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 : EC917
Submitter : Ms. Janet Engstrom Date & Time: 10/27/2005 08:10:34
Organization : Ms. Janet Engstrom
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I support the unrestricted sale of emergency contraception as an "over-the-counter" product. The safety and effectiveness of this product have been studied extensively. The consumer's ability to use the product correctly if it were offered over-the-counter has also been studied and these studies demonstrate that consumers can use the product correctly and safely, and that they don't "over-use" the product.

The availability of this product over-the-counter is an important step in protecting women's health. Currently, many women are unable to obtain a prescription for the product because they can not get an appointment with a health care provider quickly enough to get a prescription. And, in some parts of the country, women are being denied this product even when they have a prescription.

By removing the requirement of a prescription, women should have greater access to a product that can prevent an untimely pregnancy. This is particularly important for the most vulnerable of women -- women who don't have access to a care provider or access to pharmacist that will dispense the product.