The COVID-19 pandemic offers important insights for dealing with the next pandemic, according to a new book chapter co-authored by Professor Nicholson Price.
COVID-19 and the Law: Disruption, Impact and Legacy
COVID-19 and the Law: Disruption, Impact and Legacy (Cambridge University Press, 2023) addresses a number of legal aspects of the pandemic. Price and his collaborators specifically examine how innovation law worked—and failed to work—in applying new health care technologies, and how the system can improve in the future.
The chapter—which Price wrote with Rachel E. Sachs of Washington University, Lisa Larrimore Ouellette of Stanford University, and Jacob S. Sherkow of the University of Illinois—grew out of a series of regular posts on a blog run by Ouellette about innovation and patent law. Price recently answered five questions about the issues raised in the book:
1. The chapter that you co-authored clearly shows that the lack of interagency coordination at the federal level had quite a negative impact on the fight against COVID-19. What specifically were the issues?
At the beginning, there just wasn't much coordination in terms of testing, in particular. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) should have been thinking about how to do testing in a robust and coordinated way. But instead, the CDC developed its own diagnostic kit and the FDA's emergency authorization was not very coordinated.
There was even an incident where the CDC blocked an FDA official from visiting the agency to resolve issues around testing, which is just bonkers. They said it was a scheduling misunderstanding, but there shouldn't be schedule misunderstandings in something like this. This should be “all hands on deck,” and that doesn't just mean all hands on deck doing whatever they think is the right thing to do. That means all hands on deck talking to each other and working to move the ship in the right direction. And it turns out that wasn't happening.
2. How can this be avoided in the future?
Unsurprisingly, the answer to this is we need more robust coordination. We might think about Congress requiring collaboration. There is a requirement that exists now for the National Institutes of Health to report annually about its collaboration between agencies; Congress could require more such reporting to signal that collaboration is a priority, generally.
Otherwise, these agencies—the CDC, the FDA, and the Centers for Medicare and Medicaid Services—are all subunits of the US Department of Health and Human Services. They all answer to the same secretary. So there is also effort that can be made at a department level to require collaboration.
3. Another issue that your chapter discusses is the tension between allowing experimental treatments and demanding evidence that they work. How do we strike that balance correctly?
This is a perennial tension in the development of new medical technologies. Patients clamor for access to new technology, while on the other hand, we want to know that this stuff works—but it's hard to figure out whether it works, and often it takes quite a while.
In the context of emergencies, we essentially decide that we're going to swing that balance to allow access: We promote access earlier when we don't have as much data but think it's more likely than not that it's going to work and are convinced that it’s safe to use. Honestly, that makes a lot of sense.
Sometimes this worked really well. We had the controversial approval of hydroxychloroquine, which was based on some evidence, though not a lot. But the more robust, ongoing clinical trials ultimately concluded, no, it doesn't work. So the FDA pulled the emergency use authorization.
On the other hand, convalescent plasma blood products from people who had already had COVID and recovered looked like they might work, so we started giving them. But it was in the context of clinical trials scattered in lots of different places without coordination. We didn’t do a good job of actually figuring out the real evidence.
In the future, to the extent that we're going to allow access to medicines early, we need to pair that access with robust data. If we have limited access to a treatment, we should randomize within those limitations, so that we're actually doing clinical trials and we'll know if the treatment works. We’ve got to coordinate, to make sure we have long-term data on outcomes, so that six months later we're not operating with the same relatively thin evidence.
4. On the positive side, Operation Warp Speed was surprisingly successful in developing effective vaccines, yet getting the vaccines distributed was another area where the system fell short. What can we learn from the vaccine experience?
How quickly the vaccine was developed seemed like an astonishing bright spot in the pandemic. It was utterly remarkable and a demonstration of how to put lots of different innovation actors to work in a coordinated and effective way: Let's make sure we clear the path. Let's give grants for early scientific-stage research. Let's give advance-purchase commitments to make sure that companies are scaling up manufacturing early because they know there's going to be demand. It was an impressive coordinated policy effort to drive innovation forward.
Then that policy coordination, that focus, seemed to disappear once we had vaccines available. We knew that initial supplies were going to be limited. We knew that distribution would require a wide range of venues to reach people. We knew there were going to be concerns about who could get access. Yet there just didn’t seem to be focus on how to get shots in arms. It got politicized in a crazy way, with an apparent lack of focus on policy effort or coordination, which is kind of stunning.
So what do we do instead? First off, we should continue to invest in research and development. Then we should try to figure out what works in terms of vaccine distribution. Right now we recognize that politicization is something that matters in a way that I don't think we did five years ago. I don't know exactly how we come back from that, but public health overall is under-researched and under-studied in the US and elsewhere. A key aspect of public health is how you ensure uptake of interventions. When we have a remarkably effective intervention like this, devoting even a fraction of our resources to getting it into use would potentially have huge payoffs.
5. Are there any other important lessons or takeaways from the whole pandemic experience?
There's a really interesting line of argument that goes something like, “Drug companies are making way too much money off of vaccines. We should make this public. They shouldn't be making any money off of this.”
I understand the impulse, especially since companies had a lot of government support early on, but I think it's deeply misguided for two reasons. One reason is considering how much the pandemic was costing at its height every day. If the companies made the vaccines available a month earlier or a week earlier or even a day earlier than they would otherwise have been, overall, it's a huge bargain in terms of lives and the economy.
The second reason is what we saw happen when the pandemic hit: A substantial number of big companies rushed into this space to make a boatload of money, and they devoted a huge number of resources. Frankly, that's what we want them to do. We want them to jump in. And the way we've structured drug development, the way to make them jump in is to make sure that if their product works, they'll get a giant pot of money at the end.