Share The Wealth by Chris Gupta
September 01, 2003

Who's regulating the regulators (Part one)?

..."Not only does this change take the FDA into formerly uncharted waters as a regulatory agency (one that's sympathetic to those it seeks to regulate), it also opens the door to untold millions of cases of "drug abuse" of a different stripe."

I loathe admitting when The New York Times gets something right. It makes me feel like part of the establishment crowd when I agree with a piece they've written. But, every once in a while, a clear voice of reason and conscience finds its way into those pages...

And usually, it's echoing something I'VE SAID BEFORE.

Such is the case in a recent article about the Food and Drug Administration's lax (or nonexistent) regulation of false or misleading claims in TV ads for pharmaceuticals. You might remember me spouting off about this in an earlier Daily Dose ("Safety patrol?" 3/25/03). I was lamenting the fact that people assume the FDA stringently regulates drug ads on TV - and that only medicines that are totally safe can be advertised on prime time.

That's just not the case, however. As I mentioned back then, the FDA's "enforcement" practices amount to no more than writing letters to offending drug companies - letters I felt were likely to be completely ignored...

But by the targeted drug companies - not the FDA's OWN LAWYERS!

According to the New York Times, at least part of the problem is behind the doors at the hallowed halls of the FDA (there's a shocker, huh?). In one example given, regulators identified misleading claims in a series of TV ads for the Prevacid antacid drug. Immediately, they drafted a letter of warning to Tap Pharmaceuticals (Prevacid's makers)...

This letter then sat on the FDA chief counsel's desk for TWO AND A HALF MONTHS while millions continued to see the TV spots and ask their docs for prescriptions of the drug. The reason the letter was held up? So that the FDA's lawyers could review whether the letter (or the regulation process itself) infringed on the company's right to promote its products under the first amendment!

That means that the goal of the FDA is no longer to protect the citizens of this country from the potentially harmful effects of drugs and the predatory marketing practices of drug makers. It's to create as tolerant an environment as possible for the promotion of prescription drugs - and to facilitate the ever-increasing tax revenues from sales of these drugs.

This is a pretty scary shift in priorities, isn't it?

Not only does this change take the FDA into formerly uncharted waters as a regulatory agency (one that's sympathetic to those it seeks to regulate), it also opens the door to untold millions of cases of "drug abuse" of a different stripe. More next time...

Daily Dose

August 29, 2003



posted by Chris Gupta on Monday September 1 2003
updated on Saturday September 24 2005

URL of this article:



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