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 : EC743
Submitter : Ms. Kenneth Prussner Date & Time: 10/13/2005 08:10:55
Organization : Ms. Kenneth Prussner
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Pardon me, before I comment on the issue, I want to comment on this 'docket management comment form.' As a consumer, I find this whole process to be very complicated. Can it not be simplified...at least for consumers. By the way, was this form made by the committee that made the camel?:) And, guess what...I worked 20 years in the US Government, many of them as a senior manager!

I am providing an overall response to this issue.

I think the key question is not how the 'morning after pill' should be marketed. The key issue is whether is should be marketed at all.

If it has any benefits, I believe they are very limited. Thus, they should be prescribed in a limited range of uses. Since I understand it as being a type of contraceptive, I am unaware that contraceptives are readily available and over also available over the counter.

This is my consumer's perspective. Thank you.