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.

Despite the promise phage therapy has, it has yet to become a practice used in medicine due to the constant overwhelmingly large obstacle that is FDA approval. The approval process is riddled with problems that make approval for phage therapy an incredibly tedious process. The largest obstacle and issue with the FDA approval process is the fact that the FDA wishes to see promising results regarding the use of phages against bacterium, but require scientist to jump through hoops with little to no resources or funding. This can best be seen The Forgotten Cure, when the FDA made completely unreasonable request towards Sulakvelidze and Intralytix when they requested Intralytix to “determine the rate at which each of the phages in Intralytix’s proposed VRE cocktail would mutate inside an experimental animal”. This request was deemed unreasonable by Sulakvelidze, and noted that “if they [FDA] persist in this, it will be very difficult for us to carry on”. These roadblocks intentionally put in place by the FDA can hinder or completely prevent phage therapy companies from continuing on with their research. This can cause approval for phage therapy to take an incredibly long time, as it wasn’t until 2006 that phages were approved by the FDA just for food usage. Unfortunately, the FDA is a government agency, and for phage therapy to be approved it must meet and overcome every rule and regulation set in place.

I think the best way to improve the process of phage therapy is to loosen the reigns a little on the companies that are participating in this research. It is obvious that phage therapy, unfortunately, is relatively unknown and under-appreciated, meaning these companies have a hard enough time securing funding and the means necessary to do this type of research. In combination with reduced funding, the FDA putting up unnecessary roadblocks and obstacles can make it extremely difficult for these companies to succeed. This could be largely contributing to the lack of the fully achieved potential and promise phage therapy holds. I understand that the FDA is simply doing its duty, as it is trying to ensure phage therapy is completely free of any potential threats to public health, however the process of scientific inquiry is already a long and drawn out process as it is. The constant interference with the FDA and the lengthy approval process continues to slow down phage therapy to a crawl. With looser regulations, and increased support from the FDA and the public, I believe the process of phage therapy approval will not only go by much smoother, but also at an increased rate.