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 : EC1080
Submitter : Miss. Gwendolyn Rucker Date & Time: 10/27/2005 10:10:19
Organization : Miss. Gwendolyn Rucker
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. No drug should be both prescriptive & over the counter at the same time. The idea is a contradiction and dilutes the definition of both terms. Prescription drugs indicate caution is required. Over-the-counter items indicate public consumption. That is the mindset of the public and if you allow an item to be both prescriptive & over the counter, then people will automatically assume the lower degree of over the counter and assume it is for public consumption.
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. The only time this should be allowed is when the active ingredients harmful properties are made unharmful in the drug that is over the counter. If it can not be made unharmful for public consumption, then it should be prescriptive.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
yes. there is the confusion in terminology as to the ingredient (which is the raw drug) and the medicine (which is the compound drug). There needs to be clarfication as to when you are discussing the ingredient drug versus the medicine drug
C. If so, would a rulemaking on this issue help dispet that confusion?
not sure
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. You would wind up with the exact same issues we have with alcohol & cigarettes. Adults will purchase and give to underage people. With the issue of the Morning-After-Pill, you would additionally have the issue of Male Sexual Predators using it as an illegal and unknown to the women method of birth control.
B. If it could, would it be able to do so as practical matter and, if so, how?
I think cigarettes & alcohol are the items that society has done this with and what we have found out is that restricting certain types of items to adults only, only makes youth want it more and allows those who do not care about others to profit from the youth's desire (illegal drivers licenses, buying for minors if they pay you more). If you must do it, the way would be to follow the alcohol & cigarettes policy. You would need to have a commission to overseee it & then the police would have to periodically setup up sting operations at stores to make sure they are only selling the items to adults. The stores would have to have the items behind the counter & only certain people at the store would have access. More regulation & more money for something that could be simply regulated by making it a prescriptiononly item.
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?
Legally sold in the prescription package, but not in the OTC package. Selling it in the OTC package would remove all restrictions on the prescriptive ingredient.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Selling them in OTC packages would be inappropriate. That would essentially remove all restrictions on the prescriptive ingredient.
GENERAL
GENERAL
The Morning-After-Pill should never become an OTC item. First, it should never be distributed, but if we must distribute, as a prescription is the only way. If this drug has the power to abort a baby that has been conceived, it is too potent for public consumption. Public consumption of the Morning After Pill as an OTC opens the doors to allow not only women to use it as a birth control option, but men also. Public consumption of the Morning After Pill as an OTC would allow male sexual predators to purchase it and for those whose minds are already disturbed to rationalize that it is okay to take advantage of a women because they can give her the Morning After Pill and she will not be pregnant. Public consumption of the Morning After Pill as an OTC would cause an increase in rapes, and child molestation because it would allow those whose minds are disturbed enough to do those things to have a measure of protection. Public consumption of the Morning After Pill as an OTC would cause an increase in STD's in youth; because they often see the only consequences of having sex as getting pregnant - this would allow them to overlook the serious consequences of STD's. Public consumption of the Morning After Pill as an OTC would cause an increase in pregnancies in youth; because they would intend to take the Morning After Pill, but would forget to actually take it due to the immaturity and irresponsibleness of youth. Public consumption of the Morning After Pill as an OTC would ultimately cost society money to maintain the regulations, to monitor criminals, to provide for the children born to teenage mothers. While it may seem that Public consumption of the Morning After Pill as an OTC would be freeing women to take charge of their lives, it would actually be stunting the advance of women in society by opening the door for women to be even more taken advantage of by sexual predators, by allowing those females and males who are irresponsbile to maintain a level of irresponsibleness, by causing public funds to be spent to enforce the OTC law of underage ---- when restricting the item to prescription only would resolve all of these issues and would be less expensive for society.