Category:

The Marketplace

FDA’s Proposed Global Regulatory Harmonization for Medical Devices

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.

Decriminalization Is Not Enough, Abolition Is a Must

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.

The Ninth Circuit Rules on Net Neutrality, Putting State Regulations of the Internet from Mozilla v. FCC to the Test

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.

Compliance and Aducanumab – How Should Providers Balance FDA and CMS Guidance?

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.

Regulating Crypto Markets through the Build Back Better Act: Crypto Investors’ Future Compliance with Wash Sale Rules

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.

Stadiums, Casinos, and Riverboats: Illinois and Chicago Hedging Their Bets on the Future of Gambling Regulations

Illinois has historically been at the forefront of gambling regulations in the United States.  Chicago, on the other hand, has resisted sanctioning formalized gambling locations until recently.  Following the passage of the 2019 Gaming Expansion Law, Illinois expanded gambling across the state and Chicago is planning to open its first casino by 2025.  Chicago is also concurrently debating an ordinance that would allow sports gambling within the city’s stadiums and arenas.

The DOJ Challenges Penguin Random House’s Acquisition of Simon & Schuster

In the United States, “The Big Five” denote the largest five publishing houses. These publishing empires print everything from medical textbooks to children’s books and together control over eighty percent of the publishing market. The Big Five includes Penguin Random House, HarperCollins, Simon & Schuster, Hachette, and Macmillan. In November of 2020, Viacom announced the sale of Simon & Schuster to Penguin Random House for $2.175 billion. A year later on November 2, 2021, the U.S. Department of Justice announced a lawsuit challenging the acquisition to ensure “fair competition in the U.S. publishing industry.”

Price Control Legislation for Generic Drugs – A Delaware Case Study

Price Control Legislation for Generic Drugs – A Delaware Case Study Andrew Thompson Associate Editor Loyola University Chicago School of Law, JD 2023 Earlier, I wrote here about how American drug prices are approximately 256 to 344 percent higher than prices in OCED member markets. Federal legislators confronting patent extensions, pay-for-delay agreements, and other tools …
Read more

The Story That Sounded Too Good to Be True Was, Indeed, Too Good to Be True.

The process of the criminal trial of the youngest woman self-made billionaire, has recently started up again after being stalled due to Covid restrictions in the past year. Former CEO and founder of Theranos, Elizabeth Holmes, and her former president and one-time boyfriend, Ramesh Balwani, have been accused of misleading investors and raising hundreds of millions of dollars by making false or exaggerated claims in defiance of the anti-fraud provisions of federal securities laws. While she is currently facing a federal indictment on twelve different charges, including two counts of conspiracy to commit wire fraud and ten counts of wire fraud, Holmes has already settled her civil charges, which were brought forth by the Securities Exchange Commission (SEC). The civil charges brought forth by the SEC have now put Silicon Valley on alert by ensuring that technology companies who claim that they have a new groundbreaking technology that can change the world must be based on factual evidence, not purely myths.