Tuesday, July 21, 2009

Adverse Event Reporting - Problem, What Problem?

As reported by the Wall Street Journal on 7/20/2009 - GAO: FDA Can't Determine Its Funding Needs "The Food and Drug Administration isn't able to reliably determine how much money it needs to regulate medical products because, among other things, its staff can't track all the adverse-event reports it handles, according to the Government Accountability Office."
(click on the title to access the full article)

Which is the worse problem? Can't track adverse-event reports or Don't know how much my budget should be to do my job adequately. Either way it sounds like a train wreck in the making.


  1. FDA's problem is not its funding needs, but its funding sources. With that rough Half a $Billion coming directly from the industries it is mandated to oversee - on behalf of the consumer - the system is engineered to fail.

    Nobody can be expected to walk past that pile of money day in day out without eventually stopping to salute it, and soon after, being blinded by it.

    The industry User Fees need to be collected by some other branch of Govt and an impenetrable firewall erected between that branch and FDA. Then Congress - who allowed this nonsense in the first place - need to be held responsible for the exclusive funding of FDA.

  2. The FDA's problems in this respect are as old as the FDA itself--way before PDUFA.

    In my view, it is really Congress that has _been_ the problem. They talk a good game. Love to trash the FDA when politically convenient to do so. (And, yes, there are some "bad actors" there.)

    But the primary reason for FDA's problem is that it has been preserved as a dysfunctional agency in these kinds of ways for most of its history. If you have minimal staff, outdated info system, and the several other problems the the Science committee review described, you gurantee these "surprises." And then the folks in Congress and beyond can be "shocked" by it--as though it wasn't their mess to begin with.

  3. In the face of Device AE reports that have increased by 310% in 5 years (588,161 reports in 2008) we have the mighty FDA, the “Gold Standard” of pharmaceutical safety as some have described it, sworn to protect the health of all American citizens.

    An agency that is apparently so inept that it can't even venture a guess as to how much it needs to budget for its operations, that admits it can't begin to investigate all AE's and that doesn’t even have a reliable record to show which AE's it has had time to investigate.

    And yet this is the agency that some would have us believe is the premier regulatory organization, an unchallengeable authority in whose hands we should gladly place our confidence, our safety, even our very lives. Better yet we should even forgo our right to hold pharmaceutical companies responsible for product failures because of the FDA’s undeniable capabilities.

    If this is so then Heaven help us, things are going to get much, much worse before they get better.

    I do agree that we can lay this mess at the feet of our Congress people. They made it, they need to fix it.

  4. I think this is the relevant bit from the WSJ article:

    "FDA told GAO while they place a priority on reviewing serious adverse-event reports, they receive "substantially" more adverse-event reports than staff can review. The FDA said the adverse-event reporting systems don't allow agency to track whether individual reports have been reviewed."

    The question becomes whether the problem is ineptitude or staff shortage and AE reporting systems that don't have tracking built into them (as is not the case in some other countries FDA equivalents).

    If the FDA can't keep up with the reports coming in--because of out-dated record-keeping systems and not enough people--it is not surprising that they don't know precisely how _far_ behind they are. It's like asking an exhausted person to run a marathon and, during the race, asking them how much sleep they would have needed to run faster.

    But this is, indeed, the "gold standard" that preemptors would like to be the last word. That is the logic of regulatory capture. First, cripple (or keep crippled) an agency. Then, canonize it.

  5. We have to ask respectfully (no insult intended in any way)- How do we know that your website is not funded by the same abusive industries? It is similar ti the 'plot get thicker' situation.
    we actually hate & dislike all this mindless for profit "products" and forgetting our NATURAL life.
    We are mostly sorry for the innocent children of the whole world.
    We hope it is the children who will blow the whistle on their fathers who abuse the world with their "industries".
    May God give them the strength, wisdom and courage (or "condition") to be the whistleblower for their own goodness, salvation and martyrdom to save the rest of us.
    We think it is the "industries" that encourage "aetheism" because TRUE religion speaks of "natural" living and fearlessness towards controlling humans and fear of only God who is kind and punish ONLY the evil.
    The gay issue & God I have no answer.
    Why are gays "increasing" w/ INDUSTRIALIZATION?
    Is it good people stressed to their max because they are not killers like most of us? Then it is the BAD society who made Gays.
    We believe gay people are the good people who reacted by changing their own psyche to this CRUERAL world while people like G.W. Bush - fake POPE Christians KILL people.
    The corporate lords changed the Bible long time ago with the help of Roman Pagans. They killed Christ & put a fake religion in it's place to profit the Devil. What a loss.
    Thank You.
    FYI- We do have three PhD's among us- just in case you think we sound loons.


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