Journal of Regulatory Compliance

Artificial Intelligence and Health Insurance Claim Denials

Jason VelliganAssociate EditorLoyola University Chicago School of Law, JD 2024 Artificial intelligence headlines are grabbing the attention of people from most industries. Artificial intelligence helps doctors diagnose and treat patients, and pharmaceutical manufacturers develop new medications. Politicians, subject matter experts, and numerous publications voice concerns over using artificial intelligence. In late 2023, class actions were …
Read more

Modernization of Cosmetics Regulation Act: Better Late Than Never?

The Food Drug & Cosmetic Act (FDCA) has been relatively unchanged regarding cosmetics since 1938. The United States cosmetics industry is primarily self-policing compared to the food, drugs, or medical device industries. CNN recently noted that around 5,000 adverse events relating to cosmetics are reported to the Food & Drug Administration (FDA), and 25% are considered serious. On December 22, 2022, Joe Biden signed the Modernization of Cosmetic Regulation Act of 2022 (MoCRA) to overhaul the cosmetics regulatory regime. The FDA’s oversight and policing of cosmetics will belatedly resemble that of food, drugs, and medical devices.

Peculiar Alliances Responding to the FDA v. Alliance for Hippocratic Medicine

The Supreme Court is currently reviewing a 5th Circuit decision to roll back 2016 and 2021 expanded indications of mifepristone, a drug originally approved by the Food and Drug Administration (FDA) in 2000. Given the Supreme Court’s hostility toward administrative agencies in the current term, a judge from a United States District Court may substitute their knowledge for that of agency scientific experts in United States FDA v. Alliance for Hippocratic Medicine.

No Post Hoc Justification for Submitting False Claims

On June 1, 2023, in a unanimous opinion, the United States Supreme Court ruled in United States et al. ex rel. Schutte et al. v. Supervalu Inc. et al. and United States et al. ex rel. Proctor v. Safe-way, Inc. that the scienter element of the False Claims Act (FCA) refers to a defendant’s knowledge and subjective beliefs. Supervalu and Safeway knew they were charging government health insurance programs more for prescription drugs than what they usually and customarily charging regular customers, in violation of the FCA.

Regulatory Implications of the FTC’s Proposed Ban on Noncompete Clauses

The landscape of post-termination benefits and rights for employees is continuously evolving. In recent developments, the Federal Trade Commission (FTC) has proposed a rule that could significantly change the dynamics of the job market by seeking to ban noncompete clauses. This proposal impacts businesses and employees and intersects with other regulatory frameworks, calling for an integrated perspective on its implications.

Florida’s War on “Woke” – First Amendment Concerns and the Stop “W.O.K.E” Act

Florida recently passed the “Stop W.O.K.E” Act (Senate Bill 147 / House Bill 7) (The “Act”), effectively banning public colleges in the state from using funds on diversity, equity, and inclusion (DEI) programs. Florida’s governor and current Presidential candidate, Ron Desantis, defines W.O.K.E as “Wrongs to Our Kids and Employees”. The passing of this legislation follows another highly controversial piece of legislation passed earlier this year, Florida’s “Don’t Say Gay” bill, that largely bars Florida educators from discussing LGBTQIA+ topics with students. Governor Desantis  has led an aggressive campaign against academic freedom to combat a perceived “woke indoctrination in [U.S] schools, that is a road to ruin for this country”. The implementation of this legislation brings up valid concerns regarding the First Amendment rights of the State’s educators and population at large. 

New Rule Proposed by the EPA to Clean Up Coal Waste in the Midwest 

On May 18, 2023, the Environmental Protection Agency (EPA) proposed a new rule to address the concern of a previous loophole that allowed pits of coal ash to sit inactive and unmonitored. The new proposed rule was created in response to the August 21, 2018 opinion by the U.S. Court of Appeals for the District of Columbia Circuit in Utility Solid Waste Activities v. EPA. 

Healthcare Bribery Whistleblower Receives the Highest SEC Award in 2022

The United States Securities and Exchange Commission (SEC) has announced that they have awarded upwards of $37 million to one whistleblower in 2022. This individual gave important information to the SEC that led to a successful enforcement action against a large European healthcare company. This award took the cake for being the highest payout to a whistleblower in 2022. What does a whistleblower program look like from the regulator’s point of view and why is it important?

The U.S. Department of Treasury Steps in to Patrol Petroleum

The US Treasury’s Office of Foreign Assets Control (OFAC) has sanctioned nine entities involved in the production, sale, and shipment of Iranian petrochemicals and petroleum to buyers in Asia, in violation of US sanctions. Six Iran-based petrochemical manufacturers and three firms in Malaysia and Singapore have been targeted for facilitating the sale and shipment of petroleum and petrochemicals on behalf of Triliance Petrochemical Co. Ltd., which OFAC previously designated for facilitating the sale of Iranian petroleum products. The sanctions are aimed at targeting Tehran’s sources of illicit revenue, and all property and interests in property of the targeted entities must be blocked and reported to OFAC.

Coinbase Global Inc. Settlement Raises More Questions for Financial Regulators

On January 4th, 2023, the New York State Department of Financial Services made public that a $100 million settlement with the cryptocurrency exchange Coinbase Global Inc. (Coinbase) has been agreed to. The settlement follows an enforcement action imposed this past August aiming to regulate cryptocurrencies. With a lot of discussion happening given the recent collapse of FTX and anti-money laundering violations by Robinhood Markets, this action begs the question: should the digital currency industry be regulated nationwide and, if so, what should these regulatory agendas look like?