Slowing release of cancer drugs
Dr. Gottlieb writes about the FDA's new way of evaluating drugs for accelerated approval:
- Delaying new treatments for the sake of generating more rigorous and complete medical evidence helps patients--to a point. But in the field of cancer, where practicing oncologists already do a very good job of developing their own medical evidence and prescribe new medicines based on the results of these scientific studies, the FDA's strict posture is probably overkill.
Delays make drug development more expensive by closing the market to small biotech firms with good ideas and delaying new drugs from getting to dying patients. The FDA is trying to save patients from the harmful effects of new medicines that have not fully proved their mettle, but in the process, many more patients will die from the extended wait for the good medicines than from using bad ones.