Navya Katragadda
Prompt: 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.
Though phage therapy has had its up and downs in the science world, it has recently become a popular field of research for many scientists who are looking for an alternative way to treat patients. FDA stands for the Food and Drug Association. The FDA’s main goal is to promote and ensure public safety by testing and approving food, drugs, treatment plans, and much more before they are distributed to people. Through the FDA is working towards ensuring the safety of the public, the process to get a drug or treatment approved by the FDA takes a long time and it costs a lot of money. The FDA gives a lot more money to pharmaceutical companies instead of researchers, which slows down the process for a treatment to get approved. No medicine or treatment can be used on patients until it gets approved by the FDA. There are four main steps in the FDA approval process. The first step is that the drug company needs to get the drug tested. The second step is send the CDER results from the test to make that the results show that the test is safe for use and distribution. The third step is that a team of CDER professionals that consists of doctors, statiscians, pharmacologists, and others will go to the company and see the data the company had collected and how they are planning to label the drug. The final step is that if the benefits of the drug outweighs the cost, then the drug will get approved for distribution and for use on patients.
Two companies, Intralytix and GangaGen, worked very hard to get their respective phage therapy ideas to get passed by the FDA. Intralytix was founded in 1998 by Sulakvelidze and is based in Baltimore, Maryland. Intralytix is a company that focuses on selling bacteriophage-based products that could combat bacterial pathogens in the environment, in medical settings, in food, and in much more. Intralytix was actually the first company to get approved by the FDA for the use of bacteriophage-based products in food. GangaGen was founded in 2003 by Dr. Ramachandran in India and was trying to find ways to fight antibiotic resistant bacteria using phages. GangaGen figured out that a bacteriophage-based protein called ectolysin that would bind to the antiobiotic resistant bacteria and eventually kill them. However, he ran into a problem when he was trying to get this treatment approved because he knew that the FDA would not approve anything that could potentially lead to toxins entering the patient’s body. So, he had to figure out a way to ensure that the phages used in the treatment would not lyse their host cell and enter the human body.
In my opinion, there are two ways that could speed up the FDA approval process for not only phage therapy but for new medication as well. The first way comes from the researcher’s side. If the researcher thinks of all the possible side effects and negative consequences of the drug or treatment and work to reduce those negative effects, then the FDA will more likely approve of the treatment or drug since it will not pose any serious consequences for the patient’s that take this. Researchers could do this by letting other scientists review their work and give their input. This would help tremendously because sometimes a fresh set of eyes can help to figure out if there are any issues. The second way would be if the FDA could allot more money to research because then the researchers will be able to consider multiple results of the treatment or drug, and then work to eliminate the negative effects and to ensure the success of the drug. It is very difficult to come up with a successful treatment or drug if the researchers do not have enough money to carry out the study to the best of their ability. It is important for researchers to put their best foot forward when conducting these studies because the treatments and drugs that come out of the study will eventually be used on patients and if the studies for the treatments and drugs are not thorough, it could be very detrimental to the patients that consume the drugs or take part in the treatments.
