What Will the Next PDUFA Look Like?

J0321180 There is an interesting conundrum developing.  PDUFA – the legislation that allows for the collection of fees from the pharmaceutical industry to be applied to the FDA budget – is up for debate and reauthorization in 2007.  The elections will be over, so there won’t be so many distractions.  Of course, elections are the year after, so who knows?

But, according to reports, there is going to be a push to increase PDUFA fees to cover post-marketing surveillance.  Already PDUFA fees are comprising a huge portion of the FDA budget.  This is perhaps not what PDUFA architects originally envisioned and during discussions of reauthorization, Congressional critics are likely to make that known. 

So for critics, this is a source of discomfort – to have the agency overseeing compliance receiving funding from the industry it is regulating.  It would appear a conflict of interest to some, though actually that has only been conjecture and no one has offered any evidence that that is actually the case.  I wish they would put up or shut up on this front, but it is not likely, particularly for those with the bully pulpit of a Senate seat.

But that is the conundrum for the FDA.  Even without the other side producing evidence, after all, a charge unanswered is a charge admitted.  How does the agency demonstrate that, by collecting more funds from industry, it is better positioned to protect public health?  It is an interesting question and one which, if the agency is going to seek these funds, the agency had better well address as they ask for them. 

J0309029To pretend that the question doesn’t exist, does not do the agency any good, just like it does it no good to pretend that the Plan B fiasco is not political, which they continue to do despite the fact that it is detrimental to their greater cause.  But to proceed to ask for funds without addressing the question of conflict of interest naturally opens the way for an opportunity for critics, even without a preponderance of evidence on their side, to prevail.  The agency does not appear particularly thoughtful in organizing their messaging, but they should get their ducks in a row on this one.

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