Posted by Michael Wonder on 24 Jul 2024
This gene therapy may not work. So why did the FDA fully approve it?
22 July 2024 - The agency has repeatedly neglected its obligation to ensure that drugs are effective.
The FDA’s mandate regarding prescription drugs is clear: to ensure that drugs approved in the United States are sufficiently safe for patients and effective against the conditions they are intended to treat. While the FDA appropriately employs a flexible approach when evaluating promising drugs for life-threatening diseases, it must not neglect its core obligation to ensure that approved drugs improve or extend patients’ lives.
