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.

For a potential drug to reach the market, statistics from the book show that only as few as eighteen percent of the medicines that make it to phase I continues on to succeed, and the average costs for drug development and approval are 8 hundred million dollars. For phage therapy, sufficient funding has always been a problem, furthermore, large pharmaceutical companies targets treatments for chronic, more profitable diseases rather than short term, low-profit treatments such as phage therapy.

Since phages are capable of mutation, the phage cocktails in phage therapy may have to change or adjusted every few years, while antibiotics remain the same formula for decades and exact mechanism can be studied thoroughly, the FDA might be concerned about the safety or stability of phage therapy. Some of the concerns surrounding phage therapy are that bursting bacterial cell might release toxins and cause septic in the patient’s body, and the phages that burst out of the cells carrying drug-resistant genes might infect other bacterial cells and transfer the genes to other bacteria via transduction. One of the ways that scientists can help prevent this from happening is to keep the phage particles within the dead bacterial cell, such as Ramachandran endeavor to prevent toxins leaving the cell by inactivating endolysin.

Besides scientific research, one of the most important things for the approval of phage therapy is to convince doubters the effectiveness and importance of phage therapy, the process would be easier of people are more accepting of the concept,