There are a lot of important facts on the FDA’s Web Page set up to provide information about the novel coronoavirus (2019-nCOV) outbreak, now dubbed COVID-19. But there are three sobering statements that stand out:
- There are no FDA-approved diagnostics for COVID-19
- There are no FDA-approved vaccines to prevent COVID-19
- There are no FDA-approved drugs to treat COVID-19
Statistics about the numbers of people who have been infected vary greatly. It is far too early to tell what will happen with this outbreak. It is not to early to prepare for it. Without the ability to readily diagnose, prevent or treat the condition – things that cannot be readily done – the main thing that can be done is planning.
When we think of an epidemic, we naturally think of the obvious concern – the safety of ourselves and those we care about. But there are consequences in store beyond that for many industries – most obviously the travel industry. And there are also dynamic concerns for the industry that makes our medicines.
- API – First there is the potential for disruption of the production of medicine due to a lack of active pharmaceutical ingredients (API), a large portion of which are manufactured in China. While there are non-Chinese API producers, many of them are in China and it stands to reason that disruption is a distinct possibility. That would have an impact on everyone relying on medicine not only to treat infections, but also to treat chronic conditions such as diabetes, blood pressure and cholesterol levels.
- Manufacturing Disruption – In the event of a widely spread contagion, it stands to reason that social isolation practices – i.e., not coming to work – could become necessary and thereby interrupting the actual manufacture of finished medicines. While API can be obtained from various sources, the manufacture of many medicines is specific to established sites.
- Medical Meetings – The effects of the outbreak on large meetings is already becoming apparent with high-profile companies pulling out of the Mobile World Congress set for Barcelona this month resulting in the cancellation of the meeting. At the very time when collaboration is essential, there may be a disruption to medical meetings commonly held around the world at which clinical data is presented and cutting edge research is discussed. A disruption in the course of research-related discourse could impact the speed of development of new medicines.
- Regulatory Oversight – Media reports this week mentioned that visitors to the campus of the Food and Drug Administration were being asked upon entry about foreign travel. Social distancing also means that regulatory meetings such as FDA Advisory Committee meetings may be put on hold – as well as the review process itself – considerably slowing down the approval of new medicines.
- Blood Supply – As anyone connected with the early days of the AIDS epidemic can attest, when you have a communicable disease where there are no diagnostics for screening, the blood supply becomes particularly vulnerable, resulting in the potential for severe shortages to emerge.
These concerns are not new with COVID-19. The circumstances were very similar during the Avian flu outbreak during the first decade of the 2000’s and extensive planning around the supply chain was undertaken by the pharmaceutical industry. We find ourselves again with an imperative to not just plan appropriately but to consider how to effectively, accurately and compassionately communicate what needs to be considered in a time of crisis. In that way, industry can minimize some of the potential side effects that are possible as we see our way through this.
The World Health Organization puts out daily situation reports that are highly detailed and comprehensive. You can access them here.
Photo – Centers for Disease Control