Tag:Journal of Regulatory Compliance
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.
Critical Infrastructure and Cybersecurity Legislation: America’s Cybersecurity Problem
Long gone are the days when cybersecurity concerns existed solely in the domain of technology teams. Various organizations, from schools to government entities (at every level), to private companies alike have fallen prey to cyberattacks. May 2021’s Colonial Pipeline attack caused chaos and a temporary gas frenzy that brought awareness of the vulnerabilities of the technology we rely on to even the least technically minded American. Cybersecurity, and more specifically, the security of critical infrastructure immediately became an issue that the U.S. Government is taking very seriously.
Stablecoins II: The Stablecoin Innovation and Protection Act of 2022
On Tuesday, February 15, 2022, Congressman Josh Gottheimer released a draft of the Stablecoin Innovation and Protection Act of 2022 (“the bill”). This legislation attempts to both define stablecoins as well as provide a legal framework in which the issuers and users of stablecoins can safely and legally operate. The bill is surprisingly brief, only nine pages long, but Gottheimer claims that it will provide greater direction and certainty to the marketplace in order to boost innovation while also protecting consumers.
First Amendment Rights and Florida’s “Don’t Say Gay” Bill
Florida’s “Don’t Say Gay” bill, which would bar Florida educators from speaking to students about LBGTQ+ topics that are not considered “age-appropriate or developmentally appropriate for students” has passed in Florida’s House and is likely to pass in the Senate as it now moves to the Republican-controlled Senate floor for a vote. The horrific piece of legislation, formally known as HB 1557, has raised questions as to whether the bill, if passed, would violate the First Amendment rights of teachers or students in public primary schools across the sunshine state.
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.
Could Anna Delvey Have Gotten Away with It? Bank Vetting for a $22 million Loan
Anna Delvey, the alleged scammer who attempted to obtain financial backing of anywhere from $22 million to $40 million in loans, is once again the subject of much debate due to the new Netflix series chronicling her alleged crimes and other actions. The question this article attempts to answer is whether she ever had a chance of realizing her goal of creating an exclusive, members-only, art club much like Soho House. This question hinges on whether she ever had a real chance to secure the funding to make it possible.