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 : EC614
Submitter : Mr. Kevin Doran Date & Time: 10/12/2005 06:10:47
Organization : Mr. Kevin Doran
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?
I am not sure if a rulemaking would be the appropriate decision or not. I would think that a clearly-stated interpretation of section 503(b) would be sufficient.
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 if a rulemaking would be the appropriate decision or not. I would think that a clearly-stated interpretation of section 503(b) would be sufficient.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I don't believe so. My interpretation is that a drug with the same active ingredient can be both prescription and OTC if used for different indications.

A drug cannot be both prescription and OTC for the SAME indication.
C. If so, would a rulemaking on this issue help dispet that confusion?
Some official documentation should be developed. But whether it should be a rulemaking or some other form of documentation should be left to the wisdom of the decision-making body.
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, the FDA would have no ability to enforce such a limitation.
B. If it could, would it be able to do so as practical matter and, if so, how?
Even if the FDA created such a law, it would be completely impractical to assume that the law would be complied with across the American population.

Such a lack of control of such a powerful and potentially dangerous drug may also create a trafficking problem across interantional political borders.
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?
Given your stated assumption, it would seem superfluous to market the prescription and OTC products differently if the drug is used for the same indication.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Given the lack of any practical enforcement of such a distinction, I cannot think of any reason why it would be innappropriate to market the two products in a single package.
GENERAL
GENERAL
I would encourage you to decide to NOT ALLOW PLAN B TO BECOME AVAILABLE AS AN OTC DRUG.

Assuming the scientific data are correct, it would be dangerous and harmful for this drug to be available to a subpopulation. No controls could be put into place to protect this subpopulation from the potentially damaging effects.

As a question: "what would be the point of making a drug both prescription and OTC for the same indication?" That would seem to be counterproductive and would ultimately cloud future pharmaceutical drug decisions.

In addition, data collected by Wendy Wright (chair of Concerned Women of America) shows the damaging effects to all of society by making such a drug available over the counter. There is no speculation in this matter. We can see the negative impacts due to other countries' decisions making this drug OTC.

Making Plan B available OTC will demote society and cause an unneccessary financial burden on our country. But most importantly, it is harmful to women and reduces their inherent dignity.