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 : EC843
Submitter : Mrs. Joy Pace Date & Time: 10/13/2005 10:10:25
Organization : Mrs. Joy Pace
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?
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
C. If so, would a rulemaking on this issue help dispet that confusion?
3
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
GENERAL
GENERAL
Do not make Emergency Contraception available over the counter.

Girls are already taking their fertility and health in their own hands with STD's and other things. Without going to thte doctor's office they will risk trying to manage everything themselves - without their parents and without a doctor.

I just met two 17 year olds. Both have STD's. One has had a miscarriage and an ectopic pregnancy. Both did not go to their mothers with their
problems or with their health care difficulties. Both do not understand the medicine they are taking, how to take it, or what to look for in symptoms.

Both are not fully mature to make their health care decisions in such adult matters. And yet they are treated as adults, and THEIR BODIES and their HEALTH will bear the brunt of their undirected decisions.

A researcher overseas just verified that OTC EC does not translate into less abortions - but into more STDs.

Please, as a survivor of DES - please do not make more hormones available to people without going to a doctor for a thorough exam - I am LUCKY to have children now, and when Planned Parenthood put me on the pill, they did not even ask about my personal hormone history.

Do not make the drugs available over the counter.

It too complicated, and ultimately dangerous for women and girls not to seek professional help.

Please safe-guard women's health and keep ALL Emergency contraception available by prescription ONLY.

Thank you - Joy Pace

P.S. I hope that you are looking into the allegations that Planned Parenthood has a deal with Barr Pharmacuticals regarding EC. If those reports are true - please look in it! We don't want profits being put before women's health. Thanks!