I predict the following verbiage from the just released IOM report on FDA reform will NOT appear in any mainstream media reporting:
“Some observers believe that drug withdrawals (which are only one potential indicator of drug safety) represent de facto failures of the drug safety regulatory system, or that newly identified unusual and serious adverse events indicate that someone made a mistake in approving the drug. This is not so.”
Thank you, IOM, for that very honest, bold, timely, and necessary statement. Sorry Senator Grassley. Can we now assign David Graham to the dustbin of history?
The IOM report makes many comments and suggestions. Herewith a few of my own (ps/ I have added the appropriate report notation for easy referral):
* Needless to say, the single most important recommendation (and the one that must happen if any of the other ones stand a chance of success) is the very last one — “substantially increased resources in both funds and personnel for the FDA.” (7.1)
* I am glad the that IOM has included in their recommendations my idea of a standing FDA advisory committee on communications. I suggested just such a committee at the November 4, 2005 FDA Part 15 hearing. (6.1)
* A comprehensive review of agency-wide risk communication plans? Absolutely. Lack of centralization has led to overlap, inconsistencies and gaps. Paul Seligman should lead such a program — and immediately. (6.2)
* Similarly, a systematic review of adverse event reporting systems. Yup. When it comes to AERS, we cannot and must not allow miscommunication to lead to health-related unintended consequences. (4.1)
* I certainly agree with the IOM that, when it comes to DTC advertising, the FDA must draw bright lines. But I do not see how a “first five years” moratorium on DTC advertising advances public safety, public health, or public knowledge. Same goes for the black triangle. All that does is triangulate on fear and give trial lawyers a wonderful new weapon in their continued quest for greed. (5.1, 5.3)
* A more timely and comprehensive posting of clinical trials on clinicaltrials.gov? Yes. But as to early stage results — that still needs more debate. (4.11)
* More robust and public discussion of post-market study results. Absolutely. (4.13)
* Adcomm members should be as free of professional conflicts as possible? Duh. But we mustn’t scare away the best and the brightest — as would happen under the proposed Enzi/Kennedy legislation. (4.10)
* Adcomm review of all new NMEs? Shouldn’t that be the decision of the professionals at the FDA? Not all NMEs are alike, so why treat them so? Bad idea. A knee-jerk, Grassley-like suggestion. (4.8)
* Include research capacity in the agency’ s mission statement. This would be a terrific idea if the agency had research capacity — which at present it does not. it should. Fund the Critical Path and then amend the mission statement. (4.7)
* Build a CDER informatics capacity? Totally. (4.6)
* Have the agency work with government partners (such as the VA and DoD), drug companies, public and private insurers, health care provider organizations, and consumer groups to plan, organize and fund confirmatory drug safety and efficacy studies of public health importance. A good idea in theory, but the wording is very vague and could easily lead to a fascist regime of so-called “evidence-based medicine.” Do we really want the editors of Consumers Report telling us which dugs are safe and effective? More debate and clarity needed here. (4.3)
* A 6-year term for the Commissioner of the FDA. Yes. Let the person chosen as Commissioner of the FDA serve as free of the political current as possible. (3.1)
The IOM report has good and bad. But a good next step is to carefully consider them all and expeditiously move forward by taking to heart the words of Goethe that appear on the frontpiece of the report:
“Knowing is not enough; we must apply. Willing is not enough; we must do.”
