On October 03, 2023, the Biden administration announced indictments and sanctions against 28 individuals and entities, including China-based companies and their employees related to the trafficking of chemicals needed for the manufacturing of fentanyl. The sanctions aim to interrupt the global supply chain of fentanyl as the administration have increased their efforts on tackling the opioid epidemic. However, rising tensions in the U.S.-China relationship have delayed progress. On September 15, 2023, President Biden added China to the list of the world’s major illicit drug producing and drug transit countries. In response, China’s Ministry of Foreign Affairs stated that the designation is a malicious smear against China. The Ministry further urged the U.S. to do things in ways that are conducive to cooperation with China, not otherwise. With growing international tensions and an epidemic still afoot, the U.S. faces a challenging uphill battle with fentanyl.
From October 2022 to January 2023, there was a nationwide Adderall shortage. This recent shortage is no surprise since the Food and Drug Administration (FDA) has announced several Adderall shortages since 2019. Although the recent shortage has ended, researchers fear there will be more Adderall shortages in the coming year as prescribing rates continue to rise. More importantly, the recent shortage has made patients worried about future shortages and concerned about why the federal government has not done more to prevent drug shortages.
The 2008 financial collapse occurred when banks began substantially increasing access to debt in the form of adjustable-rate mortgages. These types of mortgages allowed borrowers to take out home loans at an intertest rate that would increase over time. This meant that more borrowers could afford the initial mortgage payments but would end up defaulting on the loans when their adjustable interest rates kicked in. The banks then packaged these high-risk loans together and sold them as securities to mutual funds, investment banks, and pension funds. When most of these high-risk loans defaulted, the market crashed. The collapse occurred in part because the housing market lacked the regulations needed to deter this kind of high-risk lending. The recession that followed cost thousands of jobs, homes, and retirement accounts.
Juhi Desai Associate Editor Loyola University Chicago School of Law, JD 2024 As if the world has not had enough of its fair share of COVID-19-related matters, news regarding the virus has topped headlines once again. On August 26, 2022, Moderna, a pharmaceutical and biotechnology company, publicly announced it was filing two patent-infringement lawsuits against …
Janaki Padmakumar Associate Editor Loyola University Chicago School of Law, JD 2023 In one of the greatest fraud cases of the last decade, Elizabeth Holmes, founder and CEO of Theranos, was convicted of four federal fraud charges on January 4, 2022. Theranos was a private healthcare startup that claimed have invented a novel blood testing …
On February 23, 2022, the Food and Drug Administration (FDA) published a proposed regulation to amend current manufacturing practice requirements of the Quality System Regulation (QSR) (21 CFR Part 820). The FDA first announced such harmonization in 2018, however COVID-19 delayed the proposal. The FDA seeks to align Part 820 more closely with the international specific standard for medical device quality management systems set out by the International Organization for Standardizations (ISO) 13485. According to the FDA, such “harmonization should provide patients more efficient access to necessary devices, leading to improvements of life quality of the consumers.” Part 820 is part of the current mandatory regulations that ensure that all medical devices created and developed within the US market are safe. ISO 13485 is the international standard for a quality management system for medical devices required by certain countries. Therefore, any manufacturer that sells outside the US will likely need to be ISO 13485 certified. With the implementation of this new amendment, manufacturers would be able to assure their products are regulatorily compliant in both the US and international markets.
In the United States, since the 1980s, the federal prison population has increased by roughly 790%. Specifically, presently within Illinois, there are approximately 76,000 citizens who are incarcerated. In 2014, Illinois appropriated and spent nearly $1.3 billion on prison budgets. Where even though cannabis is now legal, in Illinois, roughly 90 inmates are still incarcerated for offenses relating to the use, manufacturing, and selling of cannabis. According to the Last Prisoner Project, inmates remain incarcerated even though House Bill 1438 establishes that persons who have been convicted on an offense are granted a pardon because the Bill provides no resentencing or commutation procedures, and the process to have sentences pardoned is slow.
In examining the injustices of carceral punishment, statistics like these show that these injustices are not an anomaly, but rather the norm. Because prisons are premised on punishment, rather than transformative healing, health, and prevention, prisons are a human rights issue, rather than a criminal justice issue. Prisons are premised on punishment, rather than transformative healing and health, and prevention. As a result, resources and funding which are currently given to our present system of policing and prisons should be reallocated to tools that actually serve the community, rather than on incarceration.
Net neutrality (or network neutrality) is the idea that internet service providers (ISPs), such as Verizon or Comcast, should not be able to block or prioritize different sorts of data. The Ninth Circuit, which is comprised of Alaska, Arizona, California, Guam, Hawaii, Idaho, Montana, Nevada, Northern Mariana Islands, Oregon, and Washington state, is the largest Court of Appeals in the United States both in population and land mass. Recently, the Ninth Circuit ruled in a case that net neutrality requirements applied to internet service providers in those states. This decision put to test the U.S. Court of Appeals for the District of Columbia’s 2019 decision of Mozilla v. FCC, which ruled that states would be able to create regulations regarding net neutrality.
As my colleague at Inside Compliance discussed here in September, the FDA approved Aducanumab for the treatment of Alzheimer’s Disease on June 7, 2021. Aducanumab, marketed as Aduhelm, is intended to reduce beta-amyloid levels. This compound is responsible for forming a “plaque” which inhibits neuron function and eventually triggers neuronal apoptosis (death of neurons). Now, a recent decision by CMS on insurance reimbursement for aducanumab has increased the compliance responsibilities of providers.
The Build Back Better Act, which passed through the House of Representatives in November 2021, has been stalled in the Senate for several months. Senate Majority Leader Chuck Schumer has insisted that Democrats will work until the bill is passed. Within the Build Back Better Act, cryptocurrencies are shifted from being treated like property to being treated more like traditional securities, subjecting all digital currencies to wash rules under Section 1091. With cryptocurrencies collectively evaluated at upwards of $3 Trillion in 2021, crypto investors under the Build Back Better Act would be subject to the regulatory anti-abuse rules that currently apply to both stocks and bonds. This move by Democrats is for taxing purposes, but ultimately will call into question the IRS’ ability to regulate certain crypto transactions and asset disclosures. Additionally, questions have been raised as to the future regulation of cryptocurrencies and what that will mean for one of the most volatile trading markets.