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 : EC929
Submitter : Mrs. Heather Ipema Date & Time: 10/27/2005 08:10:38
Organization : Mrs. Heather Ipema
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?
NO
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?
NO
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
NO
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, I believe that if Plan B was only available by prescription to women under age 16 it would protect them from the dangers of taking this drug without a doctor's approval and knowledge.
B. If it could, would it be able to do so as practical matter and, if so, how?
This can definitely be enforced by requiring identification before purchase and training doctors and pharmacists about the regulations. By monitoring individual pharmacy's records the FDA will know how old patients were who purchased the drug, and can enforce any illegal dispensation.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in
the same package?
No, the packaging should be different to prevent confusion and medication errors.
GENERAL
GENERAL
I believe Plan B should NOT be available over the counter under any circumstances. This is a serious drug, with a serious side effect profile as well as many moral and ethical issues surrounding its use. OTC status of Plan B might not be shown to increase use or adverse events, but its approval will be a controversial move by the FDA and only prove how powerful one lobby group is compared to another. If this administration chooses to approve this OTC switch I believe the public will lose even more respect and trust in our nation's drug supply and regulation.