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 : EC1354
Submitter : Ms. Deborah May Date & Time: 10/28/2005 03:10:13
Organization : Ms. Deborah May
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Some 39 nations have made emergency contraception available without prescription and 8 states in the U.S. have now adopted a process to streamline access of emergency contraception. The FDA's delay and ill-advised intention to restrict access to women 16 and younger is unacceptable and intolerable. Please make the decision to allow emergency contraception available to all women, all ages, and no restrictions.