Alex and the FDA in Forbes

This week’s Forbes (the Nov. 1 issue) has a feature story on Alex’s work to make drug regulation more sensible.

Alex notes that off-label drug uses are largely unregulated. No proof of efficacy is required, and off-label drug prescriptions bring a net health gain; see this paper. Yet to get a new drug approved it must go through, in addition to Phase I trials,

…Phase II and Phase III trials, which typically take years and focus on efficacy as well as safety. The long wait can cost lives and runs up new-drug costs–to an estimated $900 million per successful drug.

Tabarrok says this system makes little sense; the FDA demands costly, time-consuming efficacy tests for some uses and no tests for others. And while the FDA allows off-label prescribing by docs, it strictly limits the drugmakers’ promotion of such uses to doctors and permits none at all to patients.

Alex argues that FDA regulation ought to be reduced, making the regulation of new and old drugs more consistent. But that is not all:

Tabarrok and [Dan] Klein also offer some alternative proposals at One is to make all FDA testing optional. Drugs that didn’t go through the process would be labeled “Not FDA Approved.” Under this approach, they say, “the FDA would become a genuinely voluntary institution, much like Underwriters Laboratories.” Another idea is for the FDA to award letter grades, A to D, to claims made by drugmakers, much as it is considering doing for health claims for foods and dietary supplements. The FDA could still have its say, but wouldn’t be able to impose long delays, since a new drug could be marketed at first as “unrated.”

At the least, Tabarrok argues, the FDA should permit drug companies to sell any drug that has been approved by other sophisticated drug regulators, such as those in Canada, Australia or the European Union. Under such a system U.S. patients would get speedier access to new medicines without losing out on safety protection.

Kudos to Alex, the only sorrow is that the on-line version does not reproduce the excellent photo of him in the magazine. But you can see that at your local Borders.


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