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 : EC622
Submitter : Mrs. Margaret Tooley Date & Time: 10/12/2005 06:10:00
Organization : Mrs. Margaret Tooley
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?
The FDA should not simultaneously market an active ingredient in both prescription drug product and an OTC drug product.
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?
The FDA should not simultaneously market an active ingredient in both prescription drug product and an OTC drug product.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
yes
C. If so, would a rulemaking on this issue help dispet that confusion?
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?
No
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, there would need to be a distinction between the two for legal purposes.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
all
GENERAL
GENERAL
Allowing this pill to be sold OTC for people age 17 and up, opens the door wide open for men to buy this drug and give it (or force it upon) their "underage girlfriends"--otherwise know as statutory rape. Planned Parenthood and similar organizations already fail to report this crime in most, if not all, circumstances (despite the fact that they are required to do so by law). This will only give these predators more power to hide their crimes, and if there are any medical complications? --The girls' parents will be the last to know, yet they will be expected to pay the doctor/hospital bills!