Off-Label Use of Prescription Drugs should be Regulated by the FDA

Abstract

The FDA does not subject all uses of drugs to a rigorous approval process. There are many justifications given for this. I lay out a system that divides drug-indication sets into four categories: (1) FDA approved; (2) effective; (3) insufficient information; and (4) ineffective. Each category is treated differently so manufacturers have an incentive to get as many indications into the FDA approved category as possible. Physicians will be required to submit de-identified patient data and when prescribing drugs for indications that have insufficient data. They, or their patients, may not be reimbursed for that care unless it is part of a study. My system saves money, improves health care, and advances medical knowledge at the cost of decreased physician autonomy and possibly slightly higher regulatory cost to drug manufacturers.