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 : EC893
Submitter : Ms. Amy Bredes Date & Time: 10/17/2005 11:10:44
Organization : Ms. Amy Bredes
Category : Individual Consumer
Issue Areas/Comments
Plan B emergency contraception should be made available over the counter. It is vitally important to safeguard the physical and psychological health of women by preventing untimely pregnancies, particularly teen pregnancies. The U.S. is the richest nation on earth, and yet we still have the highest teen pregnancy rate in the western industrialized world. My daughters and millions of other girls and women need Plan B emergency contraception made easily available over the counter, and they need that accessibility now. Progestin has been proven safe and effective with minimal side effects. If its use were widespread, it is estimated that 3 million unplanned pregnancies and hundreds of thousands of abortions could be prevented annually. The pro-life Bush administration and every one concerned about womens health issues should support this potentially favorable outcome.
Thank you for considering my comments.
Amy Bredes