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 : EC1151
Submitter : Mrs. Marybeth Hagan Date & Time: 10/27/2005 03:10:45
Organization : Mrs. Marybeth Hagan
Category : Drug Industry
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?
Language must clearly indicate that the active ingredient in the Morning After Pill should, under no circumstances, be sold OTC because of potential danger to teens who might purchase the MAP and use it without proper supervision.
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?
Same as above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There will be significant confusion, and possible health hazards, if the FDA is not clear in refusing to allow the Morning After Pill to be sold over the counter.
C. If so, would a rulemaking on this issue help dispet that confusion?
Clear ruling in refusing to allow the Morning After Pill to be sold over the counter can only be beneficial. If a woman wants this pill, she should be under a doctor's supervision, taking it.
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?
Yes
B. If it could, would it be able to do so as practical matter and, if so, how?
with proof of age ID.
3
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
None
GENERAL
GENERAL
In layman's terms -- please do not allow the Morning After Pill to be sold over the counter. Such a medication should be prescribed by a doctor so that the recipient of this drug is taking it properly, especially if that recipient is a young person.