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Re: Drug costs

I can't disagree with you that FDA drug-approval costs too much.

You're probably philosophically inclined to advocate privatizing drug testing...but after the sorry record in the analogous field of corporate accounting, I wouldn't trust a drug certified as safe and efficacious by a lab hired by the drug company. I want a (theoretically) neutral third party to test the drugs.

You've given me an idea, though not necessarily one you'll approve of. What if the FDA brought the clinical trials and testing in-house, instead of setting standards for external testing and requiring a huge pile of paperwork to attest to compliance with standards? In return for relief from that cost, the drug companies would agree to donate a percentage of future production runs to a designated aid agency for distribution to the needy inside and outside of America.

Oddly enough, this might actually reduce total cost. Seems logical that much of the cost in the present process is the requirement for "meta" paperwork to support the results, that is, to demonstrate that testing was performed as required and that drug company personnel followed all the procedures, instruments were calibrated recently, and on and on. Paperwork increases when information has to cross organizational boundaries, because direct accountability and reporting is lacking; additional paperwork provides context not required for in-house efforts.

Just a thought. Other than philosophical objections, what's wrong with the idea?

--Robert

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