Question:

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.

One of the hardest parts about FDA approval or approval from any government agency for that matter is that they are all very picky when it comes to funding. This is understandably because there is only so much money to go around; however, they don’t make it easy to prove oneself to these agencies in order to receive funding. Since agencies like the FDA want to see results before deciding to throw money at a concept, groups like Intralytix and GangaGen were forced to cater to unreasonable requests without funding to begin with or give up on phage therapy for humans. Also understandably, this pushes groups like these two to the latter option, since in the world we live in there isn’t a very easy way up without monetary support. Given that the FDA doesn’t understand precisely the nature of phage (something that none of us fully understand yet, but something that some see more of than others) and asks for unreasonable results, combined with the fact that they won’t provide funding without these results, and lastly the fact that government agencies are basically comprised of red tape, the FDA has proven to be a fairly immovable roadblock.

Honestly, the only thing that I can think of that will help raise the understanding of phage usage and push for FDA approval is to continue what these companies are doing already and making products and testing on things other than humans. The more tests that are performed and the more basic knowledge that is accumulated, the more likely results will appear that give agencies like the FDA faith in this concept. All things take time. For example, funding wasn’t focused on renewable energy sources for a long time since faith and understanding was in coal. Obviously, the world has started to change its stance on that issue, and something like this will follow when the world is more ready to embrace it. The more data these groups can accumulate and the farther they can spread this information, the sooner it will be funded and the positive feedback loop occurring from this will provide Intralytix, GangaGen, and any other company like them the support they need to make real breakthroughs on phage therapy in humans.