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 : EC651
Submitter : Mrs. Mary Rapp Date & Time: 10/12/2005 06:10:46
Organization : Mrs. Mary Rapp
Category : Individual Consumer
Issue Areas/Comments
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
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?
Hopefully
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?
I doubt that it would be possible to enforce the "prescription-only" access to a drug, if that drug would also be available over the counter. Age would not be a deterrent. As we know, in our society of "me-first" mentality, youth can always find a willing person to provide the "forbidden" product. In the case of the morning after pill, not only will the young adult be at risk, as a result of access to this drug, but certainly another life is lost - the life of the defenseless, unborn child (in the case of a living embryo being prevented from implantation in the uterus). For this reason, I believe the "Morning After Pill" should be strictly regulated, ensuring that any youth , at very least, has recourse to information from a professional medical provider with regard to the risks to one's physical, psychological, emotional, and spiritual health.
B. If it could, would it be able to do so as practical matter and, if so, how?
No, I don't believe it would.
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 certainly would be inappropriate when children might obtain access.
GENERAL
GENERAL
I know our country prides itself on freedom. People have the freedom to make personal choices that don't affect others. In the case of the Morning After Pill, I believe those promoting its use are affecting others and undermining the fabric of our society by encouraging a Culture of Death. Allowing drugs which extinquish a human life is a reflection of the degradation of our society. Allowing them to be available over the counter, sends the message to our youth that "there is nothing harmful with this product". There is great harm that comes from using that product. Unfortunately, the human being who suffers the most irreversible harm is the innocent child killed by inability to implant in the mother's uterus.
According to Concerned Women for America's Wendy Wright, research from several studies shows that "Plan B" does nothing to reduce surgical abortions, and it coincides with surges in STD rates (research in UK). The FDA has no way of enforcing any regulations that it proclaims regarding prohibiting over the counter sales to minors. Please do your job and protect the youth of this country! The brainwashing of our young, to believe there is nothing wrong with taking the life of another person, has gone on long enough. Making the Morning After Pill unavailable over the counter draws a line in the sand and proclaims loud and clear that there is a definite need to consider closely the longterm effects of taking this drug.