FDA Drug Approval and Acceleration Process in Global Health Crises
What the FDA Does
According to their mission statement, “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.”
In carrying out this mission, the FDA is responsible for approving all drugs prescribed and sold in the United States.
This is an immense undertaking given the size of the pharmaceutical industry, and the weight of the responsibility of regulating an industry that commercializes products that can both cure people or cost them their lives.
FDA Approval and COVID-19
Insert an emergency situation, such as a pandemic, and the high stakes nature of the drug approval process moves from “weighty” to literally having the “weight of the world” at hand. 3,116,131 people have been infected by COVID-19 to date.
The virus has no proven treatment, cure, or vaccine. This disease has taken the lives of hundreds of thousands of people (215,696 to be exact) and in addition to its cost in human lives, it is crippling economies worldwide.
In order to resume life with some resemblance of normalcy, pharmaceutical companies are working tirelessly to produce vaccines and cures alike. However, getting a drug to market is not as simple as just producing one. The FDA is responsible for overseeing the research and development of drugs in order to approve their usage by the general public.
The FDA Approval Process
The FDA outlines its drug approval process as a 12 step process that includes 4 phases. The first step involves animal testing. If the drug proves to be non-toxic to animals, then the sponsor can submit an IND (Investigative New Drug Application), after which the drug goes into clinical trials and or studies. The clinical trials are separated into three initial phases.
They test safety, effectiveness, and the drug's effects on different populations and in combinations with different drugs. Each phase has a substantially large number of participants required for the trial than the previous phase.
Following clinical trials, there is a review meeting between the FDA and the drug sponsor. The drug sponsor will then submit a formal application called a New Drug Application (NDA).
The NDA will include all of the data about the drug and analyses of the drug. Once NDA passes the review stage, then the FDA reviews the drug's labeling to make sure it has all of the necessary relevant information.
Following this step, the facilities where the drug will be manufactured are inspected. The drug sponsor then either receives an approval or a response letter. In the case that the drug is approved, the final step is the post-market monitoring of the drug in which any adverse effects can be reported by both physicians and consumers.
Accelerated FDA Drug Approval
It can take years to get through the approval process to release a drug for sale. The FDA is known for having one of the most stringent approval processes in the world. So the question of how to streamline this process when a drug is needed in response to a global health crisis is an important one.
In response to COVID-19, the FDA has created the Coronavirus Treatment Acceleration Program (CTAP). This program is responsible for managing the delicate balance between expediting the process of getting much-needed therapies approved for public use while simultaneously monitoring the safety of said therapies.
There are currently 72 active trials for COVID-19 treatments. Additionally, 211 treatments are in the development stages. CTAP has implemented several measures to expedite the FDA drug approval process for therapies related to COVID-19.
Getting Drugs FDA Approved for COVID-19
To capture a snapshot of what the drug approval process looks like during COVID-19, we spoke with Ken Londoner, CEO of BioSig Technologies, and Dr. Jerome Zeldis, the Executive Chairman of BioSig subsidiary ViralClear Pharmaceuticals, Inc.
Zeldis is overseeing the production of ViralClear’s drug candidate Vicromax™, a potential treatment for COVID-19. Vicromax is a broad-spectrum antiviral that is said to suppress SARS-CoV-2 replication in vitro. If found to be a safe and viable treatment, Vicromax could stop the devastation of COVID-19 and may help the world resume life as we formerly knew it.
Dr. Zeldis provided the following information about the current status of Vicromax, which he and his team have been working on nonstop for the past 40 days.
Vicromax is currently moving through the FDA approval process, and in the midst of getting IRB approval at the Mayo Clinic. Vicromax has completed Phase I and Phase II in trials for other indications.
Zeldis explained that ViralClear is in the midst of preparing an IND application to be submitted. He outlined this initial process, and how it is being adjusted to accommodate the urgency of COVID-19.
Zeldis stated that when an IND is submitted, the drug company has 30 days to adjudicate, and then the FDA review division has a discussion to clarify any issues encountered, which leads either to approval, further work on the indicated concerns, or to a clinical hold.
When asked about a potential timeline for Vicromax, while adding that COVID-19 has put everyone in unchartered territory, he added the following, “I believe that we are going to submit a very complete application. We are taking a drug that has been developed years ago and have outlined in our application that we will do the additional work to bring it to 2020 standards. We don’t think any issues will slow us down.”
Both Zeldis and Londoner stressed the importance of cooperation at every level of society in order to win the fight against COVID-19.
As COVID-19 has become quite politicized in the US, there are several layers of skepticism surrounding the illness itself that might precede the efforts involved in getting treatments approved. When asked about these issues, both Zeldis and Londoner alluded that the gravity of the situation demands that everyone involved remain solution-oriented.
Zeldis discussed how all demographics, not just the elderly or those with preexisting conditions, are at risk for developing serious complications from COVID-19. The two admitted to having worked for over a month with little reprieve, and expressed an urgent optimism in the process that would potentially allow their drug to save the lives of millions.
We have created an interactive page to demonstrate engineers’ noble efforts against COVID-19 across the world. If you are working on a new technology or producing any equipment in the fight against COVID-19, please send your project to us to be featured.