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 : EC2127
Submitter : Ms. t logan Date & Time: 10/31/2005 06:10:38
Organization : Ms. t logan
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?
birth control should be readily available without additional prescription costs to consumers. The only advantge to prescription would be savings through emlpoyee insurance benefits plans, which should necessarily require birth control to be included.
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?
yes, to ensure all women have equal, unrestricted and free choice access to birth control
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
apparently - it seems it is being used to advance a conservative religious agenda to impede or deny reproductive choice, which has no place in individual choice regarding health and family planning
C. If so, would a rulemaking on this issue help dispet that confusion?
yes, if it clarifies the right of every woman to elect birth control
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?
That serves no good purpose and will become a gauntlet of delay and discouragement obstacles, in a situation where time is of the essence in preventing unintended pregnancies.
B. If it could, would it be able to do so as practical matter and, if so, how?
I would suggest a receipt from the Gyn verifying a yearly exam and consult regarding the contraceptive product choice would be good for a year. RU 40 would be the exception as it is an emergency measure that should be available at all times.
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?
like Claritin and Dimetap and many others, yes
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
absent proof of anuual exam
GENERAL
GENERAL
government, get out of the controlling women's repoductive choices business;pharmaceutical companies will still make their profit on OTC so there is no acciptable reason to keep interfering