An experimental treatment could become easier to get a hold of for hospitals with increasing numbers of COVID-19 patients. Gilead Sciences, (NASDAQ:GILD) a biopharmaceutical company, has already started ramping up approvals of applications for emergency use of an experimental coronavirus treatment called remdesivir.
The Food and Drug Administration (FDA) already has an expanded access program for experimental drugs that's more commonly known as the "compassionate use" program. Unfortunately, the compassionate use program isn't set up to handle a flood of requests that have been growing exponentially.
To access a drug in clinical trials that hasn't been approved yet, patients and their physicians need to show ineligibility for those trials. If a patient can cross this hurdle, they still need the company to submit an expanded access request to the FDA, which is the part of the process that Gilead will accelerate.
Instead of approving one application at a time, the company will streamline its approach and allow physicians and hospitals to apply for emergency use of remdesivir for multiple patients at once.
Unfortunately, healthcare providers and their COVID-19 patients might not see a significant increase in access to remdesivir. Gilead may be willing to process group applications, but there are still two roadblocks that might not be as flexible.
Gilead can streamline group applications for expanded access, but those applications still need to be reviewed by an investigational review board (IRB). Once an IRB concludes the patient knows what they're getting into, the FDA finally reviews the expanded access request.