DEC 29, 2022 11:00 AM PST

FDA Modernization Act's Impact on Drug Development

WRITTEN BY: Greta Anne

The FDA Modernization Act 2.0 was unanimously passed through the United States Senate on September 29, 2022, and officially passed through the United States House of Representatives on December 23, 2022. It is a bipartisan bill, which both the Republican Party and Democratic Party sponsor. 

The FDA Modernization Act 2.0 removes a mandatory requirement from the original Food, Drug, and Cosmetic Act of 1938 (FDCA) that mandates animal testing to ensure it will not be toxic. The Food, Drug, and Cosmetic Act of 1938 was originally passed in response to the sulfanilamide tragedy of 1937, where sulfanilamide was one of the first antibiotics in the class of “sulfa” drugs. Essentially, the pills were intolerable for patients and ended up causing damage to the their blood, kidneys, nervous system, and liver. This pressure caused the FDCA to get passed rapidly. 

The original act held clauses mandating animal testing, which resulted in the killing of countless animals around the world to further drug development. There have even been data that shows that animal testing may not be a great indicator of drug toxicity. With how developed human biology science is, animal testing may not even be necessary in many cases now. 

“I was a veterinarian, and any testing that can be done without the use of our four-footed animal friends, I think is to our advantage and certainly to their advantage… Precision medicine by using tissue cultures and some of the advanced techniques that I think we’re looking at here in the 21st Century is pretty exciting” claimed Representative Kurt Schrader of Oregon.

This bill introduced $5 million USD to support an alternative methods program to reduce animal testing. 

The FDA Modernization Act 2.0 is a great step forward to amend laws that are 83+ years old and no longer applicable, considering the technologies available to us in this day and age. As science advances, the laws governing it must also. This new act is an indicator that we are moving in the right direction.



W. Stork, “Prontosil,” Chem. Eng. News, 2005, 83(25), 102. Much of this issue was devoted to “top pharmaceuticals.” 22. 

A. A. Daemmrich and M. E. Bowden, “A Rising Drug Industry,” Chem. Eng. News, 2005, 83(25), 27-42.

About the Author
Doctor of Pharmacy (PharmD)
Greta holds her PharmD and is a writer at Labroots. She also has a strong background in neuroscience & psychology. When she is not working as a pharmacist or a writer, she enjoys fostering her creative initiatives such as traveling, working out, spending time at the beach, and cooking!
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