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Who Died Of FDA?
Jul 10, 2012
How many people got HIV because the FDA didn't even want to consider approving a home test for the deadly virus? That's the question Roger Parloff over at Fortune raises now that the FDA has approved one:
And even if the FDA's ban on considering home testing kits might have been defensible in 1988, it became less so as each year passed—as drugs become available to treat AIDS, as fears became less hysterical, and as political opposition abated and, in many cases, morphed into support. Yet the years did pass—17 of them—before the FDA in 2005 effectively lifted its ban and started considering applications for HIV home testing kits. It then took another seven years for the OraQuick test to wend its way to the approval finish line—the journey it completed last week.
To be sure, the statistics suggesting that OraQuick might avert more than 4,000 HIV infections in its first year are squishy. It could be less. It might be more.
I doubt it will be zero.
Parloff is discussing the FDA's especially tough treatment of home HIV tests, but every drug and device that is kept off the market pending FDA approval is a drug or device that isn't available for people to use to preserve their lives and well-being. And, of course, it's a drug or device whose creators can't sell it and thereby advance their lives and well-being.
To an extent, the same is true when drugs that are on the market can't be promoted for all the uses for which they are suitable. People who don't find out about them don't know to use them -- and this costs the producers sales and the would-be users the benefits the drugs could bring them. Except, of course, to the extent the producers market them anyway -- and risk huge fines.
H/T Walter Olson's Overlawyered.