Drug Approvals

Dr Henry Miller, ex of the FDA where he founded the agency’s Office of Biotechnology, had some thoughts on how to speed up vaccine approval procedures in his Wednesday op-ed. They’re good ideas; although many of them only niggle around the edges of a long-ish procedure.

I have an additional idea.

Allow doctors to broadly prescribe the vaccine—or any drug—once it’s been shown to be safe. Such drugs should be clearly marked, and the patient clearly advised, that while the vaccine has been shown to be safe, it hasn’t been shown to be effective.

This would vastly broaden the subject base for assessing effectiveness, and so greatly accelerate the assessments, and it would put what turns out to be effective drugs into the hands of doctors and patients much sooner.

Patients that get what turns out to be ineffective—but safe—vaccines will be no worse off than they would have been had no drug been permitted yet.

The market place should determine what should be available as effectiveness or ineffectiveness of particular vaccines becomes widely known rather than leaving the decision solely to government bureaucrats, no matter how well-intended they might be.