Journal of Dental Research, Vol 73, 704-708, Copyright © 1994 by International & American Associations for Dental Research Online Journals
Regulation of oral chemotherapeutic products in the United States
C. L. Trummel
Department of Periodontology, School of Dental Medicine, University of Connecticut Health Center, Farmington 06030.
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.
