The FDA is now fast-tracking new drug approvals — why that’s so worrying
Key Excerpts from Article on Website of New York Post
Posted: October 16th, 2023
The Food and Drug Administration is now regularly approving new drugs after just one or two clinical trials — a significant departure from the more rigorous vetting process the agency was previously known for, newly published research reveals. Furthermore, the authors say, there’s now less information available to the public about the results of all trials. Of the 37 drugs approved by the FDA last year, 24 (about 65%) were approved based on just one study, according to a paper published in JAMA Network Open. Only four of those 37 drugs, or about 11%, reported three or more studies before approval. Another piece of new research, published in Health Affairs Scholar, found that of the 46 new drugs approved in 2017, 19 of them (41%) were approved based on a single study — though the drugmakers conducted an average of 2.2 studies per drug, including 165 studies for the popular weight-loss drug Ozempic. The ease with which novel drugs are approved is in part the result of the 21st Century Cures Act, passed in 2016 to speed the approval of new medicines so patients could gain access to life-saving treatments. As part of that law, the FDA relaxed some standards to allow treatments for priority health conditions such as cancer to be approved with fewer supporting studies, and with less emphasis on randomized clinical trials. But in the years following the passage of the 21st Century Cures Act, the FDA has faced a firestorm of criticism over the approval process for some new drugs.