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 : EC634
Submitter : Ms. Beth Hill Date & Time: 10/12/2005 06:10:41
Organization : Ms. Beth Hill
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?
Yes ,guidelines need to be set when an ingredient can be in a prescription drug which a woman needs a doctor to write a prescription and an OTC anyone can buy.
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?
This is a very dangerous drug which can cause death.It shouldn't even be on the market. Unknowning teen age girls should not be allowed to just go up to a store and buy it without knowing the risks they are taking, possibly bleeding profusely,hemorraghing,and even death.
B. If it could, would it be able to do so as practical matter and, if so, how?
The FDA should only allow it to be PRESCRIBED by a doctor in a case or rape or incest.
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
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It should not be done,this drug has SERIOUS health risks,such as profuse bleeding, hemorraghing, even death.