Introduction
Bacteriophages (hereinafter phages) are virus particles that target specific bacteria cells.[1] Phages can act as therapeutic agents to fight antibiotic resistant bacterial infections.[2] As of February 2025, the U.S. Centers for Disease Control and Prevention estimates that over 2.8 million antibiotic resistant bacterial infections occur in the United States each year.[3] These infections present an ongoing, global threat to public health.[4] Although phage therapy is a promising new treatment, the U.S. Food and Drug Administration (hereinafter FDA) has only approved it for emergency circumstances under the “expanded access” exception.[5] Researchers are currently conducting clinical trials to obtain FDA approval for phage therapy use beyond this exception.[6]
Background
In 1917 Felix d’Herelle identified phages as bacteria killers.[7] Phages eliminate harmful bacteria by causing the bacterial cells to burst.[8] The emergence of antibiotics largely halted usage of phages to treat bacterial infections.[9] Renewed interest in in phage therapy research, however, has arisen in response to the growing crisis of antibiotic resistance.[10] Scientists globally have reported many successful phage therapy treatments for antibiotic resistant infections.[11]
Traditional antibiotic treatments aim to eliminate harmful bacteria, but because they lack specificity, often eliminate beneficial bacteria as well.[12] Beneficial bacteria are crucial to maintaining health by facilitating digestion and nutrient absorption.[13] Phage therapy’s specificity provides a significant advantage over traditional antibiotic treatment because it only targets and destroys unwanted bacteria.[14] Another concern arising from the widespread use of antibiotics is the increasing prevalence of antibiotic resistant forms of bacteria, which make antibiotic treatment less effective.[15] The specificity of phage therapy reduces the risk of bacterial resistance.[16]
Analysis
In the United States, phage therapy for the treatment of bacterial infections may only be used in emergency circumstances under the FDA’s expanded access or “compassionate use” exception.[17] Under this exception, a patient with a serious, immediately life-threating condition that cannot be treated with any FDA approved alternative may access investigational treatments.[18] For a patient with an infectious disease to access phage therapy under current regulations, the patient’s physician must submit a Single-Patient Investigational New Drug Application (hereinafter SPIND) to the FDA.[19] The SPIND must include clinical information regarding the proposed treatment method, the treatment plan, and relevant pharmaceutical data concerning the patient’s condition.[20] The physician must also demonstrate that no feasible alternative therapies exist and that they exhausted all approved treatments.[21]
When evaluating a SPIND request, the FDA considers factors such as the probable risk of treatment relative to the risks of the patient’s disease.[22] If approved, the patient receives a SPIND license number, which they must provide to the phage supplier to receive treatment.[23] The process is designed to grant patients access to “last resort” therapy.[24] The procedural requirements for obtaining innovative treatments such as phage therapy, however, create significant hurdles for patients facing serious, life-threatening conditions.[25]
In addition to the logistical challenges of requesting investigational drug treatment, physicians also face a moral dilemma.[26] For instance, they may hesitate to suggest unapproved treatment methods to patients.[27] Failure to suggest all possible options in emergency circumstances, however, may cause inequality among patient groups.[28] Although physicians have no legal obligation to discuss emergency access treatments, some patients may consequently lose potentially life-saving opportunities.[29] Effective treatment options such as phage therapy should not be constrained by the stringent limitations and practical challenges imposed by expanded access.[30]
Conclusion
Antibiotic resistance is a major public health threat. Phage therapy offers a targeted and effective approach to treating bacterial infections. Multiple institutions are currently undergoing clinical trials to obtain FDA approval for phage therapy drugs. This research demonstrates the growing enthusiasm for phage therapy and supports its potential effectiveness against bacterial infections. Given the ongoing threat of antibiotic resistance, the FDA should consider increasing phage therapy access beyond the current limited circumstances.
Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHBL or Suffolk University Law School.
Anna Fakhri is a second-year student from Easton, Massachusetts. She earned a B.S. in Biochemistry from Providence College. She has an interest in pursuing a career in transactional work.
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[1] See Andrea Bonacorsi et al., Mycobacteriophages and Their Applications, Antibiotics, Oct. 2024, at 1, (explaining phage particles targeting different bacterial species like M. tuberculosis for cell death); see also Teiji Sawa, Kiyoshi Moriyama, & Mao Kinoshita, Current Status of Bacteriophage Therapy for Severe Bacterial Infections, J. Intensive Care, Nov. 2024, at 1 (noting phage virus particles specifically attack individual bacteria cells).
[2] See Anna M. Fakhri et al., Mycobacteriophage Rita: A Cluster F1 Phage Discovered in North Easton, Massachusetts, Microbiology Res. Announcements, Sept. 2024, at 1 (stating phages have therapeutic applications).
[3] See Antimicrobial Resistance Facts and Stats, Ctrs. Disease Control & Prevention (Feb. 4, 2025), https://www.cdc.gov/antimicrobial-resistance/data-research/facts-stats/index.html [https://perma.cc/64V7-L9A3] (noting antibiotic resistant infection rates).
[4] See id. (highlighting antibiotic resistance risk).
[5] See Expanded Access, FDA (Sep. 8, 2025), https://www.fda.gov/news-events/public-health-focus/expanded-access [https://perma.cc/J23T-R9TT] (explaining expanded access).
[6] See Marion Gruber, FDA Ctr. for Biologics Evaluation & Rsch., Welcoming Remarks at the FDA and NIH Science and Regulation of Bacteriophage Therapy Workshop (Aug. 30, 2021) (highlighting clinical trials emerging may result in approved phage therapy products in market).
[7] See Martha R.J. Clokie et al., Phages in Nature, 1 Bacteriophage 31, 31 (2011) (outlining history behind phage discovery).
[8] See Gary Kaiser, Microbiology loc. 10.7A.1 (2024) (ebook). Phage virus particles work to eliminate unwanted bacterium when undergoing the lytic life cycle. Id. During this cycle, phages attach to the outer surface of a particular bacteria cell, inserts their DNA, and utilizes cellular material to form new phage particles within the cell. Id. at loc. 10.7A.2. This action causes the cell to burst or “lyse,” which kills the cell and releases more phages to restart the cycle. Id.
[9] See Clokie et al., supra note 7, at 31. Antibiotics emerged most prominently due to the ease of administering the treatment. Id.
[10] See id. at 31; see also Gruber, supra note 6 (highlighting resurgence in phage therapy research resulting from antibiotic resistance).
[11] See Robert T. Schooley et al., Development and Use of Personalized Bacteriophage-Based Therapeutic Cocktails to Treat a Patient with a Disseminated Resistant Acinetobacter baumannii Infection, Antimicrobial Agents & Chemotherapy, Oct. 2017, at 1. In the United Kingdom, a cystic fibrosis patient received treatment for an antibiotic-resistant, life-threatening infection using phages. Id.; see also James Gallagher, Phage Therapy: ‘Viral Cocktail Saved my Daughter’s Life’, Brit. Broad. Corp. (May 8, 2019), https://www.bbc.com/news/health-48199915 [https://perma.cc/8MQX-R7PM] (describing life-saving phage therapy treatment).
[12] See Noreen Iftikhar, What is Phage Therapy?, Healthline (Jan. 14, 2019), https://www.healthline.com/health/phage-therapy [https://perma.cc/5HDQ-KKXN].
[13] See Muhammad Tuhin, From Microbes to Humans: The Surprising Role of Bacteria in Your Body, Sci. News Today (Apr. 5, 2025), https://www.sciencenewstoday.org/from-microbes-to-humans-the-surprising-role-of-bacteria-in-your-body [https://perma.cc/2PJJ-CCAQ]; see also Iftikhar, supra note 12 (explaining antibiotic attacks on bacteria, including beneficial bacteria).
[14] See Sawa et al., supra note 1, at 2.
[15] See Eva Cornman, Antibiotic Resistance: Fighting a Global Threat with Phage Hunting and Infection Control, Yale Sch. Med. (May 14, 2025), https://medicine.yale.edu/news/yale-medicine-magazine/article/antibiotic-resistance/ [https://perma.cc/L6YB-SP8E] (explaining antibiotic resistance risks).
[16] See Bacteriophages and Their Use in Combating Antimicrobial Resistance, WHO (Fed. 17, 2025), https://www.who.int/europe/news-room/fact-sheets/item/bacteriophages-and-their-use-in-combating-antimicrobial-resistance [https://perma.cc/4JW9-87N2]. Phages are highly specific to their bacterial hosts, limiting the risk of bacterial resistance. Id.
[17] See FDA, supra note 5.
[18] See 21 C.F.R. § 312.40 (2025) (explaining qualifying conditions for expanded access treatment).
[19] See Cara Fiore, FDA Ctr. for Biologics Evaluation and Rsrch., Regulatory framework for the development and use of bacteriophage therapy in the U.S., Remarks at the FDA and NIH Science and Regulation of Bacteriophage Therapy Workshop (Aug. 30, 2021) (explaining method for gaining phage therapy access).
[20] See id. (outlining relevant clinical information).
[21] See id. Physicians must prove that the proposed treatment method is a last resort option. Id.
[22] See id.; see also 21 C.F.R. § 312.305 (2025) (stating potential patient benefit must outweigh treatment risk).
[23] See Fiore, supra note 19 (describes SPIND license approval procedure).
[24] See Patrick Monahan, Bacteria-Killing Viruses Discovered by Pitt Researchers are Saving Patients Who Have No Other Options, U. Pitt. Pittwire (May 13, 2022), https://www.pittwire.pitt.edu/pittwire/features-articles/bacteria-killing-viruses-antibiotic-resistant-infection [https://perma.cc/8E7S-LV3A]. Due to the lack of treatment options available, patients were able to be treated with lifesaving phages. Id.
[25] See Kaiser, supra note 8 (outlining methods to receive phage therapy).
[26] See Holly Fernandez Lynch, Devil in the Details: Physician Duties and Expanded Access, 51 J. L. Med. & Ethics 181, 181 (2023) (noting no legal duty, only moral duty to inform patients regarding lifesaving treatment).
[27] See id. (explaining caution in suggesting unapproved treatments).
[28] See Stefan F. Vermeulen et al., Do Physicians Have a Duty to Discuss Expanded Access to Investigational Drugs with their Patients?: A Normative Anaylsis, 51 J. L. Med. & Ethics 172, 178 (2023) (explaining moral obligation for informing patients regarding expanded access treatment for fair survival chances). But see Lynch, supra note 26 (highlighting ethical dilemma in suggesting unapproved therapies).
[29] See Vermeulen et al., supra note 28 (describing patient autonomy in treatment options and need for expanded access).
[30] See id. at 178 (explaining legal obligation should be imposed for recommending expanded access treatment).