Is FDA Too Slow to Deal With a Pandemic?
[Thursday, April 9, 2020]

In the last two months, FDA has announced, proposed, and implemented several measures to address the ongoing pandemic, but questions are being raised about the perceived slow speed at which FDA acts in an emergency. There have been complaints of FDA taking too long to authorize diagnostic tests and making decisions on the Emergency Use Authorizations (EUA), or allowing trials to proceed, and approving therapeutics. These complaints come from frustrated executives expecting FDA to jump on every proposal, some from politicians looking to show positive news to their constituents, and the public seeing increasingly depressing news about the spread of the infections and the mounting numbers of the dead. Some of it is true. FDA is bound by strict laws and always worried about creating precedence. FDA traditionally is a conservative organization that is built on the philosophy of protecting injury to everyone, even if it is at the cost of delayed therapies for others. In times of emergency when everyone is looking to cut the administrative process and make all options available to patients, no matter how far-fetched or frivolous, FDA sees itself as the only organization protecting the public from short-term pain and long-term consequences. FDA still asks for critical data elements to support claims, lacking which it delays if not outrightly deny. Yes, political pressure from an administration and political appointees can push FDA to make questionable decisions, such as that of the authorization of chloroquine for COVID-19, but a careful read of the decision shows a cautious FDA trying to limit the impact of the decision so as to avoid others using this as a precedence for future decisions. Similarly, of the more than 270 diagnostic test providers selling the tests after notifying FDA of their intent to file an EUA under the special policy for COVID-19, only 31 have received the EUA, one for a serological test, and rest have a disclaimer that their test has not been approved by FDA and their results must be confirmed by other FDA-authorized tests. FDA’s speed although slower for most people’s liking is measured. The decisions are and should be based on the quality of data. While the knee-jerk reaction to an emergency is to throw away the rulebooks, common sense requires the FDA to do its job. At the same time, FDA could be more transparent and probably have faster turnaround. The fact that the Agency was not as well prepared to handle the numerous emergency applications shows its lack of preparedness for the emergency. The public expects a better prepared Agency that can do its job quickly in an emergency and that should not be a tall order as it has been made to look by the FDA.