Monday, June 24, 2013

FDA speed!?

When you have a disease that can take your life away - it can be an awful experience knowing there is a "wonder drug" out there that hasn't been approved yet.  Many patients with CLL are living in that world right now with the coming tidal wave of CLL therapies.

Patients are already asking for "expanded access" protocols for drugs like ibrutinib, idelalisib, and obinituzumab.  In some cases those will be available but in other cases we will need to wait until the drugs are actually approved.

Back in the 80's when HIV was out of control, the outcry for faster action from the FDA was enormous.  Fortunately, they responded.  Now there are several mechanisms that can enable a more rapid approval of effective drugs (fast track, orphan indication, breakthrough therapy).

In our hyperlinked, social media world, new effective drugs can be broadcast by trial participants to chat forums and patients can know about the "next best thing" in near real time.  That undoubtedly makes the FDA feel glacial - but I do believe they are moving considerably more quickly than in the past (post explaining why it takes so long).  Many have asked why drugs cost so much.  I have a post describing that here.

I came across this article and I thought it was a great read.
The FDA's Cancer Czar Says He Can't Approve New Drugs Fast Enough

This article in Forbes (link here) talks about Richard Pazdur and how he has brought speed and efficiency to a government organization (yes it can happen).  While he has his critics, I think we are fortunate in the oncology community to have someone like Dr. Pazdur working to bring drugs forward.    Keep in mind, there are billions of dollars on the line with many FDA decisions.  If you don't think some people are going to be disappointed or complain - perhaps you've never lost several billion dollars.

As an aside - If you read the comments section - you will find out why I have disabled the comment section on my blog - you cannot control some of the nonsense people will write (internet graffiti).  Anyhow, I thought it was a good article.  It actually has some of the ibrutinib history included.

Thanks for reading!