COVID-19: Impact on the FDA Pipeline

FDA, Medicare Set-Aside Blog, Rx/Pharmacy on April 15, 2020
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

The impact of COVID-19 has undoubtedly been profound, but some of its effects are less obvious than others. One of the impacts associated with the COVID-19 pandemic that may not have hit home yet for many is the likely effect on the pipeline of new drug approvals through the FDA. The pandemic will likely produce a significant decline in both the volume and velocity of new drug applications submitted for FDA approval. And what’s worse is that it is very difficult to predict how long these decreases will persist.

There are many factors that will contribute to these decreases, but all of the factors center around one of two major themes – first, the cessation of clinical trial activity and second, interruptions to standard regulatory approval pathways. With regard to clinical trials, a number of pharmaceutical manufacturers are focusing a great deal of effort towards the development of a coronavirus vaccine and/or medications used for the prevention or treatment of COVID-19 and COVID-19 complications. Amgen, Pfizer, Dynavax Technologies, Gilead and GlaxoSmithKline are just a few of the pharmaceutical companies reportedly working towards developing coronavirus treatments.[1] For these companies, investments in treatments for COVID-19 will likely come at the expense of investments in treatments for other diseases. In addition, manufacturers may have difficulty recruiting participants for clinical trials for non-COVID-19 diseases due to various shelter-in-place orders and social distancing recommendations. Sufficient clinical trial data to establish the safety and efficacy of new drugs is a critical component of the new drug application process. Without this data, pharmaceutical manufacturers simply won’t be able to submit an application for FDA approval.

The FDA approval pathway has also experienced some interruptions due to COVID-19. Last month, the FDA announced that it was suspending inspections of foreign manufacturing facilities and temporarily suspending inspections of U.S. manufacturing facilities. This includes routine facility inspections which are part of the review process for new drug applications. This will almost certainly create a bottleneck for new drug applications submitted prior to the COVID-19 pandemic. When the FDA decides to resume facility inspections, there will very likely be a backlog of inspections that need to be completed. This may lead to further delays in the approval of new drugs.

The timeline for future events is uncertain and for that reason, it’s impossible to predict when normal activities will resume. It’s not outside the realm of possibility to contemplate depressed FDA pipeline activity for the remainder of 2020 and continuing well into 2021. This will negatively impact patients and prescribers by delaying the approval of desperately needed medications for certain diseases. It will also negatively impact patients and workers’ compensation insurers by potentially postponing the approval of generic medications which would otherwise have led to significant cost savings for the treatment of compensable conditions. Like many other aspects of the coronavirus pandemic, this is a very fluid situation and the outcome and eventual impact on both medications and claims is dependent upon a number of variables. As these variables begin to take shape and become clearer, we’ll continue to post updates here.