Rubio: “Now, we know that 80 percent of active pharmaceutical ingredients in the United States come from China… At a minimum you would agree that this is sort of a wake up call that perhaps we are overly dependent on a supply chain so heavily concentrated in one place in the world?”
Earlier this month, Rubio urged Food and Drug Administration (FDA) Commissioner Stephen Hahn to ensure the FDA has the necessary tools to guarantee the safety and supply of pharmaceuticals, food, and medical supplies being imported from China in light of the growing epidemic of the novel coronavirus. Last February, Rubio released a report detailing critical vulnerabilities in America’s medical supply chain, warning, “the U.S. runs the risk of losing important components of its medical supply chain to China’s government-backed industry.”
Video of Rubio’s remarks can be found here and a lightly edited transcript is below.
Rubio: First I want to acknowledge how difficult this issue has been because where it originated in China, they’re less than transparent. Whatever numbers they put out everyday I can assure you the numbers are higher as to the actual number of cases. But to date, unless they shared it with the World Health Organization, they haven’t shared the original viral sample. I know they put the code up online, but they didn’t share the sample. They haven't really been forthcoming about best practices on a host of issues. Our response is complicated by the fact that we’re dealing with a totalitarian government that’s more interested apparently in PR and in their image than they are with actually dealing with this the way we would if we had an outbreak of this kind. That is most certainly impeding our ability to develop things like a vaccine and so forth.
Azar: We need full transparency and full cooperation from China, as well as every country. And the WHO needs to hold every country accountable as they would the United States for that type of transparency and cooperation.
Rubio: The second question is have we done any estimates or do you have any view on what would happen if this virus makes itself to an underveloped country with poor or no public health. For example Haiti or Central America, and some nations in Central America in particular. The impact that that would have on those societies, not to mention many nations in the African continent, what it would mean for migration flows, for the global economy. Do you have any thoughts about how destructive it would be? The one thing is that it shows up in Italy or the Canary Islands, another thing is that it shows up in a country that already lacks any sort of basic public health and the ability to address it.
Azar: Obviously it would be very concerning if this virus spreads say to Africa or other areas that have less developed public health infrastructure because they won’t be able to take the steps towards mitigation and containment that we can take here in the United States. And so it would spread quite rapidly. This is why it’s actually so critical to get better data out of China so that we know the severity and what the mortality rates really are here so we know what we’re dealing with in terms of impact.
Rubio: Now, we know that 80 percent of active pharmaceutical ingredients in the United States come from China. And I wrote a letter about this to the FDA Commissioner, and I know there’s a lot going on, but we’ve yet to get a response. So I wanted to know a few things. Does the FDA have tools and information to track potential medical device or pharmaceutical shortages?
Azar: We do under FDASIA to be able to track with pharmaceuticals. They have to report to us if there’s any potential shortage and we’ve not received any reporting yet about potential shortages connected to the China situation. The medical device companies do not have to make those same kinds of proactive reports and that’s actually part of what we’ve suggested in legislation.
Rubio: What can we do or what would we do to mitigate shortages of particularly critical medicines if in fact we saw one coming?
Azar: It’s a very difficult challenge because the supply chains with drugs as with the rest of our economy are very much globalized and entwined with China and elsewhere. And one can’t stand up a manufacturing facility for pharmaceuticals just overnight. And so if a drug company happened to have multiple manufacturing facilities that were qualified, they could transfer their manufacturing and we would certainly work at FDA to expedite any type of inspection, regulatory approval to support that.
Rubio: Well have we coordinated with any non-Chinese suppliers or products at least in an effort to sort of think forward about what we do if in fact suddenly we face — again we’re not dealing with the most transparent government in the world in China — so if this thing came upon us fairly quickly, what option would we have to work with non-Chinese suppliers of these key ingredients?
Azar: Well we can work with any supplier that is FDA approved. One can’t just secure FDA approval overnight for either a generic ANDA or for the manufacturer, of course, of an innovative product. So we would work with those companies that hold licensing and hold patent rights to be able to expand their production in other countries.
Rubio: But have we done any work just sort of putting some of that in place just in case this comes on quickly?
Azar: We are aggressively and proactively working with all of the drug companies and device companies, and we’ve made it clear we’re available to help them. None of them have signaled any potential problems in terms of supply. There are a couple of manufacturers that do work in Hubei province, the epicenter, but they report that they have large stockpiles of supply already — of product already. But we’re aggressively working on this because it is a concern when one has this global supply chain that is intermingled throughout the world, including in China.
Rubio: Just as a last point, I think this instance calls to mind that perhaps it’s not the greatest idea for Americans in need of health care to have 80 percent of our active ingredients come from one place in the world where it can potentially serve as strategic leverage at some point in the future, but is vulnerable to this sort of disruption. At a minimum you would agree that this is sort of a wake up call that perhaps we are overly dependent on a supply chain so heavily concentrated in one place in the world?
Azar: It is and has been, and you’ve been at the forefront of calling attention to this issue. The challenge is what the appropriate remedies are for that because if we start dictating where companies make product, that could increase cost, which would increase health care and drug costs in the United States. But we’re happy to work with you and Congress on if there are supply chain management approaches that we should take that are more directive that Congress would want authorized.