Priority reviews: innovation and safety

In the CMAJ news story about the anticorruption symposium held in Toronto, Dr. Supriya Sharma, chief medical officer at Health Canada, said that the expedited 180-day priority review is justified. Her position was that, even though these drugs have more safety problems once they reach the market, it is an acceptable trade-off because they offer major benefits.1 However, that assertion is simply not true for the most part.

First, Health Canada gave a priority review to one-quarter of all the new drugs approved between 1997 and 2012, but fewer than one in six actually offered a major new therapeutic improvement.2 Second, Health Canada is not able to predict accurately which drugs should get a priority review. Out of 91 products that got such a review, only 33 were actually major therapeutic innovations.2

The bottom line is that faster drug reviews lead to more safety problems3 but only occasionally to getting really useful drugs to market more quickly.