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 : EC596
Submitter : Ms. Robin Johnson Date & Time: 10/12/2005 06:10:22
Organization : Ms. Robin Johnson
Category : Individual Consumer
Issue Areas/Comments
2
B. If it could, would it be able to do so as practical matter and, if so, how?
First of all, I can't believe you would allow this drug to be an OTC for anyone of any age. Secondly, I don't believe you will be able to keep it out of the hands of a 16 year old, anymore than we are able to keep alcohol, cigarettes and pornography out of the hands of our youth.

GENERAL
GENERAL
Greater access to Plan B does nothing to reduce surgical abortions according to a recent report she coauthored, which presents the findings of several studies on the topic. One of the studies from Scotland reported 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 revealed 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."