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 : EC1915
Submitter : Ms. Andrea Lynch Date & Time: 10/31/2005 04:10:12
Organization : Ms. Andrea Lynch
Category : Individual Consumer
Issue Areas/Comments
I am dismayed by the FDA?s continued refusal to approve Plan B for over-the-counter use. It should be approved for over-the-counter use without any age restrictions or further delay. Plan B is a safe, effective, common-sense solution to preventing unintended pregnancies and reducing the need for abortions. Denying timely access to back-up birth control does a grave disservice to American women.

There is overwhelming support for over-the-counter Plan B for women of all ages. The FDA?s own expert advisory panels and staff, along with more than 70 leading medical and public health organizations (including the American Medical Association and the American Academy of Pediatrics), recommend the approval of over-the-counter sales of Plan B without any restrictions. These doctors and scientists understand that denying young women ready access to emergency contraception puts them at unnecessary risk for unintended pregnancies. The proposed rulemaking is just another delay tactic, which the FDA should abandon. The FDA should approve over-the-counter access to Plan B for women of all ages.