Prompt 2: The Food and Drug Administration (FDA) is one of the United States federal executive departments in charge of protecting people’s public health and safety. One of the most frustrating problems associated with the FDA is the regulations that a company must pass before clearing a product. It takes an immense amount of time to pass the regulations set forth by the FDA. Intralytix stated that “it took [the FDA] almost a year, from the time they said they had no more technical questions, to issue the regulation, and that’s a long time for a company of our size to be hanging out there.” GangaGen, another phage company, found a way to isolate a single phage component with a protein that could poke a hole in the bacterial wall. They reasoned that the FDA would more readily approve phage therapy if only a single phage component could destroy a bacterial cell as easily as a whole phage. When using phages in cows, companies determined that the viruses didn’t stay in the cow’s bodies, and Intralytix proved that their phage cocktail showed efficacy by having a 99% reduction in most foods. Despite these facts, people are still wary to use phage because the thought of eating viruses quickly turns people away. Both Intralytix and GangaGen are worried that the process of FDA approval, which comes with the long time-commitments and numerous expenses, could significantly impact the success of their company. Also, Dr. Wolcott petitioned to the FDA that phages are safe to use in wounds, and the FDA allowed him to proceed with the trial to test for efficacy. However, in order to complete this, the FDA stated they must put each phage through a separate trial, and the costs would be “astronomical.” In response, Wolcott said, “The FDA should approve the process, not the individual phages.”
Since phage therapy must pass through the FDA before it can be used legally in food or humans in the United States, it caused the development and progression of phage therapy to slow. I agree with Dr. Wolcott in that the FDA needs to approve the process of phage therapy rather than testing each and every phage separately. In the end, the FDA was ultimately making it nearly impossible to approve phage therapy because of the large costs and the lengthy regulation processes. Because of these factors, people look to antibiotics instead because they’re a quick and easy solution. However, this is causing more and more mutated, antibiotic-resistant bacteria, meaning that antibiotics are becoming increasingly less effective. In order to combat this problem, people need to utilize alternative therapies, including phage therapy. There are statistics to prove its efficacy, but people are wary of consciously putting viruses into their systems. If the FDA would simply approve the entire process of phage therapy, it would save time and money for companies to begin using this method in food processing and human treatment. Although there are few concerns with the use of phage therapy, having it approved could drastically improve the well-being of many patients who are in need of alternative therapy and, as a result, save many people’s lives. Additionally, scientists and researchers could work to improve the negative label associated with phage therapy by raising awareness of its value in the medical field.
