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 : EC814
Submitter : Ms. Carol Anne Tansingco Date & Time: 10/13/2005 10:10:37
Organization : Youth for the Family (Philippines)
Category : Individual Consumer
Issue Areas/Comments
Please do not grant over the counter approval of the drug Plan B. It works similar to the normal birth control pill by preventing ovulation. However, it also prevents the living embryo from implanting in the uterus if ovulation has already occured. This very clearly is abortifacient in nature and action, which is morally reprehensible and should never be allowed.

Greater access to Plan B does nothing to reduce surgical abortions One of the studies from Scotland, reported by Wendy Wright, executive vice president for Concerned Women for America, states that "in Glasgow , morning-after pill prescriptions increased 300 percent from 1992 to 1999. Yet, abortions did not decrease. In Lothian, where schools handed out condoms and sent pupils to clinics for morning-after pills, teenage pregnancies among 13 to 15- year-olds soared 10 percent in one year."

Research from the UK also reveals that over the counter access to Plan B "coincides with surges in STD rates. In areas where a limited program began in 1999 . . . chlamydia cases rose from 7,000 in 1999 to 10,000 cases in 2002. Gonorrhea cases climbed nearly 50 percent, to nearly 3,000 cases in 2002 . . . Abortions increased by nearly 6,000 in a one year period, jumping 3.2 percent in 2003 from 2002, with the largest leap among girls under the age of 16."

Making Plan B over the counter would likewise create numerous problems especially with regard to keeping it out of the hands of minors.

In this regard, we request you fervently not to grant OTC approval to Plan B.