Thursday, March 22, 2007

FDA Advisor Rule Loophole?

Yesterday, the FDA proposed a $50,000 limit on financial ties to industry of its advisory board members (see "FDA Proposes New, Tougher Procedures for Membership on Advisory Committees").

But, as anyone can clearly see in the following "Algorithm for Considering Advisory Committee Member Participation," there is a BIG loophole (outlined in red):

Click for an Enlarged View (Can you see me now?)

Still can't read it? [I certainly hope the folks at FDA have a wall-chart version of this algorithm.]

It says, "If the individual is an SGE, does the need for the individual's services outweigh the potential for conflict of interest?" If so, Pass Go and Collect your ticket to come on board!

OK, to be fair, there are only a very few qualified physicians among the 500,000 or so out there that would be willing to serve on FDA advisory committees. I'm sure the pay is not great. Therefore, FDA needs this lopphole. Right? [BTW, maybe if the pay was higher FDA might be able to close this loophole and simplify the algorithm.]

We can argue whether or not $50,000 is still a lot of money -- I think it is -- but at least the new proposed guidelines eliminate the much-criticized 2000 Waiver Criteria. Under those criteria, "the dollar value of the disqualifying financial interest including its value in relationship to the individual's overall assets" could be considered when granting a waiver. That was a pretty big loophole. $50,000 easily may represent only 1-2% of a successful physician's assets.

1 comment:

  1. Fromy my perspective, here's my problem with the whole conflict of interest issue--are there enough leading physicians out there to staff the FDA Advisory Committee model with absolutely no conflicts of interest? I seriously doubt it.

    Do you want Dr. Bob who has never done research to be the guy reviewing the data? Or do you want Dr. Jane who has done trials for 2 or 3 different companies? I would argue Dr. Jane because she's been there and would know the questions to ask. If a doctor does research with only 1 company, I could understand the potential for bias argument. But what if she does research with multiple companies? Does that reduce the bias? How does she help/hurt one without hurting/helping the others?

    Out of context, it sounds like $50,000 is a lot of money and that conflicts should be banned. In real life, I don't think there are enough top-notch research physicians without any industry ties to put together an advisory panel to ask the penetrating questions and manage the data review.

    ReplyDelete