One of the biggest problems in phage therapy has been in the approval process.   Describe the trouble surrounding FDA approval and recommend some suggestions to improve the process of phage therapy approval.

The trouble surrounding the approval process of the FDA is due to both, the fact that phages tend to have a more negative view in the United States, and the fact that there simply may not be enough research to determine the safety of commercial phage use. Due to the lack of phage use in the Unites States, I feel as if its seen as more of a safety risk because phages haven’t been extensively used, therefore the long term ramifications of commercial phage use have yet to be determined. Also there is also a lot of skepticism surrounding phage use, for example when the FDA responded to Sulakvelidze they had a request that seemed unreasonable: “What Sulakvelidze felt was a less reasonable request was that the FDA also asked him to determine the rate at which each of the six phages in Intralytix’s proposed VRE cocktail would mutate inside an experimental animal” (92). The amount of money and time that would be needed to prove the mutation rate is astronomical and borderline impossible, and it could be agued that it really isn’t even needed. 

Some ways that I feel the phage therapy approval process can be improved is if as a society we can readily adopt the idea of using phages as a from of treatment, and try to diminish the stigma surrounding phage therapy. Secondly, I think if we can approve some form of phage therapy that seems safe and effective, I feel as if that would could help diminish stigma and help us determine the long term ramifications of phages in a real world setting (if there even are any)