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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