BB&T

The FDA is fond of claiming that it sets the “gold standard” for the world in product regulation.

But there’s one problem with this terminology — you need plenty of gold to back it up. And it is becoming increasingly clear that the agency does not have the resources that it needs to do all the things that it is “tasked” (hate that term but probably accurate in this case) with doing.

This is being made obvious by a variety of voices — voices reflecting the views of people formerly with the agency, voices of those who work with the agency and the biggest and loudest voice of all, the media. That voice, through daily articles and editorials, is revealing that the FDA is letting a whole bunch of things fall through the cracks. And those cracks appear to be getting larger by the day.

The most important opinion comes from the industry itself. Recently, at least two organizations have been formed to lobby the FDA’s interest and call for Congress to step up to the fiscal plate and provide the financing required to make sure that the FDA is able to accomplish its various tasks and do them adequately.

This probably isn’t unprecedented. But it certainly is unusual — for industry people to say they want the government to get more money to do its job.

Citizen groups usually are clamoring for a reduction of taxes, a reduction of regulation, a reduction of government, not more money to government for better (well, we hope more is better) regulation.

And the agency’s lack of gold is probably most glaringly shown in its recent attempts to gather information concerning nanotechnology and prepare for the variety of products that will come its way that are either nanotech-based or utilize nanotechnology in some form or fashion. Indications are that the agency has targeted some money for the study of nanotechnology, but that money (if it does exist and exists for this purpose) has produced nothing usable by the industry in terms of a whole range of issues — from testing standards to regulatory guidance.

And this points up the unfortunate fact of the typical governmental bind — having to trumpet what it is doing and what it plans to do, while knowing all along that it doesn’t have the resources to do either really well — an unfortunate by common bureacratic hypocrisy.

In recent months and years the agency has been saying that it wants to gear up for the technological challenges of the future or, to put it more plainly, the ability to figure out if the super-sophisticated products it must evaluate will really work and won’t kill people.

Well, sorry, but we think the agency has done a decidedly poor job in one such area, that of nanotechnology. In particular, it should have been gathering public input on the subject long before October 2006. We think it’s five to 10 years late in doing this and that its current effort is mere verbiage — essentially an attempt to say “Don’t worry, we’re working on this. Not to worry.”

Sorry, guys (and gals), we’re worried.

We’re worried that without the necessary gold to do the necessary work, and to prepare for what becomes necessary, these things can’t be done.

What we are really worried about is that the “gold standard” is very unfortunately looking a bit like fool’s gold. We think that top technology isn’t getting top-level treatment. We think that the agency is in considerable trouble in a variety of ways.

It has no leadership.

Interim leadership isn’t leadership. Andrew von Eschenbach, acting FDA commissioner, can hardly do the necessary work of seeking funds, building confidence and setting standards if he’s only a stand-in. We don’t know anything about his character, but as an “interim,” it doesn’t matter. In the current political climate he is going to be assumed as a ventriloquist’s puppet, the ventriloquist being the current administration and its hip-joined Congress.

The ventriloquism can be glaringly seen in the foot-dragging and half-measure pronouncements concerning the Plan B abortifacient and the clear message it delivers that the FDA can be controlled (not just influenced or pressured, but controlled) by factors other than science. And we don’t even have to mention what those pressures are. Republicans, Democrats, Independents, Greenies, just about everybody would agree what they are, though they’d disagree on the value and result.

Finally, we’re worried that the sad words of Podgo, that famous cartoon possum — “We have met the enemy and he is us” — will prove to be all too accurate.

It is becoming all too thinkable that history will look back at this era and say that bad, or poorly regulated, healthcare products took thousands more lives than terrorism ever did.