The FDA Can Only “Fast-Track” Medicine Because It Slow-Tracked It in the First Place

In the midst of the COVID-19 crisis, tens of thousands of people within pharmaceutical companies are working hard on tests, on medicine and methods to save those who are ill, on antiviral drugs and on vaccines. Many of these efforts have been fast-tracked by regulatory bodies such as the FDA. This is all and well. But this is also a good time to ask ourselves why this fast-tracking was necessary. Why are medicine and equipment “slow-tracked” in more normal times? And what are the consequences of the normal procedure compared to what we see with regard to COVID-19?

In late December, at the beginning of the COVID-19 epidemic, the non-crisis, standard slow-tracking process was in effect. It belonged to the CDC to develop tests for the virus and even the CDC needed an “emergency use authorization.” Already available tests from other countries would have required lengthy FDA approval and even when the sense of urgency increased, hospital labs were discouraged from quickly developing their own in-house tests. These