*This post was originally posted on the Context Matters blog*
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There has been a lot of discussion recently about the FDA's new "Breakthrough Therapy" designation. According to the FDA, this designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.
The concept of a "fast lane" or priority status is not new; the FDA has had three other programs in place for at least 20 years: Fast Track, Accelerated Approval, and Priority Review. The specifics for these are all different, but the underlying goal is to help ensure that therapies for serious conditions are reviewed and available as soon as possible. To qualify as a "Breakthrough Therapy," the FDA requires preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over an available therapy.
Bringing life-saving drugs to market faster is certainly a noble and important goal, but when you start to sift through the data around these priority lanes, is that what's really happening? We thought it would be interesting to look at some preliminary "Breakthrough Math" to see if life in the fast lane has actually made a difference in the speed and process of bringing drugs to market.
The FDA created the "Priority Review" status in 1992. Based on our preliminary analysis, in 2008 the average cycle time for "Priority" was 11.4 months, versus the "Standard" which was 21.0 months. In 2011, the average cycle time for "Priority" was 16.8 months, versus "Standard" which was 18.9 months. Interestingly enough, it appears that this fast lane has actually decreased in speed over time, with the cycle time increasing significantly from 2008 to 2011.
The European Medicines Agency (EMA), has taken a different approach: rather than creating different lanes of traffic, they have actually worked on improving the overall infrastructure of their "lanes". They don't distinguish between slow and fast lanes, yet seem to retain a faster overall speed as a whole: averaging a cycle time of only 3.5 months throughout the year in 2012.
So which one is the right approach? An analogy here is that in the U.S., we create fast lanes for high speed railcars, but don't actually invest in significantly improving our tracks and infrastructure. The data illustrates that though the fast lane may help in the short term, over the long term it starts to bog down and revert back to the standard speed. In Europe, it seems the investment in the overall infrastructure enables all of their trains to run at an optimal speed.
However, the "Breakthrough Therapy" designation is less than a year old, and it remains to be seen if it will encounter the same issues as the "Priority" designation. We will be tracking and comparing the cycle time data over the coming months to update this story and see how things evolve.