The "word" is that FDA wants to delay progressive approval by defining clinical benefit on a case by case basis and by front loading Phase I with all sorts of endpoints and metrics that it would be tantamount to going through all the hoops. The point of the Critical Path initiative was to increase certainty and reduce the need for extensive human experimentation. Instead, patients and doctors would tell innovators and the FDA how treatments are working in the real world.
The FDA would have a hand in writing regulations and guidances for accelerated approval. But it seems to me that the agency should not be the one to determine clinical benefit especially when the scientific community and patients can do that. It should just verify that products are doing what they were designed to do. The pushback on progressive approval suggests that legislative action may be required to truly bring the FDA into the 21st century.
The FDA would have a hand in writing regulations and guidances for accelerated approval. But it seems to me that the agency should not be the one to determine clinical benefit especially when the scientific community and patients can do that. It should just verify that products are doing what they were designed to do. The pushback on progressive approval suggests that legislative action may be required to truly bring the FDA into the 21st century.
