Question #2

Intralytix tried and failed to pass phage therapy through the FDA in 2002. The process of passing a drug through the FDA is challenging for any small startup company because it is typically very expensive and time consuming. In addition to expenses in time and money, Intralytix had to battle the country’s general aversion to phage treatment. At the time, American scientists had tunnel vision for antibiotics and drugs creating added resistance to the emergence of phage therapy. When the FDA was reviewing the product they found a lot of problems including the accuracy of separating lytic and lysogenic phages, a less than desirable animal model that had been used, and unknown rated at which the phages within a cocktail would mutate and affect the experimental animal. Finally, there was not sufficient evidence showing that the results of phage therapy would be different from the results of antibiotics. Intralytix  concluded that testing and revaluating each of these issues would be much too costly and time consuming so the project was put on hold.

From my experience working at a pharmaceutical company, the FDA can be used as a resource, not just a merciless judge. The best and fastest results are achieved by working directly with the FDA and approaching them in the beginning stages and asking for guidance instead of just viewing the FDA as an end location. With FDA guidance, phage therapy funds can be more focused and precise to test the most necessary components. I think it is also important to show how phage therapy has advantages over antibiotics.