2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC771
Submitter : Dr. Christopher Gayle Date & Time: 10/13/2005 08:10:15
Organization : Dr. Christopher Gayle
Category : Health Professional
Issue Areas/Comments
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
As an Obstertrician / Gynecologist and a member of ACOG, I do not support ACOG's position on this issue. Contraceptives should not be dispensed without a prescription regardless of the form packaged. This would be a poor precident to set for the medical community. EC is not needed in this country. There are plenty of options to prevent pregnancy if one takes the responsibility to do so. EC and abortion are not contraceptive choices, they are corrective choices for poor judgement and risk taking.