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 : EC1096
Submitter : Ms. Judith Wolf Date & Time: 10/27/2005 12:10:42
Organization : Ms. Judith Wolf
Category : Individual Consumer
Issue Areas/Comments
1
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?
See general comment
GENERAL
GENERAL
I am responding to this issue with the "Morning After Pill" in mind. This drug should NOT be available OTC which would allow young people unaware of the consequences to obtain it. Minors would have the opportunity to access this drug without parental knowledge even when they are still living with parents/guardians who are responsible for their health. I STRONGLY OPPOSE THE SALE OF THIS PRODUCT OF THE BARR LAB TO BE SOLD WITHOUT A PRESCRIPTION!
Thank you for your attention to this critical health and moral matter.
Sincerely,
Judith Wolf