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 : EC1332
Submitter : Ms. Cheryl Monroe Date & Time: 10/28/2005 03:10:04
Organization : Ms. Cheryl Monroe
Category : Health Professional
Issue Areas/Comments
I am not a lawyer, and have no comment on the technicalities of the rules and laws. I am a health care professional, and a woman, and I do strongly believe that Emergency Contraceptive needs to be available to women over-the-counter. If it is safe and meets all the requirements, I do not understand why the FDA is having to "play politics" with our health in this matter. EC is NOT abortion, it is a method to help women avoid the agonizing decision faced with an unwanted pregnancy. I know, I had an abortion as a young woman. I would never counsel a woman on her choice. I know that I made the right choice for me at that time in my life, but it was not easy, and has not been easy to live with. If EC available over-the-counter can keep even one woman from facing that decision, it is worth it. Please make EC available over-the-counter to women in need.