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 : EC710
Submitter : Mrs. Naomi Devine Date & Time: 10/12/2005 06:10:04
Organization : Mrs. Naomi Devine
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?
If the products are identical and for identical uses, all should be regulated.
1.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes, there is confusion. It is hard to understand why a drug should be prescription for some and over the counter for others.
C. If so, would a rulemaking on this issue help dispet that confusion?
Perhaps.
2
B. If it could, would it be able to do so as practical matter and, if so, how?
No. In practicality, this type of restiction would be nearly impossible to enforce.
GENERAL
GENERAL
All other forms of birth control pills are available only by prescription. Why would this one be sold over the counter? It is dangerous and irresponsible of the FDA to allow a drug to be sold over the counter when the Agency has determined that it is unsafe for a large sub-population. Especially in this circumstance, where this sub-population would be highly interested in the drug. If this drug is unsafe for those under 17 -- it should not be sold over the counter at all.