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 : EC1011
Submitter : Ms. Kimberly Kerlin Date & Time: 10/27/2005 10:10:40
Organization : Ms. Kimberly Kerlin
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Please make 'Plan B' (Emergency Contraception) available OTC to women of all ages!!!
It's simple really. EC is simply a back-up plan contraception--it is NOT abortion. It's administration is very time sensitive as you know and taking the time to get a doctor's appointment, getting the prescription, then taking it to the pharmacy to get it filled is sometimes just too much to do in that 72 hour time period and then it's too late. At that point we have an unplanned (and often unwanted) pregnancy that will likely either result in one of the two horrible options: 1) Abortion or 2) an unwanted and often uncared-for child enters into the world. The research and statistics don't lie-- those are the children who are at-risk for MAJOR health problems (health problems that the FDA has the power to prevent) that cause a MUCH greater drain on our community--the picture: an often abused and neglected child who didn't get any pre-natal or pediatric health care in early years that grows into an adult w/ severe mental health problems and often becomes a burden on society in some way or another.

It all becomes very complicated AFTER the unplanned/unwanted pregnancy occurs as explained above. The SIMPLE part is this little decision that the FDA has the power to make--make EC available to ALL women of ALL ages OTC and PREVENT the above from occurring all over the country!!! What an incredible Public Health champion the FDA could be for America! Please make the decision, make it now, make EC available OTC!!!
Thank you for considering the potentially dire consequences a decision to not allow it OTC could have for years to come.