Regulation of oral chemotherapeutic products in the United States.

Although many countries have well-established mechanisms for regulation of drugs dispensed by prescription order, far less attention has been directed to control of drugs sold "over-the-counter" (OTC). Since most oral chemotherapeutic agents are OTC preparations, these drugs frequently escape critical review of their safety and efficacy by regulatory agencies. Although widespread use of these OTC preparations indicates that they are generally safe, their effectiveness is not established. In some cases (e.g., detergent pre-brush rinses), there is good evidence for lack of efficacy. In the US, two recent developments suggest that more rigorous scientific review and oversight of oral chemotherapeutic agents will occur. First, the US Food & Drug Administration has initiated a process to evaluate several OTC products which claim to be effective against plaque and gingivitis. A panel of experts has been convened to establish criteria by which these products will be judged and regulated. The agency has also publicly indicated its intention to interact more closely with the dental community in discharging its responsibility for ensuring drug safety and efficacy. Second, the American Dental Association, through its Council on Dental Therapeutics, is refining criteria for evaluating various types of chemotherapeutic agents. These criteria will be used to judge the efficacy and safety of agents voluntarily submitted for review to the Council by manufacturers. Both of these developments should improve the clinical utility of such agents and may provide models for regulatory agencies in other countries.