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Journal of Regulatory Compliance

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?

The Case for Expanding Privacy Protections in a Post-Roe World

In Dobbs v. Jackson Women’s Health Organization (Dobbs), the US Supreme Court ruled that abortion is not a fundamental right protected by the Constitution. This decision resulted in additional abortion protections in California, Michigan, and Vermont, and prompted many patients, providers, regulators, and tech companies to rethink data privacy. However, because most abortions are still banned in at least 13 states, this patchwork of state abortion laws, combined with the lack of any sufficient national privacy law, puts patient privacy at risk.

Google Becomes the First to Agree to Compliance Monitoring by the DOJ

In an action to keep company executives in check, the Justice Department (DOJ), created a policy where executives and compliance chiefs sign and personally attest to the effectiveness of their compliance programs. The individuals would therefore be held personally liable for their roles in the company’s wrongdoing. The DOJ and Google had a pending dispute, which was due to Google’s non-compliance with assisting authorities in an investigation. The DOJ and Google reached an agreement, with a stipulation attached, resolving the dispute over Google’s loss of data responsive to a 2016 search warrant. In the stipulation, Google has said that it has spent over 90 million dollars on additional systems and resources to improve its compliance programs, including an agreement to allow an Independent Compliance Professional to serve as a third party to monitor that Google is fulfilling its compliance legal obligations. This policy, as already seen in the settlement with Google, is forcing compliance to become a top-tier concern for big companies or face serious consequences.