Like most other regulatory agencies, the FDA tends to be methodical and slow. However, as the coronavirus crisis sends us into uncharted territory, the FDA has changed its approach. The agency is trying to be adaptive and flexible so they can respond to the COVID-19 outbreak in a timely manner. Here are some ways the FDA is evolving amid the coronavirus upheaval.
A Radically Different Approach
Historically, FDA took an approach to regulation that prioritized the safety of the public, which meant lengthy reviews and in-depth clinical trials. Now, the FDA is taking an action-based approach, allowing companies to respond to market demands and ask for permission later. The FDA is preparing dozens of new regulations and policies to help researchers and life science companies address the pandemic. Just last week, the FDA released nine guidance documents, which is unprecedented. Essentially the FDA has had to put aside their guidelines so companies and laboratories can supply the U.S. healthcare system with the products they need to combat COVID-19.
When the coronavirus originated in Wuhan, strict FDA regulations made it challenging for U.S. companies to prepare for the possibility of an outbreak in the United States. This is part of the reason that when the virus reached the states, there was a critical shortage of tests. Now, the agency is playing catch up, and working to make sure hospitals have the equipment they need to diagnose and treat the virus and to keep their employees safe in the process.
During this crisis, the FDA is giving companies in the life sciences much more flexibility as a way to improve access to critical products like COVID-19 tests, hand sanitizer, and ventilators. For example, the FDA is allowing clinical health labs to manufacture and use their own tests for COVID-19 without needing FDA approval. The FDA has also increased the scope of what type of companies are permitted to make hand sanitizer. In addition, the FDA is allowing companies who manufacture ventilators to make adjustments to these products without any formal regulatory process.
The evolution we’re seeing in the FDA has only just begun. Clinics and life science companies are under more pressure than they have ever been as governors around the nation report concerns that hospital won’t have the products they need to keep patients safe, such as respirators and tests. The agency will likely need to relax regulations even more in the coming weeks or the current crisis will spin even further out of control.
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