2. 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.

Part of the issue surrounding FDA approval was the stigma associated with phage therapy–because the use of bacteriophages for medicinal purposes was relatively uncommon to doctors in the United States, the standards for approving any phage cocktail were relatively unclear. There was no clear set of guidelines for what boxes needed to be checked for the treatment to be cleared by the FDA, so the leadership was able to come up with unrealistic questions to vet the doctors involved in Intralytix. Perhaps another decade or so of analysis of bacteriophages and their life cycles, habits, and safety in humans will allow researchers to get FDA approval for phage therapy. Knowing the answers to any possible question that the FDA could fire at them could streamline the approval process. Doctors and researchers understand antibiotics to a great extent, but they don’t know a great deal about phages and people tend to be afraid of things they do not understand.

Additionally, Kuchment writes, “‘We used to look for phages in sewers on the street,’ he said, by removing manhole lids or drain covers. But passersby would stop to ask what they were looking for, and when Roy replied “viruses,” they looked alarmed” (109). The public would need to be unbothered by this because there is no use fighting for the approval of a drug that people refuse to use because it is so ‘strange.’ This mindset is likely widespread and can veil the FDA in their vetting of phage therapy as well as potential phage therapy patients. Again, further research can allow people to understand the many benefits and overall value of phage therapy and allow it to be welcomed into the United States.