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 : EC689
Submitter : Mrs. Pamela Al-Bawab Date & Time: 10/12/2005 06:10:07
Organization : Mrs. Pamela Al-Bawab
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
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 I don't believe a drug may be both prescription and over the counter based on uses by different subpopulations and whether the prescription and over the counter versions of the drug may be marketed in a single package.


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?
This question is a no brainer. One, the FDA does not have the people or resources to enforce these limitations. Two, any girl with a friend or sister over the age of 16 could buy this for the younger girl. How would you be able to ensure that didn't happen? I don't think you can.
B. If it could, would it be able to do so as practical matter and, if so, how?
If couldn't.
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. That would just make regulating it that much more difficult.
GENERAL
GENERAL
First I want to applaud your efforts to make this an open decision with input from the public. You say in your letter that "As an agency and as its Commissioner personally, I want to say that FDA remains committed to making safe and effective contraceptive products available to women and men who choose to use them." That's great, but also in your letter you say; "The FDA?s drug center, the Center for Drug Evaluation and Research or CDER, completed its review of this application, as amended, and has concluded that the available scientific data are sufficient to support the safe use of Plan B as an over the counter product, but only for women who are 17 years of age and older."

Do you honestly believe that the FDA would be able to watch every drug counter to make sure that no girl under the age of 17 gets their hands on this drug? I don't believe you can. I also don't believe you can police all the other girls buying this drug to make sure they don't give the drug to younger girls.

You can't make this drug available over the counter to anyone and make sure that it doesn't get in the hands of younger girls. Even as a prescription you can't ensure that no girl under the age of 17 gets their hands on it. But that's the best you can do.

Good luck with this decision. Our young women are in danger and I hope you stand to protect them by not allowing over the counter sale of this drug. Thank you for listening to my humble opinion.