Category:The Marketplace
Exploring COVID-19 Vaccine Authorization by the FDA
As of April 22, 2021, 218,947,643 million people have received the COVID-19 vaccine. Before or during the appointment, your provider directs you to a fact sheet for the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine. On the fact sheet, there were a couple of sentences that caught my eye “The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19. There is no U.S. Food and Drug Administration (“FDA”) approved vaccine to prevent COVID-19.” When I read this, I wanted more information about the difference is between being authorized or approved. Like many people, one can become hesitant when a product is not adequately tested; in fact, a Kaiser research project shows about 30% of people probably or definitely not get the vaccine.
Federal Safeguards Against Drug Shortages
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.
U.S. Sanctions International Drug Trafficking
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.
Pfizer Gets a Dose of their Own Medicine from Moderna…Legally.
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 …
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Therano-no: Key CLIA Compliance Issues
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 …
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Buy Now, Pay Later: A Lesson in Economics for Millennials and Gen-Z
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.
Terminating Ownership Rights: The Past, Present, and Future of an Artist’s Right to Terminate Record Companies’ Ownership
Starting on January 1, 2013, Section 203 of the U.S. Copyright Act of 1976 became a tool for songwriters and musicians to recapture control of their work that was registered with the United States Copyright Office on or after January 1, 1978. Who are they recapturing control from? Record companies. Songwriters own the copyrights in their work, but in making a deal with a record company to publish and promote the work, writers transfer those rights or license the work (only granting certain rights) to the company. Section 203 came into effect in 1977 and specifically concerns music created after 1978. (Music created prior to 1978 is governed by Section 304 of the Copyright Act.) Due to the limitations of Section 203, January 1, 2013, was the first opportunity for artists to terminate ownership of their songs and/or recordings from the record companies that previously owned them. Putting that into perspective, in 2017, artists that created the major hits of the 80’s (think AC/DC, Michael Jackson, and Journey) can file a notice of termination with record labels that were previously granted ownership rights at the time the music was created in an attempt to regain all control of their work. Issues with termination rights have caused quite the battle between record companies and musicians both publicly and privately. Those battles can become more complicated in cases with multiple writers, vague copyright agreements, and the death of musicians. As artists seek to exercise their termination rights, it will be interesting to see if and how the music industry will change.
How Native Advertising is Changing the PR Industry and the Way Corporations Interact with Consumers
Nearly 40% of publishers using native advertising are not compliant with the Federal Trade Commission’s (“FTC”) guidelines; this figure has improved from one year ago, when only 30% of users were following the guidelines. In 2017 alone, the FTC estimates that the revenue generated from native advertising will total $20.9 billion, with an estimated 610 new advertisers each month this number is projected to increase to $59 billion in 2018. The number of corporations using native advertising has increased over the years because of social media platforms like Instagram and Facebook, where much of the in-feed content is paid or sponsored.
The Hazards of an Unregulated Cosmetics Industry
The cosmetics industry, unknown to many, is essentially not regulated by a federal regulatory agency. Cosmetics technically fall under the purview of the Food and Drug Administration (“FDA”), but there are few requirements that manufacturers must comply with. The FDA only requires that manufacturers comply with several labeling regulations so companies can avoid listing a product’s total ingredients, and the FDA does not require manufacturers to report health complaints. The FDA instead relies on direct reports of adverse events from consumers, which has the potential to delay remedying a potentially dangerous situation. A study published in JAMA Internal Medicine found that between 2015 and 2016, the number of complaints of adverse health results related to cosmetic products more than doubled from the previous years. Additionally, the FDA only has the equivalent of six full-time inspectors to monitor three million shipments of cosmetics that come into the United States each year. Last year, inspectors only conducted tests on about 364 of those shipments, and 20 % of those shipment that were inspected led to adverse findings.
Medical Marijuana and Maintaining FDA Compliance
Regardless of opinions on legalization, many people accept the idea that medical marijuana, and more specifically CBD, can be a powerful treatment for many medical conditions. However, there has been one major roadblock: the FDA. According to the FDA, more than 90 warning letters over the past 10 years have been released to companies claiming that their cannabis products cure various symptoms. The most common is the claim that marijuana prevents or treats cancer. In 2017, as the medical properties of marijuana continue to be trumpeted to the general public, the FDA is still working to protect the public by issuing warning letters to marijuana providers making unsubstantiated claims.