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. 

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1 Response to A Question on Risk/Benefit Budgeting

  1. What do you think about the draft legislation “Safe Compounding Act of 2007” by Kennedy, Burr, Robertson?
    Apparently, they are going to try to piggyback this travesty on to PDUFA-IV.
    It has the potential to federalize pharmacy and prevent patients from receiving life-saving compounded preparations. It may open the doors for limiting doctors ability to prescribe for “off-label use”.
    The FDA has no business inspecting pharmacies. This is a States Boards of Pharmacy function. The FDA’s charter is to regulate MANUFACTURING. Their “Post- Marketing Surveillance” has been dismal (witness Zelnorm this week and Vioxx, Prozac for teenagers, OTC decongestant use in infants before that … the list is endless.)
    I worked as a Drug Information Specialist at the FDA in Rockville in the mid-70’s and it was disfunctional THEN (2 hr. martini lunches, lost files so I could not review adverse drug events and delinquent labeling changes). There was a revolving door then.
    Now the revolving door involves Senators. It only got worse with PDUFA.

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