Is FDA’s Expedited Approval Programs Leading to Bad Drugs  
[Posted on: Thursday, October 1, 2015]

Two articles in the British Medical Journal this week raise questions about the utility of FDA’s expedited approval programs such as breakthrough therapies and fast-track designations. The articles challenge if in its efforts to approve drugs fast, FDA is being lax in its safety and effectiveness analysis prior to approval. It is obvious from the review that FDA’s safety reviews were quite good in that no drugs were withdrawn from the market for safety reasons. However, the effectiveness of several drugs approved by FDA under the expedited programs was questionable many times. Also, some programs were overused in the opinion of the authors. For example, at the time of release of the breakthrough designation pathway, FDA projected 2-4 applications per year, but it received more than 250 applications in less than 2 years, granted 68 of the designations and approved 12 products under the breakthrough designation, 4 of them for chronic lymphocytic leukemia. While one can argue that these pathways have lead to more options to patients, the risk of approving ineffective treatments could negate the utility of the expedited programs. It seems there is no win for FDA; it was accused till not so long ago to be slow in approving drugs and lagging behind Europe in approval rates. Now that FDA has addressed that issue very well, questions are being raised if it has overdone its job. As we discussed before, we do not believe FDA is being fairly criticized. The authors are trying to make too much from a raw data analysis without taking into consideration the overall FDA review process. There is no argument that FDA has the resources and capabilities to do things fast and accurate.