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 : EC578
Submitter : Ms. Richard Mauro Date & Time: 10/12/2005 06:10:10
Organization : Ms. Richard Mauro
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
Greater access to Plan B does nothing to reduce surgical abortions according to a recent report, 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.


GENERAL
GENERAL
Making Plan B over the counter would create numerous problems especially with regard to keeping it out of the hands of minors. "The FDA has no mechanism for enforcing a regulation that prohibits sale to minors," she said.