Finding Cures Faster: Bring the FDA into the 21st Century with Advanced Testing

In this STAT News op-ed, Dr. Gary Michelson and Dr. Aysha Akhtar share commentary on why drug development must become more advanced in the 21st century without relying on the 83-year-old rule of the Federal Food, Drug, and Cosmetic Act of testing drugs in animals.

By Dr. Gary Michelson and Aysha Akhtar

From every sector, the cry is being raised: “We can’t go back to the way things were before the pandemic.” CEOs and politicians, educators and entrepreneurs, health professionals and scientists, all urge the importance of taking stock, adjusting, and learning. One sector in which this must happen now is drug development, where an 83-year-old rule requiring that drugs be tested in animals impedes the development of life-saving medicines.

The 1938 Federal Food, Drug, and Cosmetic Act requires that every drug be tested on animals — even though more than 90% of drugs found to be safe and effective in animals fail during human clinical trials, and even though safer and more effective methods of drug testing have been developed since then.

If Robert Califf, the new director of the Food and Drug Administration, and a bipartisan group in Congress follow through on their promises, the animal testing requirement could be history.

Read the full op-ed at Stat News.