Posted By: Joshua Baker

04/24/17

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.

Bacteriophage therapy is a rather new form of treatment in the United States and is viewed with a high degree of skepticism – a view that seemingly managed to make its way into the FDA approval process. On June 10, 2001 Sulakvelidze meet with Marissa Miller and Brown in a conference call with Washington. “Because bacteriophage therapy was new to the FDA, the government had convened regulators and experts from many different divisions. There were experts from the FDA’s Center for Biologics Review, toxicology experts, microbiologists, and regulatory affairs specialists from the National Institutes of Health.” These individuals are exceptionally knowledgeable, but in their pursuit for perfection I believe that they may serve as a hinderance. Firstly, it is important to consult and verify that drugs will be successful; however, with any form of treatment there may always be some form of risk. The FDA’s request that they determine the mutation rate of these phages seemed unnecessary and I believe is the inherit result of the skepticism mentioned above, phages aren’t widespread throughout the US as are antibiotics and can be seen as threatening. This resistance ultimately forced Sulakvelidze to shelf the project for when his NIAID budget was revoked he simply, “did not have the funding to do it.” Granted it is the duty of the FDA to protect the general populace, but I believe valuable information can be learned from witnessing the results of treatment in other nations will fewer regulations. If it has been successful there then I believe that in order for the US to stay competitive it must lower its initial standards to a place that will empower development and not stifle it.

Furthermore the FDA approval process is a rather long and tedious one. If the, “process of drug development and approval costs an average of $800 million,” then many small companies and individual ideas have no dreams of achieving success. Additionally, the process takes a total of, “10 years,” and in that time needs can change. The lengthy process and almost unaffordable processing costs makes the FDA approval process a major obstacle to any form of development. Enterprise and entrepreneurship can not grow under the stringent rules sit forth by the FDA approval process nor can many companies stay afloat throughout the entire time the process takes to run to completion. As a result I believe that the FDA approval process should be rethought of in a way that it functions as a business and prize efficiency. Too much focus on regulation can make development near impossible and I believe that in order for drug manufacturing to succeed the FDA must embrace the trail aspect of medicine and understand somethings will not be known yet take care to verify its safety. Such a system will still protect the American populace, but won’t completely hinder development.