Is the Fast Track FDA Approval of Molnupiravir a Pharmaceutical Standard?

At the end of December, the United States Food and Drug Administration approved Authorization for emergency use of Pfizer’s Paxlovid, a pill to help treat COVID-19. The next day another pill, Molnupiravir from Merck, was approved. This marked a big step in the fight against COVID-19, especially with these pills now available in several states. The pace at which these drugs have been given the green light, however, poses questions and concerns for healthcare professionals. Will the accelerated production of Molnupiravir and Paxlovid set a new standard for the production of pharmaceutical pills, for better or for worse?

Dr Kishor Wasan, Medical and Scientific Director of Skymount Medical US, has extensive experience in drug development. He is an award-winning pharmaceutical scientist and has published over 240 peer-reviewed articles on lipid-based drug delivery and lipoprotein-drug interactions. Dr Wasan says this fast-track approval and production is not a new process for the FDA or pharmaceutical researchers. So why is it getting so much attention?

“It does the trick. The FDA isn’t actually bypassing their processes – they just say, “Hey, use this process.” What is happening is that this permission is now used a lot, ”Dr Wasan said. “The general public probably didn’t even know it because it was probably only used in a variety of situations people probably didn’t know.”

Since the initial vaccine was made readily available to Americans, two variants have spread relentlessly, the current dominant variant, Omicron, crushing hospitals. With these aggravating factors at play, has there been a forced change in standard for drug approval, which will guide future authorization? Dr J. Wes Ulm, a physician, medical researcher and resident in clinical genetics at the University of Pittsburgh Medical Center, specializing in translational medicine and having applied data mining tools to drug discovery and repositioning, simply said “no “. However, according to Dr Ulm, the FDA has been willing to change aspects of its approval approach due to the public health emergency of COVID.

“It is not only the mortality from COVID 19 that has been so high, but the mortality from heart attacks, mortality and morbidity from strokes, gallstones, car accidents, sports injuries , which have grown dramatically because we just don’t have the staff to take care of people, ”Dr Ulm said. “It’s the kind of public health emergency crushing hospitals that has led to a real overhaul at the very least of the EUA process and even potentially for full approval or in the stages leading up to it.”

The key to enabling an expedited approval process is the emergency use authorization that the FDA has at its disposal. Ira leiderman, managing director of Cassel Salpeter and Company, said this emergency use authorization is one of many tools in the FDA’s tool belt. We then asked him why the FDA was using this approach and why it might be effective for these different forms of COVID-19 treatment.

“The FDA is using data collected by product developers examining the safety and efficacy of Phase 1 studies and the ultimate efficacy of large Phase 3 studies to grant this emergency use clearance that will allow these companies to sell the products and at the same time allow them to continue collecting data and to continue their filing process to obtain a full product license, ”said Leiderman. “This is not about a reduction in quality, it is just the interim measure which is one of the tools available to the FDA to expedite the approval of products important and necessary for public health purposes. “

At first glance, it appears there are steps being skipped when authorizing “emergency use”, but Dr Wasan said the benefit and risk analysis is heavily weighted. According to Dr Wasan, all COVID treatments have had a limited number of patients due to the urgency of the decision, but as more data comes in, the way the pill is prescribed may change. This limited data was one of the concerns of the Molnupiravir approval process which saw the FDA vote. 13-10 in its initial recommendation.

“The initial data looked really great, it looked like it was really safe and seemed to have significant efficacy, but as they started to see more and more patients, they found that the efficacy started in done down and that there were safety issues, ”Dr. Wasan said.

In the future, Dr Wasan may consider other cases where the developers use drugs already developed and then modify them like they did for the COVID-19 pill, as well as strike up a conversation with the FDA about the drug approval process before it is presented to them.