The FDA medical device review mechanism has come under fire from many quarters for some time now, but one of the criticisms of the 510(k) and PMA programs is that the reviews are funded by user fees, a claim that can be made of pharmaceuticals, biotech and now even FDA’s overview of food production. Opponents can complain all they want about user fees, but what can they do about them?
As has been widely reported, the Obama administration has proposed that FDA’s total budget for FY 2013 would rise by double-digit percentages, but 98% of that increase comes from user fees. Call me a cynic, but I have a tough time believing that Congress will be able to keep its hands off that last 2% – or more – of appropriated monies in an effort to get a handle on the amazingly large U.S. federal budget deficit. That’s an understandable move in the current climate, but past congresses and presidents don’t have that fig leaf to explain their lassitude where the FDA budget is concerned.
So opponents of user fees currently face a fairly immovable budgetary object, but it won’t always be that way (we hope). This raises the question, however, of why the expression of these adversarial views has had no effect. After all, it's not just outside groups who don’t like user fees. Industry doesn’t rant about them but device makers can’t be fond of them, especially the smaller firms with limited financial resources.
One way of looking at this is that nothing gets the attention of the folks on Capitol Hill like a call from a constituent. And nothing lights a fire under their behinds faster than multiple calls from constituents on a particular matter. Would that work for user fees?
I’m not claiming that outrage from the heartland would necessarily put an end to user fees, but it’s tough to see how they could be eliminated without such an outcry. And the thing I find most conspicuous about this discussion is how it always involves the same message delivered by the same faces living in the same zip codes. The conversation is all inside the Beltway.
Like it or not, Congress won’t end user fees unless someone tries to get the citizenry involved, but ask yourself this: When was the last time you heard someone with the necessary credibility (or bankroll) propose “taking it to the people”? The Alliance for a Stronger FDA is probably the best hope for such an undertaking, but I doubt seriously its member organizations are prepared to fork over the cash needed for such an effort, and the Alliance might not be interested in fighting that fight in the first place.
Ergo, we can only conclude that the effort will not be undertaken, and therefore FDA user fees are the necessary evil with which we must all live. So get over it already.