Week in Review

IN THE NEWS

• The Biden Administration announced lower prices for ten drugs selected for the Medicare drug price negotiation program, an initiative that allows Medicare to negotiate lower costs of pharmaceuticals. The U.S. Department of Health and Human Services reached agreements with the manufacturers on new prices for the drugs, all of which are “among those with highest total spending in Medicare.” The price changes will take effect in 2026 and “people enrolled in Medicare Part D are estimated to save $1.5 billion in out-of-pocket costs” according to the White House. The price negotiation program will continue to grow in the future, with additional drugs being added each year.
• The Federal Trade Commission (FTC) issued a final rule to curb marketers’ use of unfair or deceptive practices regarding consumer reviews and testimonials. The rule will prohibit the use of fake consumer reviews, buying positive or negative consumer reviews, company websites falsely claiming to provide independent reviews, the suppression of certain negative reviews, and the purchase and sale of fake social media followers. FTC Chair, Lina Khan, stated that “fake reviews not only waste people’s time and money, but also pollute the marketplace and divert business away from honest competitors.”
• The Federal Deposit Insurance Corporation (FDIC) has proposed amendments to Part 354 of the FDIC Rules and Regulations that would require certain conditions and written commitments to be instituted for parent companies acquiring banks and loan companies not subject to FDIC supervision. The proposed amendments would allow the agency to supervise industrial banks more closely, mitigate deposit insurance risks, and support market transparency. Although the proposed requirements would likely be used infrequently, the changes emphasize the FDIC’s increased commitment to oversight of the industrial bank sphere in the wake of concerns stemming from the Silicon Valley Bank collapse in 2023.
• The U.S. Food and Drug Administration (FDA) declined to approve a post-traumatic stress disorder treatment based on the psychedelic stimulant MDMA. Although widely known as an illegal recreational drug, advocates emphasize that MDMA has potential as a treatment for mental health disorders through regulated therapeutic applications. FDA declined the MDMA capsules on the basis that the clinical studies presented too much uncertainty concerning the abuse of the drug. FDA has asked the manufacturer to conduct an additional Phase 3 study, which the manufacturer has stated is “deeply disappointing.”
• The U.S. Department of Housing and Urban Development (HUD) published a notice revising the implementation of Section 8 Housing Choice Voucher rental assistance under HUD’s Veterans Affairs Supportive Housing program (HUD-VASH). The HUD-VASH program aims to increase access to affordable, permanent housing for homeless veterans via rental assistance and supportive case management services. The notice details new HUD-VASH waivers and program flexibilities, such as relaxed requirements for participants to verify their social security numbers, lower income eligibility requirements, and lower minimum rent payments.
• The U.S. Department of Agriculture (USDA) issued a final rule amending regulations governing Indian tribes or tribal organizations seeking to sponsor watershed projects. Federally recognized tribes typically have regulatory power over their land, including the ability to exert eminent domain. Alaska Native Corporations and tribal organizations, however, lack the eminent domain authority that has historically been required for watershed project sponsors. This rule will exempt Indian tribes or tribal organizations from the eminent domain requirement, allowing them to sponsor projects as needed.
• The Department of Justice published a final rule revising the implementation of Title II of the Americans with Disabilities Act, establishing requirements regarding the accessibility of Medical Diagnostic Equipment (MDE). MDE is equipment individuals use when accessing medical care, including “medical examination tables, weight scales, dental chairs, and radiological diagnostic equipment.” The rule requires public medical entities to ensure all required MDE is accessible and meets the MDE Standards. These entities cannot deny a patient care because MDE is not accessible to that person. Finally, the rule necessitates public entities to train all staff to operate accessible MDE in the correct manner.
• The Biden Administration introduced the “Time is Money” program to reduce the unnecessary time and financial burdens that corporations impose on consumers. The effort aims to increase efficiency for the average American. Key actions include making it easier to cancel subscriptions, requiring automatic cash refunds for airline tickets, allowing for the submission of online health claims, decreasing the time spent with customer service, and streamlining the ways parents communicate with schools. The Biden Administration welcomed additional ideas, providing a public portal for recommendations on additional ways to increase efficiency and decrease costs in everyday activities.

WHAT WE’RE READING THIS WEEK

• In a recent Columbia Public Law research paper, Jane C. Ginsburg, Faculty Director of Columbia’s Kernochan Center for Law, Media, and the Arts and Morton L. Janklow Professor of Literary and Artistic Property Law, discussed the implications of the  U.S. Supreme Court’s recent decisions concerning AI “training data” in US copyright law. Prior to the 2021 decision in Google v. Oracle, refined by the 2023 decision in Andy Warhol Foundation for the Visual Arts v. Goldsmith, fair use considerations of otherwise copyrightable work hinged on the transformativeness of the potentially infringing work, which would be problematic for machine learning models looking to utilize training data. However, Ginsburg emphasized that Google and Goldsmith highlighted the Court’s changing attitudes toward fair use and copyright, with greater consideration being put on the nature of the later work. Ginsburg addresses this shift as it relates to AI training models, arguing that a broader legal and regulatory framework focusing on inputs, with training data sets being deemed fair use, would be beneficial for AI innovation.
• In a recent National Bureau of Economic Research working paper, W. Bentley MacLeod, professor of economics at Princeton University, and Roman Rivera, Postdoctoral Scholar at University of California, Berkeley, analyzed variation in individuals’ responsiveness to policies for deterring crime, given their consumption needs and available employment opportunities. MacLeod and Rivera argued that understanding whether criminal activity substitutes or complements legitimate labor efforts is key to designing policies for addressing criminal activity, and individuals’ responsiveness to deterrence efforts varies widely by location and income level. MacLeod and Rivera concluded that ideal policy to reduce crime combines deterrence, work subsidies, and direct income transfers, varying by location and income.
• In an article in the Yale Journal on Regulation, Raul Carillo, a Kellis Parker Teaching Fellow at Columbia Law School, discussed the dangers of digital wallets that store consumers’ credit card information, data, and money. Carillo argued that utilizing digital wallets as a primary checking account allows platforms to potentially evade banking laws and puts consumers’ data at risk. Since data brokers are a key element of platform money usage and work for multiple applications, Carillo argued that there is an increased chance of identity fraud for consumers. To decrease potential harms, Carillo suggested the application of an “enhanced data minimization standard,” requiring brokers to work within existing banking laws.

EDITOR’S CHOICE

• In an essay in The Regulatory Review, Trevor Kirby discussed using the Inflation Reduction Act (IRA) as a way to reduce drug costs for Americans. The IRA empowered the U.S. Department of Health and Human Services (HHS) to negotiate directly with drug manufacturers on behalf of Medicare recipients for the first time in recent history. The IRA also limited out of pocket payments for Medicare Part D recipients for insulin to 35 dollars per month. The essay emphasized that experts had disputed the assertion that high costs of pharmaceuticals are justified by the innovativeness of the medicines, with studies showing that publicly funded researchers are more instrumental in drug innovation than the manufacturers themselves. The author emphasized that while the impact of the IRA was uncertain, policymakers were making lowering prescription drugs a priority in legislation.