It looks like the HHS and FDA is doing what it can right now to appease its critics within and outisde the government. This week, HHS Secretary Mike Leavitt announced that Lester Crawford, the Acting Commissioner, was being nominated as permanent Commissioner of the FDA. That is a great step, as it was necessary to get someone into the position (and, curiously, there were no other names bandied about as competition - makes me wonder why the administration didn't act on it sooner).
The FDA also announced, before 3 days of Congressional hearings, that it was going to implement a new independent Drug Safety Oversight Board. This board is something of a response to the recent scandals about drugs such as the Cox-2 inhibitors, Vioxx and Celebrex.
While it's difficult to deny that a drug safety oversight board is a good thing, it just seems like a redundant stopgap, and my wee bit of advice would be for the powers-that-be to get more non-government, non-pharma scientists on the board as soon as they can. As it stands, everyone on the board is from the FDA or another government agency, so wouldn't most of those folks still have the same interest, in a way?
And isn't it purpose of the FDA to be able to oversee drug safety in the first place? The press release claims that
FDA will enhance the independence of internal deliberations and decisions regarding risk/ benefit analyses and consumer safety by creating an independent Drug Safety Oversight Board (DSB). The DSB will oversee the management of important drug safety issues within the Center for Drug Evaluation and Research (CDER).
So to enhance Group 1's independence, we're going to have Group 2 looking over their shoulders? And how will this work, exactly? Will Group 2 simply look over all the research Group 1 has seen? Stand in on each Group 1 meeting? Make each Group 1 member submit a secret ballot that only Group 2 will see?
I know that the above sounds a bit hysterical, and again, I have no objection to there being more drug safety as we all have friends and family taking medications and we fervently hope those drugs won't harm them. But there just seems to be something very ... immature about this program (by "immature," I simply mean not fully developed, not that it seems childish).
Wouldn't it make more sense to have a task force that hears out all of the complaints, comments and suggestions of the FDA workforce as to how the agency has (seemingly) assumed a culture of pleasing industry rather than protecting human health? This task force would then issue its set of recommendations to Leavitt and Crawford for improving upon the report submission system, the analysis and investigation by the FDA scientists, and the ultimate decision-making for drug approval.
Maybe that is what this new DSB is meant to do, but that's not very clearly stated in the press release and other news stories about it. Only rarely does implementing another layer of government bureaucracy really seem to result in improved health, safety and welfare for its citizens.
This DSB might be a good measure for the very short term, but I hope it's not being hailed within FDA as the cure for what ails it. Putting another board in place to watch over others is an easy bandaid. Commissioner Crawford really needs to bite the bullet and put in place some other measures that may be tougher and be willing to take a hard look at where the FDA is failing and come up with ways to heal it.
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