Tag:Journal of Regulatory Compliance
The Discriminatory Policies against Gay and Bisexual Men that are Fueling the National Blood Crisis
This past January, the American Red Cross announced that the United States was facing its worst blood shortage in over a decade, posing a significant risk to patient care and causing doctors to make difficult decisions in determining which patients should be prioritized for blood transfusions given the dwindling supply. The staggering decrease in blood and platelet donations can be attributed to the global COVID-19 pandemic driving up the need for donations and the hesitancy people have had to leave their homes over the past two years. Even in this desperate time of need for blood, gay and bisexual men in America are still prevented from donating because of discrimination.
Formula 1 Regulations Applied to the New US Tracks
Formula 1 is a sport governed by extensive rules and regulations covering everything from the structure of the car, the engine, and the track. The 2022 season saw a new round of regulations that have the potential to change the game yet again with new budget caps for teams, a new chassis and safety car procedures with more changes expected in 2023. One of the biggest changes for the 2022 and 2023 seasons is the addition of two new United States (US) Grand Prixes with the addition of Miami for the 2022 season and Las Vegas for the 2023 season. This is just one of the many recent steps attempting to integrate the sport in the US market, but the track requirements for the new races are strict.
The End of Forced Arbitration for Sexual Assault and Harassment
Five years after the introduction of the Ending Forced Arbitration of Sexual Assault and Sexual Harassment Act(EFASASH) by Senator Kristi Gillibrand and Senator Linsey Graham, President Biden signed it into law on March 3, 2022. Without this law, employers could prohibit their workers who have experienced sexual assault or harassment from seeking recourse in court. With EFASASH, sexual predators and their employers will no longer be able to evade public accountability. In a world where eighty-one percent of women have reported experiencing some form of sexual harassment and or assault in their lifetime, forced arbitration of sexual assault and harassment claims have only worked as a silencing mechanism.
EU says “EW” to Big Tech
With new antitrust bills aimed against Big Tech stuck in Congress, across the pond, European Union (EU) lawmakers are close to an agreement on a new and sweeping digital-competition law. This large piece of legislation, known as the Digital Markets Act (DMA), is aimed at Big Tech companies and its stated purpose is to ensure fair competition and open digital markets. DMA, along with its sister act, the Digital Services Act (DSA), are flagship pieces of EU legislation that are currently in the final stages of EU lawmaking procedure.
New for 2022: Employment Compliance Trends
2021 brought on many challenges never faced before for employers, most of which surrounded the central issue of working from home. Employers struggled to keep employees focused with all the distractions of being at home, technology connectivity issues, and making sure employees could still stay connected on a personal level with co-workers. While we may finally be shifting slightly away from the work from home space, 2022 will bring on a whole new variety of employment compliance issues that companies will need to tackle. Now that employees are coming back to the office, the focus will be shifted from managing work from home experiences to minimum wage increases, discrimination protections, and marijuana legalizations just to name a few.
Biden Administration Works with the EU to Develop New Data-Sharing Agreement
After the EU invalidated the previous data transfer agreement between the EU and the US in July of 2020, many big tech companies have been left unsure how to keep business flowing from Europe without the ability to store data within the US. To the relief of these companies, the Biden Administration has reached a preliminary agreement for a new deal with the EU. Coined the Trans-Atlantic Data Privacy Framework, this new agreement works to address concerns raised by the EU.
Judge Scrutinizes Wells Fargo and FINRA Over Arbitration Selection Process
Throughout the history of the financial services industry, broker-dealers and investment advisory firms have typically required harmed investors to dispute matters through arbitration rather than the court system. Arbitration disputes between broker-dealers and former clients are generally kept confidential and decided by a purportedly impartial three-person panel; the panels are hand-selected by the parties from a randomly generated list of arbitrators employed by the Financial Industry Regulatory Authority (FINRA). FINRA utilizes a computer algorithm, the Neutral List Selection System (NLSS), which creates a list of potential arbitrators to review the matter based on the type of case. However, a recent court decision overturning a 2019 FINRA arbitration award in favor of Wells Fargo has flooded the financial services industry with widespread allegations of fraud and misconduct. In addition to vacating the arbitration award, Fulton County Superior Court Judge Belinda Edward criticized FINRA’s arbitration selection procedures as well as Wells Fargo for their role in altering the process. Wells Fargo is set to appeal the decision while FINRA now faces immense regulatory pressure to address its failure to facilitate a fair arbitration selection process.
Is Real ID IDeal?
By May 3, 2023, U.S travelers must be Real ID compliant to board domestic flights, enter nuclear facilities, visit military bases, and gain access to certain federal facilities. The implementation of the Real ID comes eighteen years after Congress passed the Real ID Act and ten years after the Department of Homeland Security (DHS) issued an enforcement plan for compliance with Real ID standards. Although U.S travelers have a little more than a year to comply with Real ID requirements, compliance may be difficult in light of the Real ID’s history and complications.
FDA-USPTO Collaboration Offers Insight on the Future of Generics
Following the Biden Administration’s release of the Comprehensive Plan for Addressing High Drug prices in September 2021, the Food and Drug Administration (FDA) responded by opening communication with the United States Patent and Trademark Office (USPTO). On September 10, 2021, the FDA sent a letter to the Under Secretary of Commerce for Intellectual Property and Director of the USPTO seeking to further develop the FDA-USPTO relationship. The letters point out that while “bringing more drug competition to the market and addressing the high cost of medicines by improving access to affordable medications is a top priority” for HHS and FDA, the FDA is constrained by its inability to regulate the price of drugs it approves. While the FDA’s 505(b)(2) hybrid NDA and 505(j) ANDA pathway decrease the cost and time to market entry for generics, the FDA’s authority is concentrated in the pre-market review stage, with post-market authority focused on actions such as product seizure of adulterated or misbranded articles, phase-4 confirmatory trials, and other actions intended to assess the safety and efficacy of drugs.
What Will it Take to Deter Corporations from Violating Environmental Regulations?
Beverage corporation Diageo has recently been fined £1.2 million for violating environmental regulations. Diageo is a multinational corporation that owns a variety of liquor brands, including Johnnie Walker, Tanqueray, Smirnoff, Captain Morgan, Don Julio, Crown Royal, and several others. Headquartered in England, it operates all over the world, with its North American subsidiary being one of its most profitable. In violation of UK regulations, the beverage company has failed to report the environmental impacts of some of its sites for the past six years and has failed to secure permits for the relevant operations. The corporation alleges that these omissions were the result of an administrative error.