Can the USA Prepare for a COVID-19 Epidemic?
In a statement before the Senate Committee on Homeland Security and Governmental Affairs on February 12, 2020, Scott Gottlieb, M.D. offered his insights and recommendations regarding the novel coronavirus outbreak.
Dr. Gottlieb, the former US Food and Drug Administration (FDA) leader, said ‘The epidemic spread of coronavirus in China — along with community transmission in Singapore, Hong Kong, and Japan — sharply increase the chance that we endure pandemic spread.’
‘Worse still, the novel coronavirus (COVID-19) may become endemic.’
‘It could take a new position as a more sinister member of the seasonal pathogens that circulate each year and infect humans.’
‘The next month is critical.’
‘We must prepare for the prospect that the virus evaded our border protections and was already introduced into the U.S. in late December or early January — when it first appears to have become epidemic in China’s Hubei province.’
‘Those index cases could have seeded community spread, and eventually, outbreaks could emerge in America. We have the capacity to contain small outbreaks. But we need to be vigilant and ready.’
‘Models suggest that from the time of the first introduction of the virus into China — which we now suspect occurred sometime in November — to the time of epidemic spread in China, was about 10 weeks.’
‘The experience in the U.S. is likely to be different, not least because our awareness of this risk is prompting collective action that can limit spread.’
‘But China’s experience shows that if cases were imported into the U.S. in early January and remain undetected, then we could still be early in our own evolution toward broader outbreaks.’
‘Right now, we’re depending largely on clinical surveillance as our primary tool for identifying potential outbreaks since we’re just now deploying diagnostic tools to the Laboratory Response Network.’
‘Moreover, we still haven’t broadened our screening criteria to include patients who don’t have a connection to recent travel to China.’
‘This limits our ability to identify secondary spread.’
‘So, we may know we’re experiencing outbreaks of this disease only when a cluster of cases of atypical pneumonia present to a hospital and trigger closer scrutiny by health officials.’
‘By that time, there could be dozens or even hundreds of cases in a local community. Controlling a broader spread could become a challenge.’
‘There are steps that we can take – both in the short term as well as the long run – to expand our supply chain for making these raw and intermediate components of drug production and mitigate risks to our supply chain.’
‘In the setting of the current public health crisis related to the novel coronavirus, I want to focus my remarks today on some of these potential actions.’
‘First, we can work to bring on alternate supply.’
‘After Hurricane Maria devastated Puerto Rico, and took offline fully 10 percent of the manufacturing capacity for drugs intended for the U.S. market, the FDA took proactive steps to restart facilities that manufactured key products and identify alternative suppliers for some products were significant and potentially harmful disruptions were believed to be unavoidable owing to the damage.’
There's idle manufacturing capacity that can be developed to address some of the immediate needs.’
‘India, for example, has about 1,500 plants that manufacture APIs (active pharmaceutical ingredients) and are running at 40 percent capacity.’
‘Second, we also need a better system for identifying these supply chain choke-points.’
‘When it comes to the kinds of starting materials that may have been disrupted by the crisis in China, the FDA would be dependent on manufacturers to identify these supply choke points.’
This is challenged by the current shortage framework.’
‘It relies on a passive reporting system from manufacturers, where we might find out too late of an impending shortage.’
‘It may not work in a crisis situation like this where information and reporting are imperfect. In the near term, the FDA can issue a solicitation for such information.’
‘U.S. officials should already have some awareness of the key components that are manufactured in China, and in the Hubei Province particular.’
‘But in the longer term, we need a more systematic process for collecting this information.’
Dr. Gottleib’s full report can be found at this link.
Separately, the FDA announced on February 14, 2020, 'if a potential shortage or disruption of medical products is identified by the FDA, we will use all available tools to react swiftly and mitigate the impact to U.S. patients and health care professionals.
These tools include closely working with manufacturers and expediting reviews of alternate supply to prevent shortages, among other measures, with the common goal of minimizing any negative impact on public health in America.
Coronavirus preparedness published by Precision Vaccinations.