|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|
| 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.
| 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.