The Forgotten Cure (9-12)
Alec Ingros
Prompt 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.
The FDA constantly makes very difficult decisions. They need to be certain about a product with out a doubt will be safe to all human uses. This being the case, sometimes the organization is too strict in some aspect. The way in which the FDA felt with Intralytix serves to support some of this groups shortcomings.
Intralytix, a biotechnology group focusing on phage use, was in the final processes of moving to clinical trial for using phage therapy as treatment against Vancomycin Resistant Enterococci. After being able to restore infected mice consistently to full health, the company, being led by Marissa Miller and Torrey Brown, applied for permits to begin clinical trials in 2001. Ultimately, the FDA were too expensive to continue onto the clinical trials. The trials came to a halt, quickly lost funding, and the company stopped further research.
Each aspect of the experimental process needs to be examined, which leads to an approval process that is too long and expensive for most companies. To satisfy the concern over each step of the new process, the FDA aquires specialists from the National Institutes of Health. The average cost is around $800 million from start to finish for an experimental procedure to gain FDA approval. In addition to this, it is about a 10 year process. In this lengthy period, the drug may no longer be as important, which could lead to companies losing investors leading to the abandonment of the project. These qualities of the FDA approval process make the production of new treatments in a timely manner a dream. This stunts entrepreneurship, continuing to keep drug production in control of major companies.
I would recommend that this process is shortened. If shortened, the promising smaller companies may still have investors to help pay for the production. This would open new possibilities for businesses. The expenses seem that they are unavoidable, so if the drug or procedure shows promise then the smaller companies may be able to gather enough investors to complete the FDA approval process.
I must agree with your proposal to shorten the time required to obtain FDA approval. It seems to be a rather extensive process that hinders development more than it protects the American people. Further, it will most certainly allow for smaller companies and independent laboratories to be more competitive in the drug manufacturing process and possibly offer a great influx of insights into new treatment methods that larger companies avoid in the interest of profit.