The F.D.A. Is in Trouble. Here’s How to Fix It

There is a deep tension between groups that want medical products to be proved safe and effective before they are made widely available and those that say that as long as those products pass a bare minimum of safety testing, patients should be able to decide for themselves. “The F.D.A. has been moving in the latter direction under great political and public pressure,” says Dr. Steven Joffe, a bioethicist at the University of Pennsylvania. If that trend continues, the nation may end up with a regulatory agency that’s powerless to make any meaningful regulations.

For all its faults and failures, the F.D.A. has traditionally done a great deal to balance access to innovations with protection from danger or fraud. To maintain that balance, the agency needs to be made stronger, not weaker.