed to intervene so as to ensure that the requirements of Article III standing a
     

Supreme Court Denies Red State Effort to Intervene in Mifepristone Case

20. Únor 2024 v 16:15

The Supreme Court is scheduled to hear oral argument in FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine, the combined cases concerning the Food & Drug Administration's regulation of mifepristone, on March 26.

This morning, on the Orders List, the Court denied a motion to intervene filed by Missouri, Kansas, and Idaho. These states argued that the should be allowed to intervene so as to ensure that the requirements of Article III standing are met so that the Court can reach the merits. (This is, I take it, a tacit admission that the plaintiffs' standing claims are quite tenuous, as I have argued at length in some of the poses linked below.) The states base this argument, in part, on their successful motion to intervene in the trial court (which Adam Unikowsky dissects here). In any event, the Court rejected the motion.

The Court also ruled on two applications to file late-submitted amicus briefs, one from the American Bar Association and one from former Commissioners of the FDA. Interestingly enough, the Court rejected the former brief, but accepted the latter. Looking at the two briefs, this seems like a reasonable call. The FDA Commissioners brief provides relevant expertise that might be absent from other filed briefs. The ABA brief, not so much. Indeed, one has to wonder why the ABA brief was filed at all, as this case does not relate (even tangentially) to the needs or interests of the legal profession and does not add much given what has already been filed on the FDA's behalf in this case. Moreover, filing briefs like this is something the ABA should avoid if it wants to be seen as an apolitical organization that represents the legal profession and can speak to questions relating to the practice of law with any degree of authority.

The Court also denied a motion to intervene filed by Gregory J. Roden as "Next Friend of Americans en ventre sa mere." No surprise there.

For those interested in more about this case, yesterday I participated in a panel discussion on this case with my colleague Jessie Hill, sponsored by the Law-Medicine Center at the Case Western Reserve University School of Law. Video of that program may be viewed here.

Also, here are my prior blog posts about this case and the issues it raises:

The post Supreme Court Denies Red State Effort to Intervene in Mifepristone Case appeared first on Reason.com.

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