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 : EC810
Submitter : Dr. Ronald Young Date & Time: 10/13/2005 10:10:09
Organization : Ob Gyn Associates
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?
No. Marketing Plan B as a prescription vs. OTC based on age has never been done in the past, and would be unfair to pharmacists and stores who decide to carry the medication. How could you possibly enforce such a plan.


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?
No
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes.
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 cannot enforce such a plan. It would not be practical to do such. You would only create a great confusion for stores who carry such a medication.
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?
The only way that it could be done is to make EVERY purchase require an I.D.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
When it is being used for any use not indicated - which would be impossible to determine.
GENERAL
GENERAL
Plan B has not been shown to be effective in reducing the number of abortions when it is placed OTC. The trials in this country and in other countries are clear on this point. They have actually shown that sexual activity increases. Even if this product is found to be "safe" for younger people, it doesn't mean it is right to make it OTC. Will we really be helping females? Or will we actually cause more harm? If a teenager is raped, this may promote her to take Plan B and not seek medical help. This could prevent her from getting treatment for an STD, thus causing future infertiltiy. Also, will we see an increase risk of cervical cancer because the poor may use Plan B as contraception, instead of going to get her pap smear in order to get a better contraceptive. Will we see an increase cost of medical care because of the irregular bleeding present when people use this as a contraceptive method instead of emergency contraception only. We all know that Plan B will not be used as marketed. Just because something is "safe" doesn't mean it is the best thing for the population. Thank you for the work you are doing.