Expedited FDA Approvals are Now the Norm
[Thursday, July 11, 2019]

Three out of four new drugs approvals by the FDA use expedited approval pathways making faster than normal review by FDA the normal process compared to it being used only for exceptional cases about 10 years ago. Also, more than half of the new drugs approved by the FDA are for life-threatening diseases and unmet medical needs. The use of expedited approval pathways means that compared to conventional products, most of these products did not need to conduct the full battery of tests, clinical and non-clinical, and many used alternative endpoints, such as surrogate endpoints and patient-reported outcomes, for approval. Critics frequently raise doubts about the utility of expedited programs. A recent article in the Wall Street Journal criticized the overuse of expedited approval pathways by the FDA. The debate is fueled by the apparent lack of the effect of the use of expedited approval on the cost of the drugs; most new drugs are priced a heavy premium irrespective of the shorter approval pathways. The article discusses ways to discount the price of drugs approved via expedited approval pathways citing a few examples of post-approval failures. However, the questions have been raised and addressed about the reliability of drugs approved via faster regulatory process. Expedited approval is an important regulatory tool to get faster patient access to new state-of-the-art treatments. Like all processes it has its limitations, but its utility has been demonstrated time and again. So, while a few critics will always find ways to challenge the new norm, it is here to stay. Sponsors should actively pursue a multitude of expedited approval pathways available without fear of a few negative articles in the news.