Here's a piece from Pharmalot blog that discusses whether the increased speed of FDA approvals is perhaps harmful. I read this post as it is a topic that I've frequently wondered about the past couple years. It seems like every other day there is an announcement for a company that has a new drug on an expedited FDA review path for an "unmet medical need" -- so much so that the club doesn't seem that exclusive. The post indicates that in 2012 that more than half the drugs approved by FDA actually went by an expedited path.
This article concerns a recent review of a cohort of 20 drugs FDA approved in 2008. It discusses the findings and what the possible implications might be as a result. So what did we find?
- Efficacy testing on expedited review drugs versus "normal" path drugs was performed on only 1/5 the number (median) of patients for the expedited set (104 vs. 580 patients)
- Expedited review drugs spent a median time of 7.7 months under review versus 13.2 months for normals. Duh? Isn't expedited review by definition shorter?
- The number of patients exposed to the drugs during testing was much lower for expedited review versus normals (median 626 vs. 2133)
Moreover, drugs are supposed to go through post-marketing studies. Data shows for these 20 drugs, that of the 85 studies planned, only 26 were completed by Jan 2013, and another 8 were submitted for review. That means 60% of the studies have yet to be completed or submitted. Critics worry that this sets the stage for safey problems to emerge. However, this article doesn't present any known problems with this particular cohort of 20 drugs. Maybe there is a latent problem but it hasn't emerged yet in recognizable form.
Proponents of expedited review presumably are happy that new drugs are getting through FDA faster. There has been constant harping in the past decade by pharma and investors that the review process is too long and unpredictable. This of course has been aggravated by issues like "patent cliffs" and unproductive R&D departments. Now that this seems to be mitigating, we have those worried more about safety raising their concerns about the pendulum swinging too far. So your position likely has to do with your political leanings, commercial interests and tolerance for risk?
The question seems to be do we need to put in more safeguards now before a problem develops? Or do we wait to put in safeguards quickly once we spot an issue? That's the conundrum that has presented itself. Which side do you land on?
Posted by Bruce Lehr Oct 29th 2013.