The NIH could start using this authority immediately to put itself at the center of a multifront campaign to develop effective treatments for COVID-19. No one would be compelled to participate, but it could offer major benefits for academic and corporate partners—and there is reason to think both would eagerly welcome the help.
What the NIH will require from Congress to do this, however, is money. Although it has a lot of flexibility to create a new framework for coordination, moving appropriated money around to enable the work to proceed isn’t quite so easy to do on the fly.
Annie Lowrey: Where is the government?
The NIH can start with the limited funding flexibility it has. But when Congress returns for further emergency legislation later this month, it needs to prioritize a meaningful infusion of cash—nothing near the scale of the economic relief it has undertaken, but in the billions, and if the effort is also to include support for vaccine work, maybe in the tens of billions—to the NIH for this purpose. And legislators should consult with the agency’s leadership to see whether any additional legal authorities are required for the work to proceed swiftly.
Second, work toward effective treatments requires the active cooperation and total commitment of the Food and Drug Administration. There is no getting around the fact that the FDA slowed the process of making tests available to Americans, wasting precious time and impeding containment efforts. The agency knows this, and is eager to do better. But it still lacks the necessary urgency to avoid slowing down efforts to develop treatments.
The FDA is responsible for a wide array of biomedical responses to the coronavirus—including not only potential treatments but also diagnostics, laboratory accreditation, medical- and safety-equipment certification, various importation procedures, and much else. All of these are important. But the agency needs to focus special resources and attention on potential treatment paths, separating these from its normal approval work and implementing new procedures to collaborate closely with manufacturers at every step.
One model here, as Gottlieb has suggested, could be the agency’s “Real-Time Oncology Review” process, in which the FDA reviews clinical-trial data for promising drugs for particularly deadly cancers as results become available, rather than only after the entire trial has concluded. This can speed the process quite a bit, and a similar procedure with COVID-19 treatment trials is clearly in order.
Read: Why does the president keep pushing a malaria drug?
But the degree of urgency and focus must be even greater than the FDA’s most accelerated processes today. We are in the midst of a global pandemic that threatens countless lives, and our response to it threatens economic ruin. An effective drug for those who are most endangered would dramatically alter these circumstances. The FDA should treat its role in facilitating our response to this disaster as the single most important task it has confronted in its history. And enabling the rapid development of a safe and effective treatment must be at the top of its agenda.