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 : EC1146
Submitter : Dr. meredith cassidy Date & Time: 10/27/2005 02:10:33
Organization : Dr. meredith cassidy
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?
I think that EC should remain a prescription medication for ALL women. I have had patients over age 17 in my OB and GYN practice who cannot follow simple instructions typed on a prescription and reviewed in an office setting. I have multiple patients who stop their antibiotic prescriptions or other prescriptions because of nausea. I have great concern about the potential for misuse and abuse of EC if available over the counter.
I think that if women/people want EC available--have Planned Parenthood distribute it from their centers. To me this is the most logical and will minimize the potential for abuse.