The FDA plays a critical role in our nation’s response to the COVID-19 pandemic. It helps decide which medicines are safe and effective to treat the disease. It evaluates the accuracy and reliability of laboratory tests. And it will play a central role in assessing potential vaccines.
But will the FDA bureaucracy move with the kind of speed necessary to deal with such a crisis? Some critics are concerned it will not. Even before the rush of the pandemic, the Agency was accused of being slow to evaluate drugs; critics also complained that it denied access to life-altering medications for desperately ill patients.
If it were still the 1970s, these criticisms would be well placed. Back then, it took more than three years, on average, for the FDA to review drugs. Review time is now less than one year. Back in the 1970s, it was rare for pharmaceutical companies to obtain expedited review for new medications. Now, these kind of Abbreviated New Drug Applications – or ANDAs – are quite common:
In fact, in 2017, more than 80% of drugs qualified for some kind of expedited review:
If anything, some experts worry that the Agency is moving too quickly, at the behest of industry, to bring drugs to market before the risks are known, followed up by lax oversight of ongoing experience with the drugs. In the face of a global pandemic, that means we risk an already hasty agency being pressured to be even faster.
My guess: The FDA is not too slow to handle this crisis. In fact, the pandemic is serious enough that we should be willing to take more risks than we might in a more typical situation: when there are many alternative treatments for the disease in question or when the disease doesn’t affect many people. In these more typical situations, we might have taken FDA reforms too far, and sped up the process more than is in the best interest of the general public. But in the case of the pandemic, it makes sense to bring drugs and vaccines to market more quickly; it is reasonable to accept a higher risk of side effects than we might otherwise tolerate.
We shouldn’t face the pandemic with an obsolete view of the FDA as an organization that is too slow to handle a crisis. Given the many reforms made to the Agency over the past four decades, perhaps we have the FDA we need right now to take on this new challenge.
Peter Ubel is a physician and behavioral scientist who blogs at his self-titled site, Peter Ubel, and can be reached on Twitter @PeterUbel. He is the author of Critical Decisions: How You and Your Doctor Can Make the Right Medical Choices Together. This article originally appeared in Forbes.
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