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 : EC649
Submitter : Mrs. Jodi Wagner Date & Time: 10/12/2005 06:10:28
Organization : Mrs. Jodi Wagner
Category : Health Professional
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?
I am not sure.
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?
I am not sure.
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?
I am 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?
I do not think so. I especially do not think it would work with Plan B. Most of the males who are having sex with girls 16 and under are over 18 years old. They would figure out a way to get it and it would not be difficult.
B. If it could, would it be able to do so as practical matter and, if so, how?
No, I worked as a retail pharmacist for six years and I do not see how this would be feasible. We have enough drug diversion as it is with very heavily regulated drugs like narcotics.

Also, look at the example of alcohol and cigarettes. With all the precautions that are taken to make sure that minors do not to alcohol and cigarettes, they majority of people start smoking when they are minors and minors abuse alcohol in large numbers. If you make Plan B otc for girls 17 and older it will end up in the bodies of girls younger than that without a prescriber's supervision, without a doubt. The FDA doesn't have the funding or personnel to regulate this and the brunt of it will fall on pharmacists, store clerks, etc. and it would not be done effectively.
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?
Absolutely not. Otc packaging must have labeling that has complete adverse effects, drug interactions, dosage, etc. Prescription drugs do not have this labeling because it is prescribed under the care of a prescriber and the patient receives counseling from a pharmacist.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If one circumstance had less supervision by health care professionals.
GENERAL
GENERAL


I am particularly concerned about minor girls who are the victims of statutory rape or incest. Men would be able to easily access these drugs and repeatedly expose their victims to large amounts of hormones in order to cover up their crimes. Girls are already being coerced into abortions in order to cover up these crimes and now their bodies will be exposed to hormones, which may increase their risk of cancer later in life. People who work at abortion clinics are now being investigated in Kansas for covering up crimes of statutory rape. Pharmacists, store clerks, etc. may also help to cover up statutory rape if Plan B became a third class of drugs for girls under 16.

The benefits of this drug do not outweigh the risks. Plan B does not cure or treat a disease. Fertility is not a disease. It is unwise to make a hormone that may increase health risks widely availabe.