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 : EC785
Submitter : Mrs. Kathryn St Pierre Date & Time: 10/13/2005 08:10:18
Organization : Mrs. Kathryn St Pierre
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
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?
NO, it would be written and codify this duality such that it would be used for political purposes insteda of for the safety of a drug for the general public.
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
GENERAL
GENERAL
To Whom It May Concern,

I am writing in response to the FDA's request for public input on the "morning after" pill. I understand that the FDA is trying to decide whether to make this drug available as both an over the counter medication for one sector of the population as well as a prescription medication for another sector: girls of under 16 years of age.

This question makes clear that the Food and Drug Administration is not committed to ensuring the safety of the drugs it permits. If this drug is safe for one sector of the population to use without a doctor's oversight then it surely should be safe for anyone to use. An objection may be raised that the younger girls will not follow the instructions of the drug properly and thus bring harm to themselves if taking the drug without a doctor's oversight. I think that the same objection can be made regarding the older group of women. How many people innocently take more than the recommended doseage of pain reliever? A woman could easily think that "more is better" if they are afraid of being pregnant. The higher doses have clearly greater health risks and side effects thereby rendering the use of this drug extremely unsafe.

Also, the easy access of this drug would give women of all ages a false sense of security in their sexual activity. If women think that all they have to do is take this pill the morning after any incident of intercourse, they will undoubtedly increase their sexual activity. This will increase the number of times they take the drug which will again increase the risks and side effects. This could lead to not just women having increasing problems with the drug itself, but also increasing problems that come with intercourse itself: ie. sexually transmitted diseases.

I believe making this drug available as an over the counter medication is a grave mistake. It is clear that women's safety and health is compromised by this drug in the first place; increasing its availability makes that situation even more dangerous to women.

Sincerely,
Kathryn St Pierre