Map of life expectancy at birth from Global Education Project.

Wednesday, June 14, 2006

Our enemies never stop thinking about new ways to harm our country and our people, and neither do we

Jerry Avorn and William Shrank, in NEJM (and yup, it really is off limits to rabble this time) break another story that your liberal media has once again expended vast resources to utterly ignore.

In a nutshell, the FDA, purporting to fix the incomprehensible and largely feckless so-called "drug labels" (actually those full pages of tiny print that are stuffed into the box, and generally tossed by the pharmacist before the drug gets to you), has promulgated regulations which don't actually do that. However, following the close of public comments, the ever vigilant guardians of the public welfare inserted a paragraph which states that the FDA-approved label, "wheter it be in the old or new format, preempts . . . decisions of a court for purposes of product liabliity litigation." What this means is that it will be essentially impossible for anybody who is injured by drugs to sue the manufacturer. The only way around this would be to prove that the company had intentionally committed fraud in getting the label approved -- something nearly impossible to do.

What happens in practice is that data on the so-called "label" on risks of drugs lag several years behind the known facts. This doesn't require fraud on the part of the manufacturers, just foot-dragging combined with inefficiency and indifference on the part of the FDA. So even if side effects and counterindications aren't on the label, and you are harmed by the drug, you have no legal recourse.

By the way, the industry has been trying to get legislation passed that will accomplish this for years. They have not been able to get Congress to go along. But who needs democracy, when you have a Decider?

You can read about the new regulations here, on the FDA web site. Funny thing, though, the public summary doesn't mention this minor element of the new regs.

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