"Sophisticated Doctors" - another approach

Mark A. R. Kleiman suggests that doctors may often know more about a patient's needs and risks than the FDA.

Some know much more than others about pharmacology generally, or about a specific drug or class of drugs. While it makes sense to have a regulator in the middle to protect the less-knowledgeable from the persuasive powers of the drug companies, it make no sense to overrule the decisions of doctors and patients who may be as knowledgeable about a drug as the FDA regulators themselves, and are certainly more knowledgeable about the details of a particular case.

The SEC came up with a fix for the analogous problem in capital markets: the "sophisticated investor" rule. In the securities case, "sophistication" means no more than deep pockets and experience in high-risk investing. But in the case of drugs, why not craft categories of "sophisticated" doctors and patients who could, by passing examinations, win for themselves the right to prescribe, or to use, drugs not yet approved for marketing to the general public?

While decentralizing the individual prescription is great, I would have one concern.  An old saying goes, "To a man with a hammer, everything looks like a nail."   A doctor certified to prescribe a particular non-approved drug may opt for it in situations better suited to a competitor.

Another approach would be to certify pharmacists to dispense non-approved drugs on a doctor's request.  They, too, are professionals and keeping up with pharmacology  is even more a part of their job than a doctor's.

After basic testing for general safety, the FDA could issue a provisional approval that pharmacists would have to stay up on to remain certified.  That would allow the FDA apply even more rigorous testing for final approval without delaying availability, and could provide a larger statistical base for that testing.

I agree with Kleiman that the FDA is a great place to collect statistics and do testing, but giving them absolute authority for approval has questionable value.  This approach moves the prescription decision closer to the the patient's unique situation without resorting to drug by drug certification.