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 : EC908
Submitter : Mrs. Heather Thomas Date & Time: 10/18/2005 01:10:53
Organization : Mrs. Heather Thomas
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, It makes no sense. The plan B pill should not be available for over the counter purchase. It WILL be abused and could and will damage many lives.
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 would hope so. The age of 16 is very young and young people even 18 and under are not mature enough to make such a life changing
decision such as taking a drug like Plan B
B. If it could, would it be able to do so as practical matter and, if so, how?
Yes, on such an ethical issue as the abortion pill, mature adults have to guide and guard our young people from painful decisions on some drugs
GENERAL
GENERAL
I am against the Plan B drug. Espeially for OTC availability.