ADEQUACY OF FDA’S PRESCRIPTION CRITERIA IN PHYSICIAN EVALUATION OF PROPOSED SWITCHES OF DRUG PRODUCTS* TO OVER-THE-COUNTER SWITCH

Futurists have forecast that, by the turn of the century, a majority of today’spre-scription drugs will be switched to over-the-counter (OTC) status. Currently, the Food and Drug Administration (FDA) evaluates potential switch candidates primar-ily using safety, effectiveness, and labeling criteria. These criteria may not be ade-quate because of the reported mishaps associated with OTC drug use. The criteria implicitly assume that consumers understand and follow labeled directions. They also do not take into consideration whether or not the switched drug product will be beneficial to consumers or is really needed in the market. Need for verbal counseling and market need for the product are two additional criteria that may be necessary for evaluating potential switch candidates. Since switch evaluation committees are comprised mainly of physicians, this project surveyed a nation wide sample of pri-mary care and internal medicine physicians to assess on a drug-specific basis whether or not the existing FDA criteria are sufficient to evaluate potential switch candidates, and whether the two proposed criteria contribute to physicians’switch decision mak-ing process. A total of 197physicians participated in the study. Promethazine, rani