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 : EC924
Submitter : Mrs. Joan Soldano Date & Time: 10/27/2005 08:10:23
Organization : Mrs. Joan Soldano
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?
Docket: 2005N-0345; RFI # 0910-AF72: The "morning-after" pill should require a doctor's prescription. It should not be available as over-the- counter medication for any age group.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
Docket: 2005N-0345; RFI # 0910-AF72: The "morning-after" pill should require a doctor's prescription. It should not be available as over-the- counter medication for any age group.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
Docket: 2005N-0345; RFI # 0910-AF72: The "morning-after" pill should require a doctor's prescription. It should not be available as over-the- counter medication for any age group.
GENERAL
GENERAL
Docket: 2005N-0345; RFI # 0910-AF72: The "morning-after" pill should require a doctor's prescription. It should not be available as over-the- counter medication for any age group.