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 : EC1000
Submitter : Ms. Alicia Matheny Date & Time: 10/27/2005 09:10:32
Organization : Ms. Alicia Matheny
Category : Individual Consumer
Issue Areas/Comments
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?
I think that the FDA should be able to approve the morning-after pill, also known as emergency contraception, without delay. The morning-after pill, if available without a prescription, would reduce the high number of unwanted pregnancies and resulting abortions in the United States. It would be an inconvenience to require a prescription for it, especially for poor women without access to a physician, and there are many poor women who suffer unwanted pregnancies in this country. Please consider this fact in your decision-making and vote yes on this. Thank you.
The morning-after pill, also known as emergency contraception, has been delayed long enough. Please consider this and release it for use without a prescription. Thank you.