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 : EC960
Submitter : Ms. Nissa Thompson Date & Time: 10/27/2005 08:10:11
Organization : Ms. Nissa Thompson
Category : Academia
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?
Emergency contraception needs to become available over the counter immediately for the health and safety of all women in the United States! The constant delays to this initiative are sickening and evidence of a government that wishes to deny women control over their OWN BODIES.