Improving the Biosimilar and Generic Drug Approval Process

Andrew Thompson Senior Editor Loyola University Chicago School of Law, JD 2023 As discussed previously here and here, patent evergreening and patent thickets are key drivers of prescription drug prices that also operate as a barrier to entry which blocks generic manufacturers from placing lower-cost alternatives on the market. This post will examine how newly …
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New Incentives from the DOJ to Urge Companies to Self-Report Crimes

In an action meant to incentive companies to self-report their wrongdoings, the Justice Department (DOJ), has announced big changes to its Corporate Enforcement Policy (CEP). The Department of Justice has long been fighting against corporate criminality in its pursuit to maintain the integrity of the financial market. On January 17, Assistant Attorney General Kenneth A. Polite, Jr., announced revisions to the Criminal Division’s Corporate Enforcement Policy. Some of the revisions include up to a 75 percent reduction in fines for companies that voluntarily report their wrongdoings and fully cooperate with investigations and up to a 50 percent reduction for companies that fully cooperate with investigations even if they do not voluntarily disclose the crime. These incentives further soften the aggressive stance that the Biden administration originally took against Corporate America in 2021.

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?

What Does The “ENABLERS Act” Mean for Attorney Regulation?

The Financial Crimes Enforcement Network (FinCEN) is a bureau of the U.S. Department of Treasury committed to safeguarding the financial system by detecting and preventing money laundering, the financing of terrorism, and other illicit activity since the 1970s. The Bank Secrecy Act (BSA) expanded the definition of “financial institution.” The ENABLERS Act (Act) is the latest proposed amendment that seeks to expand the provisions of the BSA to several different professions, such as lawyers, trust companies, investment advisors, accountants, public relations firms, and art dealers, amongst others. Should this amendment pass, it will be the most significant money laundering reform yet. It will expand its reach by requiring these financial service providers to adopt anti-money laundering safeguards to close the loophole in the U.S. anti-money laundering system. The safeguard will require these professionals to help prevent and report cases of money laundering by implementing due diligence rules in their practice to ensure that the money entering the system is not “dirty.” This is currently not required of lawyers or any of these other professions.

How the FTC’s Proposed Non-Compete Rule May Impact Non-Profit Hospitals

On January 18, 2023, the Federal Trade Commission (FTC) proposed a new rule for regulating non-compete clauses. The proposed rule, which has been named the “Non-Compete Rule,” could potentially ban employers from entering into, or attempting to enter into, a non-compete clause with employees and independent contractors collectively referred to as “workers.” The proposed rule has recently sparked several discussions on the scope and constitutionality of the rule. One concern is how the proposed rule, if finalized, would impact the healthcare industry and especially non-profit hospitals.

Fighting the Climate Crisis and Public Health Problems: A Step in the Right Direction

On December 20, 2022, the Environmental Protection Agency (EPA) finalized a regulation that will require heavy-duty trucks and vehicles to adopt new, more stringent standards in order to reduce smog and pollution. The EPA implemented this measure as part of its Clean Trucks Plan, a three-year plan, created to reduce emissions from heavy-duty vehicles, in hopes of addressing the climate crisis and improving public health. The new standards set by this regulation are stronger than the current ones by more than 80%. Nonetheless, many are disappointed that the regulation is not as stringent as they had hoped for.

Affordable Housing: No Oversight, No Progress

Originally passed in 2003, the Illinois Affordable Housing Planning and Appeal Act (AHPAA) requires cities with populations of at least 1,000 residents and less than ten percent affordable housing to submit their affordable housing plans to the state. Gail Schechter sits on the Illinois Housing Appeals Board, but she has never heard a case. The board was brought together in 2009 and fully appointed by Governor Pat Quinn in 2012 to provide checks and balances while Illinois communities create affordable housing. Affordable housing developers who believe they have been treated unfairly or rejected by a municipality are given a chance to appeal a city’s decision to reject their project. However, developers are not utilizing the appeals process. According to Schechter via WBEZ, “a developer just wants to do business. If they can’t build what they want to build, they’ll go to another community.”

Nowhere to Hide: The Corporate Transparency Act Seeks to Unmask the Beneficial Owners of Shell Companies

In January of 2021, Congress adopted substantial changes to the nation’s anti-money-laundering laws, including enacting a new federal statute, the Corporate Transparency Act (CTA or Act), that will establish a centralized database of corporate beneficial ownership. The CTA mandates that by 2025 (or, in some cases, by 2024) all domestic and foreign companies doing business in the U.S. must provide information about the true beneficiaries of their operations by complying with new reporting requirements. The legislation is designed to capture information on an estimated 32 million companies that operate in unregulated areas or are too small to trigger disclosure obligations under other federal laws yet can be used by criminals, terrorists, and other bad actors to hide money laundering and other illicit financial activities. The Treasury Department’s Financial Crimes Enforcement Network bureau (FinCEN) explained the need for a beneficial ownership database, stating, “Illicit actors frequently use corporate structures such as shell and front companies to obfuscate their identities and launder their ill-gotten gains through the U.S. financial system. Not only do such acts undermine U.S. national security, but they also threaten U.S. economic prosperity: shell and front companies can shield beneficial owners’ identities and allow criminals to illegally access and transact in the U.S. economy, while creating an uneven playing field for small U.S. businesses engaged in legitimate activity.” FinCEN issued its final rule on the CTA’s reporting requirements on September 29, 2022. Although the regulations resolve many of the issues that arose after the Act’s passage, a number of compliance challenges and questions still remain.

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.

The Tax Gap and What it Means for Taxpaying Entities

Every three years, the Internal Revenue Service (IRS) releases the estimated gross tax gap calculated for the three years prior. Recently, the estimated tax gap for the years 2014 to 2016 was revealed to be $496 billion. This startlingly high number represents a continuing trend of noncompliance by American taxpayers that feeds into the federal budget deficit.