A Question on Risk/Benefit Budgeting

J0342031 It is Friday and I tend to allow myself a little wiggle room on Fridays to wander far and wide, topically.

One of the reasons I’m really ready for Friday is that I attended the Pediatric Advisory Committee meeting this week on Wednesday that considered ADHD labeling.  The meeting had a theme – "Long Day’s Journey into Night".  It began at 7:30 and lasted 11 hours.  If you didn’t have ADHD when it began, you certainly did by time it ended. 

Dr. David Graham, with whom all are familiar, delivered an analysis that examined use of ADHD drugs within a closed system, which is his specialty.  However, during his analysis, he did something that actually made me laugh out loud.  He mentioned that the budgeting for his program for next year would be cut and therefore added something to the effect that he did not know how many of these types of studies would be able to be done in the future.

I’m  no purist, but the purpose of FDA Advisory meetings is supposed to be science.  This did not stop the chair of the committee, who appeared in no hurry to get home, from bringing this matter up before the committee as a topic of discussion, apparently unaware that they do not have Congressional budgetary authority. 

It did, however raise a question for me, and now I finally get to my point.  How much of the FDA budget is earmarked for risk analysis and how much for benefit analysis?  Is the public any more protected if the FDA focuses on exposing risk, or are they actually put at risk if the benefit side of the equation is also well enunciated?

I think some accountability is in order.  After all, the user fees are paying a good portion of the FDA budget.  Does it not seem that industry should know how their dollars are being used, just as Congress likes to know how its money is spent? 

I’m just raising the thought.  Have a good weekend. 

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
This entry was posted in FDA Policy, PDUFA. Bookmark the permalink.

One Response to A Question on Risk/Benefit Budgeting

Comments are closed.