|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|
| 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.