Category: Regulation

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Unsecure Health: What the BIOSECURE Act Could Mean for the Biopharmaceutical Industry

A Note by Megna Raghuraman

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On January 19, 2025, TikTok, a social media platform owned by Chinese company ByteDance which provides short form video content to over 170 million users, shut down in the United States. The bill to block TikTok was passed in April 2024 with an overwhelming majority in both the House and the Senate due to growing bipartisan fears of national security risks. The Supreme Court upheld the TikTok ban, sharing Congress’s national security concerns of TikTok’s collection of data privacy. However, the ban lasted a mere eighteen hours. The first day of President Trump’s term, his administration effectively stalled the ban and brought TikTok back to the U.S. via executive order. However, while the Trump administration appears supportive of TikTok in the U.S., the executive order only delays the ban: TikTok must eventually sever its ByteDance—and essentially Chinese—connection to maintain … Read the rest

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Weighty Consequences: How GLP-1 Agonist Litigation Highlights the Need for Greater FDA Off-Label Prescription Oversight

A Note by Carson Poupore

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With 42.4 percent of United States adults suffering from clinical obesity and 9.2 percent of adults suffering from it severely, the following archetypical story is far too familiar in recent years. Seeking dietary control and weight loss, a patient consults their physician. The physician, comporting with their standard of care, prescribes Ozempic, which is popularly understood to resolve the patient’s issue. Based on information communicated by Novo Nordisk, Ozempic’s manufacturer, the physician fully informs their patient of Ozempic’s side effect risks. The patient starts the prescription and feels a newfound sense of hopeful control. But this feeling is short-lived. Soon after, the patient constantly feels nauseous, vomits after eating, and suffers from abdominal pain. The patient never expected this. After correlating these unforeseen symptoms with Ozempic prescription, the patient concludes that they would never have taken … Read the rest

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Deception by Delivery Fees: Demanding Consumer Protections and Transparency in the Face of Deceptive Fee Practices

A Note by Deanna Nila

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The use of online food delivery platforms has seen a rampant increase in recent years, with the global food delivery market being valued at a whopping $242.09 billion in 2023. With the rise and fall of the COVID-19 pandemic, bustling consumer lifestyles, and the increased digitalization of everyday interactions, the ability to order food delivery from over thousands of different restaurant options has never been more convenient. Every day, thousands of busy consumers utilize apps like DoorDash, Uber Eats, or GrubHub to have food or groceries delivered right to their door step. Many have even become reliant on these services, such as those with mobility issues or those who do not own vehicles. While the necessity and convenience of having food delivery at our fingertips has made it a booming business, consumers have found that this convenience can sometimes … Read the rest

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Which Side Are You On: Cemex, Mandatory Bargaining, and the Future of Organized Labor

A Note by Jarrett Krouss

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Under President Joe Biden, the frequency of union elections exploded– election petitions increased by roughly a quarter in 2024 compared to 2022 and 2023, and were double those filed in 2021. While many factors have likely contributed to the rise in union elections, the August 2023 National Labor Relations Board (“NLRB”) decision in Cemex Construction Materials Pacific, LLC plays a major role. A three-to-one ruling of the NLRB Board, Cemex lowered requirements for the issuance of mandatory bargaining orders. . . .… Read the rest

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HIGH EXPECTATIONS: WHAT RESCHEDULING MARIJUANA COULD MEAN FOR THE CANNABIS INDUSTRY

A Note by Elsie Layman

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On January 12, 2024, the U.S. Department of Health and Human Services (HHS) released a review addressed to the U.S. Department of Justice’s Drug Enforcement Administration (DEA) that recommended marijuana (Cannabis sativa L.) be rescheduled from Schedule I to Schedule III of the Controlled Substance Act.[1] The unredacted recommendation was released as a result of the effort of Matthew Zorn, who filed a Freedom of Information Act complaint against HHS in September 2023.[2] Zorn announced the recommendation would be released on January 11, 2024 on his blog, writing: “I win . . .  Impossible just takes a few weeks.”[3] The release of this recommendation is a win not only for Zorn and people who enjoy the drug recreationally, but for the U.S. cannabis market, which was valued at $13.2 billion in 2022.[4]

[1]… Read the rest

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A BITTER PILL TO SWALLOW: AMERICA’S UNREGULATED SUPPLEMENT INDUSTRY AND THE COST TO CONSUMERS

A Note by Jessica Bury

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In 2021, the global dietary supplement market was worth USD 149 billion, and was projected to grow to USD 240 billion by 2028.[1] The U.S. alone was responsible for approximately thirty-two percent of the market.[2] This growth is attributable to a variety of societal changes including increased concerns over healthcare costs, skin health, shifts in lifestyle choices, celebrity endorsements, fears about immune system health resulting from COVID-19, greater self-care awareness, and sports and fitness trends.[3] Although supplement use within American society is rampant, with 57.6% of adults aged twenty and over consuming at least one dietary supplement within the past month, few people understand how they are produced, manufactured, and regulated.[4] A 2019 survey indicated that a majority of Americans overestimate the FDA’s role in regulating supplements, assuming that the FDA tests supplements before sale … Read the rest

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FROM GUIDELINES TO GRIDLOCK: THE CHALLENGES FACING DOJ AND FTC’S NEW MERGER GUIDELINES AND THE PATH FORWARD

A Note by James Zhang

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The year of 2023 has seen the lowest level of M&A activity in over a decade, since the period after the 2008 global financial crisis.[1] Inflation, rising interest rates and fear of a recession halved Global M&A deal values to $2.5 trillion USD from their peak of more than five trillion dollars in 2021.[2] In the midst of such difficult situations, increasing regulation scrutiny has cast yet another shadow over the flickering future of the M&A market.

On December 18, 2023, the U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) released the 2023 Merger Guidelines.[3] This is the final version after gathering public feedback from the draft version released in July 2023.[4] This guideline marks another step forward of the Biden administration’s aggressive and interventionalist antitrust policy.[5] It not only lowers … Read the rest

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TELEMENTAL HEALTH TAKES CENTER STAGE: HOW PANDEMIC-ERA WAIVERS OPENED THE DOOR TO BETTER MENTAL HEALTH CARE

A Note by Jabari Turner

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Millions of Americans were stuck in their houses during the COVID-19 pandemic.[1] The rising death tolls, financial insecurity, and growing uncertainty increased anxiety, depression, and a surge in emergency department visits for mental health conditions.[2] Federal and state-level licensing alongside permit waivers allowed many Americans needing mental health care, access to telemental health services.[3] As a result, Americans had more options in and out-of-state that were unavailable before the pandemic.[4] During the pandemic, federal agencies waived previous telehealth restrictions.[5] Moreover, in most states, through executive orders, out-of-state mental health providers in good standing were permitted to provide telemental services to patients.[6]

Telehealth gives patients and providers better access, options, and overall healthcare treatment and management without needing to be physically present.[7] In addition, it gives providers more continuity of care, and better … Read the rest

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BRINGING ACCOUNTING STANDARDS INTO THE MODERN ERA: ANALYZING THE FINANCIAL ACCOUNTING STANDARDS BOARD’S PROPOSED DISCLOSURE REQUIREMENTS FOR DIGITAL ASSETS

A Note by Zack Stutler

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Technology’s growth over the past decade has permeated all aspects of life.[1] Financial markets have not been isolated from this increasing digitization.[2] More specifically, the introduction of digital assets (crypto-currency, non-fungible tokens, etc.) has taken the world by storm.[3] With the introduction of new assets comes the need for new regulations. While consumer regulations are important, so too are regulations on companies and how they report their ownership of digital assets.[4]

Regulations on companies are important because they increase the transparency of companies as well as look out for the interest of investors and the general public.[5] Without government intervention and regulations, corporations would logically operate in profit-maximizing ways that are self-serving.[6] This self-serving nature often lacks an eye for public interest and may promote a lack of disclosure which is not optimal … Read the rest

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IS STARBUCKS A BANK? HOW THE BILLIONS CONSUMERS UPLOAD ONTO STARBUCKS CARDS SHOULD BE REGULATED

A Note by Mackenzie Morgan

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As technology has continued to advance, so have company reward programs. In 2021, Starbucks customers loaded $11 billion onto mobile Starbucks Cards,[1] accounting for almost half of all Starbucks sales.[2] The amount of money consumers have loaded onto their mobile applications to prepay for their coffee orders has allowed Starbucks to overtake most banks in terms of assets.[3] “85% of US banks have less than $1 billion total in assets, illustrating the major player Starbucks has become in this space.”[4] Should the billions of dollars that consumers have uploaded onto Starbucks Cards be regulated by the federal government?

… Read the rest