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 : EC1945
Submitter : Ms. Mellisa Julius Date & Time: 10/31/2005 04:10:18
Organization : Ms. Mellisa Julius
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 Food and Drug Administration should NOT approve the over-the-counter (OTC) sale of emergency contraception -it should stay under the control of a prescription. If a drug product is going to alter the hormonal status of a person, a prescription shold be required.
1.
C. If so, would a rulemaking on this issue help dispet that confusion?
We are all familiar with items that are sold only to purchasers over a certain age, including alcohol, tobacco, and the nicotine patch. Therefore it would be even easier to supply some sort of identification when picking up an emergency contraception prescription. It people complain about begin protected then they must have something to hide. It is contradicting to say that it is an invasion of privacy to ask someone to prove who they are by simply asking for an identifaction Limiting the sale of emergency contraception to young women is a good idea. Women need to grow up and take responsibility for their actions and their body. The FDA's job is to determine safety and efficacy, and by limiting the sale of emergency contraception to a prescription that is what they are doing.
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?
If it is over the counter then...it is over the counter and there shouldn't be any discrimination. If there is question as to who should be permitted to obtain the drug product, then it should be a prescriptio.
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?
If there is no difference is what is really being put into one's body, why should it matter what the package looks like?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If the ingredients in the drug is different or there are higher amounts in one than the other.
GENERAL
GENERAL
Some 39 nations have made emergency contraception available without prescription and 8 states in the U.S. have now adopted a process to streamline access of emergency contraception. Nations are fighting and killing their own people....should we? It goes with the old saying...if your friend jumps off a bridge are you going to? Women who are 16 and younger should not even have reason to need emergency contracption. What are we telling are young women...it is ok to use and abuse your bodies? Again...there is a lack of respect for oneself!