FDA Drug Approvals Require Less Rigorous Evidence, Study Finds (2)

An ongoing push to speed new medicines to patients has led to the growth of new Food and Drug Administration programs with relaxed evidence standards for approving drugs, according to an analysis from researchers at Harvard Medical School and Brigham and Women’s Hospital.

The findings, released Tuesday, mean patients and their doctors may not fully understand the risks and benefits of taking the latest medicines, especially when the majority of newly approved drugs offer “extremely modest benefits” over existing therapies, corresponding author Jonathan J. Darrow said in an interview.

“There’s nothing inherently wrong with faster approval of drugs. It ...