Speed vs. Safety: Understanding the FDA’s Role in Drug Approval

In today’s world, science moves at a breakneck speed, constantly influenced by political and social needs. Groundbreaking medicines are developed every year, giving people an arsenal with which to fight a seemingly ever-expanding number of diseases. In light of recent crises such as COVID-19, one question has come to loom large: when it comes to drug approval, how fast is too fast? The U.S. Food and Drug Administration (FDA), tasked with protecting public health through the regulation of items such as drugs and food, sits at the center of this ethical balancing act — carefully walking the line between speed and safety. However, as commercial and societal pressures intensify, so have the ethical dilemmas surrounding the FDA’s role.

The FDA’s drug approval process is designed to be rigorous: most new treatments go through multiple phases of inspection, with each intended to verify the efficacy and potential side effects of the drug. Yet, this system can take years, delaying critical access to potential life-saving medications for patients that don’t have long to live. This paradox raises critical ethical questions: when does “caution” become harm? Who decides what level of risk is acceptable? And, perhaps most importantly, what should the FDA emphasize in its approval of drugs?

To reach conclusions, we must first understand the underlying issues. A key tension lies in the battle between non-maleficence (the principle of “do no harm”) and beneficence (the duty to help). Accelerating drug approval may help terminally-ill patients gain early access to therapies, but it can also expose them  to unknown harms if evidence and data are too limited. The FDA’s Emergency Use Authorization (EUA) system, used during the COVID-19 pandemic, serves as a key highlight of this issue. The EUA allowed for the use of vaccines and treatments without full clinical trial data, effectively expediting clinical response but raising public concerns about safety, particularly after pauses like that of the Johnson & Johnson vaccine due to rare clotting events [1].

Similarly, the Accelerated Approval Pathway (AAP)—designed for drugs treating serious or life-threatening conditions—has come under scrutiny. The 2021 approval of Aduhelm (aducanumab) for Alzheimer’s disease, despite minimal evidence of clinical benefit, sparked backlash against the AAP from scientists, ethicists, and members of the FDA advisory committee, three of whom resigned in protest [2]. Critics argued that the decision reflected not scientific rigor, but industry lobbying and political pressure. Yet, for families facing an incurable disease, even modest hope was considered justification enough. This raises a core question — how much do individual patient interests matter in the drug approval process? Should patients who are willing to suffer side effects, as long as they receive immediate care, be able to gain expedited access to a treatment?

These cases underscore how an environment of urgency can override long-standing protocols. Pharmaceutical companies, advocacy groups, and lawmakers all exert their own influences—sometimes pushing the FDA to act swiftly in ways that stretch or challenge its ethical foundations. The Right to Try Act of 2018, for example, allows terminally ill patients to access experimental treatments without FDA oversight. While it has been hailed as empowering, it bypasses safety review mechanisms designed to protect the vulnerable, and has raised questions about the importance of autonomy vs. paternalism in end-of-life care [3].

Ethical concerns also extend to justice and equity. Do fast-tracked drugs benefit all communities equally? Often, the answer is no. Marginalized populations are less likely to be represented in clinical trials and may face barriers to accessing newly approved treatments due to cost or location [4]. The risk, then, is not only approving unsafe drugs but also creating or reinforcing disparities in care availability and access.

The FDA is not static—it is an evolving, respondent entity. In response to criticism, it has tightened requirements for post-market studies under accelerated approvals and pulled back endorsements when follow-up trials fail to confirm initial suspected benefits. For example, in the case of Makena, a drug approved to prevent preterm birth, the FDA recently recommended withdrawal after post-approval data showed limited effectiveness [5]. These reversals, while controversial, reflect the agency’s efforts to balance responsiveness with accountability.

Ultimately, the FDA's decisions are more than just data-driven scientific evaluations. They are ethical judgments made under conditions of uncertainty and nuance. Carefully balancing special interests with overarching regulatory and ethical principles is essential—exceptions should not be made for cases that go against ideas of equality and accessibility. As we look to the future, the challenge is not to choose between speed and safety, but to develop a framework that better integrates both. This means improving data transparency, patient representation, and public communication, while reaffirming that ethical vigilance must serve as the ultimate guide to all regulatory action.

Designed By: Jackie No

Edited By: Alec Vazquez-Kanhere

REFERENCES

[1] U.S. Food and Drug Administration. (2021). Emergency Use Authorization for Vaccines Explained. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

[2] Dyer, O. (2024). Aduhelm: Biogen abandons Alzheimer’s drug after controversial approval left it unfunded by Medicare. The BMJ, q281–q281. https://doi.org/10.1136/bmj.q281

[3] Brown, B., Ortiz, C., & Dubé, K. (2018). Assessment of the Right-to-Try Law: The Pros and the Cons. Journal of Nuclear Medicine, 59(10), 1492–1493. https://doi.org/10.2967/jnumed.118.216945

[4] Bibbins-Domingo, K., & Helman, A. (2022). Barriers to Representation of Underrepresented and Excluded Populations in Clinical Research. In www.ncbi.nlm.nih.gov. National Academies Press (US). https://www.ncbi.nlm.nih.gov/books/NBK584407/

[5] Commissioner, O. of the. (2023, April 6). FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena. FDA. https://www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena

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Rewriting the Clock: Aging, Intervention, and the Push to Redefine Disease

If I had an extra hour every day, I would spend it...

This application classic is the Pumpkin Spice Latte of essay prompts: wildly overdone, kind of expected, and weirdly unavoidable. And yet, every time we encounter it, thousands of us pretend that this hypothetical 60 minutes will change the trajectory of humanity. We’ll finally write that novel, discover the cure to an obscure disease, win a Nobel Prize, or maybe even do all three. But let’s be honest: for most of us, that extra hour would dissolve into the background noise of daily life. We’d wake up ten minutes later, scroll through a few more TikToks, and spend a little longer debating whether to go to the gym before deciding to just go tomorrow. That’s the bonus hour, gone before it even knows it’s extra. But what if it wasn’t just an hour? What if you could get an extra month? An extra year? Maybe even ten?

Thanks to breakthroughs in aging research, that question is no longer just a lazy hypothetical. Scientists are beginning to ask whether aging, once considered an immutable force of nature, might actually be something we can delay, manage, or even treat. Drugs like Metformin and Rapamycin, originally developed for diabetes and immunosuppression, are now being repurposed for their potential to slow cellular aging. At the same time, pressure is mounting to reclassify aging as a disease. Together, these shifts have pushed the idea of gaining extra time beyond the realm of wishful thinking that turns bonus hours into Nobel Prizes. But what we do with that time, and who gets access to it, might expose not just what science makes possible but what society is willing, or unwilling, to make fair. Because if time really is the most valuable thing we have, then how we define it, regulate it, and distribute it might say more about us than we are ready to admit.

Despite growing scientific interest, aging has yet to be classified as a disease by the Food and Drug Administration (FDA), which continues to define it as a natural and biological process [6]. Similarly, other influential health bodies, such as the World Health Organization, have taken similar stances, focusing on aging healthily and age-associated decline without calling aging a condition in its own right [4]. This debate goes beyond dictionary definitions; it shapes what gets studied, funded, and ultimately delivered to patients. Such ambiguity has created a regulatory limbo: researchers cannot officially run clinical trials for anti-aging treatments because aging lacks formal recognition as a disease. Without FDA approval pathways, dedicated funding, or clear incentives, progress grinds to a halt, financial support dwindles, and the science remains stuck in preclinical gridlock [6].

Thus, some proponents of the classification of aging as a disease argue that the standstill movement of pharmaceuticals in biogerontology reflects a failure of policy rather than of science [1]. Certainly, the science is ready; we know cellular degeneration can be studied and potentially slowed. However, the FDA’s current system is built for discrete diseases with quick symptom onset and measurable outcomes. Aging doesn’t work like that. It’s gradual, multi-systemic, and notoriously hard to measure, making it incompatible with the approval models we currently use [6]. In a field where innovations are moving faster than the regulatory definitions meant to govern them, a regulatory reclassification would enable researchers to focus on aging itself rather than navigate complex administrative hurdles [5]. Indeed, promising drugs that already show significant efficacy in model organisms, like Rapamycin and Metformin, could finally be tested with long-term, large-scale studies instead of operating in the shadows of off-label use. Aging, defined as a disease, would transform longevity science from a patchwork of workarounds to a legitimate, regulated frontier of innovation.

Until then, scientists and biotech companies are forced to get creative. Consider studies like TAME, Targeting Aging with Metformin, which sidesteps the mention of aging altogether, instead looking at whether Metformin can delay multiple chronic diseases at once [3]. It’s regulatory rule-bending, not to deceive, but to function within a system that is not yet designed to ask the questions scientists are ready to answer. But while the system stalls, time doesn’t. Many of the researchers studying aging don’t have decades to wait for the FDA to catch up. It’s try or die. That’s why some of the same scientists who publicly urge caution about drugs like rapamycin are privately taking it themselves [7]. Simply put, it’s the research equivalent of “Do as I say, not as I do.”

Undoubtedly, such instances of off-label use reveal growing divides. Because aging is not classified as a disease, drugs like Rapamycin, when used preventatively, fall outside FDA-approved indications. As a result, patients must often pay out of pocket, bypassing insurance coverage entirely. These costs, combined with the need for access to longevity-focused physicians and private health networks, place anti-aging interventions firmly out of reach for most people. What emerges is a two-tiered healthcare system, where the wealthy not only receive better treatment, but they also potentially get more years of it [3]. 

Defining aging as a disease does not just risk changing how we treat older adults—it risks changing what we expect from them. As medical innovation continues to push the boundaries of life extension, choosing not to intervene has become increasingly stigmatized. In the current healthcare system, declining procedures like cardiac bypasses or transplants, even in one’s nineties, are condemned, even deemed as unnatural [3]. As sociologist Sharon Kaufman notes, what was once optional care is now standard, and what was once standard has become morally expected [3]. The technological imperative, the idea that we can intervene, has quietly become an ethical one: that we must. Framing aging itself as a disease would only deepen this shift, making it even harder for individuals to age on their own terms without being seen as irresponsible, irrational, or in decline. In the pursuit of treating aging, we may forget how to respect it.

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Ultimately, it is undeniable that science is ready to treat aging. Rather, the urgent question is whether we are, too. The stakes are higher than simply clinical trials or regulatory reform. When time becomes something to be purchased, prescribed, or postponed, it stops being a shared human experience and starts becoming a new kind of currency, one that not everyone can afford. In chasing longer lives, we risk narrowing down what it means to live well. And if we’re not careful, the future of aging won’t be defined by biology or breakthroughs but by who’s allowed to grow old with dignity and who’s quietly denied the chance.

Reviewed By: Aria Eaddy

Designed By: Sonali Patel

References:  

1. de Grey, A. D. N. J. (2005). Resistance to debate on how to postpone ageing is delaying progress and costing lives: Open discussions in the biogerontology community would attract public interest and influence funding policy. EMBO Reports, 6(Suppl 1), S49–S53. https://doi.org/10.1038/sj.embor.7400399 

2. Kaufman, S. R., Shim, J. K., & Russ, A. J. (2004). Revisiting the biomedicalization of aging: Clinical trends and ethical challenges. The Gerontologist, 44(6), 731–738. https://doi.org/10.1093/geront/44.6.731

3. Lugo, N. (2024, October 8). Breakthrough research: Common medication may hold key to slowing aging. Virtue Recovery Center. https://www.virtuerecoverycenter.com/breakthrough-research-common-medication-may-hold-key-to-slowing-aging/

4. Mendoza-Núñez, V. M., & Mendoza-Soto, A. B. (2024, February 24). Is aging a disease? A critical review within the framework of ageism. Cureus, 16(2), e54834. https://doi.org/10.7759/cureus.54834

5. Newcomb, T. (2023, January 6). Humans can start living longer—Once the FDA does this. Popular Mechanics. https://www.popularmechanics.com/science/health/a42419017/anti-aging-drugs-fda-approval/

6. Tournas, L., & Marchant, G. E. (2019). The fountain of youth revisited: Regulatory challenges and pathways for healthspan promoting interventions. Food and Drug Law Journal, 74, 405–426.

7. Whalen, J. (2024, March 15). A transplant drug shows promise for extending life. Should you take it? The Washington Post. https://www.washingtonpost.com/business/2024/03/15/rapamycin-longevity-drug/

Prison Healthcare and Human Rights: Addressing Medical Neglect in the U.S. Penal System

The U.S. prison system can house about 1.9 million people, making it the world’s largest incarcerated population [1]. However, despite the mandate under the Eighth Amendment prohibiting cruel and unusual punishment, incarcerated individuals frequently experience inadequate healthcare. This issue has raised significant ethical concerns regarding human rights and systemic disparities in access to care. Prisoners, regardless of their crimes, have the right to proper medical treatment. However, a combination of underfunding, staff shortages, and systemic barriers often leads to substandard care.

The Ethical Foundations of Prison Healthcare

Medical ethics is grounded in four key principles: Autonomy, Beneficence, Nonmaleficence, and Justice [2]. While incarcerated individuals inherently have limited personal freedoms, these principles are crucial in the ethics of prison healthcare. Autonomy, in a medical context, refers to a patient’s right to make informed decisions about their own care. However, prisoners often have little to no control over when they receive medical attention, frequently experiencing long wait times for physician visits, dental treatments, and specialist care. Justice means that prisoners, like all individuals, should receive equal access to healthcare. However, the systemic disparities in healthcare between the general and prison populations fail to uphold this ethical standard. Regarding beneficence and nonmaleficence, medical professionals have a duty to act in the best interests of their patients and avoid causing harm. Yet in prison, there are daily reports of delayed treatments, inadequate chronic disease management, and preventable deaths [3].

Medical Neglect in U.S. Prisons: Case Studies and Systemic Barriers

Where should we point the blame? Despite the legal requirement to provide healthcare, there is widespread neglect due to systemic deficiencies. Many prisons operate with limited medical staff, which can lead to delays in treating conditions. Prisons also house a disproportionately high number of individuals with chronic conditions such as diabetes, hypertension, and HIV, which can exacerbate health disparities [4]. Another factor is mental health. Over 40% of incarcerated individuals suffer from mental health disorders [5]. Punishments like solitary confinement have been linked to worsening psychiatric symptoms, raising ethical concerns regarding inhumane treatment.

Role of Private Healthcare Providers in Prisons

Many prisons attempt to contract private healthcare companies to provide medical services [6]. While privatization is intended to cut costs, many argue that for-profit companies have incentives to minimize care, reducing expenses at the cost of prisoner health. As a consequence, prisons may fail to provide necessary treatments, delay access to life-saving medications, and refuse specialist referrals due to cost concerns.

International Standards & U.S. Shortcomings

International human rights frameworks support the right to healthcare for incarcerated individuals. The United Nations Standard Minimum Rules for the Treatment of Prisoners state that prisoners must receive the same medical care available to the general population [7]. However, the U.S. has consistently fallen short of these standards, with reports of neglect, medical rationing, and underfunding being common across state prison systems.

Medical neglect in U.S. prisons represents an ethical failure that undermines the principles of justice and human dignity. Although incarcerated individuals have lost certain freedoms, their right to healthcare remains protected under both legal and ethical frameworks. In order to address prison healthcare disparities, we must recognize that access to care is a fundamental human right.

Edited By: Makayla Gorski

Designed By: Eugene Cho

References

[1] Wagner, Wendy Sawyer and Peter. “Mass Incarceration: The Whole Pie 2024.” Prison Policy Initiative, 14 Mar. 2024, www.prisonpolicy.org/reports/pie2024.html. 

[2] - Beauchamp, T., & Childress, J. (2019). Principles of Biomedical Ethics: Marking Its Fortieth Anniversary. The American Journal of Bioethics, 19(11), 9–12. https://doi.org/10.1080/15265161.2019.1665402

[3] - Maruschak, Laura M. “Medical problems of jail inmates.” PsycEXTRA Dataset, Nov. 2006, https://doi.org/10.1037/e500022007-001. 

[4] “The health status of soon-to-be-released inmates: A report to Congress, volume 2.” PsycEXTRA Dataset, Mar. 2002, https://doi.org/10.1037/e514682006-001. 

[5] - James, Doris J., and Lauren E. Glaze. “Mental health problems of prison and jail inmates.” PsycEXTRA Dataset, June 2017, https://doi.org/10.1037/e557002006-001. 

[6] Noga Shalev, “From Public to Private Care The Historical Trajectory of Medical Services in a New York City Jail”, American Journal of Public Health 99, no. 6 (June 1, 2009): pp. 988-995. https://doi.org/10.2105/AJPH.2007.123265

[7] - The United Nations Standard Minimum Rules for the Treatment of Prisoners (the Nelson Mandela Rules), 26 Mar. 2016, https://doi.org/10.18356/9789213589427.