Hard to believe, but three quarters of advisory committees in the Center for Drug Evaluation & Research do not have a permanent chair,The In Vivo Blog reports. Using simple math, that’s 12 out of 16 committee chairs. Only four - Anethestic & Life Support Drugs, Pharmaceutical Science, Psychopharmacologic Drugs and Reproductive Health Drugs - have a permanent chair, the blog writes.
And FDA is having a hard time finding committee members. Why? The blog points to new conflict of interest rules, which restrict participation based on financial holdings (see here), and unspecified "downsides" to serving on a committee. What could these be? We prefer not to speculate, but there is an awful lot of politicking that occurs and complaints from anxious drugmakers. And let's not forget the annoying media attention for those high-profile drugs.
In slow times, this may not matter too much, but as the blog points out, there will be more new meds before an advisory committee this year since 2004. This is unlikely to provide much comfort to pharma ceo's who complain about the FDA approval process. Of course, a committee chair is still a high-profile opportunity. So if you're interested, reach out to Janet Woodcock.
9 Comments
Reaching out to Janet Woodcock is a metaphor probably best left alone, but, if called, I will serve.
No chance of that, though.
" Psychopharmacologic"
Gee, I would be happy to serve on this one! :)
I volunteer. No conflicts here. And I do publish alot and got an ISI review as being a leader in my field. And I have been continuously funded in my career as a researcher, I am a physician, and I do psychopharmacology researcher. So contrary to a detractor who wrote on my web site: "The reason there are advisory boards made up of consultants is because those are the researchers & clinicians that are getting involved so to speak. Unlike arrogant ivory tower asses like Dr Bremner who see fit to judge others when he does nothing to drive [the process of drug approval, presumably he would say that they are actually getting involved]."
My response is that I was never invited. Maybe because I was non compliant?
I am not trying to strut my stuff. I am just saying... what gives?
I'd like to ask: why haven't I been invited before?
Well said, Doug. In the unlikely event we are not called to serve, how about creating a 'shadow' Advisory Board when important issues arise?
EXCELLENT idea JiM, I'm On!!!
Great! There are a lot of terrific candidates, more and more every day, including former FDA reviewers as the 'newbies' take over.
Here's my advise - If you agree Janet, I'm here for you. 1. DTC - Don't 2. If you can't stop DTC give the consumer equal time by promoting the DTP (Direct to Pharma)system - A method to rate/rank drugs and devices - by consumers and for consumer/doctor decision making. 2. Split the FDA into two completely unattached entities, one for approval and one for monitoring. Unless preemption become law then you can close down the monitoring half. Big savings! 3. Promote total revamp of the Adverse Event System.
I think I'm OK on the financial holdings qualification but I'm too afraid to look!
Jaynesday - Thank you for your comments. We at the Agency are always interested in hearing from interested citizens. We greatly appreciate your sharing your thoughts, and you can be confident that they will be given thorough and thoughtful attention. Our public health mission depends on listening to concerned Americans like you. Only in this way will we be able to maintain the Agency as the Gold Standard it has always been.
Love, xoxox
J.
Thanks Janet, Glad to hear about your mission. Stay tuned to this site. We often discuss issues that you might want to consider. Feel free to chime in at any time. Please keep us informed about any positive change that our suggestions provide. We look forward to your report. We all depend on a Gold Standard FDA.