|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 :||EC2158|
|Submitter :||Ms. Janet Donaghy||Date & Time:||10/31/2005 06:10:43|
|Organization :||Ms. Janet Donaghy|
|Category :||Individual Consumer|
| I am opposed to and outraged by the constant delays in permitting EC to be sold over the counter without a prescription.
EC is most effective (95%) if taken within 24 hours after unprotected sexual intercourse - when a condom breaks, birth control is not used, or if a sexual assault occurs. Forcing women to get a prescription before they can obtain Plan B is an unwise and unnecessary burden on all women, especially poor women who may not have access to a physician. Moreover, requiring a physician's prescription increases the total cost of EC dramatically.
The FDA's expert advisory panel recommended with a 23-4 vote that EC be made available over the counter without prescription almost two years ago. We cannot allow politics to interfere with women's health.