Category: Health Care

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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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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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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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Disclosure Dilemma: Is Disclosure to the Government Enough to Invoke the False Claims Act’s Public Disclosure Bar?

By Daniel Naydenov

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The federal government has a significant financial interest in the $3 trillion dollar health care industry. Due to limited administrative resources, the government’s biggest allies in the fight against health care fraud are individual whistleblowers who are able to file lawsuits under the False Claims Act’s qui tam provisions and share in the recovery. The Act contains a public disclosure bar to prevent parasitic suits by opportunistic whistleblowers. This Note analyzes two contrasting decisions from the Sixth and Seventh Circuits interpreting who qualifies as the “public.” In both cases, the court was asked to determine whether a health care provider’s self-disclosure of misconduct to the federal government was sufficiently public to bar future suits. Ultimately, this Note argues that the Seventh Circuit’s interpretation is more persuasive and closer to striking the proper balance between incentivizing whistleblowers and inhibiting opportunism.… Read the rest